INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST

K984079 · Alfa Scientific Designs, Inc. · JHI · Feb 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984079
• Device Name: INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Feb 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Instant-View Pregnancy Urine Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for laboratory and professional use only.

Device Story

Instant-View Pregnancy Urine Dip-Strip Test is a single-step, qualitative, lateral flow chromatographic immunoassay. It utilizes a sandwich complex format consisting of anti-hCG antibody/hCG/anti-hCG antibody. The device accepts urine samples; the presence of hCG is detected visually via the appearance of a test (T) line on the strip. A control (C) line confirms proper test function. Designed for use by healthcare professionals in clinical laboratories or physician offices. Results are read visually by the operator to determine pregnancy status, aiding in clinical decision-making for early pregnancy diagnosis.

Clinical Evidence

Clinical evaluation conducted in a clinical laboratory and three physician offices by personnel with diverse educational backgrounds and experience. The study compared the Instant-View test results against the predicate device. Results showed 100% correlation/agreement with expected outcomes.

Technological Characteristics

Lateral flow immuno-chromatographic strip; sandwich complex format (anti-hCG antibody/hCG/anti-hCG antibody); visual readout; internal control line; sensitivity approximately 25 mIU/ml; calibrated against WHO 3rd IS 75/537.

Indications for Use

Indicated for the qualitative detection of hCG in urine to aid in the early diagnosis of pregnancy in professional and laboratory 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

• OSOM Pregnancy Urine Test (K953383)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo consists of the company's name in all caps, with a stylized graphic to the left. Above the logo is the date 2/16/99 written in cursive.

Medical Diagnostic Devices. Contract R&D. OEM 11494 Sorrento Valley Rd, Suite F & M San Diego, CA 92121 Tel: [phone] Fax: [phone] E-mail: [e-mail]

## 510(K) Summary (K984079)

## Submitter

Name and address: Alfa Scientific Designs, Inc. 11494 Sorrento Valley Rd, Suite M San Diego, CA 92121 619-350-9798 (Tel) 619-350-9709 (Fax)

Contact Person: Naishu Wang, MD, Ph.D.

Date Prepared: 12/30/98

Device Name

Common Name: Human Chorionic Gonadotropin (hCG) Test

Trade Name: Instant-View™ Pregnancy Urine Dip-Strip Test

Classification name: 21CFR section 862.1155, Class II. A Qualitative Human Chorionic Gonadotropin (hCG) test system.

Predicate device

The Instant-View™ Pregnancy Urine Dip-Strip Test is substantially equivalent to other legally marketed devices for the similar intended use. The device used for comparison study is OSOM Pregnancy Urine Test made by Wyntek Diagnostic, Inc., 510K#: K953383.

A single step, visually read, qualitative chromatographic

Device description

Intended use

The Instant-View The Pregnancy Urine Dip-Strip Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.

510(K) Summary

Continued on next page

K984079

1

immunoassay, single use strip test

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| Summary of the<br>similarities to the<br>predicate device | The intended use and performance characteristics:<br>Both devices are intended to use for an early detection of hCG<br>in human urine at the level close to 25 mIU/ml (OSOM claimed<br>a sensitivity to hCG as low as 30 mIU/ml) or greater (calibrated<br>against the WHO 3rd IS 75/537). |
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| | Technological characteristics:<br>Both devices are one step, qualitative, visual lateral flow<br>immuno-Chromatographic test in a sandwich complex format of<br>anti-hCG antibody /hCG/ anti-hCG antibody. |
| | Interpretation of results:<br>The presence of C line serves as an internal quality control, and<br>the presence of the T line indicates a positive result. |
| Discussion and<br>Conclusion | The accuracy by correlation of the results from the Instant-ViewTM Pregnancy Urine Dip-Strip Test and the legally marketed test compared is 100%, indicating that the Instant-ViewTM Pregnancy Urine Dip-Strip Test is substantially equivalent to this existing legally marketed product. |
| | The evaluation results from clinical lab and three physician's offices conducted by the persons with diverse educational backgrounds and working experience agreed 100% with the results expected. |
| | Based on the results of the correlation and POL studies, we may conclude that the Instant-ViewTM Pregnancy Urine Dip-Strip Test is as safe, as effective, and performs as well as the legally marketed device. Therefore, this test is suitable for use by health care professionals with diverse educational backgrounds and work experience. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 6 1999

Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite F&M San Diego, CA 92121

K984079 Re:

> Trade Name: Instant-View Pregnancy Urine Dip-Strip Test Regulatory Class: II Product Code: 75 JHI Dated: January 6, 1999 Received: January 11, 1999

Dear Dr. Wang:

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 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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Page 2

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.gov/cdrh/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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510(k) Number (if known): K984079

Device Name: Instant-View
Pregnancy Urine Dip-Strip Test

Indications For Use:

The Instant-View Pregnancy Urine Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

This test is for laboratory and professional use only.

Lain Corzin
Division Sign-Off

(Division Sign-Off) (Status Lagi. On)
Division of Clinical Laboratory Devices 510(k) Number___ K 984079

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** V
(Per 21 CFR 801.109)

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)