# K991850: Safe at-Home Test Kit for Monitoring Hemoglobin Alc

- Pathway: 510(k) (Traditional)
- Applicant: Biosafe Laboratories, Inc.
- Decided: Nov 26, 1999 after 178 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The Safe at-Home Test Kit for Hemoglobin Alc is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative determination of hemoglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.

Source page: https://510kreport.com/device/K991850
Methodology: https://510kreport.com/methodology