Cleared Traditional

K110579 - ARCHITECT B12 REAGENTS

K110579 is an FDA 510(k) clearance for ARCHITECT B12 REAGENTS, 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 219-day FDA review.

K110579 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
219d
Days
Class 2
Risk

K110579 is an FDA 510(k) clearance for the ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS. 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 October 6, 2011 after a review of 219 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K110579

510(k) Number K110579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2011
Decision Date October 06, 2011
Days to Decision 219 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
131d slower than avg
Panel avg: 88d · This submission: 219d
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 K110579.
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
K121994 · Siemens Healthcare Diagnostics, Inc. · Nov 2012
ARCHITECT B12
K121314 · Abbott Laboratories · May 2012
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
K112443 · Axis-Shield Diagnostics, Ltd. · Dec 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
K110413 · Beckman Coulter, Inc. · May 2011
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · Siemens Healthcare Diagnostics · Feb 2010
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
K090588 · Beckman Coulter, Inc. · May 2009