OSOM CARD II HCG-URINE TEST, MODEL 102

K990578 · Wyntek Diagnostics, Inc. · JHI · Mar 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990578
• Device Name: OSOM CARD II HCG-URINE TEST, MODEL 102
• Applicant: Wyntek Diagnostics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The OSOM® Card II 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

OSOM Card II hCG-Urine Test is a lateral flow immunochromatographic assay; detects human chorionic gonadotropin (hCG) in urine samples. Device utilizes membrane-bound anti-hCG antibodies; presence of hCG results in blue test line appearance in result window. Intended for professional laboratory and clinical use; provides qualitative results for early pregnancy detection. Healthcare providers interpret visual color lines to determine pregnancy status; results assist in clinical decision-making regarding patient care. Device offers rapid, point-of-care diagnostic capability.

Clinical Evidence

Clinical evaluation included comparison against OSOM Classic hCG-Urine Test using 217 urine specimens, demonstrating 99.1% sensitivity and 100% specificity. Additional multi-site evaluation 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

Lateral flow immunochromatographic assay; utilizes membrane-coated anti-hCG antibodies. Visual readout via color line development. Standalone, non-electronic, disposable test card.

Indications for Use

Indicated for qualitative detection of hCG in urine for early pregnancy diagnosis 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 TestPack Plus hCG Urine Test
• Wyntek's OSOM® Classic hCG-Urine Test

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date 3/9/99 written in black ink. Below the date is a logo that features a circle with a stylized figure inside, including a heart shape. To the right of the logo is the word "Wyntek" in bold, black letters, with the word "diagnostics" in smaller letters underneath.

8.

K980578

OSOM Card II hCG 510 (k)

619452 3198 619.452.3258

| 510 (k) Summary |
|-----------------|
|-----------------|

Diagnostics Inc ISO9001

EN46001 Certified

6146 Nancy Ridge Drive San Diego California 92121 USA

wnte diagnostics COM

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

Contact Person: Shu-Ching Chenq

Product Name:

Proprietary Name: Common Name: Classification Name: Classification Number: OSOM® Card II hCG-Urine Test hCG Urine Pregnancy Test Kit Human chorionic gonadotropin (hCG) test 75JHI

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

Substantial Equivalence: OSOM® Card II hCG-Urine Test is substantially equivalent to Abbott TestPack Plus hCG Urine Test and Wyntek's OSOM® Classic 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 II hCG-Urine Test, when compared to 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, an evaluation of the OSOM® Card II hCG-Urine Test was conducted at three physician's offices. Each site tested the randomly coded panel consisting of neqative, low positive and moderate positive samples for three days. The results obtained had 100% agreement with the expected results.

Applicant Signed: SL-cury ca Feb. 22, 1999 _ Date: _ Date: _ Date: _ Date: _ Date: _ Date: _ Date: _ Date: _ Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Shu-Ching Chenq

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Re: K990578 Trade Name: OSOM® Card II hCG-Urine Test Regulatory Class: II Product Code: JHI 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 (OS) 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

K990578 510 (k) Number: TBD

Device Name: OSOM®Card II hCG-Urine Test

Indication For Use:

The OSOM® Card II 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.

Clan Cogen
(Division Sign-Off)

Division of Clinical Laboratory I. evices KGOJOS 510(k) Number.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use