Cleared Abbreviated

K063329 - ABBOTT ARCHITECT HAVAB-M

K063329 is an FDA 510(k) clearance for ABBOTT ARCHITECT HAVAB-M, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LOL cleared through the Abbreviated 510(k) pathway after a 164-day FDA review.

K063329 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
164d
Days
Class 2
Risk

K063329 is an FDA 510(k) clearance for the ABBOTT ARCHITECT HAVAB-M. 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 April 16, 2007 after a review of 164 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K063329

510(k) Number K063329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2006
Decision Date April 16, 2007
Days to Decision 164 days
Submission Type Abbreviated
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
62d slower than avg
Panel avg: 102d · This submission: 164d
Pathway characteristics
Standards-based clearance path.

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 24
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K063329.
ADVIA CENTAUR HAVM ASSAY
K081716 · Siemens Healthcare Diagnostics, Inc. · Jul 2008
MONOLISA ANTI-HAV EIA
K063318 · Bio-Rad Laboratories · May 2007
MONOLISA ANTI-HAV IGM EIA
K063319 · Bio-Rad Laboratories · May 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