Search Results

Liquichek Anti-SS-B Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-B autoantibodies.

Liquichek Anti-SS-B Control, EIA is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

The provided document, a 510(k) Summary for the Bio-Rad Liquichek Anti-SS-B Control, EIA, does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.

The document focuses on:

• Device Description: Composition and intended use of the Liquichek Anti-SS-B Control, EIA.
• Substantial Equivalence: A comparison of the Bio-Rad device to a predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit) to establish technological similarities.
• FDA Clearance: The FDA's letter granting 510(k) clearance, confirming substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria. The document does not describe performance studies, sensitivity/specificity, sample sizes used for testing, ground truth establishment, expert qualifications, or MRMC studies.

The device itself is an "unassayed quality control," meaning it's a control material for other assays, not a diagnostic test with performance metrics like sensitivity or specificity being developed or evaluated in this document. Its "performance" would likely refer to its stability, consistency, and ability to produce expected results in the assays it controls, but this is not detailed here.

Ask a specific question about this device