Cleared Traditional

HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (K933722) - FDA 510(k) Clearance

Class I Chemistry device.

K933722 · Horizon Diagnostics, Inc. · Chemistry device
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Jun 1996
Decision
1046d
Days
Class 1
Risk

K933722 is an FDA 510(k) clearance for the HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Horizon Diagnostics, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 1046 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Horizon Diagnostics, Inc. devices

Submission Details

510(k) Number K933722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1993
Decision Date June 13, 1996
Days to Decision 1046 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
958d slower than avg
Panel avg: 88d · This submission: 1046d
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

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