MIDSTREAM HOME REGNANCY TEST

K973825 · Germaine Laboratories, Inc. · DHA · Dec 19, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973825
• Device Name: MIDSTREAM HOME REGNANCY TEST
• Applicant: Germaine Laboratories, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Device Story

MidStream™ Home Pregnancy Test is a lateral flow immunoassay for qualitative detection of hCG in urine. Device consists of an absorbent wick and membrane containing monoclonal and polyclonal antibody reagents. User urinates on wick; specimen migrates via capillary action. hCG in specimen binds to colored conjugate, forming a visible band on the membrane if concentration is ≥25 mIU/ml. A procedural control band appears regardless of hCG presence. Designed for home use by laypersons. Results are interpreted visually by the user. Provides rapid pregnancy determination; aids in early clinical decision-making regarding reproductive health.

Clinical Evidence

Clinical trial included 112 female participants. Study evaluated usability, labeling comprehension, and result interpretation. Comparison between participant-read results and laboratory results demonstrated 99.1% overall agreement. Confirms suitability for over-the-counter use.

Technological Characteristics

Lateral flow immunoassay using monoclonal and polyclonal antibody reagents. Detects hCG concentrations ≥25 mIU/ml. Standardized to WHO Third International Standard. No cross-reactivity with hLH (500 mIU/ml), hFSH (1000 mIU/ml), or hTSH (1000 µIU/ml). Form factor: absorbent wick and membrane test strip.

Indications for Use

Indicated for non-professional, over-the-counter use by individuals to identify hCG in urine to aid in pregnancy determination.

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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## "Summary of Safety & Effectiveness"

The MidStream™ Home Pregnancy Test is intended for non-professional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by urinating on the absorbent wick and observing for the formation of colored bands. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

The MidStream™ Home Pregnancy test detects hCG concentrations of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hLH (500 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.

Clinical trials using MidStream™ were conducted which included 112 female participants. The results of the study showed that the majority of the participants found MidStream™ Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

The comparison study between the participants results and laboratory results indicated an overall agreement of 99.1%. The overall results of the clinical trial confirm that MidStream™ Home Pregnancy Test is a suitable test for over-the-counter pregnancy testing.

Martin O'Connor, Regulatory Affairs

9-30-97
Date

16973825

Premarket Notification 510(k) Number

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 19 1997

Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center Suite 230 78229 San Antonio, Texas

Re : K973825 MidStream™ Home Pregnancy Test Regulatory Class: II Product Code: DHA, LCX September 30, 1997 Dated: Received: October 7, 1997

Dear Mr. O'Connor:

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, 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 Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

Enclosure

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## Indications For Use

1973825 510(k) Number:

Device Name: MidStream™ Home Pregnancy Test

"Indications For Use" -

MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

U. Michell Arnald for AC/Attorney

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973825

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Or

Over-The-Counter Use