Cleared Traditional

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

K891605 is an FDA 510(k) clearance for COAT-A-COUNT(TM) FENTANYL (TKFN1), manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K891605

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.

DJG Device Classification - Class 2, Special Controls

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 177
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K891605.
HYCOR ACCUPINCH MORPHINE TEST
K900173 · Hycor Biomedical, Inc. · Mar 1990
TARGET OPIATES-R
K890978 · V-Tech, Inc. · Nov 1989
TARGET OPIATES-V
K890979 · V-Tech, Inc. · Oct 1989
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