Cleared Traditional

K980331 - IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL

K980331 is the FDA 510(k) clearance for IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL by More Diagnostics. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K980331 · More Diagnostics · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
47d
Days
Class 1
Risk

K980331 is an FDA 510(k) clearance for the IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WH.... Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on March 16, 1998 after a review of 47 days - a notably fast clearance 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: 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 K980331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1998
Decision Date March 16, 1998
Days to Decision 47 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
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K980331.
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · Medical Analysis Systems, Inc. · Jun 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
K981590 · Bio-Rad · Jun 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · Bio-Rad · Apr 1998
VIGIL TDM CONTROLS
K972819 · Beckman Instruments, Inc. · Aug 1997
PRECINORM TDM CONTROLS
K971060 · Boehringer Mannheim Corp. · Jul 1997
LYPHOCHEK REMEDI CONTROL
K972174 · Bio-Rad · Jun 1997