Cleared Traditional

K861412 - DIRECT READOUT MODULE ACCESSORY

K861412 is the FDA 510(k) clearance for DIRECT READOUT MODULE ACCESSORY by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 1 Chemistry device (product code JQP) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K861412 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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May 1986
Decision
38d
Days
Class 1
Risk

K861412 is an FDA 510(k) clearance for the DIRECT READOUT MODULE ACCESSORY. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K861412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date May 23, 1986
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQP Calculator/data Processing Module, For Clinical Use

All 48
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K861412.
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K834490 · Lkb Instruments, Inc. · May 1984