OPUS PROGESTERONE

K971725 · Behring Diagnostics, Inc. · JLS · Jun 18, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971725
• Device Name: OPUS PROGESTERONE
• Applicant: Behring Diagnostics, Inc.
• Product Code: JLS · Clinical Chemistry
• Decision Date: Jun 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1620
• Device Class: Class 1

Intended Use

OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in serum or heparanized plasma, used in the diagnosis and treatment of disorders of the ovaries or placenta. OPUS Progesterone is intended for use with the OPUS analyzers

Device Story

OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) reagent kit; used with OPUS immunoassay analyzers. Input: human serum or heparanized plasma samples. Operation: sequential binding immunoassay using enzyme-labeled mouse monoclonal antibody. Output: quantitative progesterone concentration. Used in clinical laboratory settings; operated by laboratory personnel. Output provides clinicians with progesterone levels to assist in diagnosing and managing ovarian or placental disorders.

Clinical Evidence

Bench testing only. Precision: Intra-assay %CV 8.2-14.4%; Inter-assay %CV 9.7-14.4%. Accuracy by recovery: 80-111%. Accuracy by correlation: 83 serum samples compared to commercial assay (r=0.97, slope=0.99, y-intercept=-0.19).

Technological Characteristics

Fluorogenic enzyme immunoassay (ELISA). Reagents include enzyme-labeled mouse monoclonal antibody. Six-point calibrator system. Designed for use with automated fluorometric OPUS analyzer system. Quantitative measurement principle: sequential binding.

Indications for Use

Indicated for the quantitative measurement of progesterone in human serum or heparanized plasma 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.

Predicate Devices

• DPC Coat-a-Count® Progesterone

Submission Summary (Full Text)

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K971725

Behring Diagnostics Inc. OPUS® Progesterone 510(k) Notification

JUN 18 1997

### Summary for 510(k) OPUS Progesterone

.

## Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:

Manufacturer:

Behring Diagnostics Inc. 151 University Avenue Westwood. MA 02090 617-320-3117 Attn: Ruth Forstadt

Preparation date:

May 8, 1997

#### Name/ Classification: 2. Device

OPUS Progesterone: Progesterone Test System Class | (862.1620) Classification Number:

### Identification of the legally marketed device: 3.

DPC Coat-a-Count® Progesterone

#### Proposed Device Description: 4 .

OPUS Progesterone is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of progesterone in human serum or heparanized plasma.

### Proposed Device Intended Use: 5.

OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in human serum or heparanized plasma. OPUS Progesterone is intended for use with the OPUS analyzers.

CONFIDENTIAL

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Behring Diagnostics Inc. OPUS® Progesterone 510(k) Notification

### Medical device to which equivalence is claimed and comparison 6. information:

The OPUS Progesterone assay is substantially equivalent in intended use to the DPC Coata-Count® Progesterone. The DPC Coat-a-Count® Progesterone, like the proposed product, use a labeled antibody for the quantitative measurement of progesterone in human serum or heparanized plasma.

The OPUS Progesterone differs from the DPC Coat-a-Count® Progesterone in the technique employed for the quantitative measurement of progesterone. While the DPC Coat-a-Count® Progesterone employs competitive immunassay, the OPUS Progesterone test system is one of sequential binding. Progesterone is labeled with 1185 in the DPC Coat-a-Count® Progesterone, while in the OPUS Progesterone test the antibody is an enzyme labeled mouse monoclonal. Also, the OPUS Progesterone includes a six-point calibrator sytem, whereas the DPC Coat-a-Count® Progesterone includes a seven-point calibrator system. Additionally, the OPUS Progesterone is used with a fully automated fluorometric instrument system, while the DPC Coat-a-Count® Progesterone uses a gamma counter.

### Proposed Device Performance Characteristics: 7 .

## Precision

Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 8.2% to 14.4%.

Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assaved over a five day period to total 20 replicates. %CV ranged from 9.7% to 14.4%.

## Accuracy by Recovery

Recovery was determined by spiking previously assayed and pooled human serum matrix with five different levels of Progesterone. The samples were assayed using OPUS Progesterone in duplicate. Percent recovery ranged from 80 to 111%.

## Accuracy by Correlation

OPUS Progesterone was compared to a commercially available Progesterone assay by evaluation of 83 serum samples ranging from 0.44 to 37.92 ng/ml. A correlation coefficient of 0.97 was obtained, with a y-intercept value of -0.19 and a slope of 0.99.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird or an abstract human figure with three curved lines. The symbol is positioned to the right of the text, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 18 1997

Ruth Forstadt Regulatory Affairs Associate Behring Diagnostics Inc. 151 University Avenue Westwood, Massachusetts 02090

K971725 Re: OPUS® Progesterone Test System Requlatory Class: I Product Code: JLS Dated: May 8, 1997 Received: May 9, 1997

Dear Ms. Forstadt:

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 The general controls provisions of the Act 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 requlations 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) requlation (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 requlation (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 gener 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 Gutman

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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Behring Diagnostics Inc. OPUS® Progesterone 510(k) Notification

Page of of

K971725 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_

参

OPUS Progesterone Test System

Indications For Use:

OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in serum or heparanized plasma, used in the diagnosis and treatment of disorders of the ovaries or placenta. OPUS Progesterone is intended for use with the OPUS analyzers

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

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

(Division Sign-Off)

• Division of Clinical Laboratory Devices,

510(k) Number 2171725

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

DOCCC

Confidential