Cleared Traditional

K931124 - ABUSCREEN ONLINE CALIBRATORS

K931124 is the FDA 510(k) clearance for ABUSCREEN ONLINE CALIBRATORS by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K931124 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1993
Decision
152d
Days
Class 2
Risk

K931124 is an FDA 510(k) clearance for the ABUSCREEN ONLINE(R) CALIBRATORS. 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 August 3, 1993 after a review of 152 days - an extended review 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: 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K931124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1993
Decision Date August 03, 1993
Days to Decision 152 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
65d slower than avg
Panel avg: 87d · This submission: 152d
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 75
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K931124.
CEDIA DAU 5-DRUG CALIBRATORS
K935792 · Microgenics Corp. · Jan 1994
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
K935794 · Microgenics Corp. · Jan 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550 · Roche Diagnostic Systems, Inc. · Jan 1994
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753 · Roche Diagnostic Systems, Inc. · Jul 1993
ABUSCREEN CALIBRATION STANDARD
K932754 · Roche Diagnostic Systems, Inc. · Jul 1993
ROCHE ABUSCREEN ONLINNE CALIBRATORS
K923340 · Roche Diagnostic Systems, Inc. · Aug 1992