Cleared Traditional

URINE CALIBRATORS AND CONTROLS MODIFICATION (K935101) - FDA 510(k) Clearance

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

K935101 · Diagnostic Reagents, Inc. · Toxicology device
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Jan 1994
Decision
99d
Days
Class 2
Risk

K935101 is an FDA 510(k) clearance for the URINE CALIBRATORS AND CONTROLS MODIFICATION. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 99 days - within the typical 510(k) review window.

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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K935101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date January 27, 1994
Days to Decision 99 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
12d slower than avg
Panel avg: 87d · This submission: 99d
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 K935101.
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
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K060645 · Roche Diagnostics Corp. · May 2006
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · Roche Diagnostics Corp. · Dec 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · Dade Behring, Inc. · Oct 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · Roche Diagnostics Corp. · Aug 2003