Cleared Traditional

K984152 - SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT

K984152 is an FDA 510(k) clearance for SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) ..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K984152 · Beckman Coulter, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
71d
Days
Class 2
Risk

K984152 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 71 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K984152

510(k) Number K984152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1998
Decision Date January 29, 1999
Days to Decision 71 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 87d · This submission: 71d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K984152.
REDI-TEST OPIATES
K991883 · Advantage Diagnostics Corp. · Sep 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · Princeton BioMeditech Corp. · Aug 1999
RAPIDONE - OPIATES TEST
K990820 · American Bio Medica Corp. · Jul 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · Syva Co. · Jan 1999
DBEST OPIATES TEST KIT
K983190 · Ameritek, Inc. · Nov 1998
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · Princeton BioMeditech Corp. · Jun 1998