(112 days)
The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device. This type of document confirms that a device is substantially equivalent to a previously marketed device, without requiring a full premarket approval application. It does not typically include the detailed technical study information that would allow me to populate the table and answer the specific questions about acceptance criteria and device performance as if it were an AI diagnostic device study.
Therefore, many of the questions cannot be answered based on the provided text alone. The text focuses on the regulatory clearance process rather than a detailed technical performance study.
However, I can extract what limited information is available and explain why other information is not present.
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document is an FDA clearance letter, not a detailed study report. It mentions that the device is "substantially equivalent" to predicate devices, implying its performance is comparable, but does not provide specific acceptance criteria or reported performance metrics like sensitivity, specificity, or accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC study was performed, and this device (KRONUS IA-2 Autoantibody RIA Assay Kit) is an in vitro diagnostic assay kit, not an AI-assisted diagnostic tool. Therefore, questions about human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is an in vitro diagnostic assay kit, not an algorithm. The "standalone" performance would typically refer to the assay's performance itself, which is what would be evaluated. However, specific results from such an evaluation are not present in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided document. For an assay kit, ground truth would typically be established through clinical diagnosis, often incorporating multiple factors beyond just the assay result.
8. The sample size for the training set
This information is not present in the provided document. For an in vitro diagnostic assay, there might not be a "training set" in the machine learning sense, but rather a set used for assay development and validation.
9. How the ground truth for the training set was established
This information is not present in the provided document.
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Image /page/0/Picture/0 description: The image shows a partial logo on the left and the word "DEPART" on the right. The logo appears to be a stylized representation of a human services symbol. The word "DEPART" is written in a bold, sans-serif font. The image is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
KRONUS Market Development Associates, Inc. c/o Ms. Heather Viele Director of Technical Affairs 12554 West Bridger Street Suite 108 Boise, ID 83713
APR 1 0 2008
Re: K073590
Trade/Device Name: KRONUS IA-2 Autoantibody RIA Assay Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test systems Regulatory Class: Class II Product Code: OIF Dated: March 24, 2008 Received: March 25, 2008
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 does 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 Part 801); 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
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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 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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Paler H. Boter
Robert L. Becker, Jr., M.D., Ph.D., Ph.B Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K073590 510(k) Number (if known):
Device Name:
KRONUS IA-2 Autoantibody RIA Assay Kit
Indications for Use Statement:
The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Pursuant to 21 CFR 801.109)
· ·
Over
Over-the-counter Use
m chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073590
§ 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).