SAS HCG URINE CONTROLS

K990755 · Sa Scientific, Inc. · JJX · Mar 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990755
• Device Name: SAS HCG URINE CONTROLS
• Applicant: Sa Scientific, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

SASTM hCG Urine Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.

Device Story

SASTM hCG Urine Controls function as quality control materials for SASTM pregnancy test kits. Used in clinical laboratory settings by professional personnel to verify test performance and accuracy. The device provides a known sample to validate the assay's ability to detect human chorionic gonadotropin (hCG) in urine. By comparing test results against expected values, clinicians ensure the reliability of pregnancy test kit outputs, supporting accurate diagnostic decision-making and patient care.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic control.

Technological Characteristics

In vitro diagnostic quality control material for hCG urine pregnancy testing. Formulated for professional use to monitor assay performance.

Indications for Use

Indicated for professional use to monitor the performance and accuracy of SASTM pregnancy test kits.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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## MAR 1 9 1999

Harbi A. Shadfan, Ph.D. President SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240

Re: K990755 Trade Name: SASTM hCG Urine Controls Regulatory Class: I Product Code: JJX Dated: March 5, 1999 Received: March 8, 1999

## Dear Dr.Shadfan:

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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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/cdrl/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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## INDICATIONS FOR USE

pplicant:

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

Establishment Reg. No .: 1645225

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

K990755

Device Name: SASTM hCG Urine Controls

**Indication For Use:**

idication For Use: SASTM hCG Urine Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) - 1 - 1 -

Prescription Use

Over-the-Counter

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