Cleared Traditional

K993491 - QUICKPAC II ONE STEP OPIATES TEST

K993491 is an FDA 510(k) clearance for QUICKPAC II ONE STEP OPIATES TEST, manufactured by Syntron Bioresearch, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K993491 · Syntron Bioresearch, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
14d
Days
Class 2
Risk

K993491 is an FDA 510(k) clearance for the QUICKPAC II ONE STEP OPIATES TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Syntron Bioresearch, Inc. (Simi Valley, US). The FDA issued a Cleared decision on October 29, 1999 after a review of 14 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 Syntron Bioresearch, Inc. devices

FDA 510(k) Submission Details - K993491

510(k) Number K993491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date October 29, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Toxicology devices follow this clearance model.

Regulatory Consultant

California Department of Health Services
JAMES M BARQUEST

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 189
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K993491.
VERDICT -II OPIATES 2000
K992111 · Medtox Diagnostics, Inc. · Dec 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · Roche Diagnostics Corp. · Nov 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · Syntron Bioresearch, Inc. · Oct 1999
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · Phamatech · Oct 1999
REDI-TEST OPIATES
K991883 · Advantage Diagnostics Corp. · Sep 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · Princeton BioMeditech Corp. · Aug 1999