Cleared Traditional

K920078 - AFFINITY B12

K920078 is the FDA 510(k) clearance for AFFINITY B12 by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K920078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
37d
Days
Class 2
Risk

K920078 is an FDA 510(k) clearance for the AFFINITY B12. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 37 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K920078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date February 14, 1992
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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 K920078.
ACCESS VITAMIN B12 ASSAY
K933142 · Bio-Rad Laboratories, Inc. · Nov 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · Bio-Rad · Aug 1993
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074 · Baxter Diagnostics, Inc. · Oct 1992
CIBA CORNING ACS T3 IMMUNOASSAY
K913646 · Ciba Corning Diagnostics Corp. · Oct 1991
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343 · Ciba Corning Diagnostics Corp. · Mar 1991
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776 · Microgenics Corp. · Nov 1990