VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)

K973030 · Johnson & Johnson Clinical Diagnostics, Inc. · JJY · Sep 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973030
• Device Name: VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
• Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum in the diagnosis and treatment of myocardial infarction. VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum. VITROS Cardiology Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of CK-MB.

Device Story

VITROS Immunodiagnostic Products CK-MB system consists of reagent pack, calibrators, and controls for quantitative measurement of CK-MB enzyme in human serum; used in clinical laboratory settings by trained personnel. Device operates on VITROS Immunodiagnostic System; provides quantitative results to assist clinicians in diagnosis and treatment of myocardial infarction. System monitors performance via dedicated controls and calibration. Output enables healthcare providers to assess cardiac injury status; facilitates timely clinical decision-making for patients suspected of myocardial infarction.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and performance characteristics of the reagent system.

Technological Characteristics

In vitro diagnostic reagent system for quantitative enzyme measurement; utilizes immunodiagnostic assay principles on the VITROS Immunodiagnostic System platform. Includes reagent pack, calibrators, and controls for serum analysis.

Indications for Use

Indicated for use in human serum to measure creatine phosphokinase or its isoenzymes for the diagnosis and treatment of myocardial infarction.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

SEP - 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ann M. Quinn Manager, Regulatory Affairs Johnson & Johnson Clinical Diagnostics 100 Indigo Creek 14650 Rochester, New York

Re : K973030 VITROS Immunodiagnostic Products CK-MB Reagent Pack (GEM.1300), CK-MB Calibrators (GEM.C300) Regulatory Class: I & II Product Code: JJY, JHX, JIX August 13, 1997 Dated: August 14, 1997 Received:

Dear Ms. Quinn:

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 The general controls provisions of provisions of the Act. 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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verily 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.

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

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/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

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

## Statement of Intended Use (Appendix D)

## 510(k) Number (if known): VITROS Immunodiagnostic Products CK-MB Reagent Pack Device Name: VITROS Immunodiagnostic Products CK-MB Calibrators VITROS Immunodiagnostic Products Cardiology Controls Indications for Use: VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum in the diagnosis and treatment of myocardial infarction. VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum. VITROS Cardiology Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of CK-MB. (Division Sign-Off) (Division Sign-Only aboratory I. evices 510(k) Number (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 1 Over-The-Counter Use Prescription Use OR

(Optional Format 1-2-96)

Page 1 of 1

Ortho-Clinical Diagnostics

(Per 21 CFR 801.109)

VITROS Immunodiagnostic Products CK-MB Reagent Pack VITROS Immunodiagnostic Products CK-MB Calibrators VITROS Immunodiagnostic Products Cardiology Controls