DADE TRU-LIQUID CARDIAC CONTROL

K982591 · Dade Behring, Inc. · JJX · Aug 5, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982591
• Device Name: DADE TRU-LIQUID CARDIAC CONTROL
• Applicant: Dade Behring, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 5, 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 programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure, 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 accuracy and precision of laboratory testing procedures for cardiac markers, specifically Troponin-I, CK-MB, and Myoglobin. The device is used by laboratory personnel within clinical laboratory quality assurance programs to verify the performance of diagnostic assays. By providing known values for these specific cardiac markers, the control allows clinicians and laboratory technicians to validate that their testing equipment and reagents are functioning correctly, thereby ensuring the reliability of patient test results used in clinical decision-making.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic quality control material.

Technological Characteristics

Liquid, tri-level quality control material. Formulated for use with Troponin-I, CK-MB, and Myoglobin assays. No specific materials of construction, energy sources, or software algorithms are described.

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

• Dade TRU-Liquid Cardiac Control (K981622)

Submission Summary (Full Text)

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## AUG - 5 1998

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## 510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Cardiac Control July 25, 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<br>1851 Delaware Parkway<br>Miami, Florida 33125 |

Registration Number 1017272

The Dade® TRU-Liquid™ Cardiac Control with expanded indications is substantially equivalent in terms of intended use and safety and effectiveness to the current Dade® TRU-Liquid™ Cardiac Control manufactured by Dade Behring, previously cleared under Document Control No., K981622.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 5 1998

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

K982591 Re : Dade TRU-Liquid Cardiac Control Regulatory Class: I Product Code: JJX Dated: July 24, 1998 Received: July 24, 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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 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 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): 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 programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure, specifically Troponin-I, CK-MB and Myoglobin.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K98259

OR

Over-The-Counter Use

1 Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)