# K012525: Thermo Dma Fructosamine Assay, Model 7500-135/235

- Pathway: 510(k) (Abbreviated)
- Applicant: Thermo Dma, Inc.
- Decided: Oct 4, 2001 after 59 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. The FDA summary names its predicate without a number.
- (no number) Sigma Diagnostics Fructosamine (Procedure No. 463): named in the summary without a submission number

## Indications for use
This reagent is intended for the in vitro quantitative determination of Fructosamine (glycated protein) in human serum when run on the Hitachi 704 automated chemistry analyzer. Measurements of fructosamine are used as an aid for short-termn glycemic control related to diabetes management.

Source page: https://510kreport.com/device/K012525
Methodology: https://510kreport.com/methodology