Cleared Traditional

K965186 - AXSYM B12

K965186 is an FDA 510(k) clearance for 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 90-day FDA review.

K965186 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
90d
Days
Class 2
Risk

K965186 is an FDA 510(k) clearance for the 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 March 24, 1997 after a review of 90 days - within the typical 510(k) review window.

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 - K965186

510(k) Number K965186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date March 24, 1997
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K965186.
ELECSYS VITAMIN B12 ASSAY
K973702 · Boehringer Mannheim Corp. · Nov 1997
ELECSYS FOLATE
K973674 · Boehringer Mannheim Corp. · Nov 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · Diagnostic Products Corp. · May 1997
AIA-PACK B12 ASSAY
K964348 · Tosoh Medics, Inc. · Jan 1997
BUHLMANN VITAMIN B6 REA
K955561 · American Laboratory Products Co., Ltd. · May 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · Bio-Rad Laboratories, Inc. · Jan 1996