Cleared Traditional

K163220 - Atellica CH Phencyclidine (Pcp) (FDA 510(k) Clearance)

K163220 · Siemens Healthcare Diagnostics, Inc. · Toxicology device
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Apr 2017
Decision
141d
Days
-
Risk

K163220 is an FDA 510(k) clearance for the Atellica CH Phencyclidine (Pcp). Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2017 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel. 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K163220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2016
Decision Date April 06, 2017
Days to Decision 141 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
54d slower than avg
Panel avg: 87d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -