Cleared Traditional

K951134 - CEDIA VITAMIN B12 (NO BOIL) ASSAY

K951134 is an FDA 510(k) clearance for CEDIA VITAMIN B12 (NO BOIL) ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K951134 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
120d
Days
Class 2
Risk

K951134 is an FDA 510(k) clearance for the CEDIA VITAMIN B12 (NO BOIL) ASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 120 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K951134

510(k) Number K951134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date July 11, 1995
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 66
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K951134.
BUHLMANN VITAMIN B6 REA
K955561 · American Laboratory Products Co., Ltd. · May 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · Bio-Rad Laboratories, Inc. · Jan 1996
OPUS B12
K953455 · Behring Diagnostics, Inc. · Aug 1995
VISTA B12 ASSAY
K941235 · Syva Co. · Aug 1994
ACCESS VITAMIN B12 ASSAY
K933142 · Bio-Rad Laboratories, Inc. · Nov 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · Bio-Rad · Aug 1993