Cleared Traditional

K842314 - DUOCLON COLOR-CEPT

K842314 is an FDA 510(k) clearance for DUOCLON COLOR-CEPT, manufactured by Organon, Inc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K842314 · Organon, Inc. · Chemistry device
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Aug 1984
Decision
73d
Days
Class 2
Risk

K842314 is an FDA 510(k) clearance for the DUOCLON COLOR-CEPT. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Organon, Inc. (Walker, US). The FDA issued a Cleared decision on August 24, 1984 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K842314

510(k) Number K842314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date August 24, 1984
Days to Decision 73 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
16d faster than avg
Panel avg: 89d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 95
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K842314.
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
K844347 · Fisher Diagnostics · Jan 1985
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · Stanbio Laboratory · Sep 1984
BETA-HCG HEMAGGLUTINATION TEST
K842181 · Sero-Immuno Diagnostics, Inc. · Aug 1984
SLIDE PREGNANCY TEST
K842110 · Immunostics Co., Inc. · Jul 1984
PREG-BETA ONE HOUR TUBE TEST
K841853 · Intl. Diagnostic, Inc. · Jun 1984
K842314 · DUOCLON COLOR-CEPT
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