Autostat II Rheumatoid Factor IgM ELISA

• • Ongoing Z-2200-2019 FDA Class II ·initiated 19 Mar 2018

  Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.

• • Completed Z-2134-2019 FDA Class II ·initiated 21 Feb 2018

  Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.

510(k) Number

K994338 ↗

FDA Product Code

DHR

FDA applicant

Cogent Diagnotics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5775

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical use of the Autostat II Rheumatoid Factor IgM ELISA, and how does it function in a lab setting?

  The Autostat II Rheumatoid Factor IgM ELISA is designed for the qualitative detection of IgM rheumatoid factor antibodies in human serum, aiding in the identification of rheumatoid arthritis. It operates as an enzyme-linked immunosorbent assay (ELISA) that measures specific antibody levels to support diagnostic evaluation. This test is intended for use on automated EIA instruments in clinical laboratory settings, where it helps clinicians assess potential rheumatoid arthritis by detecting elevated IgM rheumatoid factor levels.

• How is the Autostat II Rheumatoid Factor IgM ELISA supplied, and is it intended for single-use or repeated testing?

  The device is supplied as a 96-well ELISA kit, meaning it comes pre-organized for testing multiple samples at once. It is intended for single-use only in clinical laboratory settings, meaning each kit should not be reused for subsequent tests. This ensures accuracy and prevents cross-contamination.

• Does this device require any special handling or storage conditions, and is sterility maintained?

  The provided data does not specify storage conditions or sterility assurances for the Autostat II Rheumatoid Factor IgM ELISA. However, as an in vitro diagnostic test, it is reasonable to assume standard laboratory storage practices (e.g., refrigeration if required) should be followed to maintain integrity. Since it is a single-use kit, sterility is likely preserved until first use, but users should refer to the manufacturer’s instructions for precise handling and storage guidelines.

• What regulatory pathway was followed for FDA clearance, and what does this mean for its use in clinical settings?

  The Autostat II Rheumatoid Factor IgM ELISA received FDA 510(k) clearance (K994338) under the substantial equivalence pathway, meaning it was determined to be as safe and effective as a legally marketed device. This clearance was granted by the Immunology (IM) Advisory Committee and falls under Class II medical device regulations (21 CFR 866.5775). Clinically, this indicates the device meets FDA standards for use in detecting IgM rheumatoid factor in human serum, though final interpretation of results should be made by qualified healthcare professionals.