# K142448: VARIANT II TURBO HbA1c Kit - 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Mar 24, 2015 after 203 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130002 (2013). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130002: Tina-Quant HBA1C Gen. 2 Test System, Roche Diagnostics (2013). Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack (2015), 4 descendants of its own
- K252749: Medconn 8K Glycated Hemoglobin Test System (2026), 0 descendants of its own
- K242911: Medconn Glycated Hemoglobin Test system (2025), 0 descendants of its own
- K220999: Hipro Glycosylated Hemoglobin (HbA1c) Test System (2024), 0 descendants of its own
- K182651: HbA1c Advanced (2019), 0 descendants of its own

## Indications for use
The VARIANT™ II TURBO HbA1c Kit- 2.0 is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System and VARIANT II TURBO Link Hemoglobin Testing System. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The VARIANT II TURBO HbA1c Kit- 2.0 is intended for Professional Use Only. The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.

Source page: https://510kreport.com/device/K142448
Methodology: https://510kreport.com/methodology