# K063400: Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 1, 2006 after 22 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: 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)
- K040872: Variant II Hemoglobin A1C, Bio-Rad Laboratories, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- 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.
- Dec 8, 2009 · Not classified · Z-1898-2011: Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.
- Oct 12, 2009 · Not classified · Z-0867-2010: Product update kit CD rom will not upload. As a result, the device cannot be run.
- Oct 17, 2008 · Not classified · Z-1041-2009: Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.

## Indications for use
The Bio-Rad VARIANT II TURBO Hemoglobin A1C Program with CDM 4.0 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 TURBO Hemoglobin AiC Program with CDM 4.0 is intended for Professional Use Only. For In Vitro Diagnostic Use. Measurement of percent hemoglobin AlC is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K063400
Methodology: https://510kreport.com/methodology