Cleared Traditional

K111260 - A/C ENZYMATIC VITAMIN B6 ASSAY

K111260 is the FDA 510(k) clearance for A/C ENZYMATIC VITAMIN B6 ASSAY by Anticancer, Inc.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K111260 · Anticancer, Inc. · Chemistry device
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Jul 2012
Decision
448d
Days
Class 2
Risk

K111260 is an FDA 510(k) clearance for the A/C ENZYMATIC VITAMIN B6 ASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Anticancer, Inc. (San Diego, US). The FDA issued a Cleared decision on July 26, 2012 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Anticancer, Inc. devices

Submission Details

510(k) Number K111260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2011
Decision Date July 26, 2012
Days to Decision 448 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
360d slower than avg
Panel avg: 88d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K111260.
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
K140496 · Beckman Coulter, Inc. · Sep 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
K133512 · Siemens Healthcare Diagnostics · Jan 2014
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 B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · Abbott Laboratories · Oct 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
K110413 · Beckman Coulter, Inc. · May 2011