Cleared Traditional

CHOLINESTERASE GEN.2 TEST SYSTEM (K061093) - FDA 510(k) Clearance

Class I Toxicology device.

K061093 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
75d
Days
Class 1
Risk

K061093 is an FDA 510(k) clearance for the CHOLINESTERASE GEN.2 TEST SYSTEM. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K061093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2006
Decision Date July 03, 2006
Days to Decision 75 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 87d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.