# K974396: Irma Blood Analysis System with Optional Lifescan Surestep Pro Blood Glucose Module

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: Dec 18, 1997 after 27 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) IRMA Blood Analysis System: named in the summary without a submission number
- (no number) Lifescan SureStep Pro Blood Glucose Module: named in the summary without a submission number

## Indications for use
The IRMA® Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hect in whole blood are performed such as the clinical laboratory or patient bedside. The IRMA/Lifescan SureStep®Pro glucose module is intended for quantitative measurement of glucose in a sample of whole blood. It can be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates. It can also be used by lay persons for capillary blood glucose monitoring in the home. The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance. The electrolyte measurements (Na+ K+) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrythmia. Common disease states which utilize these measurements are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients. The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia. The measurement of glucose on the module is used to monitor glucose levels in diabetic patients. It is not intended to be used for the diagnosis of diabetes.

Source page: https://510kreport.com/device/K974396
Methodology: https://510kreport.com/methodology