# K122472: Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Decided: Oct 26, 2012 after 73 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: 4 generations back to K926469 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090699: Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730, Bio-Rad Laboratories, Inc. (2009) Summary page 5.

## Most influential descendants
- K130990: Variant (TM) II Turbo HBA1C Kit - 2.0 (2013), 0 descendants of its own

## Indications for use
The Bio-Rad VARIANT II TURBO HbA1c Kit - 2.0 is intended for the quantitative determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT II TURBO HbA1c Kit - 2.0 is intended for Professional Use Only.

Source page: https://510kreport.com/device/K122472
Methodology: https://510kreport.com/methodology