# K984529: Hemochek Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Laboratories, Inc.
- Decided: Jan 28, 1999 after 38 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861697 (1986). 2 ancestors in all.
4 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.

## Most influential descendants
- K990899: Hemochek-A1C Sample Collection Kit (1999), 3 descendants of its own
- 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

## Indications for use
The HemoChek Sample Collection Kit is indicated 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 a filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over an 8-12 week period. The results are to be evaluated by the patient's physician. The product is not indicted for the diagnosis of diabetes mellitus.

Source page: https://510kreport.com/device/K984529
Methodology: https://510kreport.com/methodology