Cleared Traditional

K883405 - TRIGLYCERIDES REAGENT (PRODUCT #88218)

K883405 is the FDA 510(k) clearance for TRIGLYCERIDES REAGENT (PRODUCT #88218) by Hichem Diagnostics. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K883405 · Hichem Diagnostics · Chemistry device
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Sep 1988
Decision
33d
Days
Class 1
Risk

K883405 is an FDA 510(k) clearance for the TRIGLYCERIDES REAGENT (PRODUCT #88218). Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 33 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 Hichem Diagnostics devices

Submission Details

510(k) Number K883405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1988
Decision Date September 13, 1988
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
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 114
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K883405.
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · Roche Diagnostic Systems, Inc. · Aug 1989
TRIGLYCERIDES - GPO REAGENT
K890337 · Alpkem Corp. · Mar 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · Em Diagnostic Systems, Inc. · Feb 1989
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
K881702 · Biotrol, USA, Inc. · May 1988
TRIGLYCERIDES (GPO-TRINDER)
K880628 · Tech-Co, Inc. · Mar 1988
A-GENT TRIGLLYCERIDES GPO
K874187 · Abbott Laboratories · Jan 1988