(35 days)
AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.
Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.
This document is an FDA 510(k) clearance letter for the AuraFlex® TSH-3 device, which is a fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH). The letter indicates that the device has been found substantially equivalent to predicate devices. However, the provided text does not contain the acceptance criteria, details of a study that proves the device meets those criteria, or any of the specific information requested in points 1-9 of your prompt.
The document primarily focuses on:
- The FDA's decision of substantial equivalence (K980574).
- Regulatory classifications (Class II, Product Codes JLW, JIS).
- Applicable general and special controls provisions of the Federal Food, Drug, and Cosmetic Act.
- Instructions for the manufacturer regarding CLIA complexity, labeling, promotion, and other responsibilities.
- The intended use of the device ("third generation" fluorescent enzyme immunoassay for quantitative determination of TSH in human serum or plasma using the AuraFlex system to diagnose thyroid or pituitary disorders).
Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods. This information would typically be detailed in the 510(k) submission itself or a separate study report, which is not part of this letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 4 1998
M. John Taylor Director of Quality and Regulatory Affairs Alfa Biotech (UK) Ltd. 4 Spring Lakes Estate Deadbrook Lane Aldershot Hants GU12 4UH
K980574 Re : AuraFlex® TSH-3 Regulatory Class: II Product Code: JLW, JIS February 12, 1998 Dated: Received: February 17, 1998
Dear Mr. Taylor:
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 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 Requlations, Title 21, Parts 800 to 895. ਉੱ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 requlations.
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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/dsmamain.html".
Sincerely yours,
Steven Sitman
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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510(k) Premarket Notification Alfa Biotech (UK) Ltd AuraFlex® TSH-3
510(K) Number (if known): ......... K980574
Device Name: AuraFlex TSH-3
Indications for Use:
AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.
Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off)
Division of Clinicai Laboratory Devices
510(k) Number K980574
Prescription Use
(Per 21 CFR 801. 109)
Over-The-Counter Use __
Optional Format 1-2-96)
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.