IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5

K991796 · Diagnostic Products Corp. · DDR · Jun 9, 1999 · Immunology

Device Facts

• Record ID: K991796
• Device Name: IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
• Applicant: Diagnostic Products Corp.
• Product Code: DDR · Immunology
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

Turbo Myoglobin is a solid-phase, two-site chemiluminescent enzyme IMMULITE® immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).

Device Story

IMMULITE Turbo Myoglobin is an in vitro diagnostic assay for use on the IMMULITE Automated Analyzer. It utilizes a solid-phase, two-site chemiluminescent enzyme immunometric assay principle to measure myoglobin levels in serum or heparinized plasma samples. The device is operated by laboratory personnel in a clinical setting. The analyzer processes the sample and provides a quantitative measurement of myoglobin, which clinicians use as an aid in the diagnosis of acute myocardial infarction (AMI). By providing rapid myoglobin quantification, the device assists healthcare providers in the timely assessment of patients presenting with symptoms of AMI, potentially facilitating faster clinical decision-making and intervention.

Technological Characteristics

Solid-phase, two-site chemiluminescent enzyme immunometric assay. Designed for use with the IMMULITE Automated Analyzer. Analyte: myoglobin. Sample types: serum or heparinized plasma.

Indications for Use

Indicated for the quantitative measurement of myoglobin in serum or heparinized plasma as an aid in the diagnosis of acute myocardial infarction (AMI).

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Submission Summary (Full Text)

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JUN 9 1999

K991796

### 510(k) Summary Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Name:<br>Address: | Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, California 90045-5597 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Telephone Number:<br>Facsimile Number: | [phone]<br>[phone] |
| Contact Person: | Edward M. Levine, Ph.D.<br>Director of Clinical Affairs |
| Date of Preparation: | May 25, 1999 |
| Device Name:<br>Trade: | IMMULITE® Turbo Myoglobin |
| Catalog Number: | LSKMY1 (100 tests), LSKMY5 (500 tests) |
| Common: | Reagent system for the determination of myoglobin in<br>serum or heparinized plasma. |
| Classification: | Class II device, 75-DDR (21CFR 866.5680) |
| Manufacturer: | Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, California 90045-5597 |
| Sole U.S. Importer: | Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, California 90045-5597 |
| Establishment Registration<br>Number | DPC's Registration Number is 2017183 |
| Description of Device: | IMMULITE® Turbo Myoglobin is a clinical device for use<br>with the IMMULITE® Automated Immunoassay Analyzer. |

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# K991796

## Intended Use of the Device:

Turbo Myoglobin is a solid-phase, two-site chemiluminescent enzyme IMMULITE® immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).

#### Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo Myoglobin.

Edward Stein
E. ADAM LEWIS, Ph.D.

Edward M. Levine, Ph.D. Director of Clinical Affairs

5/25/99
**Date**

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three overlapping, curved shapes that resemble a human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

9 1999 JUN

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Re: K991796

> Trade Name: Immulite Turbo Myoglobin Regulatory Class: II Product Code: DDR Dated: May 25, 1999 Received: May 26, 1999

Dear Dr. Levine:

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 legally marketed predicate 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 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 Regulations, 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 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 action. In addition, FDA may publish further announcements 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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#### Kggingl 510(k) Number (if known):_ Device Name: IMMULITE® Turbo Myoglobin

Indications For Use:

IMMULITE® Turbo Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI):

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Numb
K991796

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Us (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-

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