Cleared Traditional

K935101 - URINE CALIBRATORS AND CONTROLS MODIFICA...

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

K935101 · Diagnostic Reagents, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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.

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 77
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