(276 days)
The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.
Not Found
This letter from the FDA is an approval for a medical device (N-Assay® TIA Apolipoprotein B Test Kit) and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates a substantial equivalence (510(k)) pathway, which means the device was found to be as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies and acceptance criteria as would be needed for a Premarket Approval Application (PMA) for a novel device.
Therefore, I cannot fulfill your request using the provided text.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CRESTAT DIAGNOSTICS, INC. c/o Ms. Mary Rees Official Correspondent KAMIYA TECHNOLOGY SERVICES 374 Goodhill Road Weston, CT 06883 - - -------
AUG - 1 1997
Re: Re: K964296/5002 Trade Name: N-Assay® TIA Apolipoprotein B Test Kit Regulatory Class: II Product Code: DER Dated: May 04, 1997 Received: May 09, 1997
Dear Ms. Rees:
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, Druq, 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, qood 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 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 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 wow 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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Stevens Autman
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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Page of
K964296 10(k) Number lil knownl:
N-Assay TIA APO B Test Kit cvice Name:_
dications from Use: * *
The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.
Peter E. Mayhew
(Division Sign-Off) Division of Clinical Labora 510(k) Number _
PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF ורונו)EE
Concurrence of CDRH, Office of Device Evaluation (ODE)
11:30 1 : 5 ? : CER 801 : (13)
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Over The Counter Use ... ____
(Optional Formal 1-2-96)
§ 866.5580
Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).