Cleared Traditional

K954608 - CEDIA DAU MULTI-DR CALIBRATOR/PRI

K954608 is an FDA 510(k) clearance for CEDIA DAU MULTI-DR CALIBRATOR/PRI, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code DKB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954608 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
83d
Days
Class 2
Risk

K954608 is an FDA 510(k) clearance for the CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K954608

510(k) Number K954608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date December 26, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 88d · This submission: 83d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKB Calibrators, Drug Mixture

All 80
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K954608.
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
EMIT IIC CALIBRATORS
K935192 · Syva Co. · Mar 1995
DRUGS OF ABUSE CALIBRATOR
K950139 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
K945289 · Medi-Tech, Inc. · Dec 1994