SAS ONE-STEP PREGNANCY

K990741 · Sa Scientific, Inc. · JHI · May 10, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990741
• Device Name: SAS ONE-STEP PREGNANCY
• Applicant: Sa Scientific, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: May 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

SASTM One-Step Pregnancy is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only.

Device Story

SAS™ One-Step Pregnancy is a rapid, visual, in vitro diagnostic test for qualitative hCG detection in urine. Designed for professional clinical use; aids in early pregnancy diagnosis. Device utilizes lateral flow immunoassay technology; provides visual results to healthcare providers. Results assist in clinical decision-making regarding pregnancy status.

Clinical Evidence

No clinical data provided; substantial equivalence established via 510(k) regulatory pathway for a qualitative in vitro diagnostic test.

Technological Characteristics

Lateral flow immunoassay for qualitative hCG detection in urine. Visual readout. Professional use only.

Indications for Use

Indicated for professional use to qualitatively detect human chorionic gonadotropin (hCG) in urine to aid in early pregnancy detection.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 1999

Josh Wessling Regulatory Affairs SA Scientific 4919 Golden Ouail San Antonio, TX 78240

Re: K990741

> Trade Name: SAS™ One-Step Pregnancy Regulatory Class: II Product Code: 75 JHI Dated: April 21, 1999 Received: April 22, 1999

Dear Mr. Wessling:

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 at [phone] or at its internet address "http://www.fda.gov/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 Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240 Ph: [phone] Fax: [phone]

Establishment Reg. No .: 1645225

1499074

510(k) Number: K964995

Device Name: SASTM One-Step Pregnancy

SASTM One-Step Pregnancy is a visual and rapid test for the Indication For Use: qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only.

Ten Willie for Jean Cooper

ion of Clinical Labor. 510(k) Number.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

Prescription Use
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Over-the-Counter _____________________________________________________________________________________________________________________________________________________________