Cleared Traditional

K964346 - PARAMAX TRIGLYCERID REAGENT

K964346 is the FDA 510(k) clearance for PARAMAX TRIGLYCERID REAGENT by Dade Intl., Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K964346 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
148d
Days
Class 1
Risk

K964346 is an FDA 510(k) clearance for the PARAMAX TRIGLYCERID REAGENT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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 Intl., Inc. devices

Submission Details

510(k) Number K964346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date March 28, 1997
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 112
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K964346.
TGL FLEX REAGENT CARTRIDGE
K010871 · Dade Behring, Inc. · Jul 2001
WAKO L-TYPE TRIGLYCERIDE TEST
K993466 · Wako Chemicals USA, Inc. · Nov 1999
DMA TRIGLYCERIDES PROCEDURES
K971113 · Data Medical Associates, Inc. · May 1997
OLYMPUS LIPASE REAGENT
K963424 · Olympus America, Inc. · Jan 1997
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
K961281 · Diagnostic Chemicals , Ltd. · Aug 1996
TRUE TRIGLYCERIDE
K960088 · Diagnostic Chemicals , Ltd. · Apr 1996