(56 days)
The Varelisa ReCombi ANA Profile EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (Systemic Lupus Erythematosus), Scleroderma (Progressive Systemic Sclerosis), MCTD (Mixed Connective Tissue Disease), SS (Sjögren's Syndrome) and Polymyositis/ Dermatomyositis. The Varelisa ReCombi ANA Profile individually detects antibodies against dsDNA, RNP(68 kDa, A, C), Sm(B,B',D) SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, Centromere and Jo-1.
The Varelisa ReCombi ANA Profile is an enzyme immunoassay for the individual qualitative determination of 8 antinuclear antibodies in serum or plasma.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence of the Varelisa ReCombi ANA Profile to its predicate devices specifically relate to a high degree of correlation in the results.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High degree of correlation between new device and predicate devices. | Overall Sample Agreement: 107 out of 112 samples (96% agreement) showed the same result between the new device and the predicate devices (Varelisa ANA Profile and Varelisa dsDNA Antibodies Assay). |
| Individual Parameter Agreement: 845 of 876 single determinations (96%) were in agreement between the new device and the predicate devices. | |
| Reference Sera Agreement: A total agreement was observed when comparing results for ANA Reference Sera CDC-1 to CDC-10; all 10 sera showed correct specificities with both the new and predicate devices. | |
| Agreement Table (n=876 determinations): | |
| Varelisa ANA Profile and Varelisa dsDNA Abs. Assay | |
| positive | |
| VARELISA ReCombi ANA Profile | positive |
| equivocal | |
| negative |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 112 samples were used, including 20 apparently healthy blood donors.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that existing samples (including "apparently healthy blood donors") were tested using both devices.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the given text. The ground truth for the comparison is the results obtained from the predicate devices, not an independent expert consensus on patient status.
4. Adjudication Method for the Test Set
- This information is not applicable as the comparison is directly between the results of the new device and the predicate devices. There's no mention of a human adjudication process for discrepancies.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a diagnostic kit (an in-vitro diagnostic device) compared to predicate devices, not on the impact of a device on human readers' interpretive performance.
6. Standalone Performance Study
- Yes, a standalone study was done, in the sense that the Varelisa ReCombi ANA Profile was tested independently on the 112 samples and its results were then compared to those of the predicate devices. The performance metrics of 96% agreement (overall and individual parameter) are indicative of its standalone performance in relation to the predicate.
7. Type of Ground Truth Used
- The "ground truth" for this study was the results obtained from the predicate devices (Varelisa ANA Profile and Varelisa dsDNA Antibodies Assay). Additionally, the study used ANA Reference Sera CDC-1 to CDC-10 from the Centers of Disease Control and Prevention for which the "correct specificities" served as another form of ground truth.
8. Sample Size for the Training Set
- This information is not provided as this is an in-vitro diagnostic device and the "training set" concept (as usually applied to AI/machine learning) is not directly relevant here. The device's formulation and manufacturing would be based on internal development and validation, but not a "training set" in the computational sense.
9. How Ground Truth for Training Set Was Established
- This information is not applicable as there is no mention of a training set in the AI/machine learning context. The development of the Varelisa ReCombi ANA Profile would have involved rigorous R&D and internal validation to ensure its reagents and methodology accurately detect the target antibodies, but this isn't described in terms of a "training set" and "ground truth" as typically understood in AI studies.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).