# K171971: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Lite-On Technology Corp. H.S.P.B.
- Decided: Jan 25, 2018 after 209 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942782 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K942782: Piccolo (TM), Abaxis, Inc. (1995) Summary page 5.
- K950164: Piccolo (TM) Primary Health Panel Reagent Rotor, Abaxis, Inc. (1995) Summary page 5.

## Most influential descendants
- K251074: Tru Liver Health Test Panel (2025), 0 descendants of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own

## Indications for use
The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. - Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. - Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. - Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. - Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. - Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

Source page: https://510kreport.com/device/K171971
Methodology: https://510kreport.com/methodology