Cleared Traditional

K914033 - CHOLESTECH LIPID MONITOR SYST

K914033 is an FDA 510(k) clearance for CHOLESTECH LIPID MONITOR SYST, manufactured by Cholestech Corp.. The device is a Class 1 Chemistry device with product code JGY cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K914033 · Cholestech Corp. · Chemistry device
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Sep 1991
Decision
17d
Days
Class 1
Risk

K914033 is an FDA 510(k) clearance for the CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 17 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 Cholestech Corp. devices

FDA 510(k) Submission Details - K914033

510(k) Number K914033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date September 27, 1991
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

JGY Device Classification - Class 1, General Controls

Product Code JGY Colorimetric Method, 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 - JGY Colorimetric Method, Triglycerides

All 16
Devices cleared under the same product code (JGY) and FDA review panel - the closest regulatory comparables to K914033.
TRIGLYCERIDES REAGENT
K954187 · Schiapparelli Biosystems, Inc. · Oct 1995
DNA TRIGLYCERIDE PROCEDURE
K941063 · Data Medical Associates, Inc. · Jul 1994
IL TEST(TM) TRIGLYCERIDE
K931116 · Instrumentation Laboratory CO · Mar 1994
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · Data Medical Associates, Inc. · Jul 1990
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · Sigma Diagnostics, Inc. · Sep 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · Heraeus Kulzer, Inc. · Feb 1989