(276 days)
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No
The summary describes a calibrator for an immunoassay, which is a chemical test, and there is no mention of AI or ML in the provided text.
No
The device is a calibrator for in vitro diagnostic test kits, used for measurement, not for treatment or therapy.
No
This device is a calibrator for test kits that measure apoproteins. It does not directly diagnose a condition but aids in the accurate measurement of biomarkers by diagnostic test kits.
No
The device is a calibrator for an immunoassay kit, which are typically physical reagents and materials, not software. The summary provides no information suggesting it is a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "Calibrator" for "Test Kits" that measure substances ("Apoprotein A-1 and Apoprotein B") in "human serum." This is a classic description of a product used in laboratory testing of human samples to aid in diagnosis or monitoring.
- Immuno turbidimetric assays: The test kits it calibrates are described as "immuno turbidimetric assays," which are common methods used in IVD testing.
While the "Device Description" is not found in the provided text, the intended use alone is sufficient to classify this device as an IVD. It is a component used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.
Product codes
DER
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 866.5580
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.
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
K964294/S002 Re : Trade Name: N-Assay® A-1/B MULTI Calibrator Set 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, 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 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 requlation 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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Paqe 2
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 requlation (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,
Steven 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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