Cleared Traditional

K180835 - SEKURE Acetaminophen L3K Assay (FDA 510(k) Clearance)

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

K180835 · Sekisui Diagnostics P.E.I., Inc. · Toxicology device
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Feb 2019
Decision
315d
Days
Class 2
Risk

K180835 is an FDA 510(k) clearance for the SEKURE Acetaminophen L3K Assay. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on February 8, 2019 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sekisui Diagnostics P.E.I., Inc. devices

Submission Details

510(k) Number K180835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date February 08, 2019
Days to Decision 315 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
228d slower than avg
Panel avg: 87d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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.