(46 days)
CardioQuant™ Cardiac Assessment Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of clinical diagnostic test methods for troponin I, CK-MB and myoglobin. These external controls compliment the monitoring of the test performance by the kit specific controls provided by each test device manufacturer.
Not Found
This is a New 510(k) K991447 for a Class I device, CardioQuant™ Cardiac Assessment Controls. As such, there is no discussion of acceptance criteria, device performance, or study design. There would have been no requirement for clinical studies to prove substantial equivalence. All the information that can be extracted is described below.
1. A table of acceptance criteria and the reported device performance
Not applicable for this device and 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable for this device and 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable for this device and 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this device and 510(k) submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable for this device and 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for this device and 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for this device and 510(k) submission.
8. The sample size for the training set
Not applicable for this device and 510(k) submission.
9. How the ground truth for the training set was established
Not applicable for this device and 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
JUN 11 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Joseph P. Laurino, Ph.D. Director of Scientific Operations Spectral Diagnostics, Inc. 135-2 The West Mall Toronto Ontario M9C 1C2
Re: K991447
Trade Name: CardioQuant™ Cardiac Assessment Controls Regulatory Class: I Product Code: JJY Dated: April 22, 1999 Received: April 26, 1999
Dear Dr. Laurino:
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 legally marketed predicate 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 regulatory 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.
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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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
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Spectral Diagnostics, Inc. CardioQuant™ Cardiac Assessment Controls 510(k) Notification
510 (k) Number (if Known) : time
Device Name : CardioQuant™ Cardiac Assessment Controls
Indications for Use:
CardioQuant™ Cardiac Assessment Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of clinical diagnostic test methods for troponin I, CK-MB and myoglobin. These external controls compliment the monitoring of the test performance by the kit specific controls provided by each test device manufacturer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Prescription Use Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Peter E. Maurer
§ 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.