Cleared Traditional

K100903 - ANTI-HAV

K100903 is an FDA 510(k) clearance for ANTI-HAV, manufactured by Roche Professional Diagnostics. The device is a Class 2 Microbiology device with product code LOL cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K100903 · Roche Professional Diagnostics · Microbiology device
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Oct 2010
Decision
187d
Days
Class 2
Risk

K100903 is an FDA 510(k) clearance for the ANTI-HAV. Classified as Hepatitis A Test (antibody And Igm Antibody) (product code LOL), Class II - Special Controls.

Submitted by Roche Professional Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 5, 2010 after a review of 187 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 Roche Professional Diagnostics devices

FDA 510(k) Submission Details - K100903

510(k) Number K100903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2010
Decision Date October 05, 2010
Days to Decision 187 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 102d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOL Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K100903.
LIAISON XL ANALYZER
K141116 · DiaSorin, Inc. · Jul 2014
ARCHITECT HAVAB-G
K113704 · Abbott Laboratories · Jun 2012
LIAISON XL ANALYZER MODEL 10050
K103529 · DiaSorin, Inc. · Jan 2011
ANTI-HAV IGM
K093955 · Roche Diagnostics · Jun 2010
MONOLISA ANTI-HAV IGM EIA
K092353 · Bio-Rad Laboratories, Inc. · Oct 2009
MONOLISA ANTI-HAV EIA
K092355 · Bio-Rad Laboratories, Inc. · Oct 2009