(37 days)
The IRMA Blood Analysis System is intended for professional use in those settings where blood analysis of blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hct in whole blood are performed such as the clinical laboratory 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 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. Conditions which utilize these measurements for diagnosis are malnutrition, 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 multiuse 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 multi-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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the IRMA® Blood Analysis System with an Optional Multi-Use Cartridge. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does NOT contain information about:
- Specific acceptance criteria metrics (e.g., sensitivity, specificity, accuracy targets).
- Any study that proves the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- The type of ground truth used (e.g., pathology, outcomes data).
The document is purely a regulatory clearance notice and details the device's intended use and indications for use. It states that the system measures blood gases (pCO2 and pO2), pH, Na+, K+, iCa++, and Hct in whole blood, either with a single-use or multi-use cartridge, in settings such as clinical laboratories or patient bedsides. The indications for use are for assessing acid-base status, hydration, electrolyte balance, cardiac arrhythmias, disease states related to calcium, anemia, and blood loss.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.