Cleared Traditional

K893917 - EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421

K893917 is an FDA 510(k) clearance for EMDS TRIGLYCERIDE (TRIG), manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K893917 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1989
Decision
90d
Days
Class 1
Risk

K893917 is an FDA 510(k) clearance for the EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421. 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 August 28, 1989 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K893917

510(k) Number K893917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date August 28, 1989
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

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 134
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K893917.
COULTER TRIGLYCERIDES GPO REAGENT
K897159 · Coulter Electronics, Inc. · Mar 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231 · Roche Diagnostic Systems, Inc. · Feb 1990
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
K894310 · American Research Products Co. · Sep 1989
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