IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5

K991795 · Diagnostic Products Corp. · MMI · Jun 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991795
• Device Name: IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
• Applicant: Diagnostic Products Corp.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Turbo Troponin I is a solid-phase, two-site chemiluminescent enzyme IMMULITE® IMMODETTE Thiroo - Hopenin 1- 15-a USMULITF Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).

Device Story

IMMULITE Turbo Troponin I is an in vitro diagnostic assay used with the IMMULITE Automated Analyzer. It utilizes a solid-phase, two-site chemiluminescent enzyme immunometric assay principle to measure troponin I levels in patient serum, heparinized plasma, or EDTA plasma. The device is operated by laboratory personnel in a clinical setting. The analyzer processes the sample and provides a quantitative result to the clinician. This output assists healthcare providers in the diagnosis of acute myocardial infarction (AMI), facilitating timely clinical decision-making and patient management.

Clinical Evidence

No clinical data provided in the summary document.

Technological Characteristics

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

Indications for Use

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

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

{0}------------------------------------------------

g 1999 JUN

## 510(k) Summary Safety and Effectiveness

K991795

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: | Diagnostic Products Corporation |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Address: | 5700 West 96th Street<br>Los Angeles, California 90045-5597 |
| Telephone Number: | [phone] |
| Facsimile Number: | [phone] |
| Contact Person: | Edward M. Levine, Ph.D.<br>Director of Clinical Affairs |
| Date of Preparation: | May 25, 1999 |
| Device Name: | |
| Trade: | IMMULITE® Turbo Troponin I |
| Catalog Number: | LSKTI1 (100 tests), LSKTI5 (500 tests) |
| Common: | Reagent system for the determination of troponin I in<br>serum, heparinized, or EDTA plasma. |
| Classification: | Class II device, 75-MMI (21CFR 862.1215) |
| 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 Troponin I is a clinical device for use<br>with the IMMULITE® Automated Immunoassay Analyzer. |

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K991795". The characters are written in a cursive style with varying stroke thicknesses.

### Intended Use of the Device:

Turbo Troponin I is a solid-phase, two-site chemiluminescent enzyme IMMULITE® IMMODETTE Thiroo - Hopenin 1- 15-a USMULITF Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA 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 I he until prosence in this sating DPC substantial equivalence for IMMULITE® Turbo Troponin I.

Edinco Lecca

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

5/24/99

Date

{2}------------------------------------------------

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.

#### ਹੈ ।ਰਿਹੇਰੇ JUN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K991795 Re: Trade Name: Immulite Turbo Troponin I Regulatory Class: II Product Code: MMI 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.

{3}------------------------------------------------

### Page 2

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 vours,

Steven Putman

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

{4}------------------------------------------------

510(k) Number (if known): Device Name: IMMULITE® Turbo

Indications For Use:

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

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

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

\$\checkmark\$

Prescripti (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-

96)