# K153692: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Infrared Laboratory Systems, LLC (Dba Synermed)
- Decided: Jun 24, 2016 after 184 days
- Product code: CGA (Glucose Oxidase, 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 K872494 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872494: Hitachi 717 Chemistry Analyzer, Boehringer Mannheim Corp. (1987) Summary page 5.
- K903063: Synermed Glucose Reagent Kit, Synermed, Inc. (1990) Summary page 5.

## Indications for use
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma. The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random access, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.

Source page: https://510kreport.com/device/K153692
Methodology: https://510kreport.com/methodology