IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

K022118 · Diagnostic Products Corp. · JHX · Jul 22, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022118
• Device Name: IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
• Applicant: Diagnostic Products Corp.
• Product Code: JHX · Clinical Chemistry
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and is designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in patient management and the assessment of prognosis of myocardial infarction.

Device Story

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay; used with IMMULITE Automated Analyzer. Input: patient serum or heparinized plasma. Process: sample, ligand-labeled anti-CK-MB monoclonal antibody, and alkaline phosphatase-labeled anti-CK-BB monoclonal antibody incubated in test unit with immobilized anti-ligand; forms antibody sandwich complex; centrifugal wash removes unbound conjugate; chemiluminescent substrate (phosphate ester of adamantyl dioxetane) added; hydrolysis by alkaline phosphatase produces unstable intermediate; sustained light emission measured by luminometer. Output: photon output proportional to CK-MB concentration. Used in clinical laboratory settings by trained personnel. Healthcare providers use quantitative results to aid in myocardial infarction management and prognosis assessment.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and performance characteristics of the assay.

Technological Characteristics

Solid-phase, two-site chemiluminescent immunometric assay. Components: ligand-labeled monoclonal antibody, alkaline phosphatase-labeled anti-CK-BB monoclonal antibody, immobilized anti-ligand solid phase. Substrate: phosphate ester of adamantyl dioxetane. Energy source: luminometer for photon detection. Operation: 37°C incubation with intermittent agitation. System: IMMULITE Automated Analyzer.

Indications for Use

Indicated for the quantitative measurement of CK-MB in serum or heparinized plasma as an aid in the management and prognosis assessment of myocardial infarction in patients.

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.

Predicate Devices

• IMMULITE CK-MB (K004002)

Submission Summary (Full Text)

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# JUL 2 2 2002

18

# 510(k) Summary of 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: | Diagnostic Products Corporation |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 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, Clinical Affairs |
| Date of Preparation: | June 28, 2002 |
| Device Name:<br>Trade: | IMMULITE® Turbo CK-MB |
| Catalog Number: | LSKCP1 (100 tests), LSKCP5 (500 tests) |
| CFR: | A creatine phosphokinase/creatine kinase or isoenzymes<br>test system is a device intended to measure the activity of<br>the enzyme creatine phosphokinase or its isoenzymes (a<br>group of enzymes with similar biological activity) in<br>plasma and serum. Measurements of creatine<br>phosphokinase and its isoenzymes are used in the diagnosis<br>and treatment of myocardial infarction and muscle diseases<br>such as progressive, Duchenne-type muscular dystrophy. |
| Common: | Reagent system for the determination of creatine kinase<br>isoenzyme MB (CK-MB) in serum or heparinized plasma. |
| Classification: | Class II device, JHX (21CFR 862.1215) |
| Panel: | Clinical Chemistry |
| CLIA Complexity<br>Category: | We believe the category to be moderate, based on previous<br>classification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, California 90045-5597 |
| Establishment Registration<br>Number: | DPC's Registration Number is 2017183 |

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Substantially Equivalent Predicate Device:

IMMULITE CK-MB (K004002)

Description of Device:

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer.

## Intended Use of the Device:

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and is designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in patient management and the assessment of prognosis of myocardial infarction.

## Technology:

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent immunometric assay. based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.

The patient sample, a ligand-labeled anti-CK-MB monoclonal antibody and an alkaline phosphatase-labeled anti-CK-BB monoclonal antibody are simultaneously introduced into the Test Unit containing immobilized anti-ligand, and incubated for approximately 6 minutes at 37°C with intermittent agitation. During this time, CK-MB in the sample forms an antibody sandwich complex which. in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash; substrate is then added and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes bydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CK-MB in the sample.

## 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 CK-MB.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, resembling an abstract bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUL 2 2 2002

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96ht Street Los Angeles, CA 90045

Re: k022118

> Trade/Device Name: IMMULITE® Turbo CK-MB Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX Dated: June 28, 2002 Received: July 1, 2002

Dear Dr. Levine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 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

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#### 510(k) Number (if known): KO22-118 IMMULITE® Turbo CK-MB Device Name:

Indications For Use: The IMMULITE Turbo CK-MB is for in vitro diagnostic use with the IMMULITE Analyzer – for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma, as an aid in patient management and the assessment of prognosis of myocardial infarction.

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Congen
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022118