# K991109: Creatinine Reagent, Product NO CR105-01, Creatinine Reagent, Product NO CR105-02

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: May 25, 1999 after 54 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The creatinine reagents: Alkaline Diluent (R1), product No. CA105-01 and Picric Acid (R2), product No. CA105-02 are intended for in vitro diagnostic use in the automated, quantitative determination of creatinine in serum, plasma and urine.

Source page: https://510kreport.com/device/K991109
Methodology: https://510kreport.com/methodology