# K974784: Avl Opti Critical Care Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Feb 24, 1998 after 64 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861087 (1986). 15 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874832: Nova Stat Profile 5 Analyzer + Quality Control, Nova Biomedical Corp. (1988) Summary page 1.
- K946206: Ciba Corning 8-- Series CO-Oximeter, Ciba Corning Diagnostics Corp. (1995) Summary page 1.
- K895317: Avl Model 995HB PH/Blood Gas Analyzer, Avl Scientific Corp. (1990) Summary page 1.
- K954482: Sendx 100 PH, Blood Gas & Electrolyte Analysis System, Cirrus Medical,Inc. (1995) Summary page 1.
- K945240: Irma Blood Analysis System, Diametrics Medical, Inc. (1995) Summary page 1.
- K940918: I-Stat 200 Portable Clinical Analyzer, I-Stat Corp. (1994) Summary page 1.
- K972673: Avl 9181 Electrolyte Analyzer, Avl Scientific Corp. (1997). 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”.
- K823480: IL 943 Flame Photometer, Instrumentation Laboratory CO (1983) Summary page 1.
- K944089: Avl Opti PH/Blood Gas Analyzer, Avl Scientific Corp. (1994) Summary page 1.
- K961161: Avl Opti 1 PH/Blood Gas Analyzer, Avl Scientific Corp. (1996) Summary page 1.

## Most influential descendants
- K984299: Avl Opti Critical Care Analyzer (1998), 4 descendants of its own
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own
- K131126: Opti Cca-TS2 (2013), 1 descendant of its own
- K200986: OPTI® B-Lac Cassette (2021), 0 descendants of its own
- K052027: Opti Lion Electrolyte Analyzer, Model GD7200 (2005), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K974784
Methodology: https://510kreport.com/methodology