(27 days)
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No
The document describes a blood analysis system that measures various blood parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The focus is on direct measurement of blood components.
No
The device is described as a blood analysis system intended for quantitative measurement of various blood parameters to assess acid-base status, hydrational status, and monitor glucose levels, among other diagnostic purposes. It is explicitly stated that the glucose module is "not intended to be used for the diagnosis of diabetes," which differentiates it from a therapeutic device directly treating a condition. Its function is to provide information for diagnosis and monitoring, not direct treatment.
Yes
The device measures various blood parameters (blood gases, pH, electrolytes, hematocrit, glucose) that are used to assess acid-base status, oxygenation, hydration, diagnose specific disease states (e.g., thyroid abnormalities, renal failure), and monitor conditions like anemia and diabetes. These measurements directly aid in diagnosis or patient management based on physiological parameters.
No
The device description is not provided, but the intended use clearly describes a "Blood Analysis System" that performs "direct measurement of blood" for various analytes. This strongly implies the use of hardware components for sample handling and analysis, which would not qualify it as a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hct in whole blood" and "quantitative measurement of glucose in a sample of whole blood." These measurements are performed on biological samples (blood) outside of the body to provide information about a person's health.
- Indications for Use: The indications for use describe how the results of these measurements are used to assess various physiological states and aid in the diagnosis and monitoring of diseases (e.g., acid-base status, state of oxygenation, hydrational status, thyroid abnormalities, anemia, glucose levels in diabetic patients). This aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or screening.
- Sample Type: The device analyzes "whole blood," which is a biological specimen.
The fact that it is used in clinical laboratories, at the patient bedside, and even by lay persons for home glucose monitoring further supports its classification as an IVD, as these are common settings for IVD use.
N/A
Intended Use / 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++ 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.
Product codes
CHL, CGA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults and neonates
Intended User / Care Setting
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 ... It can be used in a clinical setting to measure glucose in arterial, venous, and capillary samples... It can also be used by lay persons for capillary blood glucose monitoring in the home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
DEC 18 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Steve Boeh Director, Quality Assurance and Requlatory Affairs Diametrics Medical, Inc. 2658 Patton Road Saint Paul, Minneapolis 55113
Re : K974396 Diametrics Medical IRMA Blood Analysis System Regulatory Class: II Product Code: CHL, CGA Dated: November 17, 1997 Received: November 21, 1997
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 reqistration, 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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
Paqe 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 diaqnostic 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
510(k) Number: Device Name:
K974396 IRMA Blood Analysis System with Optional Lifescan SureStep®Pro Blood Glucose Module
Statement of Intended 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++ 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.
U Michael H. Atkin W. Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974396
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
National F . . .