Cleared Traditional

K051327 - ABBOTT AXSYM B12

K051327 is an FDA 510(k) clearance for ABBOTT AXSYM B12, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K051327 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
75d
Days
Class 2
Risk

K051327 is an FDA 510(k) clearance for the ABBOTT AXSYM B12. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 3, 2005 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K051327

510(k) Number K051327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2005
Decision Date August 03, 2005
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDD Device Classification - Class 2, Special Controls

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 62
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K051327.
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · Dade Behring, Inc. · Nov 2007
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20
K062467 · Axis-Shield Diagnostics, Ltd. · Nov 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · Roche Diagnostics Corp. · Apr 2006
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · Bayer Healthcare, LLC · Jul 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
K013899 · Ortho-Clinical Diagnostics · Jan 2002
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · Bayer Corp. · Dec 1999