Cleared Traditional

ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE (K011353) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011353 · ACON Laboratories, Inc. · Toxicology device
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Jul 2001
Decision
88d
Days
Class 2
Risk

K011353 is an FDA 510(k) clearance for the ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 30, 2001 after a review of 88 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K011353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2001
Decision Date July 30, 2001
Days to Decision 88 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
1d slower than avg
Panel avg: 87d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 214
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