Cleared Traditional

K890978 - TARGET OPIATES-R

K890978 is the FDA 510(k) clearance for TARGET OPIATES-R by V-Tech, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K890978 · V-Tech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
263d
Days
Class 2
Risk

K890978 is an FDA 510(k) clearance for the TARGET OPIATES-R. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 263 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all V-Tech, Inc. devices

Submission Details

510(k) Number K890978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date November 17, 1989
Days to Decision 263 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 87d · This submission: 263d
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 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K890978.
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K902194 · Immunotech Corp. · Jul 1990
MILENIA(TM) OPIATES
K901577 · Diagnostic Products Corp. · May 1990
HYCOR ACCUPINCH MORPHINE TEST
K900173 · Hycor Biomedical, Inc. · Mar 1990
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · Diagnostic Products Corp. · Sep 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