CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3

K982845 · More Diagnostics · JJT · Aug 21, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982845
• Device Name: CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
• Applicant: More Diagnostics
• Product Code: JJT · Clinical Chemistry
• Decision Date: Aug 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Device Story

Cardiac Markers Control (Single Use) is a quality control product used in clinical laboratory settings. It serves as a reference material to monitor the performance of analytical test systems. By processing the control alongside patient samples, laboratory personnel can assess test precision and identify systematic analytical deviations caused by variations in reagents or instrumentation. The device is provided in three levels to cover different concentration ranges. It is intended for professional use by laboratory technicians to ensure the accuracy and reliability of cardiac marker assays, thereby supporting clinical decision-making regarding patient cardiac health.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

In vitro diagnostic control material provided in three levels for single use. Designed for compatibility with standard clinical laboratory cardiac marker analytical systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a control material to estimate test precision and detect systematic analytical deviations in clinical laboratory test systems for cardiac markers.

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

AUG 21 1998

James W. Snipes Official Correspondent MORE Diagnostics, Inc. P.O.Box 6714 93412 Los Osos, California

Re : K982845 Cardiac Markers Control (Single Use) Levels 1,2,3 Requlatory Class: I Product Code: JJT August 8, 1998 Dated: Received: August 12, 1998

Dear Mr. Snipes:

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 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements 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 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 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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510(k) Number (if known): \$98385

CARDIAC MARKERS CONTROL (SINGLE USE) THREE LEVELS Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | <div style="text-align:center;">for smontgomery</div> |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 4982845 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |