# K980883: N-Assay Glu-UL

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Sep 3, 1998 after 178 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853464 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853464: Glucose SR Liquid Stable Reagent Set, Medical Analysis Systems, Inc. (1985) Summary page 2.

## Indications for use
The intended use for the N-ASSAY Glu-UL Reagent is for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K980883
Methodology: https://510kreport.com/methodology