# K973696: Synchron System Hemoglobin Alc Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Nov 24, 1997 after 59 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934070 (1994). 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)
- K934070: Tina-Quant Hemoglobin A1C, Boehringer Mannheim Corp. (1994) Summary page 1.

## Recalls of this device
- Aug 18, 2003 · Not classified · Z-1156-04: Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
- Aug 15, 2003 · Not classified · Z-1155-04: LDL Cholesterol component in controls are unstable.

## Indications for use
The SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Kit, in conjunction with SYNCHRON HbA1c Calibrators and SYNCHRON HbA1c Hemolyzing Reagent, is intended for the quantitative determination of Hemoglobin Alc concentrations in whole blood on SYNCHRON Clinical Systems.

Source page: https://510kreport.com/device/K973696
Methodology: https://510kreport.com/methodology