Cleared Traditional

K010871 - TGL FLEX REAGENT CARTRIDGE

K010871 is the FDA 510(k) clearance for TGL FLEX REAGENT CARTRIDGE by Dade Behring, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K010871 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
108d
Days
Class 1
Risk

K010871 is an FDA 510(k) clearance for the TGL FLEX REAGENT CARTRIDGE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 9, 2001 after a review of 108 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 Behring, Inc. devices

Submission Details

510(k) Number K010871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date July 09, 2001
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
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 93
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K010871.
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
K130332 · Ortho-Clinical Diagnostics, Inc. · May 2013
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · Olympus America, Inc. · Mar 2007
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546 · Dade Behring, Inc. · Jan 2005
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