Cleared Traditional

K860815 - SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)

K860815 is the FDA 510(k) clearance for SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K860815 · Diagnostic Products Corp. · Chemistry device
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Jul 1986
Decision
129d
Days
Class 2
Risk

K860815 is an FDA 510(k) clearance for the SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB). Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 129 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K860815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date July 11, 1986
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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 49
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K860815.
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343 · Ciba Corning Diagnostics Corp. · Mar 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
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945 · Ciba Corning Diagnostics Corp. · Feb 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