Cleared Traditional

K972891 - ABUSCREEN ONLINE FOR AMPHETAMINES WITH ...

K972891 is the FDA 510(k) clearance for ABUSCREEN ONLINE FOR AMPHETAMINES WITH ... by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code DKZ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K972891 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1997
Decision
57d
Days
Class 2
Risk

K972891 is an FDA 510(k) clearance for the ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUM.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry 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

Submission Details

510(k) Number K972891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1997
Decision Date October 01, 1997
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 124
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ONTRAK TESTCUP AMPHETAMINES
K962411 · Roche Diagnostic Systems, Inc. · Oct 1996
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K955934 · Biosite Incorporated · Feb 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
K955935 · Biosite Incorporated · Feb 1996