Cleared Traditional

K063318 - MONOLISA ANTI-HAV EIA (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063318 · Bio-Rad Laboratories · Microbiology device
May 2007
Decision
182d
Days
Class 2
Risk

K063318 is an FDA 510(k) clearance for the MONOLISA ANTI-HAV 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.

Submission Details

510(k) Number K063318 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
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 174d · 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.