# K130860: Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Decided: Apr 25, 2013 after 28 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program, Bio-Rad Laboratories Inc., Clinical Systems Divisi (2006) Summary page 1.

## Indications for use
The Bio-Rad VARIANTTM 11 Hemoglobin Alic Program is intended for the percent determination of hemoglobin Alic in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Aic Program is intended for Professional Use Only. For in vitro diagnostic usge. Measurement of percent hemoglobin Alic is effective in monitoring long-term glucose control in individuals with diabetes mnellitus. The VARIANTrm II (-thalassemia Short Program 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 (HPLC). The Bio-Rad VARIANT II P-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT 11 Hemoglobin Testing System. For in vitro diagnostic use. Measurement of the percent hemoglobin A2 and F are effective in screening of(- thalassemnia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains)

Source page: https://510kreport.com/device/K130860
Methodology: https://510kreport.com/methodology