# K070819: Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Decided: Jun 25, 2007 after 91 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926469 (1993). 4 ancestors in all.
1 later device descends 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 2.
- K063400: Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0, Bio-Rad Laboratories, Inc. (2006) Summary page 2.

## Most influential descendants
- K140801: Variant II Turbo Link Hemoglobin A1C Program/Testing System (2014), 0 descendants of its own

## Recalls of this device
- Oct 25, 2011 · Not classified · Z-0399-2012: It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
- Sep 12, 2011 · Not classified · Z-0027-2012: 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-0026-2012: 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
- Jul 28, 2011 · Not classified · Z-3159-2011: The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.
- Feb 19, 2010 · Not classified · Z-1259-2011: The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.

## Indications for use
The Bio-Rad VARIANT IITURBO Link Hemoglobin Alc Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Measurement of percent hemoglobin Al c is effective in monitoring long-term glucose control in individuals with diabetes mellitus. The VARIANT IITURBO Link Hemoglobin Alc Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system. The Bio-Rad VARIANT IITURBO Link Hemoglobin Alc Program is intended for Professional Use Only.

Source page: https://510kreport.com/device/K070819
Methodology: https://510kreport.com/methodology