Cleared Traditional

K000610 - RESOLUTION CHOLESTEROL MONITOR

K000610 is an FDA 510(k) clearance for RESOLUTION CHOLESTEROL MONITOR, manufactured by Lifestream Technologies, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K000610 · Lifestream Technologies, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Jul 2000
Decision
149d
Days
Class 1
Risk

K000610 is an FDA 510(k) clearance for the RESOLUTION CHOLESTEROL MONITOR. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Lifestream Technologies, Inc. (Post Falls, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 149 days - within the typical 510(k) review window.

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: 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 Lifestream Technologies, Inc. devices

FDA 510(k) Submission Details - K000610

510(k) Number K000610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2000
Decision Date July 21, 2000
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
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 186
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