(195 days)
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No
The document describes a calibrator set for a turbidimmunometric assay, which is a standard laboratory technique and does not mention any AI or ML components.
No
Explanation: This device is a calibrator set used to calibrate an assay for quantitating C-Reactive Protein levels, which is a diagnostic function, not a therapeutic one.
No
Explanation: This device is a calibrator set, intended for use in calibrating an assay to quantitate C-Reactive Protein. It is not an assay itself, and therefore not a diagnostic device.
No
The summary describes a calibrator set for a turbidimmunometric assay, which are typically physical reagents used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used "in the calibration of the Crestat Diagnostics N-Assay TIAGRP turbidimmunometric assay for quantitating serum levels of C-Reactive Protein. in human serum." This describes a product used in vitro (outside the body) to analyze a human sample (serum) for diagnostic purposes (quantitating C-Reactive Protein levels, which are used in diagnosing and monitoring various conditions).
- Calibration: Calibrators are essential components of many IVD assays. They are used to establish the relationship between the signal measured by the assay and the concentration of the analyte in the sample. This is a core function within the IVD workflow.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DCK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping heads. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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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Page
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
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Concurrence of CORH, Office of Device Evaluation (ODE)
Prescription Lise
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OR
Over-The-Counter Use_
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Division of Clinical Laboratory Devices
510(k) Number _