Cleared Traditional

K180835 - SEKURE Acetaminophen L3K Assay

K180835 is an FDA 510(k) clearance for SEKURE Acetaminophen L3K Assay, manufactured by Sekisui Diagnostics P.E.I., Inc.. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 315-day FDA review.

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

FDA 510(k) Submission Details - K180835

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
Combination Product No
PCCP Authorized No
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.

LDP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 30
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K180835.
Atellica CH Acetaminophen 2 (ACTM)
K261364 · Siemens Healthcare Diagnostics, Inc. · Jul 2026
Acetaminophen
K202644 · Sekisui Diagnostics P.E.I., Inc. · Feb 2022
ROCHE ACETAMINOPHEN ASSAY
K110726 · Roche Diagnostics · Dec 2011
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · Siemens Healthcare Diagnostics · Aug 2010
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
TRIAGE TOX DRUG SCREEN
K043242 · Biosite Incorporated · Feb 2005