Cleared Traditional

K020792 - ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K020792 is an FDA 510(k) clearance for ACETAMINOPHEN ASSAY FOR THE ADVIA INTEG..., manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K020792 · Bayer Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
122d
Days
Class 2
Risk

K020792 is an FDA 510(k) clearance for the ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 11, 2002 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - 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 Bayer Diagnostics Corp. devices

FDA 510(k) Submission Details - K020792

510(k) Number K020792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date July 11, 2002
Days to Decision 122 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
35d slower than avg
Panel avg: 87d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDP Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 31
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K020792.
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
TRIAGE TOX DRUG SCREEN
K043242 · Biosite Incorporated · Feb 2005
ACETAMINOPHEN-SL ASSAY
K042330 · Diagnostic Chemicals , Ltd. · Jan 2005
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp. · Jan 2002
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · Beckman Coulter, Inc. · Jun 2001
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000