Pharmacia B2 Micro EIA

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K900449 ↗

FDA Product Code

JZG

Device Class

Class II

Regulation

21 CFR Part 866.5630

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Pharmacia, Inc. →

• What clinical conditions is the Pharmacia B2 Micro EIA used to monitor?

  The Pharmacia B2 Micro EIA is designed to measure beta-2-microglobulin levels, a biomarker linked to renal function, inflammatory diseases, and certain malignancies. Elevated levels may indicate impaired kidney function, active inflammation, or progression of conditions like multiple myeloma. Clinicians use it to track disease activity or treatment response in these contexts.

• How is the Pharmacia B2 Micro EIA supplied, and what storage requirements apply?

  This device is supplied as a single-use reagent kit, meaning each kit is intended for one testing procedure only. No special storage conditions are required beyond refrigeration (typically 2–8°C) and protection from light. Always follow standard laboratory practices for immunological assays to maintain integrity until use.

• Is the Pharmacia B2 Micro EIA reusable, or is it intended for single-use only?

  The Pharmacia B2 Micro EIA is explicitly designed for single-use only. Each kit contains reagents calibrated for one assay cycle, and reuse could compromise accuracy or introduce contamination. Adherence to single-use guidelines ensures reliable results and compliance with FDA clearance requirements.

• What regulatory classification and clearance status does this device hold?

  The Pharmacia B2 Micro EIA is classified as a Class II device under FDA regulation 866.5630, with clearance via a 510(k) submission (K900449). It was determined substantially equivalent to a predicate device through the Immunology (IM) Advisory Committee review process. The clearance does not imply suitability for MRI use or alternative diagnostic contexts.

• Can this test be performed on plasma or only serum samples?

  The Pharmacia B2 Micro EIA is validated for use with both serum and plasma samples. Beta-2-microglobulin levels are measurable in either matrix, though clinicians should follow standard sample preparation protocols (e.g., centrifugation for plasma) to ensure consistency. Always verify sample type against the assay’s instructions for optimal results.