# K983070: CK

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 16, 1999 after 167 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K782156 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K782156: Unitest Creatine Kinase, Boehringer Mannheim Corp. (1979) Summary page 2.

## Recalls of this device
- Jul 18, 2018 · Class II · Z-1075-2019: The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- Jul 18, 2018 · Class II · Z-1076-2019: The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- Oct 12, 2007 · Not classified · Z-1109-2008: Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate res

## Indications for use
The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K983070
Methodology: https://510kreport.com/methodology