CLEARBLUE EASY EASY READ PREGNANCY TEST

K041404 · Unipath , Ltd. · LCX · Jun 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041404
• Device Name: CLEARBLUE EASY EASY READ PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jun 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a Clearbite Easy Easy Read Fregnancy. The test is indicated for use from three days before the expected period.

Device Story

Clearblue Easy Easy Read Pregnancy Test is an over-the-counter lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine. Device intended for home use by consumers to detect pregnancy. User applies urine sample to absorbent tip; hCG, if present, binds to labeled antibodies; complex migrates to test zone; visual signal indicates presence of hCG. Results interpreted visually by user. Provides early detection capability starting three days before expected period. Benefits include convenient, rapid, and private pregnancy confirmation.

Clinical Evidence

No clinical data provided; device relies on established immunoassay technology for hCG detection.

Technological Characteristics

Lateral flow immunoassay; qualitative detection of hCG in urine; visual readout; over-the-counter home use format.

Indications for Use

Indicated for over-the-counter use by individuals to detect human chorionic gonadotropin (hCG) in urine to determine pregnancy, starting from three 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.

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

JUN - 8 2004

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

Re: k041404

Ko 11-Device Name: Clearblue Easy Easy Read 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 20, 2004 Received: May 26, 2004

Dear Ms.Roberts:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobate) is the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978) as ecordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmette 710 (110) that to hevice, subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the detect coursements for annual registration, listing of general controls provisions of ractice, 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 your device is elabilitied (oss as controls. Existing major regulations affecting your device It may be subject to suen additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, ovcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri brounder of your device complies with other requirements of the Act that I DA has made a acterinaliations administered by other Federal agencies. You must of ally Federal statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice er it rart 807), laboring 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) I his letter will anow you to begin mailoning of substantial equivalence of your device to a legally premaired notincation: "The PDF interessification 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, II you desire specific mionitation association of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the In Viro Diagnostic De reserence to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other belief general ers, 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,

Sean 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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## Indications for Use

#### 510(k) Number (if known):

# Ko41404

Clearblue Easy Easy Read Pregnancy Test Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a Clearbite Easy Easy Read Fregnancy. The test is indicated for use from three days before the expected period.

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

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safetv

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