Cleared Traditional

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (K050125) - FDA 510(k) Clearance

Class I Toxicology device.

K050125 · More Diagnostics · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all More Diagnostics devices

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 672
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K050125.
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · Helena Laboratories · Oct 2013
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · Dade Behring, Inc. · Sep 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · Roche Diagnostics Corp. · Mar 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · Roche Diagnostics Corp. · Jan 2007
TDM CONTROL SET
K060429 · Roche Diagnostics Corp. · Mar 2006
ELECSYS PRECICONTROL BONE
K051543 · Roche Diagnostics Corp. · Oct 2005