Cleared Traditional

K861793 - TWIN TRIGLYCERIDES GPO/CHOLESTEROL

K861793 is an FDA 510(k) clearance for TWIN TRIGLYCERIDES GPO/CHOLESTEROL, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K861793 · Boehringer Mannheim Corp. · Chemistry device
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Jun 1986
Decision
49d
Days
Class 1
Risk

K861793 is an FDA 510(k) clearance for the TWIN TRIGLYCERIDES GPO/CHOLESTEROL. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 49 days - a notably fast clearance cycle.

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: 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 - K861793

510(k) Number K861793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date June 27, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 116
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K861793.
TRIGLYCERIDES
K862033 · Pointe Scientific, Inc., · Jul 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K861670 · Data Medical Associates, Inc. · Jul 1986
TRIGLYCERIDES GPO-TRINDER
K861635 · Catachem, Inc. · Jun 1986
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
K860730 · Trace Scientific , Ltd. · Apr 1986
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690 · Catachem, Inc. · Mar 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164 · Sterling Diagnostics, Inc. · Feb 1986