# K090737: Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jun 3, 2009 after 75 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K031043: D-10 Hemoglobin A1C, Bio-Rad Laboratories, Inc. (2003) Summary page 1.

## Indications for use
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. For in vitro diagnostic use. The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K090737
Methodology: https://510kreport.com/methodology