Cleared Traditional

K060773 - ONLINE TDM PROCAINAMIDE

K060773 is the FDA 510(k) clearance for ONLINE TDM PROCAINAMIDE by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LAR) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K060773 · Roche Diagnostics Corp. · Toxicology device
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Aug 2006
Decision
154d
Days
Class 2
Risk

K060773 is an FDA 510(k) clearance for the ONLINE TDM PROCAINAMIDE. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 23, 2006 after a review of 154 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K060773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date August 23, 2006
Days to Decision 154 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
67d slower than avg
Panel avg: 87d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAR Enzyme Immunoassay, Procainamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - LAR Enzyme Immunoassay, Procainamide

All 22
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K060773.
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · Dade Behring, Inc. · Oct 2003
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971716 · Bayer Corp. · Jun 1997
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · Boehringer Mannheim Corp. · Oct 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · Boehringer Mannheim Corp. · Aug 1996
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · Diagnostic Reagents, Inc. · Aug 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · Abbott Laboratories · Apr 1996