CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

K981474 · Spectral Diagnostics, Inc. · JJY · May 7, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981474
• Device Name: CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
• Applicant: Spectral Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended 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.

Device Story

Cardiac STATus™ Controls are assayed quality control materials used to monitor the performance of Spectral Diagnostics Inc. Cardiac STATus™ rapid diagnostic tests for CK-MB, Myoglobin, and Troponin I. These external controls are used in conjunction with the internal controls provided within each test device to ensure the accuracy and reliability of the rapid test results. They are intended for use by laboratory personnel within a quality assurance program to verify that the test system is functioning correctly before or during patient sample analysis. By providing known values for these cardiac markers, the controls allow clinicians to validate the performance of the rapid test, thereby supporting accurate clinical decision-making regarding cardiac events.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Assayed quality control materials containing CK-MB, Myoglobin, and Troponin I. Designed for use with Spectral Diagnostics Inc. Cardiac STATus™ rapid test devices. Standalone control product.

Indications for Use

Indicated for use as assayed quality control materials to monitor the performance of Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests in clinical laboratory settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone].

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 [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 (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