# K011586: Irma SL Blood Analysis System GL Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: Nov 16, 2001 after 177 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K891480 (1989). 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)
- K891480: Ysi Model 2300 Stat Glucose and L-Lactate Analyzer, Yellow Springs Instrument Co., Inc. (1989) Summary page 1.

## Indications for use
The glucose sensor is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of glucose, in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use. The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

Source page: https://510kreport.com/device/K011586
Methodology: https://510kreport.com/methodology