Cleared Traditional

MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY (K854945) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854945 · Ciba Corning Diagnostics Corp. · Hematology device
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Feb 1986
Decision
63d
Days
Class 2
Risk

K854945 is an FDA 510(k) clearance for the MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY. 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 February 11, 1986 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1810 - the FDA hematology device 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

Submission Details

510(k) Number K854945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date February 11, 1986
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
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 Hematology devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 36
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K854945.
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343 · Ciba Corning Diagnostics Corp. · Mar 1991
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
VITAMIN B12 57CO/FOLATE 125I -
K840462 · Corning Medical & Scientific · Jun 1984
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
K833142 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
QUANTAPHASE B-12-COBALMIN-FOLATE-
K833247 · Bio-Rad · Oct 1983