# K983253: Precision A1C Home HBA1C Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Nov 20, 1998 after 65 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: 3 generations back to K861697 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K861697: Self Assure/GHB (Capillary-Blood Collection Kit), Awareness Technology, Inc. (1986) Summary page 1.
- K974491: Accu-Chek A1C Hemoglobin Test, Boehringer Mannheim Corp. (1998) Summary page 1.

## Indications for use
The Precision Alc Home HbAlc Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbAlc (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus. The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

Source page: https://510kreport.com/device/K983253
Methodology: https://510kreport.com/methodology