Cleared Traditional

K851377 - DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA

K851377 is an FDA 510(k) clearance for DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLA..., manufactured by Diagnon Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K851377

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.

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 68
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