# K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: May 7, 2007 after 80 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 K926469 (1993). 2 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984268: Variant II Hemoglobin A1C Program, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack (2015), 4 descendants of its own
- K090699: Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730 (2009), 2 descendants of its own
- K122472: Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System (2012), 1 descendant of its own
- K252749: Medconn 8K Glycated Hemoglobin Test System (2026), 0 descendants of its own
- K242911: Medconn Glycated Hemoglobin Test system (2025), 0 descendants of its own

## Recalls of this device
- Jun 15, 2009 · Not classified · Z-1013-2010: Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

## Indications for use
The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for Professional Use Only. Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K070452
Methodology: https://510kreport.com/methodology