Cleared Traditional

OLYMPUS TRIGLYCERIDE REAGENT (K922229) - FDA 510(k) Clearance

Class I Chemistry device.

K922229 · Olympus Corp. · Chemistry device
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Jul 1992
Decision
51d
Days
Class 1
Risk

K922229 is an FDA 510(k) clearance for the OLYMPUS TRIGLYCERIDE REAGENT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on July 2, 1992 after a review of 51 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 Olympus Corp. devices

Submission Details

510(k) Number K922229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1992
Decision Date July 02, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 47
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K922229.
TRIGLYCERIDES
K924710 · Em Diagnostic Systems, Inc. · Jan 1993
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
K924573 · Em Diagnostic Systems, Inc. · Nov 1992
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
K924694 · Olympus Corp. · Oct 1992
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
K915084 · Beckman Instruments, Inc. · Jan 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
K915732 · Em Diagnostic Systems, Inc. · Jan 1992
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · Em Diagnostic Systems, Inc. · Nov 1991