(192 days)
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No
The summary describes a standard RIA assay kit for antibody detection, with no mention of AI or ML technologies.
No
The device is an assay kit used for diagnosis and not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the assay "is useful as an aid in the diagnosis of Type I diabetes mellitus." This directly indicates its use for diagnostic purposes.
No
The device is described as an "Assay Kit" and a "RIA Assay Kit," which are laboratory tests involving physical reagents and procedures, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative determination of glutamic acid decarboxylase antibody in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis.
- Aid in Diagnosis: The intended use also states it's "useful as an aid in the diagnosis of Type I diabetes mellitus." This further confirms its role in providing diagnostic information.
- Device Description: The device is described as an "Assay Kit," which is a common format for IVD products used to perform specific tests on biological samples.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Product codes
NWG
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)
Not Found
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
Not Found
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the circle.
NOV - 4 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Heather Viele Director of Technical Affairs KRONUS, Inc. Boise Research Center 12554 West Bridger Street Suite 108 Boise, ID 83713
Rc: K051061
Trade/Device Name: KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NWG Dated: September 19, 2005 Received: September 20, 2005
Dear Ms. Viele:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
K051061 KRONUS Glutamic Acid Decarboxylase Antibody (GADAb) RIA
Indications for Use
510(k) Number (if known): K051061
Device Name:
KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit
Indications for Use Statement:
The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
(Please Do Not Write Below This Line -- Continue On another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Pursuant to 21 CFR 801.109)
OR
Over-the-counter Use
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(K)_KO5106