Cleared Traditional

K931124 - ABUSCREEN ONLINE(R) CALIBRATORS

K931124 is an FDA 510(k) clearance for ABUSCREEN ONLINE CALIBRATORS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K931124

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.

DKB Device Classification - Class 2, Special Controls

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 87
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