(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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with its wings spread, positioned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 1998
Steve Boeh . Director, Quality Assurance and Regulatory Affairs Diametrics Medical, Inc. 2658 Patton Road Saint Paul, Minnesota 55113
Re : K980523 IRMA® Blood Analysis System with Optional Multi-Use Cartridge Regulatory Class: II Product Code: CHL, JFP, JGS, CEM, GKF Dated: February 2, 1998 Received: February 10, 1998
Dear Mr. Boeh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use and Intended Use Statement
510(k) Number: Device Name:
IRMA Blood Analysis System with Optional Multi-use cartridge
Indications for Use
Statement of Intended Use
The IRMA Blood Analysis System is intended for professional use in those settings where The il Mir Chood Analysis of Stort as blood gases (pCO2 and pO2), pH, Na ", K*, iCa** and Het 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 The pri, poozi pe 2 per 2 and state of oxygenation. Common causes of acid-base assess acid-base status and clais only child only abnormalities, drugs and poisons, and fluid imbalance.
The electrolyte measurements (Na , K )are used to assess hydrational status, aid in the The cloodrofylo modern and metabolic acid-balance, and prevention of cardiac draghosio of roopinatiry and motates which utilize these measurements for diagnosis are arrrythinia. "Ournition, 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.
(Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980823
Page 3
§ 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.