Cleared Traditional

K063319 - MONOLISA ANTI-HAV IGM EIA

K063319 is the FDA 510(k) clearance for MONOLISA ANTI-HAV IGM EIA by Bio-Rad Laboratories. It is a Class 2 Microbiology device (product code LOL) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K063319 · Bio-Rad Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
182d
Days
Class 2
Risk

K063319 is an FDA 510(k) clearance for the MONOLISA ANTI-HAV IGM EIA. Classified as Hepatitis A Test (antibody And Igm Antibody) (product code LOL), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Hauts-De-Seine, FR). The FDA issued a Cleared decision on May 3, 2007 after a review of 182 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3310 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Rad Laboratories devices

Submission Details

510(k) Number K063319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2006
Decision Date May 03, 2007
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOL Hepatitis A Test (antibody And Igm Antibody)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LOL Hepatitis A Test (antibody And Igm Antibody)

All 24
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K063319.
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
K082050 · DiaSorin, Inc. · Nov 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · Siemens Healthcare Diagnostics, Inc. · Jul 2008
MONOLISA ANTI-HAV EIA
K063318 · Bio-Rad Laboratories · May 2007
ABBOTT ARCHITECT HAVAB-M
K063329 · Abbott Laboratories · Apr 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS
K060770 · Ortho-Clinical Diagnostics, Inc. · Sep 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
K060678 · Ortho-Clinical Diagnostics, Inc. · Sep 2006