CLEARVIEW EASY HCG PREGNANCY TEST

K993703 · Unipath , Ltd. · JHI · Dec 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993703
• Device Name: CLEARVIEW EASY HCG PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The CLEARVIEW EASY HCG Pregnancy Test, an in vitro diagnostic device, is intended to be used for the early detection of pregnancy via a urine test. The CLEARVIEW EASY HCG Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine. It is for professional use and for use in the physician's office.

Device Story

Clearview Easy HCG Pregnancy Test is an in vitro diagnostic device for qualitative detection of hCG in urine samples. Used in professional settings and physician offices to confirm pregnancy. Device utilizes lateral flow immunoassay technology; urine sample applied to test device; hCG binds to specific antibodies; visual indicator confirms presence of hormone. Provides rapid qualitative result for clinical decision-making regarding pregnancy status.

Clinical Evidence

No clinical data provided in the document; substantial equivalence established via technological and intended use comparison.

Technological Characteristics

Lateral flow immunoassay for qualitative detection of hCG in urine. Professional-use diagnostic test format.

Indications for Use

Indicated for the early detection of pregnancy by qualitative detection of human chorionic gonadotrophin (hCG) in urine. Intended for professional use in physician offices.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 2 1999

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

Re: K993703

Trade Name: Clearview Easy HCG Pregnancy Test Regulatory Class: II Product Code: JHI Dated: October 28, 1999 Received: November 2, 1999

Dear Ms. Roberts:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

INDICATIONS FOR USE STATEMENT

510(k) Number: ~~To be assigned~~ K993703

Device Name: CLEARVIEW EASY HCG Pregnancy Test

Indications for Use:

The CLEARVIEW EASY HCG Pregnancy Test, an in vitro diagnostic device, is intended to be used for the early detection of pregnancy via a urine test. The CLEARVIEW EASY HCG Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine. It is for professional use and for use in the physician's office.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993303 |

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)