SIGNAL PREGNANCY TEST KIT

K974021 · Sa Scientific, Inc. · LCX · Dec 19, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974021
• Device Name: SIGNAL PREGNANCY TEST KIT
• Applicant: Sa Scientific, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Rapid one-step visual test for the qualitative detection of hCG in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.

Device Story

Signal™ One-Step Pregnancy Test Kit is an immunochromatographic assay for qualitative hCG detection in urine. Device consists of an absorbent wick and a membrane containing polyclonal and monoclonal antibodies. Operation: user applies urine to wick; capillary action draws sample across membrane; hCG binds to antibody-conjugate complex. Output: visual interpretation of colored lines in test window; two lines indicate positive (hCG present), one line indicates negative. Designed for over-the-counter home use by lay users. Results provide rapid pregnancy status information to assist in clinical decision-making or personal health management.

Clinical Evidence

Bench testing only. Performance studies including specificity, sensitivity, accuracy, interfering substances, and stability resulted in >99% acceptance. A laboratory comparison study of 100 test devices against the SAS™ Pregnancy Strip resulted in >99% accuracy.

Technological Characteristics

Immunochromatographic lateral flow assay. Utilizes polyclonal and monoclonal antibodies on a reagent pad and test strip. Qualitative visual readout. No external energy source required. Standalone test kit.

Indications for Use

Indicated for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early pregnancy detection. Intended for over-the-counter home use by individuals seeking pregnancy status.

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

• Be Sure® Plus Pregnancy Test Kit

Reference Devices

• SAS™ Pregnancy Strip

Submission Summary (Full Text)

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KY40Ci

## 510(K) SUMMARY

## DEC 1 9 1997

| 510(k) Number: | K974021 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name: | Signal™ One-Step Pregnancy Test Kit |
| Submitted by: | SA Scientific, Inc.<br>4919 Golden Quail<br>San Antonio, TX, 78240 |
| Contact: | Mike Crisp<br>Ph: [phone]<br>Fax: [phone] |
| Product Name: | Signal™ One-Step Pregnancy Test Kit |
| Classification: | Human chorionic gonadotropin (hCG) test system |
| Intended Use: | Rapid one-step visual test for the qualitative detection of<br>hCG in human urine to aid in the diagnosis of pregnancy.<br>This test is intended for over-the-counter home use. |
| Description of Device: | Signal™ detects the presence of hCG in urine by using a<br>combination of polyclonal and monoclonal antibodies on the<br>reagent pad and the test strip. The assay begins functioning<br>with the addition of urine onto the absorbent wick.<br>Through capillary action the urine is pulled along the<br>membrane to the reagent pad where the hCG reacts with the<br>conjugate. Positive results are determined by two colored<br>lines in the window. The absence of hCG produces only<br>one colored line in the window. |
| Substantial Equivalence Device: | Be Sure® Plus Pregnancy Test Kit |
| Clinical Reference Device: | SAS™ Pregnancy Strip |
| Performance Data: | Specificity, Sensitivity & Accuracy, Interfering Substances,<br>and Stability Studies resulted in >99% acceptance. A<br>laboratory Comparison Study of 100 test devices with SAS™<br>Pregnancy Strip Test Kits resulted in >99% accuracy. |
| Date Originally Prepared: | October 28, 1997 |

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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 eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEC 1 9 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Harbi Shadfan · President SA Scientific, Inc. 4919 Golden Quail 78240 San Antonio, Texas

K974021 Re : Signal™ Preqnancy Test Kit Regulatory Class: II Product Code: LCX October 21, 1997 Dated: Received: October 22, 1997

Dear Dr. Shadfan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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 The general controls provisions of the Act 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 requlations 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 In addition, FDA may publish further announcements action. 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/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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## Indications For Use

510(k) Number: K974021

Device Name: Signal™ Pregnancy Test Kit

"Indications For Use" -

Signal™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for over-the-counter use.

J.D. Wilbanks for AW. Montgomery

(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

ﮨﮯ Over-The-Counter Use (Optional Format 1-2-96)