Cleared Traditional

K932548 - ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS

K932548 is an FDA 510(k) clearance for ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K932548 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1993
Decision
217d
Days
Class 2
Risk

K932548 is an FDA 510(k) clearance for the ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 29, 1993 after a review of 217 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 - K932548

510(k) Number K932548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date December 29, 1993
Days to Decision 217 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
130d slower than avg
Panel avg: 87d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

Product Code DLJ Calibrators, Drug Specific
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 - DLJ Calibrators, Drug Specific

All 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K932548.
PHENOBARBITAL CALIBRATORS
K945316 · Diagnostic Reagents, Inc. · Jan 1995
PHENYTOIN CALIBRATORS
K945337 · Diagnostic Reagents, Inc. · Dec 1994
CEDIA DAU THC CALIBRATORS
K935795 · Microgenics Corp. · Apr 1994
DUPONT ACA URINE METHADONE CALIBRATOR
K934144 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279 · Roche Diagnostic Systems, Inc. · Aug 1993
URINE CALIBRATOR AND CONTROL
K931506 · Diagnostic Reagents, Inc. · Jul 1993