# K091742: Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 14, 2009 after 59 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SYNCHRON Systems Creatinine (CR-S) Reagent: named in the summary without a submission number

## Most influential descendants
- K093458: Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298 (2009), 0 descendants of its own

## Recalls of this device
- Aug 15, 2019 · Class II · Z-1422-2020: It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to

## Indications for use
CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E9 concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX PRO Systems). 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.

Source page: https://510kreport.com/device/K091742
Methodology: https://510kreport.com/methodology