(195 days)
The N-Assay TIA Multi CRP CAlibrator Set is intended to be used in the calibration of the Crestat Diagnostics N-Assay TIAGRP turbidimmunometric assay for quantitating serum levels of C-Reactive Protein. in human serum.
Not Found
I am sorry, but the provided text from the FDA letter (K965110/S001 for N-Assay® TIA MULTI C-Reactive Protein Calibrator Set) does not contain the information required to answer your request.
The letter is a notification of substantial equivalence for a medical device (a calibrator set for an assay). It outlines regulatory compliance and allows the device to be marketed. However, it does not describe:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria (including all the specified details like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.).
This type of information would typically be found in the 510(k) submission document itself, which is not provided, or a separate study report. The letter is a regulatory approval, not a scientific study summary.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CRESTAT DIAGNOSTICS c/o Mary Rees KAMIYA TECHNOLOGY SERVICES 374 Goodhill Road Weston, CT 06883
JUL - 3 1997
K965110/S001 Re: Trade Name: N-Assay® TIA MULTI C-Reactive Protein Calibrator Set Regulatory Class: II Product Code: DCK Dated: May 21, 1997 Received: May 23, 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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Flectronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known):_K965110
N-Assay TIA Multi CRP Cglibrator Set Device Name:
Indications For Use:
The N-Assay TIA Multi CRP CAlibrator Set is intended to be used in the calibration of the Crestat Diagnostics N-Assay TIAGRP turbidimmunometric assay for quantitating serum levels of C-Reactive Protein. in human serum.
Titu E. Moslemí
linical Laboratory Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH, Office of Device Evaluation (ODE)
Prescription Lise
(Per 21 CFR 801.109!
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number _
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).