# K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Decided: Dec 27, 2006 after 20 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K991127: Variant II B-Thalassemia, Bio-Rad (1999) Summary page 1.
- K003280: Variant II Total GHB, Bio-Rad (2000) Summary page 1.

## Most influential descendants
- K130860: Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software (2013), 0 descendants of its own

## Recalls of this device
- Dec 9, 2008 · Not classified · Z-1395-2009: The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

## Indications for use
Hemoglobin A1c The Bio-Rad VARIANT II Hemoglobin A1c Program with CDM 4.0 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 Hemoglobin A1c Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Total GHb The VARIANT II Total GHb Program with CDM 4.0 is intended for the separation and area percent determination of total glycated hemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC). The VARIANT II Total GHb Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Measurement of percent hemoglobin A1 C is effective in monitoring long-term glucose control in individuals with diabetes mellitus. Beta-thalassemia The VARIANT II Beta-thalassemia Short Program with CDM 4.0 is intended for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography. The VARIANT II Beta-thalassemia Short Program with CDM 4.0 is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Measurement of percent HbA2 and HbF are used for evaluation of Beta-thalassemia, a hereditary hemolytic anemia.

Source page: https://510kreport.com/device/K063643
Methodology: https://510kreport.com/methodology