FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

K040866 · Armkel, LLC · LCX · Oct 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040866
• Device Name: FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
• Applicant: Armkel, LLC
• Product Code: LCX · Clinical Chemistry
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses

Device Story

Device is an at-home, OTC, battery-powered digital pregnancy test. Input: urine sample applied to absorbent tip. Principle: immunochromatographic assay using colloidal gold label; identical to analog predicate. Transformation: internal microchip with circuitry/algorithm interprets immunochemical reaction on chromatographic strip. Output: digital display screen showing 'YES+' (pregnant), '-- NO' (not pregnant), or '?' (error). Used by lay users at home. Benefit: provides clear, unambiguous digital result instead of analog lines, aiding user interpretation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and identical immunochemical assay principles to the predicate device.

Technological Characteristics

Immunochromatographic assay; plastic housing with integrated microchip and LCD screen. Detection limit: 25 mIU/mL. Standardized to WHO 3rd International Reference Standard. Single-use device. Software developed under moderate level of concern life cycle processes.

Indications for Use

Indicated for the early detection of pregnancy (hCG in urine) in women of childbearing age by lay users prior to expected menses.

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

• FIRST RESPONSE® One-Step Pregnancy Test (k992232)
• CLEARBLUE® Easy Digital Pregnancy Test (k030659)

Submission Summary (Full Text)

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## OCT 1 9 2004

## FIRST RESPONSE® One-Step Digital Pregnancy Test 510(k) Premarket Notification

K040866

nril | 200 Page 4 of 17

## 510(K) SUMMARY

| Submitted by: | Church & Dwight Co., Inc./ArmKel, LLC<br>469 North Harrison Street<br>Princeton, NJ 08543 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky<br>Director, Regulatory Affairs<br>[phone] |
| Date Prepared: | April 2004 |
| Proprietary Name: | FIRST RESPONSE® One-Step Digital Pregnancy Test |
| Common Name: | At-home Pregnancy Test (OTC) |
| Classification Name: | Human chorionic gonadotropin (hCG) test system [21 CFR §862.1155; LCX]<br>Kit, Test, Pregnancy, hCG, Over-the-Counter |
| Predicate Device: | FIRST RESPONSE® One-Step Pregnancy Test<br>— 510(k) #K992232<br>and<br>CLEAR BLUE® Easy Digital Pregnancy Test (Unipath Ltd., UK)<br>— 510(k) #K030659 |

Description of Device: The FIRST RESPONSE® One-Step Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a device intended for use by the lay user in the early detection of pregnancy by the detection of hCG, a placental hormone in urine. The FIRST RESPONSE® One-Step Digital Pregnancy Test labeling provides for the use of the test as early as three (3) days before the expected period. [Refer to K992232.] The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays. the result of the immunochemical reaction on the Display Screen of the device housing, as opposed to an analog display of the predicate device. The immunochemical reagents that are striped onto a chromatographic strip are unchanged from the predicate FIRST RESPONSE® One-Step Pregnancy Test.

Following the instructions for use provided with the device, the test is performed by placing the Absorbent Tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds, then allowing the test to continue for 3 minutes. During this time, a blinking clock icon appears on the Display Screen of the device housing to indicate that the test is working. After the elapse of 3 minutes, a digital display of the result appears on the Display Screen: a "YES+" test result indicates that the pregnancy hormone (hCG) was detected (pregnant); a "-- NO" test result indicates that the pregnancy hormone (hCG) was not detected (not pregnant). A " ? " (question mark) appears when a test error has occurred.

Intended Use of the Device: The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device for use by the lay user for the early detection of pror to the expected menses.

Technological Characteristics: Both the subject 510(k) device and the predicate FIRST RESPONSE® One-Step (analog) Pregnancy Test device utilize the identical principles for the assay of hCG: an immunochromatographic assay using colloidal gold as a direct label. The subject 5100 k ) device differs solely in that it provides a digital display of the test result for the consumer to read in place of the colored lines of the predicate device. The digital version of the device incorporates into the stick housing an electronic component consisting of a microchip with specific circuitry and algorither ne aple of determining and correctly interpreting the reaction result and displaying a simple "YES+" or a Display Screen. The digital device is battery powered and will display the result for at least thirty minutes after completion of the reaction. All components are integrated and unitized into the stick housing.

Image /page/0/Picture/10 description: The image shows the logo for First Response Digital Pregnancy Test. The logo is in black and white and features the words "First Response" in a stylized font. The words "The One-Step Digital Pregnancy Test" are also present in a smaller font. The logo is simple and easy to read.

Church & Dwight Co., Inc. ARMKEL, LLC

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

OCT 1 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Armkel, LLC Church & Dwight CO., Inc. 469 North Harrison Street Princeton, NJ 08543-5297

Re: k040866

> Trade/Device Name: FIRST RESPONSE™ One- Step Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: August 26, 2004 Received: August 27, 2004

Dear Mr. Kolakowski:

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,

Jean M. Cooper, U.S. 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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| 510(k) Number: | K040866 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | FIRST RESPONSE® One-Step Digital Pregnancy Test |
| Indications for Use: | The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses |
| Prescription Use<br>(Per 21 CFR §801.109) | OR Over-the-Counter Use <span style="text-decoration:underline;">X</span> |

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K040866