(18 days)
SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit.
The test is for professional use.
Not Found
I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "SASTM RSV Control Kit."
This letter primarily focuses on:
- Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
- Regulatory Classification: Identifying the device as Class I and its regulation number and product code.
- General Controls: Reminding the applicant of general control provisions of the Act (registration, listing, GMP, labeling, etc.).
- Indications for Use: Confirming the intended use of the SASTM RSV Control Kit as controls for use with the SASTM RSV Test Kit.
The document does not include any performance data, study designs, sample sizes, ground truth methodologies, or expert qualifications that would be required to describe acceptance criteria and a study proving device performance against them.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that could represent water or movement.
MAR 1 7 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ricardo R. Martinez Director of Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240
Re: K030628
Trade/Device Name: SASTM RSV Control Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 25, 2003 Received: February 27, 2003
Dear Mr. Martinez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety 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: (210) 699-8800 Fax: (210) 699-6545
Establishment Reg. No.: 1645225
501(k) Number: K030628
Device Names:
SAS™ RSV Control Kit
Indications for Use:
SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit.
The test is for professional use.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) Division Sign-Off)
| Division of Clinical Laboratory Devices |
|---|
| 510(k) Number |
| Prescription Use | X | or | Over-the-Counter |
|---|---|---|---|
| ------------------ | ---------- | ---- | ------------------ |
§ 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.