# K040872: Variant II Hemoglobin A1C

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Apr 15, 2004 after 13 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 4 (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.
3 later devices descend from it; 2 cite 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)
- K984268: Variant II Hemoglobin A1C Program, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K063400: Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 (2006), 2 descendants of its own
- K070819: Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716, (2007), 1 descendant of its own
- K140801: Variant II Turbo Link Hemoglobin A1C Program/Testing System (2014), 0 descendants of its own

## Recalls of this device
- Sep 12, 2011 · Not classified · Z-0020-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 12, 2011 · Not classified · Z-0021-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 12, 2011 · Not classified · Z-0022-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Mar 24, 2010 · Not classified · Z-1342-2011: The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.

## Indications for use
The Bio-Rad VARIANT II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II TURBO Hemoglobin A1c Program is intended for Professional Use Only. For In Vitro Diagnostic Use. Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K040872
Methodology: https://510kreport.com/methodology