# K971505: Synchron Systems Cholesterol (Chol) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jun 11, 1997 after 47 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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: 2 generations back to K883181 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934046: Beckman Cholesterol Reagent, Beckman-Diagnostic Systems Group (1993) Summary page 2.
- K881498: Synchron CX (TM)4 Clinical Analyzer, Beckman Instruments, Inc. (1988) Summary page 2.
- K881495: Synchron CX (TM)5 Clinical Analyzer, Beckman Instruments, Inc. (1988) Summary page 2.
- K926060: Synchron CX5CE Clinical Analyzer, Beckman Instruments, Inc. (1993) Summary page 2.
- K904220: Synchron CX4-CE, Beckman (1990) Summary page 2.
- K904219: Synchron CX 7 Clinical Analyzer, Beckman (1990) Summary page 2.
- K950958: Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta), Beckman Instruments, Inc. (1995) Summary page 2.
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L, Beckman Instruments, Inc. (1997) Summary page 2.

## Recalls of this device
- Nov 10, 2021 · Class II · Z-0399-2022: Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown partic

## Indications for use
The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

Source page: https://510kreport.com/device/K971505
Methodology: https://510kreport.com/methodology