(30 days)
The TheraTest EL-β2GPITM (IgM-IgG-IgA) is a set of in vitro diagnostic tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against serum beta 2-glycoprotein I (β2GPI). This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.
The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the screening for autoantibodies in human serum directed against the serum glycoprotein beta 2glycoprotein I (B2GPI). This measurcment aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.
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This document is a 510(k) premarket notification for two in vitro diagnostic tests: TheraTest EL-β2GPI™ (IgM-IgG-IgA) and TheraTest EL-β2GPI™ Scr. The FDA has determined these devices are substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the detailed study information required to fill out the requested table and answer all points about acceptance criteria and device performance. This document primarily focuses on the FDA's decision regarding substantial equivalence based on the 510(k) submission, and not the specific performance study conducted by the manufacturer.
Therefore, I cannot provide a complete answer to your request using only the provided text. The document refers to an "enclosure" which likely contains the performance data, but that enclosure is not part of this input.
A partial response based on what can be inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. Often, for 510(k)s, the acceptance criteria relate to demonstrating comparable performance (e.g., sensitivity, specificity, accuracy, precision) to a legally marketed predicate device.
- Reported Device Performance: Not detailed in this document. The document confirms the device is an in vitro diagnostic test for measuring autoantibodies, which "aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders." This implies the performance would be measured in terms of its ability to detect these autoantibodies.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in this document.
4. Adjudication method for the test set
- Not specified in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- Not applicable as this is an in vitro diagnostic (assay-based) device, not an imaging device requiring human reader interpretation in the same way.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is an in vitro diagnostic test, meaning its performance is inherently "standalone" in its measurement of analytes. The "human-in-the-loop" would be the clinician interpreting the test results in the context of other clinical information, not directly interacting with the measurement itself.
7. The type of ground truth used
- For an in vitro diagnostic test for autoantibodies, the ground truth would typically be established through:
- Clinical diagnosis: Confirmation of APS or autoimmune thrombotic disorders through established clinical criteria, potentially including other laboratory tests and patient history.
- Reference laboratory methods: Comparison to a gold standard or well-established reference method for autoantibody detection (e.g., western blot, immunofluorescence, or other highly sensitive/specific assays).
- Outcomes data: Although less common for establishing initial analytical performance, long-term patient outcomes could be part of a broader validation.
- However, the specific type of ground truth used for this device is not detailed in the provided document.
8. The sample size for the training set
- Not specified in this document.
9. How the ground truth for the training set was established
- Not specified in this document.
To get the full details, you would need to consult the complete 510(k) submission, particularly the "enclosure" mentioned in the letter, which would contain the performance study data.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).