CLINITEST HCG PREGNANCY TEST

K032563 · Bayer Healthcare, LLC · JHI · Dec 23, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032563
• Device Name: CLINITEST HCG PREGNANCY TEST
• Applicant: Bayer Healthcare, LLC
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. The test is utilized with the Clinitest Status analyzer and is intended for near patient (point of care) and centralized laboratory locations.

Device Story

Clinitest hCG Pregnancy Test is a qualitative sandwich-type immunochromatographic assay. Input: urine specimen applied to test cassette. Principle: anti-beta hCG antibodies coupled to colloidal gold particles bind hCG in sample; complex migrates to test line containing anti-alpha hCG antibodies, forming visible pink line. Control line uses goat anti-mouse IgG. Device is used with Clinitek Status analyzer; instrument reads reflectance of test line, reference line, and calibration bar. Output: qualitative result (positive, negative, or borderline). Borderline results prompt retest in 48-72 hours. Used in point-of-care or lab settings by professionals. Benefits: automated reading removes subjectivity of visual interpretation, providing standardized results based on 25 mIU/mL cutoff.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data: precision/reproducibility (intra-instrument CV <10% weak, <4% moderate/strong; inter-instrument CV <11% weak, <4.6% strong) and method comparison study (n=3120) against visually read predicate. Agreement analysis showed 99.7% negative agreement and 99.1% positive agreement after resolving discrepancies with RIA.

Technological Characteristics

Qualitative sandwich-type immunoassay; monoclonal anti-alpha hCG antibodies (test line), goat anti-mouse IgG (control line), colloidal gold-labeled anti-beta hCG. Dimensions: test cassette. Connectivity: Clinitek Status analyzer. Calibration: internal self-calibration via white plastic bar and reference line. Standards: ISO 14971, ISO 13485, IEEE 1012, ISO/IEC 12207, AAMI/ANSI SW68, IEC 60601-1-2.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine specimens to aid in the detection of pregnancy. Intended for use in near-patient (point-of-care) and centralized laboratory settings using the Clinitek Status analyzer.

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

• Clinitest hCG Pregnancy Test (K023944)
• Quidel QuickVue One-Step hCG Combo (K020801)

Submission Summary (Full Text)

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K032563

DEC 2 3 2003

# Appendix A Summary of Safety and Effectiveness

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

## 1. Submitters Information

| Contact person: | Mary E. Gray, RAC<br>NPT Regulatory Affairs Manager |
|------------------------|---------------------------------------------------------------------------------------------------|
| Address: | Bayer Healthcare, LLC<br>Subsidiary of Bayer Corporation<br>63 North Street<br>Medfield, MA 02052 |
| Phone: | [phone] |
| Fax: | [phone] or [phone] |
| e-mail address: | [e-mail] |
| Date Summary Prepared: | November 7, 2003 |
| 2. Device Information | |

# 〜に〜it

| Proprietary Name: | Clinitest® hCG Pregnancy Test |
|------------------------|------------------------------------------------|
| Common Name: | hCG Test System |
| Classification Name: | Radioimmunoassay, Human Chorionic Gonadotropin |
| Classification Number: | 21 CFR 862.1155, Class II |
| Classification Panel: | Clinical Chemistry and Clinical Toxicology |

## 3. Predicate Device Information

| Device Name: | Clinitest hCG Pregnancy<br>Test | Quidel QuickVue One-Step<br>hCG Combo |
|-------------------|---------------------------------|---------------------------------------|
| Manufacturer: | Bayer Healthcare, LLC | Quidel Corporation |
| 510(k)<br>Number: | # K023944 | # K020801 |

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# Appendix A Summary of Safety and Effectiveness

#### 4. Device Description

The Clinitest® hCG is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in urine. The device is read by the Clinitek Status instrument.

#### 5. Statement of Intended Use

The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. The test is utilized with the Clinitest Status analyzer and is intended for near patient (point of care) and centralized laboratory locations.

### 6. Summary of Technological Characteristics

The Clinitest hCG Pregnancy Test is similar in technological characteristics, device performance and intended use, therefore, is substantially equivalent to the predicate performanoo and intenace ass, nency Test (# K023944) and the Quidel QuickVue One-Step hCG Combo test (# K020801).

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 2003

Ms. Mary E. Gray NPT Regulatory Affairs Manager Bayer Healthcare, LLC Subsidiary of Bayer Corporation 63 North Street Medfield, MA 02052

k032563 Re: Trade/Device Name: Clinitest® hCG Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: November 7, 2003 Received: November 10, 2003

Dear Ms. Gray:

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 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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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 Butman

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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# INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K032563 |
|---------------------------|---------|
|---------------------------|---------|

Bayer Healthcare Clinitest® hCG Pregnancy Test Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use a r he Bayer Fredit four of human chorionic gonadotropin (hCG) in unne qualitatio mother in used to obtain a Clinitek Status analyzer result of positive, borderline or negative and is intended for near patient (point-of-care) and centralized laboratory locations.

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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)

Carol C Benson

Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) /<032563