# K984574: Infinity Glucose Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Feb 11, 1999 after 50 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 K980026 (1998). 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)
- K980026: Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST), Trace America, Inc. (1998) Summary page 1.

## Indications for use
The Sigma Diagnostics INFINITY™ Glucose Reagent is a device intended to measure glucose quantitatively in serum or urine. Measurements obtained by the device are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K984574
Methodology: https://510kreport.com/methodology