# K861697: Self Assure/GHB (Capillary-Blood Collection Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Awareness Technology, Inc.
- Decided: Aug 19, 1986 after 106 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
No predicates in its family tree.
12 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971919: Ezchek/Hba Blood Collection Kit (1997), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K861697
Methodology: https://510kreport.com/methodology