(51 days)
The HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The HEP-ANA Test System is intended for use as an aid in the diagnosis of certain autoimument diseases.
The RhiGene HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate, similar to the predicate device. Diluted serum samples are incubated on substrate slides coated with HEP-2 (human epithelial) cells. Incubation allows the anti-nuclear antibodies (ANA) present in the samples to react with the antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins, labeled with fluorescein isothiocyanate (FITC), are added forming complexes with the nuclear bound antibodies. Following another washing step, coverslips are mounted and then the slides are examined with a fluorescence microscope. The total incubation time (at room temperature in a moist chamber) of the assay is 40 minutes.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the RhiGene HEP-ANA Test System:
Acceptance Criteria and Device Performance
The core of the acceptance criteria is predicated on the new device, the RhiGene HEP-ANA Test System, demonstrating substantial equivalence to a legally marketed predicate device, the RhiGene Titer-Fluor ANA Test System (K872845). While explicit numerical acceptance targets aren't given in the summary, the study's goal was to show comparable performance.
The "reported device performance" refers to the RhiGene HEP-ANA Test System. It's compared directly to the predicate device, with results indicating equivalence rather than specific performance metrics in isolation.
| Acceptance Criterion (Implicit) | Reported Device Performance (RhiGene HEP-ANA Test System) | Predicate Device (RhiGene Titer-Fluor ANA Test System) |
|---|---|---|
| Clinical Specificity (Healthy Donor Serum) | 82% | 78% |
| Sensitivity (Autoimmune Diseases Population) | 75% | 75% |
| Overall Performance Characteristics | Comparable | Comparable |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single number.
- "a healthy donor serum population"
- "an autoimmune diseases population"
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "In-house studies," implying they were conducted by RhiGene Inc. The samples appear retrospective as they are described as "populations" rather than detailing a prospective enrollment strategy.
- Sample Size: Not explicitly stated as a single number.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The ground truth for the healthy and autoimmune populations would have been established through clinical diagnosis, but the involvement of specific experts for validating these diagnoses for the study is not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the summary.
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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:
- An MRMC study was not performed. This device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis tool requiring human reader interpretation. The performance is based on the assay's output as interpreted by laboratory personnel.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A "standalone" study in the typical AI sense (algorithm only) was not performed as this is a traditional laboratory assay. However, the performance metrics (specificity and sensitivity) are representative of the device's inherent capability, with human involvement primarily in performing the assay and interpreting the fluorescent patterns, not the "algorithm" itself. The comparison is between two similar lab assays.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For specificity, the ground truth was derived from a "healthy donor serum population." This implies individuals diagnosed as healthy, likely through clinical evaluation or self-reported health.
- For sensitivity, the ground truth was derived from "an autoimmune diseases population." This implies individuals with a clinical diagnosis of an autoimmune disease.
- The document implies that the ground truth for these populations was established through standard clinical diagnostic practices, rather than a specific expert consensus for this study.
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The sample size for the training set:
- This information is not applicable as this is not a machine learning or AI device that requires a "training set." The device is a chemical/biological assay.
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How the ground truth for the training set was established:
- This information is not applicable as this is not a machine learning or AI 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).