# K980523: Irma Blood Analysis System  with Optional Multi-Use Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: Mar 19, 1998 after 37 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.

## 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*t and Het in whole blood are performed such as the clinical faboratory or the patient bedside. The system may utilize either a single-use or a multi-use cartridge for these measurements. 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 arrhythmia. Common disease states which utilize these measurements for diagnosis 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. These indications for use of the IRMA Blood Analysis System which utilizes the multi-use cartridge are identical to those of the IRMA Blood Analysis System which utilizes the single-use cartridge. The System will now offer the user an option to choose which cartridge platform best fits their needs either the single-use or muilti-use cartridge. Both platforms offer the following sensors: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, and hematocrit. Similar to the single-use cartridge, the sensor arrays of the multi-use cartridge will also be packaged in various combinations.

Source page: https://510kreport.com/device/K980523
Methodology: https://510kreport.com/methodology