Cleared Traditional

K983556 - ABUSCREEN ONLINE BENZ 300 CALIBRATORS

K983556 is an FDA 510(k) clearance for ABUSCREEN ONLINE BENZ 300 CALIBRATORS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K983556 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
63d
Days
Class 2
Risk

K983556 is an FDA 510(k) clearance for the ABUSCREEN ONLINE BENZ 300 CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on December 15, 1998 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K983556

510(k) Number K983556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date December 15, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K983556.
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
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K972835 · Diagnostic Reagents, Inc. · Aug 1997