Cleared Traditional

K983344 - DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE

K983344 is the FDA 510(k) clearance for DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K983344 · Dade Behring, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 1999
Decision
272d
Days
Class 2
Risk

K983344 is an FDA 510(k) clearance for the DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 22, 1999 after a review of 272 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K983344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date June 22, 1999
Days to Decision 272 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
184d slower than avg
Panel avg: 88d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 144
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K983344.
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp. · Feb 2000
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K990649 · Bayer Corp. · Jul 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · Bayer Corp. · Jun 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
K984006 · Bayer Corp. · Mar 1999
LIQUID GLUCOSE (OXIDASE) REAGENT SET
K970781 · Pointe Scientific, Inc., · Apr 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · Bayer Corp. · Feb 1997