# K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 9, 2015 after 205 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: 3 generations back to K926469 (1993). 5 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142448: VARIANT II TURBO HbA1c Kit - 2.0, Bio-Rad Laboratories, Inc. (2015) Summary page 4.
- K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU, Bio-Rad Laboratories, Inc. (2007) Summary page 4.

## Most influential descendants
- 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 D-100™ HbA1c test 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 D-100 Hemoglobin Testing System. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The D-100™ HbA1c test is intended for Professional Use Only. Calibrators: The D-100™ HbA1c Calibrator Pack is for the calibration of the D-100 Hemoglobin Testing System used for the quantitative determination of hemoglobin A1c(HbA1c) in human whole blood.

Source page: https://510kreport.com/device/K151321
Methodology: https://510kreport.com/methodology