# K052464: Tina-Quant Hemoglobin A1C Gen.2 Test

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 30, 2005 after 22 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: 1 generation back to K934070 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K072714: Tina-Quant Hemoglobin A1C Gen.2 Test System (2008), 2 descendants of its own
- K110313: Tina-Quant HBA1C Gen.2 (2011), 0 descendants of its own
- K102914: TQ HBA1C GEN3 (2011), 0 descendants of its own

## Indications for use
The Tina-Quant Hemoglobin A1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin A1c in whole blood. HbA1c results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K052464
Methodology: https://510kreport.com/methodology