CLEARBLUE EASY DIGITAL PREGNANCY TEST

K030659 · Unipath , Ltd. · LCX · May 2, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030659
• Device Name: CLEARBLUE EASY DIGITAL PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-the-counter qualitative urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

Device Story

Clearblue Easy Digital Pregnancy Test is an over-the-counter, qualitative, lateral flow immunoassay for urine hCG detection. User applies urine to test stick; device detects hCG levels at 50mIU/ml threshold. Integrated digital display provides clear 'Pregnant' or 'Not Pregnant' result, replacing traditional visual line interpretation. Designed for home use by lay individuals to confirm pregnancy starting from the first day of a missed period. Simplifies result interpretation, reducing potential for user error associated with reading faint test lines.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and performance specifications for hCG detection.

Technological Characteristics

Lateral flow immunoassay; qualitative urine hCG detection; digital display output; sensitivity 50mIU/ml; over-the-counter home-use form factor.

Indications for Use

Indicated for over-the-counter qualitative detection of pregnancy in urine for individuals from the first day of a missed period. Sensitivity is 50mIU/ml hCG.

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)

{0}------------------------------------------------

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 stylized image of an eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY = 2 2003

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

Re: k030659

> 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: February 28, 2003 Received: March 3, 2003

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).

{1}------------------------------------------------

Page 2 -

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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

l I Page Of

K030659 -510 (K) NUMBER (IF KNOWN) : CLEARBLUE EASY DIGITAL PREGNANCY TEST DEVICE NAME: INDICATIONS FOR USE:

CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-thecounter qualitative urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

Alan Cooley

(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number JA

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

.

OR

Over-The-Counter-Use (Optional Format 1-2-96)