Cleared Traditional

K842677 - EMIT D.A.U. OPIATE ASSAY

K842677 is the FDA 510(k) clearance for EMIT D.A.U. OPIATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K842677 · Syva Co. · Toxicology device
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Sep 1984
Decision
78d
Days
Class 2
Risk

K842677 is an FDA 510(k) clearance for the EMIT D.A.U. OPIATE ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology 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 Syva Co. devices

Submission Details

510(k) Number K842677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date September 26, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 87d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K842677.
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
K872391 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1987
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
K871698 · Immunalysis Corporation · Jun 1987
TDX R OPIATES
K854421 · Abbott Laboratories · Nov 1985
EMIT 700 OPIATE ASSAY
K843162 · Syva Co. · Sep 1984
MODIF. OF EMIT URINE OPIATE ASSAY
K833581 · Syva Co. · Jan 1984