Cleared Traditional

K891605 - COAT-A-COUNT(TM) FENTANYL (TKFN1)

K891605 is the FDA 510(k) clearance for COAT-A-COUNT(TM) FENTANYL (TKFN1) by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code DJG) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K891605 · Diagnostic Products Corp. · Chemistry device
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Sep 1989
Decision
192d
Days
Class 2
Risk

K891605 is an FDA 510(k) clearance for the COAT-A-COUNT(TM) FENTANYL (TKFN1). Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K891605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date September 28, 1989
Days to Decision 192 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
104d slower than avg
Panel avg: 88d · This submission: 192d
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 126
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K891605.
EMIT(R) II OPIATE ASSAY
K902577 · Syva Co. · Jul 1990
MILENIA(TM) OPIATES
K901577 · Diagnostic Products Corp. · May 1990
HYCOR ACCUPINCH MORPHINE TEST
K900173 · Hycor Biomedical, Inc. · Mar 1990
ABUSCREEN FP FOR MORPHINE
K890888 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · Roche Diagnostic Systems, Inc. · Sep 1988
EMIT HVA OPIATE ASSAY
K881941 · Syva Co. · Aug 1988