Cleared Traditional

K123947 - ARCHITECT IVANCOMYCIN

K123947 is an FDA 510(k) clearance for ARCHITECT IVANCOMYCIN, manufactured by Biokit, S.A.. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K123947 · Biokit, S.A. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
251d
Days
Class 2
Risk

K123947 is an FDA 510(k) clearance for the ARCHITECT IVANCOMYCIN. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Biokit, S.A. (Llissa D'Amunt, Barcelona, ES). The FDA issued a Cleared decision on August 29, 2013 after a review of 251 days - an extended review cycle.

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. 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.

View all Biokit, S.A. devices

FDA 510(k) Submission Details - K123947

510(k) Number K123947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2012
Decision Date August 29, 2013
Days to Decision 251 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
164d slower than avg
Panel avg: 87d · This submission: 251d
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 K123947.
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · Siemens Healthcare Diagnostics, Inc. · Aug 2023
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 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