Cleared Traditional

K983190 - DBEST OPIATES TEST KIT

K983190 is the FDA 510(k) clearance for DBEST OPIATES TEST KIT by Ameritek, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K983190 · Ameritek, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
68d
Days
Class 2
Risk

K983190 is an FDA 510(k) clearance for the DBEST OPIATES TEST KIT. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 68 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 Ameritek, Inc. devices

Submission Details

510(k) Number K983190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date November 18, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 87d · This submission: 68d
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 K983190.
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · Princeton BioMeditech Corp. · Aug 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
K984152 · Beckman Coulter, Inc. · Jan 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · Syva Co. · Jan 1999
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · Princeton BioMeditech Corp. · Jun 1998
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
K974840 · Roche Diagnostic Systems, Inc. · Apr 1998
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · Phamatech · Aug 1997