Cleared Traditional

DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 (K062191) - FDA 510(k) Clearance

Class I Toxicology device.

K062191 · Dade Behring, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 2006
Decision
21d
Days
Class 1
Risk

K062191 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS .... Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 21 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K062191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date August 21, 2006
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 87d · This submission: 21d
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 201
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K062191.
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · Baxter Healthcare Corp · Feb 1990
EMIT (R) HVA NEGATIVE URINE
K883210 · Syva Co. · Sep 1988
DADE TDM CONTROL
K883190 · Baxter Healthcare Corp · Sep 1988
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · Baxter Healthcare Corp · Feb 1988