(14 days)
SASTM hCG Serum Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.
SAS™ hCG Serum Controls
This document is an FDA 510(k) clearance letter for a device named "SAS™ hCG Serum Controls." It primarily addresses regulatory approval and provides a brief "Indications For Use" statement.
Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document is a regulatory approval notice, not a study report.
Therefore, I cannot provide a table or answer the specific questions about the study design and results. The document only confirms the device's intended use:
Indications For Use:
SASTM hCG Serum 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
MAR 1 9 1999
Harbi A. Shadfan, Ph.D. President SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240
Re: K990720 Trade Name: SAS™ hCG Serum Controls Regulatory Class: I Product Code: JJX Dated: March 4, 1999 Received: March 5, 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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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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INDICATIONS FOR USE
SA Scientific, Inc. olicant: 4919 Golden Quail San Antonio, TX 78240 Ph: (210) 699-8800 Fax: (210) 699-6545
Establishment Reg. No .: 1645225
K990720 510(k) Number: _
Device Name: SAS™ hCG Serum Controls
Indication For Use:
SASTM hCG Serum Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.
Han
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990720
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) 1999 11
Prescription Use
Or
Over-the-Counter
A-2..
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.