FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST

K070054 · Church & Dwight Co., Inc. · LCX · May 4, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070054
• Device Name: FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
• Applicant: Church & Dwight Co., Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy prior to the expected menses. The test is indicated for use from four days before the expected period, that is, five days before the missed period.

Device Story

The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an OTC, battery-powered, single-use diagnostic device for home pregnancy detection. It utilizes an immunochromatographic assay with colloidal gold labeling to detect hCG in urine. The device integrates a chromatographic strip with electronic/optical components, a microprocessor, and algorithms. Upon urine application, the device performs immunochemical reactions; the internal optical system reads the reaction result, and the microprocessor interprets the data to display a clear 'YES+' or '-NO' on an integrated screen. This digital output replaces the traditional colored-line interpretation, simplifying results for the lay user. The device displays the result for at least 30 minutes post-reaction, aiding clinical decision-making by providing early, unambiguous pregnancy confirmation.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Immunochromatographic assay; colloidal gold label; battery-powered; integrated electronic/optical components; microprocessor-based digital display; unitized stick housing.

Indications for Use

Indicated for lay users for early pregnancy detection via urine hCG testing, starting 5 days before the expected missed period.

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

• CLEAR BLUE® Easy Digital Pregnancy Test (K041404)

Reference Devices

• First Response Early Result Pregnancy Test (K030258)

Submission Summary (Full Text)

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| 3.0 510(k) SUMMARY | | K070054 |
|--------------------------|-----------------------------------------------------------------------------------------|--------------|
| 3.1 Submitted by: | Church & Dwight Co., Inc<br>469 North Harrison Street<br>Princeton, NJ 08543 | |
| 3.2 Contact Person: | Cynthia Davidson<br>Manager, Regulatory Affairs<br>[phone]<br>[phone] FAX | MAY - 4 2007 |
| 3.3 Date Prepared: | December 28, 2006 | |
| 3.4 Proprietary Name: | FIRST RESPONSE® GOLD™ Digital Pregnancy Test | |
| 3.5 Common Name: | At-home Pregnancy Test (OTC) | |
| 3.6 Classification Name: | Human chorionic gonadotropin (hCG) test system<br>[21 CFR §862.1155] 75 LCX; Class II | |
| 3.7 Predicate Device: | CLEAR BLUE® Easy Digital Pregnancy Test (Unipath<br>Ltd., UK), K041404 | |

3.8 Description of Device: The FIRST RESPONSE® GOLD™ 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 device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions on a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays the result of the immunochemical reactions on the Display Screen of the device in a manner similar to the predicate device.

3.9 Intended Use and Indication for Use of the Device: The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy prior to the expected menses. The test is indicated for use from four days before the expected period, that is, five days before the missed period.

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## 3.0 510(K) SUMMARY

3.10 Technological Characteristics: The subject 510(k) device and its analog counterpart First Response Early Result Pregnancy Test (K#030258) utilize the identical immunochemical principles for the assay of hCG: an immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in that it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The digital version of the device incorporates into the stick housing electronic and optical components along with a microprocessor and specific algorithms capable of determining and correctly interpreting the reaction result and displaying a simple "YES+" or "-NO" on 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Church & Dwight Co., Inc. c/o Ms. Cynthia Davidson Regulatory Affairs Manager 469 North Harrison Street Princeton, NJ 08543

MAY - 4 2007

Re: k070054

Trade/Device Name: FIRST RESPONSE® Gold™ 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: April 11, 2007 Received: April 12, 2007

Dear Ms. Davidson:

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 onte 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 tolling of [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopers, M.S., D.V.M.

Séan M. Cooper, M.S., 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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## ADDIGATIONS FOR SECT SEPS FOR FECTORY.

| 510(k) Number: | K070054 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | FIRST RESPONSE® GOLD™ Digital Pregnancy Test |
| Indications for Use: | The First Response Gold Digital Pregnancy Test is an in<br>vitro diagnostic test device intended for the early detection of<br>pregnancy by the lay user up to five (5) days sooner than the<br>day of the missed period (four (4) days before the day of the<br>expected period). The test detects human chorionic<br>gonadotropin in urine. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/ OR Over-the Counter Use X Part 21 CFR 801

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

Division Sign-On

Office of In Vit > Diagnostic Device ිvaluation and Safety

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