# K102914: TQ HBA1C GEN3

- Pathway: 510(k) (Special)
- Applicant: Roche
- Decided: Jan 20, 2011 after 111 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934070 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072714: Tina-Quant Hemoglobin A1C Gen.2 Test System, Roche Diagnostics Corp. (2008) Summary page 1.

## Indications for use
The Tina-Quant Hemoglobin A Ic Gen. test is in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 800 analyzers for the quantitative determination of mmol/mol hemoglobin Alc (IFCC) and %hemoglobin Alc ((DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry analyzers. HbA I c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K102914
Methodology: https://510kreport.com/methodology