Cleared Traditional

K915732 - ABBOTT QUICKSTART TIGLYCERIDES REAGENT

K915732 is the FDA 510(k) clearance for ABBOTT QUICKSTART TIGLYCERIDES REAGENT by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K915732 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1992
Decision
26d
Days
Class 1
Risk

K915732 is an FDA 510(k) clearance for the ABBOTT QUICKSTART TIGLYCERIDES REAGENT. 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 January 15, 1992 after a review of 26 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 K915732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date January 15, 1992
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 111
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K915732.
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ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · Em Diagnostic Systems, Inc. · Nov 1991
TRIGLYCERIDES REAGENT SET
K914609 · Sterling Diagnostics, Inc. · Nov 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638 · Em Diagnostic Systems, Inc. · Mar 1991