# K971919: Ezchek/Hba Blood Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Flexsite Diagnostics, Inc.
- Decided: Sep 5, 1997 after 105 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: 1 generation back to K861697 (1986). 1 ancestor in all.
11 later devices descend from it; 6 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861697: Self Assure/GHB (Capillary-Blood Collection Kit), Awareness Technology, Inc. (1986) Summary page 1.

## Most influential descendants
- K984529: Hemochek Sample Collection Kit (1999), 4 descendants of its own
- K990899: Hemochek-A1C Sample Collection Kit (1999), 3 descendants of its own
- K141944: Home Access Aic Test (2015), 2 descendants of its own
- K983172: Accu-Base Hemoglobin A1C Sample Collection Kit (1998), 2 descendants of its own
- K993787: Appraise-Cardio Sample Collection Kit (2000), 1 descendant of its own

## Indications for use
For over-the-counter at home or doctor's office use to obtain a finger stick whole blood sample for laboratory testing to monitor jong-term (4-8 weeks) blood sugar control in diabetes. Test results should be evaluated together with a personal doctor. This product is not indicated for the diagnosis of diabetes mellitus.

Source page: https://510kreport.com/device/K971919
Methodology: https://510kreport.com/methodology