(55 days)
The QUANTA Plex™ ANCA Profile is a fluorescent immunoassay for the semi-quantitative detection of anti-MPO and anti-PR3 antibodies in human serum. The presence of these antibodies is used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of the autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis.
Not Found
This is a 510(k) premarket notification for a medical device (QUANTA Plex™ ANCA Profile) and does not contain the specific details of a study that proves the device meets acceptance criteria in the format requested. The document is an FDA clearance letter and an "Indications For Use" statement.
Therefore, most of the information requested in your prompt cannot be extracted from this document, as it would typically be found in the actual clinical study report submitted to the FDA, not in the clearance letter itself.
However, I can provide a limited response based on the information available:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy. These would be detailed in the study report that accompanied the 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
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 document does not provide information on the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This document does not describe any adjudication method.
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:
This device is an "immunological test system" (QUANTA Plex™ ANCA Profile), which is an in-vitro diagnostic device for semi-quantitative detection of antibodies (anti-MPO and anti-PR3). It is not an AI-assisted imaging or diagnostic tool where a "human reader" would "improve with AI assistance." Therefore, an MRMC comparative effectiveness study in the context of human reader improvement with AI is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This document does not specify if a standalone performance study was done. For an immunological test system, "standalone performance" refers to the accuracy of the assay itself, which would have been part of the validation studies conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states the device aids in the diagnosis of "autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis." For immunological tests designed to detect antibodies for diagnosis, the ground truth for validating the diagnostic accuracy would typically involve clinical diagnosis based on a combination of patient symptoms, other laboratory tests, biopsy (pathology), and specialist clinical assessment. However, the specific method for establishing ground truth is not detailed in this document.
8. The sample size for the training set:
This document does not provide information on the sample size for a training set. This information would be found in the detailed study report.
9. How the ground truth for the training set was established:
This document does not provide information on how the ground truth for a training set was established.
In summary, the provided document is a regulatory clearance letter and an indication for use, not a detailed clinical study report. Therefore, it lacks the specific information required to answer most of your detailed questions about acceptance criteria and study particulars.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by flowing lines, suggesting movement and connection.
MAY 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers 9900 Old Grove Rd. San Diego, CA 92131-1638
Re: K050715
R050715
Trade/Device Name: QUANTA Plex™ ANCA Profile Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MOB Dated: March 17, 2005 Received: March 18, 2005
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 510(1) production is substantially equivalent (for the indications for referenced above and nave decemined the ences marketed in interstate commerce use stated in the encrosure) to regally manoletal Device Amendments, or to devices that prior to May 26, 1970, the chaomism aan the provisions of the Federal Food, Drug, and Cosmetic have been fectassified in accordance wif a premarket approval application (PMA). You may, Act (Act) that to the require approval othe general controls provisions of the Act. The general therefore, market the device, subject to an igent in the manual registration, listing of devices, good controls provisions of the rich and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aconvols. Existing major regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sourcerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that 1 Dr. I issualle ty our device complies with other requirements of the Act or that i Dria made a decemination administered by other Federal agencies. You must comply with ally Foural statutes and regarding and limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, moractires, offacturing practice requirements as set forth in the quality labeling (21 CFR Part 0017, good management of any if applicable, the electronic product radiation systems (QB) regalaters (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisions (Soctions 551 - 12 - 12 - 22 - 22 - 25 - 12 - 12 - 12 - 12 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 I ms letter will and w you to cogn mains of substantial equivalence of your device to legally
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Page 2 – Mr. Brys C. Myers
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), please If you desire specific advice is 1 3 % (240) 276-0131. Also, please note the regulation entitled, Comace the Office of Octification" (21CFR Part 807.97). You may obtain other IMISoranding by reference to psystemsibilities under the Act from the Division of Small general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(201) +45-6597 of acts intludema/dsmamain.html
Sincerely yours,
Robert Mackay
Robert L. Becker, Jr., M.D., PhD 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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510(k) Number (if known): K050715
Device Name: QUANTA Plex™ ANCA Profile
Indications For Use:
The QUANTA Plex™ ANCA Profile is a fluorescent immunoassay for the semi-quantitative detection of anti-MPO and anti-PR3 ene Bear quarteration The presence of these antibodies aacountinounce in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of the autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Mana Chan
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Satety
510(k) K050715
§ 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).