# K072714: Tina-Quant Hemoglobin A1C Gen.2 Test System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 18, 2008 after 206 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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 K934070 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K052464: Tina-Quant Hemoglobin A1C Gen.2 Test, Roche Diagnostics Corp. (2005) Summary page 1.

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

## Recalls of this device
- Oct 4, 2016 · Class II · Z-0395-2017: Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over

## Indications for use
For the quantitative determination of percent hemoglobin A1c in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K072714
Methodology: https://510kreport.com/methodology