(26 days)
SASTM hCG-Check is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. This test is for over-the-counter home use.
SAS™ hCG-Check is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.
The provided document is a 510(k) clearance letter from the FDA for the SAS™ hCG-Check device, which is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This document does not contain any information regarding specific acceptance criteria, study details, or performance data as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document primarily focuses on regulatory approval, substantial equivalence, and general administrative information.
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MAY 4 1000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Josh Wessling Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240
Re: K991193 Trade Name: SAS™ hCG-Check Regulatory Class: II Product Code: LCX Dated: April 7, 1999 Received: April 8, 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 (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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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. Applicant: 4919 Golden Quail San Antonio, TX 78240 Ph: (210) 699-8800 Fax: (210) 699-6545
Establishment Reg. No.: 1645225
K 991193 510(k) Number: __
Device Name: SAS™ hCG-Check
SASTM hCG-Check is a rapid visual test for the qualitative Indication For Use: detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. This test is for over-the-counter home use.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K991193
MICC
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
Over-the-Counter
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.