Cleared Traditional

K060738 - TDM N-ACETYLPROCAINAMIDE

K060738 is the FDA 510(k) clearance for TDM N-ACETYLPROCAINAMIDE by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LAN) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K060738 · Roche Diagnostics Corp. · Toxicology device
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Aug 2006
Decision
149d
Days
Class 2
Risk

K060738 is an FDA 510(k) clearance for the TDM N-ACETYLPROCAINAMIDE. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 16, 2006 after a review of 149 days - within the typical 510(k) review window.

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 K060738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date August 16, 2006
Days to Decision 149 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
62d slower than avg
Panel avg: 87d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAN Enzyme Immunoassay, N-acetylprocainamide
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 - LAN Enzyme Immunoassay, N-acetylprocainamide

All 17
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K060738.
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · Dade Behring, Inc. · Oct 2003
NAPA EIA ASSAY
K983812 · Diagnostic Reagents, Inc. · Nov 1998
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · Bayer Corp. · Jun 1997
AXSYM N-ACETYLPROCAINAMIDE
K955422 · Abbott Laboratories · Apr 1996
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915 · Syva Co. · Aug 1992
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · Em Diagnostic Systems, Inc. · Sep 1987