Cleared Traditional

K222439 - Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)

K222439 is an FDA 510(k) clearance for Atellica CH Phencyclidine (Pcp), manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 361-day FDA review.

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

FDA 510(k) Submission Details - K222439

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.

LEH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LEH Radioimmunoassay, Vancomycin

All 29
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K222439.
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · Siemens Healthcare Diagnostics, Inc. · Apr 2016
ONLINE TDM Vancomycin Gen.3
K152245 · Roche Diagnostics Operations (Rdo) · Jan 2016
ARCHITECT IVANCOMYCIN
K123947 · Biokit, S.A. · Aug 2013
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
K072036 · Biokit, S.A. · Mar 2008
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · Diagnostic Products Corp. · Dec 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · Roche Diagnostics Corp. · May 2006