Cleared Traditional

CEDIA DAU MULTI-DRUG CALIBRATORS (K980853) - FDA 510(k) Clearance

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

K980853 · Boehringer Mannheim Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
47d
Days
Class 2
Risk

K980853 is an FDA 510(k) clearance for the CEDIA DAU MULTI-DRUG CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on April 21, 1998 after a review of 47 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K980853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date April 21, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 87d · This submission: 47d
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 55
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K980853.
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209 · Beckman Coulter, Inc. · Nov 1998
DRUG CALIBRATOR II
K982871 · Dade Behring, Inc. · Oct 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403 · Beckman Instruments, Inc. · May 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