Cleared Traditional

K871698 - RESUBMISSION OF URINE HEROIN/MORPHINE K...

K871698 is the FDA 510(k) clearance for RESUBMISSION OF URINE HEROIN/MORPHINE K... by Immunalysis Corporation. It is a Class 2 Chemistry device (product code DJG) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K871698 · Immunalysis Corporation · Chemistry device
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Jun 1987
Decision
48d
Days
Class 2
Risk

K871698 is an FDA 510(k) clearance for the RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on June 15, 1987 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - 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 Immunalysis Corporation devices

Submission Details

510(k) Number K871698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1987
Decision Date June 15, 1987
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 Chemistry 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 K871698.
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE
K873757 · Diagnostic Products Corp. · Oct 1987
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE
K873758 · Diagnostic Products Corp. · Oct 1987
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
K872391 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1987
TDX R OPIATES
K854421 · Abbott Laboratories · Nov 1985
EMIT D.A.U. OPIATE ASSAY
K842677 · Syva Co. · Sep 1984
EMIT 700 OPIATE ASSAY
K843162 · Syva Co. · Sep 1984