(14 days)
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.
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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.
§ 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).