(93 days)
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.
This document is a letter from the FDA regarding the 510(k) premarket notification for the AIA NexIA Automated Enzyme Immunoassay System. It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, the letter does not contain any information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the provided text. The document focuses solely on the regulatory approval from the FDA, and not on the technical performance studies of the device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lori Robinson JUN 27 1997 Manager, Quality Assurance Tosoh Medies, Inc. -373 D Vintage Park Drive Foster City, California 94404
Re : K971103 AIA NexIA Automated Enzyme Immunoassay System Regulatory Class: I Product Code: KHO Dated: June 10, 1997 Received: June 11, 1997
Dear Ms. Robinson:
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 requlations 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 requirement, 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 Reqister. 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 Gutman
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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TOSOH MEDICS, INC.
PREMARKET NOTIFICATION
INDICATION FOR USE STATEMENT
AIA NexIA Automated Enzyme Immunoassay System
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
P.Bernhardt 6/24/97
(fornwn)
✓ for prescription use
(per 21 CFR 801.101)
K971103
0025
§ 862.2560 Fluorometer for clinical use.
(a)
Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.