BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST

K023944 · Bayer Corp. · JHI · Feb 11, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023944
• Device Name: BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
• Applicant: Bayer Corp.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Bayer Diagnostics Clinitest® hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlU/ml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.

Device Story

Bayer Diagnostics Clinitest® hCG Pregnancy Test is a one-step chromatographic immunoassay for qualitative hCG detection in urine. Device utilizes a membrane strip pre-coated with anti-hCG capture antibody and goat anti-mouse IgG control. Patient urine reacts with colloidal gold particles coated with anti-hCG monoclonal antibody; mixture migrates via capillary action. Positive result indicated by colored test line; control and reference lines appear to validate test and provide 25 mIU/mL intensity benchmark. Used in professional/laboratory settings; results interpreted visually by healthcare personnel. Comparison of test line intensity against reference line allows estimation of hCG concentration relative to 25 mIU/mL cut-off. Assists clinicians in pregnancy diagnosis.

Clinical Evidence

Bench testing only. Sensitivity study (N=280) evaluated hCG concentrations from 0-50 mIU/mL; results confirmed detection at 25 mIU/mL cut-off. Accuracy study (N=200) compared visual results against a commercial immunoradiometric assay, demonstrating 100% agreement.

Technological Characteristics

One-step chromatographic immunoassay; lateral flow membrane strip. Components: anti-hCG capture antibody, goat anti-mouse IgG, colloidal gold particles coated with anti-hCG monoclonal antibody. Cut-off: 25 mIU/mL (calibrated against WHO 3rd IRP). Visual readout via test, control, and reference lines.

Indications for Use

Indicated for the rapid qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy in professional and laboratory settings.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• SureStep™ hCG/Combo (II) Pregnancy Test

Reference Devices

• Adaltis Italia immunoradiometric assay (Magnetic Solid Phase)

Submission Summary (Full Text)

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K023944

### Summary of Safety and Effectiveness

# FEB 1 1 2003

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

- 1. Submitter Information
Contact person: Thomas F. Flynn

Baver Diagnostics Address: 63 North Street Medfield, MA 02052

| Phone: | [phone] |
|---------|--------------------------|
| FAX: | [phone] |
| e-mail: | [e-mail] |

#### 2. Device Information

| Proprietary Name: | Bayer Diagnostics Clinitest® hCG Pregnancy Test |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | An hCG test system is a device intended for early<br>detection of Pregnancy. It is intended to measure hCG, a<br>placental hormone in urine. |

| Classification Name: Human Chorionic Gonadotropin (hCG) test system for the |
|-----------------------------------------------------------------------------|
| use in early detection of pregnancy. |

#### 3. Predicate Device Information

SureStep™ hCG/Combo (II) Pregnancy Test Name:

#### 4. Device Description

Human Chorionic Gonadotropin (hCG) test system for the use in early detection of pregnancy.

#### ട. Statement of Intended Use

The Bayer Diagnostics Clinitest® hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlU/ml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.

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#### . Summary of Technological Characteristics

The Bayer Diagnostics Clinitest® hCG Pregnancy Test is a one-step chromatographic immunoassav for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine. The test cut-off is 25 mlU/ml hCG in urine. The test device contains a membrane strip that was pre-coated with anti-hCG capture antibody on the test line region and goat anti-mouse IgG on the control band region. During testing, the patient specimen is allowed to react with the colloidal gold particles that have been coated with anti-hCG monoclonal antibody. The mixture then moves along or across the membrane chromatographically by capillary action. For a positive result, a colored band with a specific anti-hCG-antibody-colloidal gold particle complex will form on the membrane in the test region. A strong colored line will always appear in the control region and another light colored line will always appear in the reference region. The color intensity of the reference line has been adjusted to a level of approximately 25 mlU/ml hCG. Comparison of the test line intensity to the reference line intensity will allow the estimation of whether the positive results are less than, equal to or greater than 25 mlU/ml hCG in serum.

#### 7. Performance Data

### Sensitivity

The Bayer Diagnostics Clinitest® hCG Pregnancy Test detects urinary hCG concentrations at 25 mlU/mL (Calibrated against WHO 310 IRP).

A sensitivity study was performed by spiking negative urine. medium specific gravity with hCG standard to the concentrations of 0, 5, 10, 15, 20, 25 and 50 miU/mL. The urine pool was prepared from 4 donors. The samples were blindlabeled and tested with the Clinitest® hCG Pregnancy Test using two different validation lots of product. A total of 280 samples were tested. Samples were randomly distributed among four visual readers for each product lot.

| hCG Concentration<br>mlU/mL | 0 | 5 | 10 | 15 | 20 | 25 | 50 |
|-----------------------------|----|----|----|----|----|----|----|
| N = | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Number of<br>Positives | 0 | 5 | 9 | 13 | 15 | 18 | 20 |
| Number of<br>Negatives | 20 | 15 | 11 | 7 | 5 | 2 | 0 |

### Clinitest hCG Lot 1 N=140

### Clinitest hCG Lot 2 N=140

| hCG Concentration<br>mIU/mL | 0 | 5 | 10 | 15 | 20 | 25 | 50 |
|-----------------------------|----|----|----|----|----|----|----|
| N = | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Number of<br>Positives | 0 | 3 | 9 | 10 | 13 | 19 | 20 |
| Number of<br>Negatives | 20 | 17 | 11 | 10 | 7 | 1 | 0 |

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### Accuracy

Two external sites were contracted to perform testing on the Clinitest® hCG test (validation lot 59421). A total of 200 visual test results were obtained. Site one tested 98 samples and site 2 tested 102 samples. The samples were prepared by pooling four urine specimens of medium specific gravity, aliquoting and spiking with hCG. The samples were divided by site.

| Sample | Site 1 | Site 2 | Total |
|-----------------------|--------|--------|-------|
| 0 mlU/mL Lablot # 1 | 33 | 35 | 68 |
| 25 mlU/mL Lablot # 2 | 33 | 33 | 66 |
| 100 mlU/mL Lablot # 3 | 32 | 34 | 66 |
| | | | 200 |

Clinitest® hCG Visual Results

The results of the Clinitest® hCG external site data compared to a commercial hCG assay results The commercial assay was an immunoradiometric assay (Magnetic Solid Phase) made by ADALTIS Italia, purchased through Polymedco, Inc. There was 100% agreement of sample results with the commercial hCG assay.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# FEB 1 1 2003

Mr. Thomas F. Flynn Director of Regulatory Affairs Bayer Diagnostics Baver Corporation 63 North Street Medfield, MA 02052-1688

Re: k023944

> Trade/Device Name: Bayer Diagnostics Clinitest® hCG Pregancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: November 21, 2002 Received: November 26, 2002

Dear Mr. Flynn:

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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K.O. 2394

Device Name:

Indications for Use:

The Bayer Diagnostics Clinitest® hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlU/ml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.

Jlan Coogen
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(Division Sign-Off)

Division of Clinical Labora 510(k) Number -

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter

(Optional

Use (Per 21 CFR 801.109) Format 1-2-96)