510(k) Report

510(k) · Cleared

Cleared

Avl Opti Critical Care Analyzer

K974784510(k) TraditionalCleared Feb 24, 199864-day reviewClass II21 CFR 862.1600

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Avl Scientific Corp. · CEM Electrode, Ion Specific, Potassium

Cleared on Feb 24, 1998 as substantially equivalent to K874832 (Nova Biomedical Corp., 1988) and 9 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1986. 5 later devices descend from it.

Decided
Feb 24, 1998
Review
64 days
Class
Class II
Product code
CEM
Recalls
None
Predicates
10

Its longest line of descent runs back 3 generations to K861087 (1986). 15 ancestors in all, the oldest K823480 (1983). 5 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 3 other ancestors1994: 3 other ancestors1990: 1 other ancestor1988: 1 other ancestor1983: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor2005: 1 descendant cleared1999: 1 descendant cleared1998: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant clearedK861087 · Avl Model 983 Electrolyte Analyzer · Avl Scientific Corp. · 1986K961458 · Avl 9180 Electrolyte Analyzer · Avl Scientific Corp. · 1996 · recalledK972673 · Avl 9181 Electrolyte Analyzer · Avl Scientific Corp. · 1997 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K972673 · Avl 9181 Electrolyte Analyzer · Avl Scientific Corp. · 1997 · recalledK961458 · Avl 9180 Electrolyte Analyzer · Avl Scientific Corp. · 1996 · recalledK861087 · Avl Model 983 Electrolyte Analyzer · Avl Scientific Corp. · 19860
  1. Root · 3 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
  2. 2 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
  3. 1 generation backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
  4. This deviceK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  5. Descendant · cites it directly · 4 of its ownK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  6. Descendant · cites it directly · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
  7. Descendant · 2 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
  8. Descendant · 3 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
  9. Descendant · cites it directly · 0 of its ownK052027 Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 2005 · Recalled

Most influential descendants

Showing 5 of 5 · See all
  • K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly4descendants
  • K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
  • K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 2 generations on1descendant
  • K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 3 generations on0descendants
  • K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K861087Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp.1986—
−2K961458Avl 9180 Electrolyte AnalyzerAvl Scientific Corp.19961
−1K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp.19977
0 (this device)K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.1998—
+1K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.1998—
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.1999—
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.2013—
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.2021—
+1K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.20054

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198610
198710
198810
199010
199430
199530
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200510
201310
202110
FIG. 1 — Lineage of K974784, 1986–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CEM device

  1. #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K874832Nova Stat Profile 5 Analyzer + Quality Control
Summary page 1
…n function, safety and efficacy to a number of currently marketed devices known as 'Combi Analyzers' and "Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrol…
Nova Biomedical Corp.1988—
*K946206Ciba Corning 8-- Series CO-Oximeter
Summary page 1
…efficacy to a number of currently marketed devices known as 'Combi Analyzers' and "Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as…
Ciba Corning Diagnostics Corp.1995—
*K895317Avl Model 995HB PH/Blood Gas Analyzer
Summary page 1
…er of currently marketed devices known as 'Combi Analyzers' and "Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] a…
Avl Scientific Corp.1990—
*K954482Sendx 100 PH, Blood Gas & Electrolyte Analysis System
Summary page 1
…ted devices known as 'Combi Analyzers' and "Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Phot…
Cirrus Medical,Inc.1995—
*K945240Irma Blood Analysis System
Summary page 1
…i Analyzers' and "Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI…
Diametrics Medical, Inc.19954
*K940918I-Stat 200 Portable Clinical Analyzer
Summary page 1
…nt of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyz…
I-Stat Corp.199419
*K972673Avl 9181 Electrolyte Analyzer
Our OCR of the scanned summary read K972763, FDA’s number for Hemaprompt (Aerscher Diagnostics). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AVL 9181”.
Avl Scientific Corp.19977
*K823480IL 943 Flame Photometer
Summary page 1
…995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089 and K961161]. (4) Descr…
Instrumentation Laboratory CO1983—
*K944089Avl Opti PH/Blood Gas Analyzer
Summary page 1
…analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089 and K961161]. (4) Description of the new device The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], i…
Avl Scientific Corp.1994—
*K961161Avl Opti 1 PH/Blood Gas Analyzer
Summary page 1
…ch as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089 and K961161]. (4) Description of the new device The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument us…
Avl Scientific Corp.1996—

Also cleared against K874832: 2 other devices →

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984
K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992
K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.20050

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
  • 4 of the 15 ancestors have a recall of any class.
  • Of its descendants, K984299 (Avl Scientific Corp., 1998) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K874832.

How does its category compare?

All CEM devices

CEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEM

1in 2025

2007: 12009: 12010: 32011: 32012: 42020: 12023: 22025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEM

180in 2012

2010: 195 days median2011: 74 days median2012: 180 days median
2007high 195 (2010) · low 74 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CEM

4in 2025

2008: 12010: 122011: 62016: 12019: 12020: 32021: 12023: 22025: 4
2007high 12 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CEM

29in 2025

2007: 662008: 2452009: 792010: 1132011: 1262012: 452013: 372014: 42015: 72016: 62017: 322018: 132019: 252020: 272021: 182022: 162023: 302024: 422025: 29
2007high 245 (2008) · low 4 (2014)2025

MAUDE reports naming product code CEM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—066
20080—1245
20091—079
2010319512113
20113746126
20124180045
20130—037
20140—04
20150—07
20160—16
20170—032
20180—013
20190—125
20201—327
20210—118
20220—016
20232—230
20240—042
20251—429
20261—0—

What is it indicated for?

The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO,, PO,, ctHb, SO,, Na" and K" in whole blood, serum and plasma as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results. pH The pH value of the blood may be the single most…

Read the full statement (1,405 words)

The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO,, PO,, ctHb, SO,, Na" and K" in whole blood, serum and plasma as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

pH

The pH value of the blood may be the single most valuable factor in the evaluation of the acid-base status of a patient. The pH value is an indicator of the balance between the buffer (blood), renal (kidney) and respiratory (lung) systems, and one of the most tightly controlled parameters in the body. The causes of abnormal blood pH values are generally classified as:

primary bicarbonate deficit ~ metabolic acidosis

primary bicarbonate excess ~ metabolic alkalosis

primary hypoventilation respiratory acidosis

primary hyperventilation respiratory alkalosis

An increase in blood, serum or plasma pH (alkalemia) may be due to increased plasma bicarbonate, or a feature of respiratory alkalosis due to an increased elimination of CO, due to hyperventilation.

A decrease of pH value (acidemia) in blood, serum or plasma may occur due to an increased formation of organic acids, an increased excretion of H'-ions in certain renal disorders, an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids. Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute, as the result of pulmonary edema, airway obstruction or medication, or may be chronic, as the result of obstructive or restrictive respiratory diseases.

The composition of serous body fluids: pleural, pericardial, ascitic and cerebrospinal fluid, is similar to serum and plasma in electrolyte content and pH. The AVL OPTI may be used for the analysis of these fluids, limited to a pH in the range between 6.8 and 7.7, as long as care is taken to ensure the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport in the cassette.

Pleural fluid

The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Patients with pneumonia may develop effusions when the infectious process extends to the visceral pleura, causing exudation of fluid into the pleural space. Fluids are divided into potentially benign and complicated effusions on the basis of pH. Fluids with a pH greater than 7.30 resolve spontaneously, whereas a pH less than 7.20 is an indication of tube drainage.

The PCO, value of arterial blood is used to assess how well the body eliminates carbon dioxide in relation to the metabolic rate of CO, production.

An arterial PCO, below the normal range is termed respiratory alkalosis and indicates hypocapnia, a condition caused by increased alveolar ventilation such as hyperventilation. An arterial PCO, above the normal range is termed respiratory acidosis and indicates hypercapnia, a sign of hypoventilation and failure, resulting from cardiac arrest, chronic obstructive lung disease, drug overdose, or chronic metabolic acid-base disturbances.

The PO, value of arterial blood has become the primary tool for the evaluation of arterial oxygenation status. Values below the normal arterial PO, (arterial hypoxemia) are usually caused by pulmonary, circulatory, or respiratory abnormalities (e.g. bronchial obstruction, vascular problems, decrease in cardiac output, increased oxygen demand, anatomical heart defect, low inspired O, content). Generally, PO, levels above 100 mmHg do not contribute significantly to the oxygen content since, with normal hemoglobin concentrations, 80 - 100 mmHg, PO, provides a 97 % saturation level, and a level greater than 100 % cannot be achieved.

Sodium

Sodium is the major cation of extracellular fluid. Its primary functions in the body are to chemically maintain osmotic pressure and acid-base balance and to transmit nerve impulses. Sodium functions at the cell membrane level by creating an electrical potential between different cell membranes causing the transmission of nerve impulses and neuromuscular excitability to be maintained. Sodium is involved in some enzyme catalyzed reactions as a cofactor. The body has a strong tendency to maintain a total base content, and only slight changes are found even under pathologic conditions.

Low sodium values, hyponatremia, usually reflect a relative excess of body water rather than a low total body sodium. Reduced sodium levels may be associated with: low sodium intake; sodium losses due to vomiting or diarrhea with adequate water and inadequate salt replacement, diuretics abuse, or salt-losing nephropathy; osmotic diuresis, metabolic acidosis; adreocortical insufficiency; congenital adrenal hyperplasia; dilution type due to edema, cardiac failure, hepatic failure; and hypothyroidism.

Elevated sodium values, hypernatremia, are associated with conditions with water loss in excess of salt loss through profuse sweating, prolonged hyperpnea, severe vomiting or diarrhea, diabetes insipidus or diabetic acidosis; increased renal sodium conservation in hyperaldosteronism, Cushing's syndrome; inadequate water intake because of coma or hypothalamic diseases; dehydration; or excessive saline therapy.

The sodium value obtained may be used in the diagnosis or monitoring of disturbances of the water balance; infusion therapies; vomiting, diarrhea, burns, heart and kidney insufficiencies, central or renal diabetes insipidus, endocrine disturbances and primary or secondary cortex insufficiency of the adrenal gland or other diseases involving electrolyte imbalance.

Potassium

Potassium is the major cation in the intracellular fluid and functions as the primary buffer within the cell itself. Ninety percent of potassium is concentrated within the cell, and damaged cells release potassium into the blood. Potassium plays an important role in nerve conduction, muscle function, and helps maintain acid-base balance and osmotic pressure.

Elevated potassium levels, hyperkalemia, can be found in oligouria, anemia, urinary obstruction, renal failure due to nephritis or shock, metabolic or respiratory acidosis, renal tubular acidosis with the K'/H" exchange and hemolysis of the blood. Low potassium levels, hypokalemia, can be found in excessive loss of potassium through diarrhea or vomiting, inadequate intake of potassium, malabsorption, severe burns and increased secretion of aldosterone. High or low potassium levels may cause changes in muscle irritability, respiration and myocardial function.

The potassium value obtained may be used to monitor electrolyte imbalance in the diagnosis and treatment of infusion therapies, shock, heart or circulatory insufficiency, acid-base imbalance, therapy with diuretics, all kinds of kidney problems, diarrhea and hyper- and hypo-function of adrenal cortex and other diseases involving electrolyte imbalance.

total Hemoglobin concentration (ctHb)

The hemoglobin is the main component of erythrocytes. It serves as the vehicle for transportation of oxygen within the bloodstream and each gram/dL of hemoglobin can carry 1.39 mL of oxygen. The oxygen combining capacity of the blood is directly proportional to the hemoglobin concentration rather than to the number of red blood cells (RBC), because some red cells contain more hemoglobin than the others.

Although oxygen transport is the main function of hemoglobin, it also serves as an important buffer in the extracellular fluid. Decreases in the amount of hemoglobin can come about as a result of a decreased concentration of hemoglobin in the erythrocytes, or a decreased number of erythrocytes that contain a normal concentration of hemoglobin.

Decreased levels are found in anemia states, hyperthyroidism, severe hemorrhage and hemolytic reactions due to transfusions of incompatible blood, reaction to chemical, infectious and physical agents as well as various systemic diseases. Increased levels are found in hemoconcentration of the blood, chronic obstructive pulmonary disease and congestive heart failure.

ctHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data.

ctHb is used to screen for disease associated with anemia, to determine the severity of anemia, to follow the response to treatment for anemia and to evaluate polycythemia.

Oxygen Saturation (SO,;%)

When each heme group of the hemoglobin molecule is associated with one molecule of oxygen, the hemoglobin is referred to as oxyhemoglobin (O,Hb). The amount of oxyhemoglobin, expressed as a fraction of the total available hemoglobin is termed, hemoglobin oxygen saturation (SO,). The largest portion (about 98%) of blood oxygen content is the oxygen bound to hemoglobin. The reference interval for arterial blood from healthy adults is typically 94 to 98%. Decrease in SO, below the critical level necessary for tissue oxygen saturation is a grave clinical situation. Low oxygen saturation may be caused by many of the same factors responsible for arterial hypoxemia, as well as from unusually large amounts of non-functional hemoglobins, high concentrations of deoxyhemoglobin, chemically altered hemoglobin or factors affecting the affinity of hemoglobin for oxygen, including: temperature, pH, PCO2, 2,3-DPG concentration and type of hemoglobin.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K974784: Avl Opti Critical Care Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974784

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026