# K073634: Multigent Creatinine (Enzymatic) Assay

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Jun 19, 2008 after 176 days
- Product code: JFY (Enzymatic Method, 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 K003261 (2000). 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)
- K003261: Creatinine Plus, Roche Diagnostics Corp. (2000) Summary page 2.

## Recalls of this device
- May 22, 2017 · Class II · Z-2867-2017: Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

## Indications for use
The MULTIGENT Creatinine (Enzymatic) assay is a device intended to measure creatinine levels in human serum, plasma, and urine using the ARCHITECT c8000 System and the AEROSET System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis,, and as a component of various calculations for determination or estimation of creatinine clearance, glomerular filtration rate (GFR) or estimated GFR (eGFR).

Source page: https://510kreport.com/device/K073634
Methodology: https://510kreport.com/methodology