(133 days)
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 in human serum.
This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Scl-70 in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Immuno Concepts RELISA® Scl-70 Antibody Test System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria. Instead, it presents the performance of the new device relative to a predicate device. Therefore, the "acceptance criteria" are implied to be a level of performance that demonstrates substantial equivalence to the predicate. Based on the conclusion, the implied acceptance was met.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | High agreement with predicate | 97.9% |
| Relative Specificity | High agreement with predicate | 100% |
| Overall Agreement | High agreement with predicate | 99.4% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The total sample size can be calculated from the
contingency table: 37 (Pos) + 3 (Bor) + 0 (Neg) + 0 (Pos) + 7 (Bor) + 0
(Neg) + 0 (Pos) + 1 (Bor) + 129 (Neg) = 177 samples. - Data Provenance: Not explicitly stated. There is no information
regarding the country of origin of the data or whether it was retrospective
or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in this context. The ground truth for
the new device's performance was established using a predicate device
(Immuno Concepts RELISA® Screening Assay, K935129) as the reference method,
not human experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The comparison was directly against
a reference method (predicate device), not against multiple human
interpretations requiring adjudication. The text mentions an assumption: "If
we assume that "borderline" results are actually positive," which is a data
interpretation choice, not an adjudication method by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not performed. This study compares
a new diagnostic assay to a predicate diagnostic assay, not the performance
of human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, this is essentially a standalone performance
study for the diagnostic device. The RELISA® Scl-70 Antibody Test System
is a laboratory assay, and its performance (sensitivity, specificity) is
measured directly against a reference method (the predicate device) without
human intervention in the final result interpretation for the purpose of
this comparison.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this study was established
using a predicate device (Immuno Concepts RELISA® Screening Assay,
K935129). This is a form of "reference standard" or "comparator method"
ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a training
set or how the device was developed/trained. This is a traditional immunoassay
kit, not an AI/ML algorithm that typically requires a training set. The data
provided is solely for the validation/comparison of the new device against its
predicate.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of
a training set for this device.
§ 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).