(16 days)
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
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This document is a 510(k) clearance letter from the FDA for the REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit. It does not contain the detailed study results, acceptance criteria, or performance data that would answer your specific questions about the device's performance characteristics.
The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device is considered as safe and effective as a device already on the market, but it does not typically involve a new, detailed clinical study with novel acceptance criteria and performance reporting in the same way a PMA (Premarket Approval) might.
Therefore, most of the information you've requested is not available in this document. Here's what can be inferred or explicitly stated:
- Acceptance Criteria and Reported Device Performance: Not provided in this document. The letter only confirms "substantial equivalence."
- Sample size used for the test set and data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and qualifications: Not provided.
- Adjudication method: Not provided.
- MRMC comparative effectiveness study: Not applicable or not mentioned in this type of FDA clearance. This is an in vitro diagnostic device for detecting antibodies, not an AI-assisted diagnostic tool that would typically involve human readers.
- Standalone performance: The letter refers to the "REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit" as the device itself, implying it's a standalone test rather than an AI algorithm assisting a human reader. However, specific performance metrics are not given.
- Type of ground truth used: Not provided in this document. For an in vitro diagnostic device, this would typically involve a reference method or clinical diagnosis in a patient cohort.
- Sample size for the training set: Not applicable for this type of device submission as described. There is no mention of an "algorithm" or "training set" in the context of machine learning. This is a laboratory test kit.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit
- Regulation Number/Name: 21 CFR 866.5660, Multiple autoantibodies immunological test system
- Regulatory Class: Class II
- Product Code: MID
- Indications for Use:
- An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma.
- For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
To get the information you asked for, one would typically need to review the actual 510(k) submission summary or detailed study reports, which are not included in this FDA clearance letter.
§ 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).