Cleared Traditional

K261364 - Atellica CH Acetaminophen 2 (ACTM)

K261364 is the FDA 510(k) clearance for Atellica CH Acetaminophen 2 (ACTM) by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code LDP) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K261364 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Jul 2026
Decision
88d
Days
Class 2
Risk

K261364 is an FDA 510(k) clearance for the Atellica CH Acetaminophen 2 (ACTM). Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 24, 2026 after a review of 88 days - a notably fast clearance 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: 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K261364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date July 24, 2026
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 27
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K261364.
Acetaminophen
K202644 · Sekisui Diagnostics P.E.I., Inc. · Feb 2022
SEKURE Acetaminophen L3K Assay
K180835 · Sekisui Diagnostics P.E.I., Inc. · Feb 2019
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