Cleared Traditional

AXIOM STABLE II TRIGLYCERIDES TEST (K842443) - FDA 510(k) Clearance

Class I Chemistry device.

K842443 · Axiom, Inc. · Chemistry device
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Sep 1984
Decision
84d
Days
Class 1
Risk

K842443 is an FDA 510(k) clearance for the AXIOM STABLE II TRIGLYCERIDES TEST. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Axiom, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984 after a review of 84 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 Axiom, Inc. devices

Submission Details

510(k) Number K842443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1984
Decision Date September 13, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
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 43
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K842443.
VISION TRIGLYCERIDES
K850031 · Abbott Laboratories · Feb 1985
TRIGLYCERIDE REAGENT
K844032 · Sigma Diagnostics, Inc. · Nov 1984
TRIGLYCERIDES GPO REAGENT
K843552 · Bio-Rad · Sep 1984
SYSTEMATE TRIGLYCERIDE 67219
K843106 · Em Diagnostic Systems, Inc. · Aug 1984
QCA TRIGLYCERIDES
K842891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K842211 · Em Diagnostic Systems, Inc. · Jul 1984