# K103531: Prestige 24I; Biolis 24I; MGC 240

- Pathway: 510(k) (Traditional)
- Applicant: Tokyo Boeki Medisys, Inc.
- Decided: Dec 1, 2011 after 365 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 K802810 (1980). 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)
- K904219: Synchron CX 7 Clinical Analyzer, Beckman (1990) Summary page 2.
- K802810: Hexokinase, Glucose, Beckman Instruments, Inc. (1980) Summary page 3.

## Indications for use
The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia; and idiopathic glycemnia, and of the pancreatic isle cell carcinoma.

Source page: https://510kreport.com/device/K103531
Methodology: https://510kreport.com/methodology