CARDIAC STATUS CONTROLS

• K Number: K972408
• Device Name: CARDIAC STATUS CONTROLS
• Manufacturer: SPECTRAL DIAGNOSTICS, INC.
• Date Cleared: 1997-07-25 ( 29 days)
• Product Code: JJT
• Regulation Number: 862.1660
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Cardiac STATus™ Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test. These external controls complement the monitoring of the test performance by the internal control provided in each test device.

Device Description

Cardiac STATus™ Controls /CK-MB/Myoglobin

AI/ML Overview

I am unable to extract specific acceptance criteria and study details from the provided text to fulfill your request. The document is a 1997 FDA 510(k) clearance letter for "Cardiac STATus™ Controls," which are quality control materials for an in-vitro diagnostic test, not a medical device that performs a diagnosis or algorithm.

The text primarily details:

• The FDA's decision of substantial equivalence for the Cardiac STATus™ Controls.
• Regulatory classifications and requirements for the device.
• Instructions for the manufacturer regarding labeling, promotion, and other regulatory obligations.
• The intended use of the Cardiac STATus™ Controls as "assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test."

There is no mention of a study involving algorithmic performance, human readers, or detailed acceptance criteria for a diagnostic device's accuracy. Thus, I cannot construct the table or answer the specific questions about sample sizes, ground truth, experts, or comparative effectiveness studies that you've asked for.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Francee S. Boches, Ph.D. Spectral Diagnostics, Inc. 135-2 The West Mall Toronto, Ontario Canada M9C 1C2

JUL 25 1997

K972408 Re : Cardiac STATus™ Controls Regulatory Class: I Product Code: JJT Dated: June 12, 1997 Received: June 26, 1997

Dear Dr. Boches:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 [phone].

This letter will allow you to begin marketing your device as described in your 510th) 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 510(k) Notification

510(k) Number (if Known): Not known at this time

Device Name : . . . . Cardiac STATus™ Controls /CK-MB/Myoglobin . . . .

Indications for Use:

Cardiac STATus™ Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test. These external controls complement the monitoring of the test performance by the internal control provided in each test device.

(PLEASE DO NOT WRITE BELOW THIS LINE -- ONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.