OSOM CARD PREGNANCY TEST, MODEL 103

K990576 · Wyntek Diagnostics, Inc. · LCX · Mar 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990576
• Device Name: OSOM CARD PREGNANCY TEST, MODEL 103
• Applicant: Wyntek Diagnostics, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

OSOM® Card Pregnancy Test is a pregnancy test intended for home use.

Device Story

OSOM® Card Pregnancy Test is an over-the-counter, immunochromatographic lateral flow assay for home pregnancy detection. Device utilizes urine sample applied to test card; membrane coated with anti-hCG antibodies. Presence of hCG in urine triggers binding, resulting in blue test line appearance. User visually interprets color line to determine positive or negative result. Device provides rapid qualitative assessment of pregnancy status, enabling early detection by lay users in home setting.

Clinical Evidence

Bench testing compared OSOM® Card Pregnancy Test against professional OSOM® Classic hCG Urine Test using 217 urine specimens, demonstrating 99.1% sensitivity and 100% specificity. Consumer testing with 74 participants evaluated against clinical status showed 100% overall agreement.

Technological Characteristics

Immunochromatographic lateral flow assay; membrane coated with anti-hCG antibodies; visual colorimetric readout (blue line); standalone test card; non-electronic.

Indications for Use

Indicated for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy for home use.

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

• Wamer-Lambert e.p.t Pregnancy Test
• Carter Wallace FIRST RESPONSE Pregnancy Test

Reference Devices

• OSOM® Classic hCG Urine Test

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a combination of handwritten and printed text along with a logo. The printed text at the top reads "MAR-04-1999 09:52". Below this, there is a handwritten date "3/9/99". To the right, there is a logo with the word "Wyntek" in bold, followed by the word "diagnostics" in a smaller font.

510k OSOM Card Pregnancy Test

619.452.3198 3 619.452.3258

#### 510 (k) Summary 8.

1509001 EN46001 Certified

Diagnostics inc.

Wyntek

રો વેદ Nancy Ridge Drive San Diego California 92121

WWW. diagnostics

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

Contact Person: Shu-Ching Cheng

Product Name:

OSOM® Card Pregnancy Test Proprietary Name: OTC Pregnancy Test Kit Common Name: Classification Name: Kit, Test, Pregnancy, HCG, OTC Classification Number: 75LCX

Intended Use: OSOM® Card Pregnancy Test is a pregnancy test intended for home use.

Description: OSOM® Card Pregnancy Test uses color immunochromatographic 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: OSOM® Card Pregnancy Test is substantially equivalent to Wamer-Lambert e.p.t Pregnancy Test and Carter Wallace FIRST RESPONSE Pregnancy Test. All these tests utilize immunochromatographic technology and anti-hCG antibodies to detect hCG in urine. All three tests interpret the results through the development of the color lines.

OSOM® Card Pregnancy Test, when compared to a Precision: professional hCG test. OSOM® Classic hCG Urine Test, with a total of 217 urine specimens, results in a sensitivity of 99.1% and a specificity of 100%. Also, a consumer testing was conducted. Of the 74 participants' results evaluated against their clinical status. OSOM® Card Pregnancy Test gave an overall agreement of 100%.

Applicant Signed: SL. Date: March 3, 1999
Shu-Ching Cheng

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### MAR - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Shu-Ching Cheng Vice President of Operations Wyntek Diagnostics, Inc. 6146 Nancy Ridge Drive, Suite 101 San Diego, California 92121

K990576 Re: Trade Name: OSOM® Card Pregnancy Test Regulatory Class: II Product Code: LCX Dated: February 22, 1999 Received: February 23, 1999

### 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 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 (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 Register. Please note: this response to vour 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 Butman

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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# 2. Device Indications For Use

K990576 510 (k) Number: TBD

# Device Name: OSOM® Card Pregnancy Test

## Indication For Use:

The OSOM® Card Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy for home use.

| (Division Sign-Off) | Sean Cooper |
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Division of Clinical Laboratory Services

| 510(k) Number | K990576 |
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| Division of Clinical Laboratory Devices | |
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| 510(k) Number | |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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