Search Results

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 Hct in whole blood are performed such as the clinical laboratory or patient bedside, and 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.

Indications for Use:
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 armythmia. 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.

These indications for use are identical to the predicate devices since the new system consists of an integration of the two predicate devices.

Not Found

This document is a 510(k) clearance letter for the Diametrics Medical IRMA Blood Analysis System, dated December 18, 1997. It primarily focuses on the regulatory approval and intended use of the device, rather than detailed performance study results or acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device study is not present in the provided text.

The document states:

• Device Name: IRMA Blood Analysis System with Optional Lifescan SureStep®Pro Blood Glucose Module
• Intended Use: For professional use to directly measure blood gases (pCO2, pO2), pH, Na+, K+, iCa++, and Hct in whole blood in clinical laboratory or patient bedside settings. The glucose module is for quantitative measurement of glucose in whole blood for adults and neonates in clinical settings, and by laypersons for capillary blood glucose monitoring at home.
• Indications for Use: Details the clinical applications of the pH, pCO2, pO2, Na+, K+, ionized calcium, hematocrit, and glucose measurements.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to predicate devices, indicating that the new system integrates two predicate devices with identical indications for use.

To answer your specific questions, a different type of document, such as a summary of safety and effectiveness, clinical study report, or internal validation report, would be required. This 510(k) clearance letter confirms regulatory approval based on equivalence but does not provide the detailed performance study data you're asking for.

Ask a specific question about this device