(15 days)
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No
The summary describes calibration controls for a cardiac panel, which are standard laboratory reagents and do not inherently involve AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is described as "controls used to assess the daily performance of the Triage Cardiac Panel," indicating it's for quality control/calibration, not for treating a disease or condition.
No
Explanation: The device is described as "controls used to assess the daily performance of the Triage® Cardiac Panel." This indicates it's a quality control material used to check the accuracy of another diagnostic device, rather than performing diagnosis itself.
No
The summary describes "controls" which are physical substances used for calibration, indicating a hardware component.
Based on the provided information, the Triage® Cardiac Calibration Controls are not an IVD (In Vitro Diagnostic) device themselves.
Here's why:
- Intended Use: The intended use states they are "controls used to assess the daily performance of the Triage® Cardiac Panel." This means they are used with an IVD device (the Triage® Cardiac Panel) to ensure that device is working correctly.
- Composition: They contain specific analytes (Myoglobin, Creatine Kinase MB, and Troponin-I) at known concentrations. This is characteristic of a control material used for calibration or quality control of a diagnostic test.
- Lack of Diagnostic Claim: The description does not indicate that these controls are used to diagnose, monitor, or treat a disease or condition in a patient.
In summary, the Triage® Cardiac Calibration Controls are a component or accessory used in conjunction with an IVD device (the Triage® Cardiac Panel) to ensure its accuracy and reliability. They are not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Triage Cardiac Calibration Controls are controls used to assess the daily performance of the Triage Cardiac Panel. These controls contain Myoglobin, Creatine Kinase MB and Troponin-I at three concentrations.
Product codes
JJY
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
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 8 1998
John F. Bruni, Ph.D. · Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Dieqo, California 92121
Re : K974827 Triage Cardiac Calibration Verification Controls Regulatory Class: I Product Code: JJY Dated: December 22, 1997 Received: December 24, 1997
Dear Dr. Bruni:
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 regulatory 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.
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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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Ditman
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
f
5 IO(k) Number if known)
Device Name: Triage® Cardiac Calibration Controls
Indications for Use:
Prescription Use V
The Triage® Cardiac Calibration Controls are controls used to assess the daily performance of the Triage® Cardiac Panel. These controls contain Myoglobin, Creatine Kinase MB and Troponin-I at three concentrations.
974827
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K974827 |
Over-The Counter Use
OR
(Optional Format 1-2-96)