DADE TRU-LIQUID CARDIAC CONTROL

K981622 · Dade Behring, Inc. · JJX · Jun 8, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981622
• Device Name: DADE TRU-LIQUID CARDIAC CONTROL
• Applicant: Dade Behring, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance quarrer control accession the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.

Device Story

Dade TRU-Liquid Cardiac Control is a liquid, tri-level quality control material used in clinical laboratories. It serves as an assayed control to monitor the performance, accuracy, and precision of laboratory assays for cardiac markers, specifically Troponin I, CK-MB, and Myoglobin. The control is processed by laboratory personnel alongside patient samples to verify that the analytical system is functioning within established parameters. By comparing the measured values of the control against the provided assay ranges, clinicians and laboratory technicians can validate the reliability of patient test results, ensuring consistent diagnostic performance for cardiac marker testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, tri-level control material. Formulated for use with Troponin I, CK-MB, and Myoglobin assays. In vitro diagnostic quality control material.

Indications for Use

Indicated for use as an assayed quality control material in clinical laboratories to monitor the accuracy and precision of cardiac marker procedures, specifically Troponin I, CK-MB, and Myoglobin.

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.

Predicate Devices

• Liquichek Cardiac Markers Control (K961828)

Submission Summary (Full Text)

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JUN - 8 1998

K981622

## 510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Cardiac Control May 5, 1998

Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125 Contact Person: John Cramer at [phone], or by facsimile at [phone].

| Trade or Proprietary Name: | Dade® TRU-Liquid™ Cardiac Control<br>Levels 1,2 and 3. |
|----------------------------|--------------------------------------------------------|
| Common or Usual Name: | Liquid Tri-Level Cardiac Control |
| Classification Name: | Quality Control Material (Assayed and Unassayed) |
| Registration Number: | Manufacturer |
| | Dade Behring |

1851 Delaware Parkway Miami, Florida 33125

Registration Number 1017272

The proposed Dade® TRU-Liquid™ Cardiac Control is substantially equivalent in terms of intended use and safety and effectiveness to the Liquichek Cardiac Markers Control manufactured by Bio-Rad Laboratories, previously cleared under Document Control No., K961828.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 8 1998

Richard D. Bliss, Jr. . Vice President Quality Assurance and Regulatory Affairs Dade Behring 1851 Delaware Parkway Miami, Florida 33125

K981622 Re : Dade® TRU-Liquid Cardiac™ Control Regulatory Class: I Product Code: JJX Dated: May 5, 1998 Received: May 7, 1998

Dear Mr . Bliss:

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 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 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 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 In addition, FDA may publish further announcements action. 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 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.qov/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):

Dade TRU-Liquid Cardiac Control Device Name:

## Indications For Use:

Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance quarrer control accession the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.

(PLEASE DO NOT WITE BELQW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number. 498/622

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