(45 days)
ANA line Blot is an antinuclear antibody screening test designed to identify IgG antibodies in human serum, against the following cytoplasmic and nuclear antigens, collectively in one strip: centromere, dsDNA, histones, Jo-1, Scl-70, SSA (SSA Ro52, SSA Ro60), SSB, Sm (SmB and SmD), RNP (RNP-70, RNP-A and RNP-C), and Ribosomal RNP (RPO). The test is intended as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE), multiple connective tissue disorders, Sjögren's syndrome, CREST syndrome, scleroderma (progressive systemic sclerosis, PSS), and myositis.
The ANA line Blot is a clinical device designed to identify antibodies in human serum, against various cytoplasmic and nuclear antigens. This product is intended strictly for in vitro diagnostic use as an aid in the diagnosis of autoimmune diseases.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the ANA line Blot™:
Acceptance Criteria and Device Performance for ANA line Blot™
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state pre-defined acceptance criteria (e.g., target percentages for agreement). Instead, it presents the results of a method comparison study and implicitly uses the agreement with a predicate device as the benchmark for "substantial equivalence."
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (ANA line Blot™ vs. Predicate) |
|---|---|---|
| Overall Agreement | Substantial Equivalence with predicate | 91% |
| Positive Agreement | Substantial Equivalence with predicate | 92% (95% CI: 88% - 96%) |
| Negative Agreement | Substantial Equivalence with predicate | 85% (95% CI: 73% - 93%) |
2. Sample Sizes and Data Provenance:
- Test Set Sample Size: 269 specimens
- 51 specimens from apparently healthy subjects (6 males, 44 females, 1 unstated; average age 49 years, range: 6-93).
- 218 specimens from autoimmune disease patients (32 males, 107 females, 79 unreported; average age 41 years, range: 10-80), including CREST syndrome, systemic lupus erythematosus (SLE), and systemic sclerosis.
- Data Provenance: Not explicitly stated, but the submission is from Diagnostic Products Corporation in Los Angeles, California, and the language implies a U.S.-based study. The data is retrospective, as it involves archived specimens tested against both devices.
3. Number of Experts and Qualifications for Ground Truth: No experts were used to establish ground truth in the context of this 510(k) submission. The study compares the performance of the new device against a legally marketed predicate device, with the predicate serving as the reference for comparison, not a "ground truth" established by experts.
4. Adjudication Method: Not applicable. There was no adjudication mentioned, as the study compared two assays directly rather than interpreting outputs requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This study is an in vitro diagnostic device comparison, not an imaging device or human-reader study. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance: Yes, a standalone performance study was performed in the sense that the ANA line Blot™ device's performance was directly measured and compared against the predicate device using patient specimens. This isn't a "human-in-the-loop" device; its output is a direct measurement for interpretation.
7. Type of Ground Truth Used: The "ground truth" in this context is the results produced by the predicate device, the Helix Diagnostics Enzyme Immunoassay Antinuclear Antibody Screening Test. This is a common approach for 510(k) submissions seeking substantial equivalence for in vitro diagnostic devices. The intent is to show that the new device performs comparably to an already cleared device.
8. Sample Size for the Training Set: Not applicable. This document describes a method comparison study for an in vitro diagnostic assay, not a machine learning or AI-based device that typically requires a training set. The device itself (ANA line Blot™) is a laboratory test, not an algorithm that "learns."
9. How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of 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).