Cleared Traditional

K831109 - DUOCLON SLIDE TEST

K831109 is an FDA 510(k) clearance for DUOCLON SLIDE TEST, manufactured by Organon, Inc.. The device is a Class 2 Immunology device with product code JHI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K831109 · Organon, Inc. · Immunology device
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Jun 1983
Decision
58d
Days
Class 2
Risk

K831109 is an FDA 510(k) clearance for the DUOCLON SLIDE TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Organon, Inc. (Walker, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology device 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.

View all Organon, Inc. devices

FDA 510(k) Submission Details - K831109

510(k) Number K831109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1983
Decision Date June 02, 1983
Days to Decision 58 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 105d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 Immunology devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 289
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K831109.
BHCG RIA KIT
K831264 · Micromedic Systems · Jun 1983
PBI BHCG RIA KIT
K831302 · Pacific Biotech, Inc. · Jun 1983
ARIA II I-HCG
K830997 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1983
BETA-QUIK-15 RIA KIT
K831223 · Pacific Biotech, Inc. · Jun 1983
B-GCG SYSTEM BY RIA
K830526 · Pcl-Ria, Inc. · Apr 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983