# K981799: CREA

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 22, 1998 after 62 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812095 (1981). 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)
- K812095: Enxymatic Creatinine Test, Boehringer Mannheim Corp. (1981) Summary page 1.

## Recalls of this device
- Jul 27, 2004 · Not classified · Z-1377-04: Precipitate formed in product.

## Indications for use
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Source page: https://510kreport.com/device/K981799
Methodology: https://510kreport.com/methodology