Cleared Special

K983697 - MODIFICATION TO ABUSCREEN ONLINE COCAIN...

K983697 is the FDA 510(k) clearance for MODIFICATION TO ABUSCREEN ONLINE COCAIN... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Special 510(k) pathway after a 51-day FDA review.

K983697 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1998
Decision
51d
Days
Class 2
Risk

K983697 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K983697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date December 11, 1998
Days to Decision 51 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 87d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 80
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