Cleared Traditional

K050125 - RAP/TAC/CSA CONTROL - LEVEL 1

K050125 is the FDA 510(k) clearance for RAP/TAC/CSA CONTROL - LEVEL 1 by More Diagnostics. It is a Class 1 Toxicology device (product code JJY) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K050125 · More Diagnostics · Toxicology device
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Mar 2005
Decision
58d
Days
Class 1
Risk

K050125 is an FDA 510(k) clearance for the RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on March 18, 2005 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - 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.

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Submission Details

510(k) Number K050125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2005
Decision Date March 18, 2005
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 87d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 464
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