QUICK & SURE ONESTEP HOME PREGNANCY TEST

K981892 · Abacus Diagnostics · LCX · Aug 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981892
• Device Name: QUICK & SURE ONESTEP HOME PREGNANCY TEST
• Applicant: Abacus Diagnostics
• Product Code: LCX · Clinical Chemistry
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Quick & Sure Onestep Home Pregnancy Test is the Abacus Diagnostics name for an "over-the-counter" (OTC) solid phase immunoassay in vitro diagnostic test kit for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an indicator of Pregnancy.

Device Story

Quick & Sure Onestep Home Pregnancy Test is an OTC solid-phase immunoassay for qualitative detection of hCG in urine. Device used by consumers at home for early pregnancy detection. Principle of operation involves lateral flow immunoassay technology where urine sample migrates across a membrane containing anti-hCG antibodies; presence of hCG results in visible line formation. Output is a visual qualitative result (positive/negative) interpreted by the user. Provides rapid pregnancy status confirmation without clinical laboratory intervention.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Solid-phase lateral flow immunoassay; qualitative detection of hCG in urine; OTC diagnostic test kit format.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an indicator of pregnancy for over-the-counter (OTC) use by the general population.

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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AUG 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Pamela Bagaria Abacus Diagnostics 6520 Platt Avenue #220 91307 West Hills, California

Re : K981892 Quick & Sure Onestep Home Pregnancy Test Regulatory Class: II Product Code: LCX Dated: July 10, 1998 Received: July 14, 1998

Dear Ms. Bagaria:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ಗ್ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 requlatory 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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510(k) Number (if known):_

Detice Name: Quick & Sure onestep Home Pregnancy Test

Indications For Use:

Quick & Sure Onestep Home Pregnancy Test is the Abacus Diagnostics name for an "over-the-counter" (OTC) solid phase immunoassay in vitro diagnostic test kit for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an indicator of Pregnancy.

(Division Sign-Off)
Division of Clinical Laboratory Deviecs
510(k) Number K981892

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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)

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