OSOM HCG-URINE TEST MODEL 101

K974159 · Wyntek Diagnostics, Inc. · JHI · Dec 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974159
• Device Name: OSOM HCG-URINE TEST MODEL 101
• Applicant: Wyntek Diagnostics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

A qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTICS USE ONLY

Device Story

The OSOM hCG-Urine Test is a lateral flow immunochromatographic assay used for the qualitative detection of hCG in urine samples. The device consists of a test stick coated with monoclonal and polyclonal antibodies. When a urine sample is applied, the presence of hCG triggers the formation of a blue test line on the membrane, providing a visual indicator of a positive result. The test is intended for use by healthcare professionals in laboratory or clinical settings to aid in the early detection of pregnancy. Results are interpreted visually by the clinician based on the appearance of color lines. The device provides a rapid diagnostic result to assist in clinical decision-making regarding pregnancy status.

Clinical Evidence

Clinical performance was evaluated by comparing the OSOM hCG-Urine Test to the Abbott TestPack Plus hCG Urine Test. Testing demonstrated 100% sensitivity and 100% specificity. Additionally, a multi-site study conducted at three physician offices using a randomized panel of negative, low positive, and moderate positive samples over three days showed 100% agreement with expected results.

Technological Characteristics

Color immunochromatographic stick technology; utilizes membrane-bound monoclonal and polyclonal antibodies; visual color line interpretation; standalone diagnostic test kit.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine for early pregnancy detection in professional laboratory and clinical settings.

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

• Abbott Test Pack hCG Urine test

Reference Devices

• Abbott TestPack Plus hCG Urine Test

Submission Summary (Full Text)

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DEC 2 4 1997

## 510 (k) Summary - OSOM hCG-Urine Test (K974159)

619.452.3258

Submitter : Wyntek Diagnostics, Inc. 6146 Nancy Ridge Dr. Ste. 101 San Diego, CA 92121 Tel: [phone], Fax: [phone]

Contact Person: Shu-Ching Cheng

Product Name:

| Proprietary Name: | OSOM ^® hCG- Urine Test |
|----------------------|------------------------------------------------|
| Common Name: | hCG-Urine Pregnancy Test Kit |
| Classification Name: | Human chorionic gonadotropin (hCG) test system |

Intended Use: A qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTICS USE ONLY

Description: Wyntek's OSOM hCG- Urine Test uses color immunochromatographic stick technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

Substantial Equivalence:

Wyntek™ OSOM® hCG- Urine Test is substantially equivalent to Abbott Test Pack hCG Urine test. Both tests utilize membrane, monoclonal and polyclonal antibodies to identify hCG in urine. Both tests also interpret the results through the development of the color lines.

Precision: The OSOM hCG-Urine Test, when compared to Abbott TestPack Plus hCG Urine Test with a limited sample size, results in a sensitivity of 100% and a specificity of 100%. Also, an evaluation of the OSOM hCG-Urine Test was conducted at three physicians offices. Each site tested the randomly coded panel consisting of negative, low positive and moderate positive samples for three days. The results obtained had 100% agreement with the expected results

Applicant Signed: St - car Un Date: " Dec 17, 1997 Shu-Ching Cheng

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 4 1997

Shu-Ching Cheng · VP Operations Wyntek Diagnostics 6146 Nancy Ridge Drive, Suite 101 San Diego, California 92121

Re : K974159 OSOM™ hCG-Urine Test Regulatory Class: II Product Code: JHI Dated: November 11, 1997 Received: November 14, 1997

Dear Mr. Cheng:

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. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 Radiological Health

Enclosure

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Device Indications For Use

974159 510 (k) Number: 1959

Device Name: OSOM™ hCG-Urine Test

Indication For Use:

The OSOM™ hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

A.H. m Al Muth

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

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use