Cleared Traditional

K961372 - SERUM TOX CALIBRATOR

K961372 is the FDA 510(k) clearance for SERUM TOX CALIBRATOR by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K961372 · Diagnostic Reagents, Inc. · Toxicology device
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May 1996
Decision
22d
Days
Class 2
Risk

K961372 is an FDA 510(k) clearance for the SERUM TOX CALIBRATOR. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 1, 1996 after a review of 22 days - a notably fast clearance 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: 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K961372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date May 01, 1996
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
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 K961372.
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287 · Beckman Instruments, Inc. · May 1997
CEDIA ANTIBIOTIC TDM MULTI-CALS
K963191 · Boehringer Mannheim Corp. · Sep 1996
AED CALIBRATORS
K961273 · Diagnostic Reagents, Inc. · May 1996
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608 · Boehringer Mannheim Corp. · Dec 1995
EMIT IIC CALIBRATORS
K935192 · Syva Co. · Mar 1995
DRUGS OF ABUSE CALIBRATOR
K950139 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995