OSOM CARD HCG-URINE TEST

K973879 · Wyntek Diagnostics, Inc. · JHI · Nov 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973879
• Device Name: OSOM CARD HCG-URINE TEST
• Applicant: Wyntek Diagnostics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The OSOM Card 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.

Device Story

The OSOM Card hCG-Urine Test is a lateral flow immunochromatographic assay for the qualitative detection of hCG in urine. The device utilizes membrane-bound anti-hCG antibodies to capture hCG present in a urine sample. If hCG is present, a red test line appears in the result window, indicating a positive result. The test is designed for use by healthcare professionals in laboratory or clinical settings. The visual output allows clinicians to confirm pregnancy status, aiding in clinical decision-making for patient care. The device provides a rapid, qualitative diagnostic result.

Clinical Evidence

Clinical performance was evaluated using 227 urine specimens compared against the Abbott TestPack Plus hCG Urine Test, demonstrating 100% sensitivity and 100% specificity. Additionally, a multi-site study at three physician offices using a blinded panel of negative, low positive, and moderate positive samples over three days showed 100% agreement with expected results.

Technological Characteristics

Immunochromatographic assay; utilizes membrane-coated anti-hCG antibodies; visual colorimetric readout; lateral flow test card format; in vitro diagnostic device.

Indications for Use

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

• Quidel RapidVue hCG Test
• Abbott TestPack Plus hCG Urine Test

Submission Summary (Full Text)

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## 510 (k) Summarv 8.

K973819
OSOM Card hCG 510 (k)

**NOV** - 4 1997

619 452 3198 619.452.3258

Diagnostics Inc. દા વેદ Nancy Ridge Drive Suite 101 San Diego California 9212 ાડિત

Wyntek

| Submitter | Wyntek Diagnostics, Inc. |
|-----------|-------------------------------|
| | 6146 Nancy Ridge Dr. Ste. 101 |
| | San Diego, CA 92121 |
| Tel | 619-452-3198 |
| Fax | 619-452-3258 |

Contact Person: Shu-Ching Cheng

Product Name:

| Proprietary Name: | |
|------------------------|--|
| Common Name: | |
| Classification Name: | |
| Classification Number: | |

OSOM™ Card hCG-Urine Test hCG Urine Pregnancy Test Kit Human chorionic gonadotropin (hCG) test 75JHI

Intended Use: The OSOM Card 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.

Description: OSOM Card hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a red test line in Result Window will appear to indicate a positive result.

- Substantial Equivalence: OSOM Card hCG-Urine Test is substantially equivalent to Quidel RapidVue hCG Test and Abbott TestPack Plus hCG Urine Test. All three 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.
- Precision: The OSOM Card hCG-Urine Test, when compared to Abbott TestPack Plus hCG Urine Test with a total of 227 urine specimens, results in a sensitivity of 100% and a specificity of 100%. Also, an evaluation of the OSOM Card 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: Shu-Ching Cheng Date: Oct 28, 1991

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 4 1997

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

Re: K973879 OSOM™ Card hCG-Urine Test Trade Name: Regulatory Class: II Tier: II Product Code: JHI Dated: September 9, 1997 Received: September 10, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 at [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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OSOM Card hCG 510 {K} - ...... -

## 2. Device Indications For Use

510 (k) Number: K973879

Device Name: OSOM Card hCG-Urine Test

Indication For Use:

The OSOM™ Card 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.

(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 _ OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)