# K130990: Variant (TM) II Turbo HBA1C Kit - 2.0

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Decided: May 9, 2013 after 29 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: 5 generations back to K926469 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122472: Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System, Bio-Rad Laboratories, Inc., Clinical Systems Divis (2012) Summary page 1.

## Indications for use
The Bio-Rad VARIANT 11TURBO HbAlc Kit - 2.0 is intended for the quantitative determination of hemoglobin Alic in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT 11 TURBO Hemoglobin Testing System. Measurement of hemoglobin Aic is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT 11TURBO HbAlc Kit -2.0 is intended for Professional Use Only.

Source page: https://510kreport.com/device/K130990
Methodology: https://510kreport.com/methodology