Cleared Traditional

K831500 - TRI-LEVEL TDM CONTROL & I II III

K831500 is the FDA 510(k) clearance for TRI-LEVEL TDM CONTROL & I II III by Ortho Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K831500 · Ortho Diagnostic Systems, Inc. · Toxicology device
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Jun 1983
Decision
50d
Days
Class 1
Risk

K831500 is an FDA 510(k) clearance for the TRI-LEVEL TDM CONTROL & I II III. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 50 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K831500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date June 30, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K831500.
EMIT 700 CONTROL SET A
K843161 · Syva Co. · Aug 1984
COMA TOXICOLOGY CONTROL
K841439 · American Dade · May 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794 · Bio-Rad · Jan 1984
EMIT-ST PHOTOMETER & DILUTER VERIFICA
K830518 · Syva Co. · Apr 1983
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
K823746 · Syva Co. · Jan 1983
THERAPEUTIC DRUG CONTROL
K822777 · Icl Scientific · Oct 1982