(15 days)
The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis.
The MESACUP Test PR-3 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with proteinase III antigen. Incubation allows the anti-PR-3 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the PR-3 bound antibodies. Following another washing step, The bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate, The intensity of the color generated is proportional to the serum concentration of anti-PR-3 antibodies, Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-PR-3 antibody in patient samples.
The provided text describes the MESACUP Test PR-3, an ELISA device for detecting IgG anti-proteinase III (PR-3) antibodies. The information focuses on its substantial equivalence to a predicate device and its intended use, rather than explicit acceptance criteria with pre-defined thresholds. However, we can infer performance metrics and the study details based on the provided summary.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria (e.g., "Sensitivity must be >= 90%") are not stated, we can infer the implicit acceptance criterion was "performance equivalent to the predicate device."
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (MESACUP Test PR-3) | Reported Predicate Device Performance (Bindazyme Human Anti-PR3 Enzyme Immunoassay) |
|---|---|---|---|
| Clinical Specificity | 100% (in healthy donor serum population) | 100% | 100% |
| Sensitivity (Vasculitis Population vs. IIF ANCA positive) | ~35% (based on predicate performance) | 35% | 35% |
| Sensitivity (cANCA positive IIF patterns) | ~87% (based on predicate performance) | 87% | 87% |
| Relative Agreement | 100% with predicate device | 100% | N/A (this is a comparison metric) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "a healthy donor serum population" and "a vasculitis population," but no numbers are provided for either group.
- Data Provenance: "In-house studies." The country of origin is not specified, but the applicant's address is in Des Plaines, IL, USA. The studies are retrospective as they are testing existing samples to determine performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned. The ground truth appears to be based on the clinical diagnosis (healthy vs. vasculitis) and other diagnostic methods (IIF ANCA positive results, cANCA positive IIF patterns), but who made these determinations is not specified.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned for establishing the ground truth. The text implies a pre-existing classification of samples (e.g., "healthy donor serum population," "vasculitis population," "IIF ANCA positive results," "cANCA positive IIF patterns").
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 In Vitro Diagnostic (IVD) assay, not an AI-powered diagnostic imaging device that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is an ELISA (Enzyme-Linked Immunosorbent Assay), which is a standalone laboratory test. Its performance is measured directly without human interpretation of its output in the same way an imaging algorithm's output would be interpreted. The "algorithm" here refers to the biochemical process of the assay itself, and its result (optical density) is read spectrophotometrically.
7. The Type of Ground Truth Used
- The ground truth appears to be a combination of:
- Clinical diagnosis: Healthy individuals vs. patients with vasculitis (specifically Wegener's granulomatosis).
- Reference laboratory tests: Immunofluorescence (IIF) ANCA positive results and cANCA positive IIF patterns.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set." This type of IVD typically undergoes development and optimization, but the term "training set" is more commonly associated with machine learning algorithms. The performance data presented is likely from a validation or test set.
9. How the Ground Truth for the Training Set Was Established
- As no "training set" is explicitly mentioned for this IVD, the method for establishing its ground truth is not detailed. For typical IVD development, calibration and controls are used, and the assay design itself is based on known biochemical interactions.
§ 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).