Cleared Traditional

K964346 - PARAMAX TRIGLYCERID REAGENT

K964346 is an FDA 510(k) clearance for PARAMAX TRIGLYCERID REAGENT, manufactured by Dade Intl., Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K964346

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

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 134
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K964346.
WAKO L-TYPE TRIGLYCERIDE TEST
K993466 · Wako Chemicals USA, Inc. · Nov 1999
TRIGLYCERIDES, TG, OR TRIG
K971324 · Carolina Liquid Chemistries Corp. · Jun 1997
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
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
K961477 · Trace America, Inc. · Aug 1996