Cleared Traditional

K933142 - ACCESS VITAMIN B12 ASSAY

K933142 is the FDA 510(k) clearance for ACCESS VITAMIN B12 ASSAY by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K933142 · Bio-Rad Laboratories, Inc. · Chemistry device
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Nov 1993
Decision
130d
Days
Class 2
Risk

K933142 is an FDA 510(k) clearance for the ACCESS VITAMIN B12 ASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 130 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K933142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date November 05, 1993
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
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 48
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K933142.
OPUS B12
K953455 · Behring Diagnostics, Inc. · Aug 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · Microgenics Corp. · Jul 1995
VISTA B12 ASSAY
K941235 · Syva Co. · Aug 1994
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · Bio-Rad · Aug 1993
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074 · Baxter Diagnostics, Inc. · Oct 1992
AFFINITY B12
K920078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992