DADE TRU-LIQUID BILIRUBIN CONTROL

K972287 · Dade Intl., Inc. · JJX · Jul 7, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972287
• Device Name: DADE TRU-LIQUID BILIRUBIN CONTROL
• Applicant: Dade Intl., Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.

Device Story

Dade TRU-Liquid Bilirubin Control is a liquid, tri-level quality control material used in clinical laboratories. It serves as a reference sample to monitor the accuracy and precision of bilirubin assay performance. Laboratory personnel use the control to verify that analytical systems are functioning correctly. By comparing measured values against established ranges, clinicians ensure the reliability of patient bilirubin test results, facilitating accurate diagnosis and monitoring of conditions related to bilirubin levels.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid, tri-level quality control material. Intended for in vitro diagnostic use to monitor clinical laboratory bilirubin assays.

Indications for Use

Indicated for use as an assayed quality control material in clinical laboratory quality assurance programs to monitor accuracy and precision in the clinical assay of bilirubin.

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

• ChemTrak Liquid Bilirubin Control (K833097)

Submission Summary (Full Text)

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K472287

-7 1997 JUL

## 510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Bilirubin Control June 17, 1997

Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 Contact Person: Radha Goolabsingh at 305-392-5621 or Marilyn Waxberg at 305-392-5614, or by facsimile at 305-392-5622.

| Trade or Proprietary Name: | Dade® TRU-Liquid™ Bilirubin Control<br>Levels 1,2 and 3. | |
|----------------------------|--------------------------------------------------------------------------|---------|
| Common or Usual Name: | Liquid Tri-Level Bilirubin Control | |
| Classification Name: | Quality Control Material (Assayed and Unassayed) | |
| Registration Number: | Manufacturer | |
| | Dade International Inc.<br>2173 N.W. 99th Avenue<br>Miami, FL 33172 | 1025506 |
| | Dade International Inc.<br>1851 Delaware Parkway<br>Miami, Florida 33125 | 1017272 |

The proposed Dade® TRU-Liquid™ Bilirubin Control is substantially equivalent to the ChemTrak Liquid Bilirubin Control manufactured by Medical Analysis Systems, previously cleared under Document Control No., K833097, on 1/11/84. The proposed and the predicate device are intended for use as assayed quality control materials to monitor accuracy and precision in the clinical assay of bilirubin

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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 features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple, using only black and white, and is designed to be easily recognizable.

JUL - 7 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Marilyn S. Waxburg Director Regulatory Affairs . . . . . . . Dade International, Inc. 2173 N.W. 99th Avenue Miami, FL 33172

Re : K972287 Dade® TRU-Liquid™ Bilirubin Control Requlatory Class: I Product Code: JJX Dated: June 17, 1997 Received: June 19, 1997

Dear Ms. Waxburg:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chill of) child at the expire 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 acborizoof 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 compriation 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): j

Device Name: Dade TRU-Liquid Bilirubin Control

## Indications For Use:

Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off) of Clinical Laboratory Devices • ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)