Cleared Traditional

SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) (K860815) - FDA 510(k) Clearance

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

K860815 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 77
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K860815.
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · Axis-Shield Diagnostics, Ltd. · Jul 2024
Access Vitamin B12
K223289 · Beckman Coulter, Inc. · Dec 2022
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
K190298 · Beckman Coulter Biomedical GmbH · Oct 2019
LIAISON Vitamin B12
K192064 · DiaSorin, Inc. · Oct 2019
ARCHITECT B12
K121314 · Abbott Laboratories · May 2012
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · Abbott Laboratories · Oct 2011