CLEARBLUE EASY DIGITAL PREGNANCY TEST

K060128 · Unipath , Ltd. · LCX · May 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060128
• Device Name: CLEARBLUE EASY DIGITAL PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Clearblue Easy Digital Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

Device Story

Device is an over-the-counter, ready-to-use digital pregnancy test. Input: urine sample collected via stream (5 seconds) or cup (20 seconds). Principle: sandwich immunochromatographic assay using monoclonal antibodies specific for hCG. Device contains test chip, absorbent sampler, and electronic/optical components. Reader measures reflectance of light on test and control lines to determine result. Output: digital pregnancy result or error message. Used by lay users at home. Output informs user of pregnancy status, aiding in early clinical decision-making regarding prenatal care.

Clinical Evidence

Bench testing only. Performance was evaluated through analytical sensitivity and specificity studies comparing the digital test results to established hCG detection standards and the predicate device. No clinical trial data was required for this 510(k) submission.

Technological Characteristics

Sandwich immunochromatographic assay; monoclonal antibodies (anti-beta hCG, goat anti-rabbit, anti-alpha hCG, rabbit IgG). Integrated test stick and electronic reader in molded case. Reflectance-based optical sensing. Standardized against WHO 4th International Standard 75/589. Standalone device; no connectivity.

Indications for Use

Indicated for over-the-counter detection of pregnancy in urine, starting four days before the expected 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

• Clearblue Easy Pregnancy Test (K021660)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 2 5 2006

Ms. Louise Roberts Regulatory Affairs Manager Unipath Limited Priory Business Park Bedford MK44 3UP United Kingdom

Re: k060128

Trade/Device Name: Clearblue Easy 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: May 10, 2006 Received: May 15, 2006

Dear Ms. Roberts:

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/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, Ph.D. 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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## Indications for Use

510(k) Number (if known): K060128

Device Name: Clearblue Easy Digital Pregnancy Test

Indications For Use:

Clearblue Easy Digital Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

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

CAC
Division Sign-Off

Office of In Vit~o Diagnostic Device Evaluation and Safety

X60128

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