# K140801: Variant II Turbo Link Hemoglobin A1C Program/Testing System

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jun 25, 2014 after 86 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: 5 generations back to K926469 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070819: Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,, Bio-Rad Laboratories Inc., Clinical Systems Divisi (2007) Summary page 2.

## Indications for use
The Bio-Rad VARIANT II TURBO Link 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 VARIANT II TURBO Link Hemoglobin A1c Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system. The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is Professional Use Only. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K140801
Methodology: https://510kreport.com/methodology