Cleared Traditional

K953455 - OPUS B12

K953455 is the FDA 510(k) clearance for OPUS B12 by Behring Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K953455 · Behring Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
35d
Days
Class 2
Risk

K953455 is an FDA 510(k) clearance for the OPUS B12. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on August 23, 1995 after a review of 35 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K953455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1995
Decision Date August 23, 1995
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 55
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K953455.
AXSYM B12
K965186 · Abbott Laboratories · Mar 1997
AIA-PACK B12 ASSAY
K964348 · Tosoh Medics, Inc. · Jan 1997
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · Bio-Rad Laboratories, Inc. · Jan 1996
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · Microgenics Corp. · Jul 1995
VISTA B12 ASSAY
K941235 · Syva Co. · Aug 1994
ACCESS VITAMIN B12 ASSAY
K933142 · Bio-Rad Laboratories, Inc. · Nov 1993