# K972609: Variant Express Glycohemoglobin Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 6, 1997 after 26 days
- Product code: LCQ (Fluorescent Immunoassay Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895661 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941616: Variant Total GHB Program, Bio-Rad (1995) Summary page 1.
- K895661: Glycotest II Glyhb Assay Kit, Pierce Chemical Co. (1989) Summary page 1.

## Indications for use
The VARIANT Express Glycohemoglobin Program is intended for the separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).

Source page: https://510kreport.com/device/K972609
Methodology: https://510kreport.com/methodology