(236 days)
The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA). FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.
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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2)". This device is an in-vitro diagnostic test for quantitative determination of human IgG rheumatoid factor antibodies.
The letter explicitly states that the device is a "Rheumatoid Factor Immunological Test System" (Regulation Name: 21 CFR 866.5775) and is a "Class II" device.
Crucially, this document is an FDA clearance letter for a laboratory test (an in-vitro diagnostic device), not an AI/ML-based medical device that would have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC, or involve human readers and their improvement with AI assistance.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML, human readers, ground truth establishment, etc., is not applicable to this type of device and will not be found in this document.
The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device, and performance measures like precision, accuracy, linearity, measuring range, interference, and agreement studies for clinical performance. These are standard validation tests for IVD products, not AI performance metrics.
In summary, based on the provided text, I cannot provide the requested information because it pertains to an AI/ML medical device, which the K-ASSAY® RF (Ver.2) is not.
I can, however, extract the following relevant information from the document as it pertains to a medical device:
- Device Name: K-ASSAY® RF (Ver.2), K-ASSAY® RF Calibrator (Ver.2)
- Regulation Number: 21 CFR 866.5775
- Regulation Name: Rheumatoid Factor Immunological Test System
- Regulatory Class: Class II
- Indications for Use: The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis (RA). FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.
- Type of Use: Prescription Use
- Predicate Device: The letter states the device is "substantially equivalent" to legally marketed predicate devices, but the specific predicate device is not named in this letter.
To reiterate, the questions about acceptance criteria, study design, sample sizes, experts, ground truth, MRMC studies, standalone performance, and training sets are not applicable to this medical device submission as described in the provided FDA 510(k) clearance letter.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).