THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE by ZEUS SCIENTIFIC, INC.

The Zeus Scientfic, Inc. PR-3 ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to PR-3. Elevated antibody levels to PR-3 may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

Disclaimer: The provided document is a 510(k) clearance letter from the FDA dated December 17, 1998, for the Zeus Scientific, Inc. Aptus (Automated) Application for the PR-3 ELISA Test System. It does not contain detailed acceptance criteria, study results, or information typically found in a clinical study report. Therefore, I cannot fully answer all aspects of your request based solely on this document.

However, I can extract information related to the device, its intended use, and limitations of the document itself concerning your request.

This document is an FDA 510(k) clearance letter dated December 17, 1998, for the Zeus Scientific, Inc. Aptus (Automated) Application for the PR-3 ELISA Test System. It indicates that the FDA found the device "substantially equivalent" to legally marketed predicate devices. This letter confirms the device's classification and permits it to be marketed.

Based on the provided document, I cannot fulfill all parts of your request as it lacks the detailed study information, acceptance criteria, and performance data typically found in a clinical study report or the 510(k) submission itself.

Here's what can be inferred or stated based only on the provided FDA clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided FDA clearance letter. A 510(k) clearance letter summarizes the FDA's decision but does not typically include the detailed acceptance criteria or the full performance data from the studies submitted by the manufacturer. These details would be contained within the original 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not available in the provided FDA clearance letter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not available in the provided FDA clearance letter.

4. Adjudication Method for the Test Set:

This information is not available in the provided FDA clearance letter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This information is not available in the provided FDA clearance letter. Given that the device is an ELISA test system for detecting antibodies, it is highly unlikely that an MRMC study (typically for image interpretation by human readers) would have been performed. This device is an in vitro diagnostic (IVD) assay.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

The device is an "Aptus (Automated) Application for the PR-3 ELISA Test System." This indicates it's an automated or semi-automated immunoassay. Performance studies for such devices typically evaluate the assay's analytical and clinical performance standalone (i.e., the device's output itself, not human interpretation of that output). However, the details of these studies are not available in the provided FDA clearance letter.

7. The Type of Ground Truth Used:

This information is not available in the provided FDA clearance letter. For an IVD like an ELISA, ground truth is typically established by:

Confirmed clinical diagnosis by a physician.
Results from a predicate or gold standard reference assay.
Pathology (if applicable to the disease state, but less direct for antibody detection).
Patient outcomes over time.

8. The Sample Size for the Training Set:

This information is not available in the provided FDA clearance letter. ELISA assays typically do not have "training sets" in the same way machine learning algorithms do. Instead, they undergo method development, optimization, and validation using various sample cohorts.

9. How the Ground Truth for the Training Set was Established:

This information is not available in the provided FDA clearance letter. As mentioned, the concept of a "training set" ground truth is less directly applicable to a traditional ELISA assay compared to AI/ML devices.

Device Specific Information from the Document:

Device Name: Aptus (Automated) Application for the PR-3 ELISA Test System
Manufacturer: Zeus Scientific, Inc.
Regulatory Class: II
Product Code: MOB
Indications for Use: The Zeus Scientific, Inc. PR-3 ELISA test system is intended for the semi-quantitative detection of IgG class antibody to proteinase-3 (PR-3) in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to PR-3. Elevated antibody levels to PR-3 may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.

To obtain the detailed information regarding acceptance criteria, study design, sample sizes, and ground truth establishment, one would need to consult the original 510(k) submission (K984315) itself, which is typically available through FDA's public databases or directly from the manufacturer.

Summary

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DEC 1 7 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

Re: K984315 Aptus (Automated) Application for the PR-3 ELISA Trade Name: Test System Regulatory Class: II Product Code: MOB Dated: December 1, 1998 Received: December 3, 1998

Dear Mr. Kopnitsky:

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 (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 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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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 diaqnostic 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): 长984315

Aptus (automated) Application for the PR-3 ELISA Test Device Name: System

Indications for Use:

Peter E. Maleni

Division Sion-

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

✓

Over-The-Counter Use

(Optional Format 1-

(Per 21 CFR 801.109)

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).