(13 days)
Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.
Not Found
This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically quality control materials for cardiac markers. It does not contain information about a study that assesses a device's performance against detailed acceptance criteria in the way described in the prompt.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, expert qualifications, adjudication methods, MRMC studies, or standalone performance) from this document. This letter primarily confirms that the device is substantially equivalent to a previously marketed device and outlines regulatory obligations.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 7 1998
Joseph P. Laurino, Ph.D. . Director of Scientific Operations Spectral Diagnostics, Inc. 135-2 The West Mall Toronto, Ontario Canada M9C 1C2
K981474 Re : Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) Requlatory Class: I Product Code: JJY Dated: April 21, 1998 Received: April 24, 1998
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 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 qeneral controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ 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 requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
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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/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
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Spectral Diagnostics Inc. Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) 510(k) Notification
510(k) Number (If Known): Not known at this time
Device Name:
Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I)
Indications for Use:
Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use i/ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-98)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981474
§ 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.