Cleared Traditional

K911578 - CHOLESTECH L.D.X. LIPID ANALYZER

K911578 is an FDA 510(k) clearance for CHOLESTECH L.D.X. LIPID ANALYZER, manufactured by Cholestech Corp.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K911578 · Cholestech Corp. · Chemistry device
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May 1991
Decision
49d
Days
Class 1
Risk

K911578 is an FDA 510(k) clearance for the CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 - K911578

510(k) Number K911578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1991
Decision Date May 15, 1991
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 172
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K911578.
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · King Diagnostics, Inc. · Sep 1991
PROACT CHOLESTEROL SYSTEMS
K912212 · Boehringer Mannheim Corp. · Aug 1991
CHOLESTECH LIPID MONITORING SYS.
K912136 · Cholestech Corp. · Jul 1991
SYNERMED CHOLESTEROL REAGENT KIT
K903015 · Synermed, Inc. · Oct 1990
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · Trace Scientific , Ltd. · Sep 1990
CHOLESTEROL (RATE) REAGENT
K902098 · Sigma Chemical Co. · Aug 1990