Cleared Traditional

K222439 - Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (FDA 510(k) Clearance)

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

K222439 · Siemens Healthcare Diagnostics, Inc. · Toxicology device
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Aug 2023
Decision
361d
Days
Class 2
Risk

K222439 is an FDA 510(k) clearance for the Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc). Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 8, 2023 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3950 - 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K222439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2022
Decision Date August 08, 2023
Days to Decision 361 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
274d slower than avg
Panel avg: 87d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEH Radioimmunoassay, Vancomycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3950
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.