CLEARBLUE EASY PREGNANCY TEST

K110433 · SPD Development Company Limited · LCX · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110433
• Device Name: CLEARBLUE EASY PREGNANCY TEST
• Applicant: SPD Development Company Limited
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Clearblue® Plus 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 (5 days before the missed period).

Device Story

Clearblue Plus 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 (line) indicates positive result. Provides rapid, qualitative assessment of pregnancy status. Results interpreted visually by user. Benefits include early pregnancy detection prior to missed period.

Clinical Evidence

No clinical data provided; device relies on bench testing to demonstrate analytical performance and substantial equivalence to the predicate.

Technological Characteristics

Lateral flow immunoassay; qualitative detection of hCG in urine. Device utilizes antibody-antigen binding principle. Form factor is a handheld test stick. No electronic components, software, or connectivity. Sterilization not applicable for this diagnostic test type.

Indications for Use

Indicated for over-the-counter detection of pregnancy in urine. Suitable for use by women starting 4 days before the expected period (5 days before the 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

• Clearblue Easy Pregnancy Test (K081635)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol of a human figure, represented by three stylized profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 1 2 2011

SPD Development Company Limited c/o Ms. Tanya Fair Regulatory Affairs Manager Stannard Way, Priory Business Park Bedford, Bedfordshire United Kingdom MK44 3UP

Re: k110433

Trade/Device Name: Clearblue Plus Pregnancy Tesst Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: April 28, 2011 Received: May 03, 2011

Dear Ms. Fair:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

C.C.

Courtney Harper, 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 Form

510(k) Number (if known): K110433

Device Name: Clearblue® Plus Pregnancy Test

Indications for Use:

Clearblue® Plus 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 (5 days before the missed period).

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

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

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

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

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k): K110433

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