# K981270: Irma Blood Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: May 1, 1998 after 24 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Johnson and Johnson Vitros Chemistry System DT60II: named in the summary without a submission number
- (no number) Buchler Digital Chloridometer: named in the summary without a submission number

## Most influential descendants
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own
- K131126: Opti Cca-TS2 (2013), 1 descendant of its own
- K200986: OPTI® B-Lac Cassette (2021), 0 descendants of its own
- K013624: Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors, Blood Analysis Portal System Plug-I (2001), 0 descendants of its own

## 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 , BUN, CI', and Hct, in whole blood are performed such as the clinical laboratory or the patient bedside. 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, ClI') 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 blood urea nitrogen is used to monitor renal disease, dialysis patients, and hyperalimentation. The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia. With the addition of BUN and CI', the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arrays of the cartridge will also be packaged in various combinations.

Source page: https://510kreport.com/device/K981270
Methodology: https://510kreport.com/methodology