Cleared Traditional

K953845 - ABUSCREEN ONLINE DRUG FREE URINE

K953845 is the FDA 510(k) clearance for ABUSCREEN ONLINE DRUG FREE URINE by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K953845 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
35d
Days
Class 1
Risk

K953845 is an FDA 510(k) clearance for the ABUSCREEN ONLINE DRUG FREE URINE. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 20, 1995 after a review of 35 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K953845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date September 20, 1995
Days to Decision 35 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
52d faster than avg
Panel avg: 87d · This submission: 35d
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 131
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K953845.
OPUS TDM CONTROLS
K954291 · Behring Diagnostics, Inc. · Nov 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322 · Medical Analysis Systems, Inc. · Oct 1995
ABUSCREEN ONLINE CONTROLS
K953739 · Roche Diagnostic Systems, Inc. · Sep 1995
MULTI-DRUG CONTROL SET
K951135 · Microgenics Corp. · Apr 1995
DRUGS OF ABUSE CONTROLS
K950138 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · Roche Diagnostic Systems, Inc. · Jan 1995