Cleared Traditional

ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK (K935550) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935550 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jan 1994
Decision
47d
Days
Class 2
Risk

K935550 is an FDA 510(k) clearance for the ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date January 03, 1994
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. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DKB Calibrators, Drug Mixture

All 93
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K935550.
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · Dade Behring, Inc. · Aug 2006
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · Dade Behring, Inc. · Oct 2003
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · Syva Co. · Dec 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255 · Dade Behring, Inc. · Feb 1999
DRUG CALIBRATOR II
K982871 · Dade Behring, Inc. · Oct 1998