Bio-Rad Monolisa Anti-HBC EIA

• • Terminated Z-1189-2008 FDA Unclassified (pre-2012) ·initiated 7 Jan 2008 ·on shared PMA P060031

  Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Qualitative and Quantitative Hepatitis B Virus Antibody assays

PMA Number

P060031 ↗

FDA Product Code

SEI

Device Class

Class II

Regulation

21 CFR Part 866.3173

Advisory Committee

Microbiology

FDA Decision

APRL

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See all devices from Bio-Rad Laboratories, Inc. →

• What is the primary purpose of the Bio-Rad Monolisa Anti-HBC EIA in clinical testing?

  The Bio-Rad Monolisa Anti-HBC EIA is designed as an enzyme immunoassay for the qualitative and quantitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (Anti-HBC) in human serum and plasma. It aids in diagnosing hepatitis B virus (HBV) infection by providing results that can be used alongside other HBV serological markers to assess HBV-related disease.

• Which types of blood samples can be tested with this assay, and what anticoagulants are compatible?

  This assay is compatible with human serum and plasma collected using potassium EDTA, sodium citrate, ACD (acid citrate dextrose), lithium heparin, or sodium heparin. The device is intended for use in microbiology laboratories to analyze these sample types for Anti-HBC antibodies.

• How is the Bio-Rad Monolisa Anti-HBC EIA supplied, and is it intended for single-use or reuse?

  The device is supplied as a ready-to-use diagnostic kit, meaning it comes pre-assembled and does not require additional preparation before use. While the provided data does not explicitly state whether it is single-use or reusable, the nature of enzyme immunoassays like this typically implies single-use per test to maintain accuracy and prevent cross-contamination.

• What regulatory pathway was followed for the approval of this device, and what class does it fall under?

  The Bio-Rad Monolisa Anti-HBC EIA was approved under the FDA Premarket Approval (PMA) pathway with PMA number P060031. It is classified as a Class II medical device under the Special Controls (SEI) product code, indicating it has been reviewed for safety and effectiveness through a rigorous approval process.

• Is this device intended for use in specific clinical settings, and what specialty does it fall under?

  The device is intended for use in microbiology laboratories and falls under the Microbiology specialty, as indicated by its advisory committee designation (MI). It is not intended for point-of-care or non-laboratory settings but rather for specialized diagnostic testing environments.