Cleared Traditional

K851377 - DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLA...

K851377 is the FDA 510(k) clearance for DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLA... by Diagnon Corp.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K851377 · Diagnon Corp. · Chemistry device
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Aug 1985
Decision
135d
Days
Class 2
Risk

K851377 is an FDA 510(k) clearance for the DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 135 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 Diagnon Corp. devices

Submission Details

510(k) Number K851377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1985
Decision Date August 21, 1985
Days to Decision 135 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 88d · This submission: 135d
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 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K851377.
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815 · Diagnostic Products Corp. · Jul 1986
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945 · Ciba Corning Diagnostics Corp. · Feb 1986
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127 · Micromedic Systems · Sep 1985
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