# K991246: Fructosamine, Model FR 106-01

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: Dec 16, 1999 after 248 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The fructosamine reagent (R1), product No. FR10-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of fructosamine in serum, or plasma.

Source page: https://510kreport.com/device/K991246
Methodology: https://510kreport.com/methodology