Monolisa Anti-HAV IgM EIA

• • Terminated Z-2201-2011 FDA Unclassified (pre-2012) ·initiated 19 Jul 2010 ·via K092353, on the same 510(k)

  The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K092353 ↗

FDA Product Code

LOL

Device Class

Class II

Regulation

21 CFR Part 866.3310

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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

• What is the Monolisa Anti-HAV IgM EIA used for?

  The Monolisa Anti-HAV IgM EIA is designed for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human serum or plasma. This helps clinicians diagnose recent or acute HAV infections, distinguishing them from past exposures where only total antibodies may be present. IgM antibodies typically appear early in infection and decline within months, making this test useful for identifying active cases.

• How is the Monolisa Anti-HAV IgM EIA kit supplied, and what does it include?

  The kit is supplied as a complete assay system for 192 tests. It includes bar-coded reagents with color-coded caps, which simplify identification and streamline laboratory workflows. The bar codes enable automated processing, reducing human error and improving efficiency. The kit is intended for in vitro diagnostic use only and does not require additional components beyond those provided.

• Is the Monolisa Anti-HAV IgM EIA kit sterile, and how should it be stored?

  The sterility of the Monolisa Anti-HAV IgM EIA kit is maintained as part of its manufacturing process, but specific sterility claims (e.g., terminally sterilized) are not detailed in the provided data. Storage conditions must adhere to the manufacturer’s guidelines, which typically include protection from extreme temperatures, light, and moisture. The kit should be stored in a clean, dry environment at the recommended temperature range (usually 2°C to 8°C) until use. Always refer to the included instructions for precise storage instructions.

• Can the Monolisa Anti-HAV IgM EIA kit be reused, or is it intended for single-use?

  The Monolisa Anti-HAV IgM EIA kit is explicitly designed for single-use only. Reusing components could compromise test accuracy, introduce contamination, or violate regulatory compliance requirements. Each reagent and component is calibrated for a specific number of tests (192 in this case), ensuring reliable performance within that defined usage. Discard any unused portions after the intended single-use cycle.

• What regulatory pathway was followed for FDA clearance of this device?

  The Monolisa Anti-HAV IgM EIA received FDA 510(k) clearance under the Traditional pathway, which means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device. This pathway involves a premarket notification submission to the FDA, where the applicant (Bio-Rad Laboratories, Inc.) provided data comparing the new device to an existing one to prove safety and effectiveness. The clearance was granted by the Microbiology Device Panel (MI) advisory committee.