VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)

K972133 · Johnson & Johnson Clinical Diagnostics, Inc. · JLS · Jun 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972133
• Device Name: VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
• Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
• Product Code: JLS · Clinical Chemistry
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1620
• Device Class: Class 1

Intended Use

VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta

Device Story

The VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators are in vitro diagnostic components used with the VITROS Immunodiagnostic System. The system measures progesterone levels in human serum or plasma samples. The device is intended for use by clinical laboratory professionals to assist in diagnosing and managing ovarian or placental disorders. The system processes samples to provide quantitative results, which clinicians use to evaluate patient hormonal status and guide therapeutic decisions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

In vitro diagnostic reagent pack and calibrators for use with the VITROS Immunodiagnostic System. Quantitative measurement of progesterone in serum/plasma. Class I device, product code JLS.

Indications for Use

Indicated for the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) to aid in the diagnosis and treatment of ovarian or placental disorders.

Regulatory Classification

Identification

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 4 1997

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

Re : K972133 VITROS Immunodiagnostic Products Progesterone Reagent Pack (GEM.1070), Progesterone Calibrators (GEM.C070) Regulatory Class: I Product Code: JLS Dated: June 5, 1997 Received: June 6, 1997

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 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 Requlations, Title 21, Parts 800 to 895. A 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 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 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 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

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## Statement of Intended Use (Appendix D)

510(k) Number (if known): VITROS Immunodiagnostic Products Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators Indications for Use: VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
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(Division Sign-Off)
Division of Clinical Laboratory Devices

| 10(k) Number | K972133 |
|--------------|---------|
|--------------|---------|

| Prescription Use | <div>✓</div> |
|------------------|--------------|
|------------------|--------------|

OR Over-The-Counter Use ______
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Progesterone Reagent Pack
(Per 21 CFR 801.109) VITROS Immunodiagnostic Products Progesterone Calibrators92

**510(k) Number (if known**

Device Name:

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