(118 days)
The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.
This device is an aid to the diagnosis of SSc. Systemic sclerosis (SSc) is an autoimmune disease characterized by microvascular damage and fibrosis of the skin and internal organs. RNA polymerase(RNAP) I, II and III are major targets of autoantibody responses in SSc patients. Each RNAP catalyzes transcription of unique sets of genes: RNAP I transcribes ribosomal RNA genes, RNAP II transcribes all protein coding genes and several small nuclear RNA genes, and RNAP III transcribes genes that produce small stable RNAs including 5S and transfer RNAs. Anti-RNAP I and anti-RNAP III antibodies are almost always present together (anti-RNAP I/II), and some sera contain anti-RNAP II antibody as well. Anti-RNAP I/II antibodies are the most common SSc related antibodies in white North American patients with SSc and is associated with diffuse cutaneous involvement, a high frequency of "renal crisis", and high mortality. In addition, it has been shown that some SSc sera contain autoantibodies recognizing RNAP II but not RNAP I or III. Antibodies to RNAP II are also present in sera from some patients with systemic lupus erythematosus (SLE) or overlap syndrome. PRINCIPLE: The anti-RNA Polymerase III ELISA Kit measures anti-RNAP III antibodies present in the serum by ELISA. Diluted Calibrators and patient serum are added to microwell coated with RNAP III antigens, allowing anti-RNAP III antibodies to react with the immobilized antigen (Sample incubation). After washing to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG is added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.
The provided text doesn't contain specific acceptance criteria with quantifiable metrics (e.g., sensitivity, specificity thresholds) or a detailed study description with performance metrics for the MBL Anti-RNA Polymerase III ELISA Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices based on general characteristics and clinical utility.
However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices and the performance characteristics established by comparison with a research method (Immunoprecipitation).
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Implied from "Substantial Equivalence") |
|---|---|---|
| Safety | The new device is as safe as the predicate devices. | "The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods." |
| Effectiveness | The new device is as effective as the predicate devices. This implies comparable performance in detecting anti-RNA Polymerase III antibodies as an aid in diagnosing Systemic Sclerosis (SSc), likely indicated by similar diagnostic accuracy (e.g., sensitivity, specificity, agreement) when compared to a recognized reference method (Immunoprecipitation) and existing diagnostic tests (predicate ANA tests). | "The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods." "Performance characteristics were established in a clinical trial via comparison with a research method, Immunoprecipitation, AND K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM." While specific numerical performance metrics (sensitivity, specificity, etc.) are not provided, their equivalence to the reference method and predicate is the implied reported performance. |
| Indications for Use | The device's intended use and scope should align with the diagnostic purpose of anti-RNA Polymerase III antibodies in SSc, similar to how predicate devices serve as aids for their respective conditions. | The anti-RNA Polymerase III ELISA Kit is a semiquantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use. |
| Technology/Principle | The technology should be well-understood and appropriate for the intended use, and similar to a predicate device. | ELISA (similar to predicate K040200 MESACUP-2 TEST CENP-B). |
| Target Analyte | Detect anti-RNA Polymerase III antibodies to aid in SSc diagnosis. | Detects anti-RNA Polymerase III antibodies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the clinical trial or test set. It only mentions "clinical trial."
- Data Provenance: The document does not state the country of origin of the data or whether it was retrospective or prospective. It just refers to "clinical and non-clinical testing data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: This information is not provided.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not indicate that an MRMC comparative effectiveness study was done.
- It refers to "comparison with a research method, Immunoprecipitation, AND K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM." This suggests a direct comparison of the device's results against a gold standard/reference method and a predicate device, rather than an evaluation of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance assessment was done. The entire premise of an ELISA kit is to provide a diagnostic result from the assay itself. The "clinical trial via comparison with a research method, Immunoprecipitation" directly evaluates the performance of the kit (the "algorithm only") against a known reference. There is no human-in-the-loop component mentioned for interpreting the ELISA results beyond standard laboratory practices.
7. Type of Ground Truth Used
- The primary ground truth used for performance validation was a research method, Immunoprecipitation. This is commonly considered a highly specific and sensitive "gold standard" for detecting autoantibodies in research and some clinical settings.
- Additionally, comparison was made against K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, which is an indirect fluorescent antibody test for antinuclear antibodies, likely serving as another comparator or a secondary form of reference for general ANA detection, although Immunoprecipitation is the more specific reference for anti-RNA Polymerase III.
8. Sample Size for the Training Set
- The document does not specify a training set size. This is common for traditional in-vitro diagnostic kits like ELISA, where algorithms are not "trained" in the machine learning sense. The kit's performance characteristics are inherent to its biochemical design and manufacturing, and validated through clinical trials, without a distinct "training set" of patient data for algorithm development.
9. How the Ground Truth for the Training Set was Established
- As there's no mention of a "training set" in the context of an algorithm, there's no information on how its ground truth was established. The development of the ELISA kit (e.g., choice of antigens, antibodies, assay conditions) would be based on scientific understanding of anti-RNA Polymerase III antibodies and their detection, rather than an iterative training process with labeled data. The validation (test set) uses Immunoprecipitation as the ground truth.
§ 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).