ONE-STEP PREGNANCY TEST

K041273 · W.H.P.M., Inc. · LCX · May 20, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041273
• Device Name: ONE-STEP PREGNANCY TEST
• Applicant: W.H.P.M., Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine. for the early detection of pregnancy. For Over-The-Counter Use.

Device Story

The One-Step Pregnancy Test is a lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine. The device utilizes a combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies. When urine is applied, the antibody-dye conjugate binds to hCG, forming a complex that migrates to a reaction zone. If hCG concentration is ≥25 mIU/ml, the complex binds to anti-hCG antibodies, producing a visible pink-rose color band. A control zone confirms reagent function via unbound conjugate. The test is intended for home use by untrained individuals. Results are visually interpreted by the user to determine pregnancy status.

Clinical Evidence

Clinical trial compared the One-Step Pregnancy Test to the Stanbio True 20 One-Step Pregnancy Test. Results showed 100% sensitivity, 100% specificity, and 100% agreement. Pregnancy results were confirmed by physical examination and/or ultrasound. Testing by untrained women of childbearing years confirmed the test can be effectively performed by lay users.

Technological Characteristics

Solid-phase sandwich immunochromatographic assay. Components: goat polyclonal anti-hCG coated membrane, mouse monoclonal anti-hCG dye conjugate. Formats: cassette, test strip, midstream. Qualitative visual readout. Sensitivity: 25 mIU/mL. Traceability: WHO 3rd International Standard.

Indications for Use

Indicated for qualitative detection of hCG in urine for early pregnancy detection in women of childbearing age. For over-the-counter use.

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

• One-Step Pregnancy Test (K031271)

Reference Devices

• Stanbio True 20 hCG

Submission Summary (Full Text)

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MAY 2 0 2004

KÖ41273

Page 20 of 38

# 510 (K) SUMMARY

Date of Summary: May 10, 2004

#### Product Name:

One-Step Pregnancy Test

### Sponsor:

WHPM, Inc. 9440 Telstar, Inc. El Monte, CA 91731

#### Correspondent:

MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915

#### Substantially Equivalent Devices:

Product: Amerisource One Step Pregnancy Test Manufactured by: W.H.P.M., Inc.

1988 - 1

### PRODUCT DESCRIPTION:

The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.

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### INTENDED USE:

The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine. for the early detection of pregnancy. For Over-The-Counter Use.

# SUMMARY OF TECHNOLOGY:

The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pinkrose color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band, demonstrating that the reagents are functioning correctly.

## PERFORMANCE DATA:

A clinical trial was done to compare the performance of the One-Step Pregnancy Test to a FDA cleared product. These data clearly demonstrate the performance of the One-Step Pregnancy Test by Amerisource is substantially equivalent to a commercially available FDA cleared pregnancy test: Stanbio True 20 One-Step Pregnancy Test

| Sensitivity = | 100% |
|---------------|------|
| Specificity = | 100% |
| Agreement = | 100% |

## STATEMENT OF SAFETY AND EFFICACY:

The One-Step Pregnancy Test when compared with another commonly used pregnancy test (Stanbio True) demonstrated 100% performance.

All pregnancy results were confirmed by physical examination and/or ultrasound.

These data clearly demonstrate the safety and efficacy of the One-Step Pregnancy Test and further confirm that the accuracy, sensitivity and specificity of this product when compared to a substantially equivalent device currently being sold.

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Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals.

W.H.P.M. confirms that any/all data provided in this submission may be released upon request.

:

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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 features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 0 2004

W.H.P.M., Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

> k041273 Trade/Device Name: One- Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chronic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: May 11, 2004 Received: May 12, 2004

Dear Ms. White:

Re:

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 devicc 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, rr you don't 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,

Jann M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510k Submission One-Step Pregnancy Test WHPM, Inc.

Page 23 of 38

Indications for Use

510(k) Number (if known): K041273

Device Name: One-Step Pregnancy Test

Indications for Use:

The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The -Counter Use

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (21 CFR 807 Subpart C)

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

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

**Division Sign-Off**

Page __ of ________________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041273