Cleared Traditional

K870408 - EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608

K870408 is the FDA 510(k) clearance for EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K870408 · Em Diagnostic Systems, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1987
Decision
29d
Days
Class 1
Risk

K870408 is an FDA 510(k) clearance for the EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on March 4, 1987 after a review of 29 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K870408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date March 04, 1987
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 112
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K870408.
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · Trace Scientific , Ltd. · May 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · Trace Scientific , Ltd. · May 1987
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
K871301 · American Monitor Corp. · Apr 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · Sigma Diagnostics, Inc. · Feb 1987
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
K864939 · Beckman Instruments, Inc. · Dec 1986
IQ TRIGLYCERIDES
K864268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986