Cleared Traditional

K962817 - DRUG CALIBRATOR II

K962817 is the FDA 510(k) clearance for DRUG CALIBRATOR II by Dade Intl., Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K962817 · Dade Intl., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
59d
Days
Class 2
Risk

K962817 is an FDA 510(k) clearance for the DRUG CALIBRATOR II. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Newark, US). The FDA issued a Cleared decision on September 16, 1996 after a review of 59 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 Dade Intl., Inc. devices

Submission Details

510(k) Number K962817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1996
Decision Date September 16, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 87d · This submission: 59d
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 78
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K962817.
CEDIA DAU MULTI-DRUG CALIBRATORS
K980853 · Boehringer Mannheim Corp. · Apr 1998
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600 · Behring Diagnostics, Inc. · Jun 1997
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
SERUM TOX CALIBRATOR
K961372 · Diagnostic Reagents, Inc. · May 1996