Cleared Traditional

MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (K072257) - FDA 510(k) Clearance

Class I Toxicology device.

K072257 · More Diagnostics · Toxicology device
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Jan 2008
Decision
170d
Days
Class 1
Risk

K072257 is an FDA 510(k) clearance for the MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on January 30, 2008 after a review of 170 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 More Diagnostics devices

Submission Details

510(k) Number K072257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date January 30, 2008
Days to Decision 170 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
83d slower than avg
Panel avg: 87d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - LAS Drug Specific Control Materials

All 82
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K072257.
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc. · Apr 1997
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · Roche Diagnostic Systems, Inc. · Feb 1995
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · Roche Diagnostic Systems, Inc. · Jan 1994
DUPONT ACA URINE METHADONE CONTROL
K934145 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · Roche Diagnostic Systems, Inc. · Jan 1992
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · Roche Diagnostic Systems, Inc. · Aug 1991