510(k) · Cleared
Recalled · 2008Piccolo Metlyte 7 Reagent Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · JLB Atp And Creatine Kinase (Enzymatic), Creatine
Cleared on Aug 26, 1999 as substantially equivalent to K830805 (Radiometer America, Inc., 1983) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 26, 1999
- Review
- 63 days
- Class
- Class I
- Product code
- JLB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K830805 (1983). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K200865Piccolo Potassium Test SystemAbaxis, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830805 | Knai Sodium Potassium Analyzer | Radiometer America, Inc. | 1983 | — |
| 0 (this device) | K992140 | Piccolo Metlyte 7 Reagent Disc | Abaxis, Inc. | 1999 | — |
| +1 | K200865 | Piccolo Potassium Test System | Abaxis, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 JLB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K830805 | Knai Sodium Potassium AnalyzerSummary page 3…ich Abaxis claims equivalence: Subject Device Predicate Device B Predicate | Manufacturer 510(k) Number | Date of SE Device , | Determination Piccolo® KNA™2 Radiometer K830805 4/8/83 Potassium Test Sodium- America, Inc. System Potassium Analyzer Piccolo Creatine | Roche Roche CK: K834502 | 2/27/84 Kinas… | 1983 |
| * | K834502 | CK-Nac ReagentSummary page 3…SE Device , | Determination Piccolo® KNA™2 Radiometer K830805 4/8/83 Potassium Test Sodium- America, Inc. System Potassium Analyzer Piccolo Creatine | Roche Roche CK: K834502 | 2/27/84 Kinase and Total | Reagents Diagnostic CO, K844987 Carbon Dioxide for carbon | Systems, Inc. 1/18/85 Test System dioxid… | 1984 |
| * | K844987 | Roche Reagents Reagent for CO2Summary page 3…05 4/8/83 Potassium Test Sodium- America, Inc. System Potassium Analyzer Piccolo Creatine | Roche Roche CK: K834502 | 2/27/84 Kinase and Total | Reagents Diagnostic CO, K844987 Carbon Dioxide for carbon | Systems, Inc. 1/18/85 Test System dioxide and creatine kinase on the COBAS FARA™ Chemistry Syst… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200865 | Piccolo Potassium Test System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2008 | Not classified | Z-2287-2008 | Process control | The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples |
| Apr 21, 2008 | Not classified | Z-2286-2008 | Process control | The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K200865 (Abaxis, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JLB devicesJLB Atp And Creatine Kinase (Enzymatic), Creatine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLB
FDA has decided no JLB device since 2007.
Median 510(k) review, days · JLB
Too few JLB 510(k)s in any year since 2007 to give a median.
Recalls per year · JLB
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLB
2in 2020
MAUDE reports naming product code JLB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 50 |
| 2012 | 0 | — | 0 | 73 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism…
Read the full statement (291 words)
Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass.
Creatinine The creatinine assay is used for the quantitation of creatinine in human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.
Glucose The glucose assay is used for the quantitation of glucose in human heparinized whole blood, heparinized plasma, or serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including adult and juvenile diabetes mellitus and hypoglycemia.
Potassium The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
Total Carbon Dioxide The total carbon dioxide assay is used for the quantitation of total carbon dioxide in human heparinized whole blood, heparinized plasma, or serum. Total carbon dioxide measurements are used in the diagnosis and treatment of primary MetlLyte 7 alkalosis and acidosis and primary respiratory alkalosis and acidosis.
Urea Nitrogen The urea nitrogen assay is used for the quantitation of urea nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992140: Piccolo Metlyte 7 Reagent Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992140
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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