# K013938: Irma SL Blood Analysis System Lactate Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: Jan 28, 2002 after 61 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- 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 lactate sensor is intended for professional and point of care use with the IRMA® Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use. Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Source page: https://510kreport.com/device/K013938
Methodology: https://510kreport.com/methodology