Cleared Traditional

K110726 - ROCHE ACETAMINOPHEN ASSAY

K110726 is the FDA 510(k) clearance for ROCHE ACETAMINOPHEN ASSAY by Roche Diagnostics. It is a Class 2 Chemistry device (product code LDP) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K110726 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
282d
Days
Class 2
Risk

K110726 is an FDA 510(k) clearance for the ROCHE ACETAMINOPHEN ASSAY. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 23, 2011 after a review of 282 days - an extended review cycle.

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

View all Roche Diagnostics devices

Submission Details

510(k) Number K110726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date December 23, 2011
Days to Decision 282 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 88d · This submission: 282d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 22
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K110726.
Acetaminophen
K202644 · Sekisui Diagnostics P.E.I., Inc. · Feb 2022
SEKURE Acetaminophen L3K Assay
K180835 · Sekisui Diagnostics P.E.I., Inc. · Feb 2019
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · Siemens Healthcare Diagnostics · Aug 2010
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
ACETAMINOPHEN-SL ASSAY
K042330 · Diagnostic Chemicals , Ltd. · Jan 2005
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp. · Jan 2002