Cleared Traditional

ARCHITECT HAVAB-G (K113704) - FDA 510(k) Clearance

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

K113704 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
195d
Days
Class 2
Risk

K113704 is an FDA 510(k) clearance for the ARCHITECT HAVAB-G. Classified as Hepatitis A Test (antibody And Igm Antibody) (product code LOL), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 28, 2012 after a review of 195 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 Abbott Laboratories devices

Submission Details

510(k) Number K113704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2011
Decision Date June 28, 2012
Days to Decision 195 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
93d slower than avg
Panel avg: 102d · This submission: 195d
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 13
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K113704.
Elecsys Anti-HAV II
K190428 · Roche Diagnostics · Aug 2019
ADVIA Centaur HAV IgM Assay
K161964 · Siemens Healthcare Diagnostics, Inc. · Oct 2016
ADVIA Centaur HAV total assay
K142758 · Siemens Healthcare Diagnostics, Inc. · Dec 2014
ANTI-HAV IGM
K093955 · Roche Diagnostics · Jun 2010
ADVIA CENTAUR HAVM ASSAY
K081716 · Siemens Healthcare Diagnostics, Inc. · Jul 2008
ABBOTT ARCHITECT HAVAB-M
K063329 · Abbott Laboratories · Apr 2007