# K990899: Hemochek-A1C Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Group, Inc.
- Decided: Dec 21, 1999 after 278 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861697 (1986). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971919: Ezchek/Hba Blood Collection Kit, Flexsite Diagnostics, Inc. (1997) Summary page 1.
- K984529: Hemochek Sample Collection Kit, Osborn Laboratories, Inc. (1999) Summary page 1.

## Most influential descendants
- K141944: Home Access Aic Test (2015), 2 descendants of its own
- K231465: Q-Pad Test System (2023), 0 descendants of its own
- K183230: OneDraw A1C Test System (2019), 0 descendants of its own

## Recalls of this device
- Jan 9, 2011 · Not classified · Z-0525-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0530-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0529-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0532-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0548-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0552-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0547-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0550-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0553-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0554-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0555-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0572-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0528-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0531-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0556-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0557-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0558-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0559-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0560-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0561-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0569-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0576-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0577-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0578-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0564-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0570-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0573-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0574-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0581-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0562-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0568-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0571-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0575-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0580-2012: Kits contain recalled Triad alcohol pads

## Indications for use
The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician’s office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.

Source page: https://510kreport.com/device/K990899
Methodology: https://510kreport.com/methodology