Cleared Traditional

K935101 - URINE CALIBRATORS AND CONTROLS MODIFICATION

K935101 is an FDA 510(k) clearance for URINE CALIBRATORS AND CONTROLS MODIFICATION, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code DKB cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

FDA 510(k) Submission Details - K935101

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
Combination Product No
PCCP Authorized No
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.

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 K935101.
URINE CALIBRATOR
K940935 · Diagnostic Reagents, Inc. · Jul 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793 · Microgenics Corp. · Mar 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · Microgenics Corp. · Mar 1994
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