AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA by COGENT DIAGNOTICS LTD.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Pr 3 in human serum. The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener's granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA). For in vitro diagnostic use only.

Device Description

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Pr 3 in human serum. This device is designed for use with the Hycor Hy. Tec Automated EIA instrument.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove the device meets those criteria. The document is primarily a 510(k) clearance letter from the FDA for two devices, the "Cogent Autostat™ II Anti-PR3 ELISA" and the "Hycor Hy-Tec Anti-PR3 ELISA". It confirms that these devices are substantially equivalent to legally marketed predicate devices.

However, based on the general nature of an ELISA for autoantibodies, particularly for conditions like Wegener's granulomatosis, we can infer some aspects of what such a submission would entail and what types of studies would be done.

Here's an attempt to answer your questions by inferring from typical IVD submissions and the provided limited text:

Table of acceptance criteria and the reported device performance:
The document does not specify exact acceptance criteria or reported device performance metrics in a numbered or statistical format. For an ELISA kit, typical performance metrics would include:
- Sensitivity: The ability of the test to correctly identify individuals with the disease (true positives).
- Specificity: The ability of the test to correctly identify individuals without the disease (true negatives).
- Accuracy: The overall correctness of the test results.
- Precision/Reproducibility: The ability of the test to produce consistent results when repeated.
- Assay Range/Linearity: The concentration range over which the assay can accurately measure the analyte.
- Interference: Lack of significant impact from common interfering substances in serum.
Without a detailed performance study section, we cannot populate this table with specific numbers. The FDA letter only states "substantial equivalence."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide this information. For substantial equivalence, studies would typically involve a prospective or retrospective collection of patient samples (both diseased and healthy controls or other disease states) to assess performance against a recognized reference method or clinical diagnosis. The country of origin and specific study design (prospective/retrospective) are not mentioned.
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):
The document does not specify the number or qualifications of experts used to establish ground truth. For diseases like Wegener's Granulomatosis, ground truth would likely be established by a combination of clinical diagnosis, physician assessment (e.g., rheumatologists, nephrologists), and possibly biopsy results, rather than solely by a specific number of individual experts interpreting imaging or similar.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in the document. Ground truth establishment for a diagnostic test like this would likely rely on consensus clinical diagnosis, rather than a specific adjudication method for interpreting individual "reads" as might be seen with imaging studies.
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 question is not applicable to the device described. The "Cogent Autostat™ II Anti-PR3 ELISA" and "Hycor Hy-Tec Anti-PR3 ELISA" are enzyme-linked immunosorbent assay (ELISA) kits, which are in vitro diagnostic laboratory tests for detecting specific antibodies in human serum. They do not involve human "readers" in the context of interpreting images or complex data where AI assistance would be relevant. There is no AI component mentioned or implied for these devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is also not applicable. These are diagnostic kits, not algorithms. Their performance is their standalone performance in terms of detecting antibodies in a sample.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
While not explicitly stated, for conditions like Wegener's Granulomatosis associated with ANCA, the ground truth would typically be:
- Clinical Diagnosis: Established by physicians based on a combination of patient symptoms, physical examination, laboratory findings (including ANCA testing and other markers), and often biopsy results (pathology) confirming vasculitis or granuloma formation.
- Outcomes Data: In some cases, long-term patient outcomes are used to confirm diagnosis, but initial ground truth for a diagnostic test is usually based on established diagnostic criteria.
The sample size for the training set:
The document does not mention a training set, as these are traditional IVD kits, not AI algorithms that require training data.
How the ground truth for the training set was established:
Not applicable, as no training set for an AI algorithm is involved.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1999

Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom

Re: K990796

Trade Name: Cogent Autostat™ II Anti-PR3 ELISA Hycor Hy-Tec Anti-PR3 ELISA Regulatory Class: II Product Code: MOB Dated: February 24, 1999 Received: March 10, 1999

Dear Ms. Knight:

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 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). 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 requirements, as set forth in the Quality System Regulation (OS) 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 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K998796

Device Name: Autostat II Anti-PR3 (cANCA)

Indications For Use:

Indications for Use - Autostat™I Kit.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Pr 3 in human serum.

Uses:

The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener's granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA).

For in vitro diagnostic use only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arthur E. Hakim

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K907

Prescription Use i/
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K990796

Device Name: Hy-Tec Anti-PR3 (CANCA)

Indications For Use:

Indications for Use - Hy·Tec Kit.

Uses:

The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of auto-immune vasculitides including Wegener's granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA).

For in vitro diagnostic use only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Mclain

(Division Sign-Off)
Division of Clinical Laboratory Devices K990794
510(k) Number

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).