Cleared Traditional

K834518 - LIQUID STABLE TRIGLYCERIDES REAGENT SET

K834518 is the FDA 510(k) clearance for LIQUID STABLE TRIGLYCERIDES REAGENT SET by Medical Analysis Systems, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K834518 · Medical Analysis Systems, Inc. · Chemistry device
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Mar 1984
Decision
72d
Days
Class 1
Risk

K834518 is an FDA 510(k) clearance for the LIQUID STABLE TRIGLYCERIDES REAGENT SET. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Walker, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 72 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K834518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date March 02, 1984
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
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 111
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K834518.
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471 · Em Diagnostic Systems, Inc. · May 1984
TRIGLYCERIDE REAGENT SET
K841062 · Medical Specialties, Inc. · May 1984
TRIGLYCERIDES REAGENT
K840780 · American Dade · Apr 1984
REAGENT SET TRIGLYCERIDES GPO
K833082 · Boehringer Mannheim Corp. · Nov 1983
LIPASE HYDROLYSIS/GLYCEROL KINASE
K832871 · Pointe Scientific, Inc., · Oct 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684 · Miles Laboratories, Inc. · Oct 1983