# K992140: Piccolo Metlyte 7 Reagent Disc

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Aug 26, 1999 after 63 days
- Product code: JLB (Atp And Creatine Kinase (Enzymatic), Creatine)
- Device class: 1
- Regulation: 21 CFR 862.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830805 (1983). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830805: Knai Sodium Potassium Analyzer, Radiometer America, Inc. (1983) Summary page 3.
- K834502: CK-Nac Reagent, Roche Diagnostic Systems, Inc. (1984) Summary page 3.
- K844987: Roche Reagents Reagent for CO2, Roche Diagnostic Systems, Inc. (1985) Summary page 3.

## Most influential descendants
- K200865: Piccolo Potassium Test System (2021), 0 descendants of its own

## Recalls of this device
- Apr 21, 2008 · Not classified · Z-2287-2008: 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: The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples

## Indications for use
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.

Source page: https://510kreport.com/device/K992140
Methodology: https://510kreport.com/methodology