Cleared Traditional

K910343 - CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY

K910343 is an FDA 510(k) clearance for CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K910343 · Ciba Corning Diagnostics Corp. · Chemistry device
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Mar 1991
Decision
36d
Days
Class 2
Risk

K910343 is an FDA 510(k) clearance for the CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 36 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K910343

510(k) Number K910343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date March 06, 1991
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 K910343.
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074 · Baxter Diagnostics, Inc. · Oct 1992
AFFINITY B12
K920078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
CIBA CORNING ACS T3 IMMUNOASSAY
K913646 · Ciba Corning Diagnostics Corp. · Oct 1991
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776 · Microgenics Corp. · Nov 1990
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
K883722 · Ciba Corning Diagnostics Corp. · Nov 1988
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815 · Diagnostic Products Corp. · Jul 1986