# K090699: Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jul 27, 2009 after 132 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 K926469 (1993). 3 ancestors in all.
2 later devices descend 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)
- K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU, Bio-Rad Laboratories, Inc. (2007) Summary page 1.

## Most influential descendants
- K122472: Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System (2012), 1 descendant of its own
- K130990: Variant (TM) II Turbo HBA1C Kit - 2.0 (2013), 0 descendants of its own

## Indications for use
The Bio-Rad VARIANT TM IITURBO HbAjc Kit -2.0 is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Bio-Rad VARIANT TM IITURBO HbA1 c kit is intended for Professional Use Only. Measurement of percent hemoglobin Al, is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K090699
Methodology: https://510kreport.com/methodology