Cleared Traditional

K993096 - PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR

K993096 is an FDA 510(k) clearance for PRIVALINK SOFTWARE ACCESSORY TO THE LIF..., 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 206-day FDA review.

K993096 · Lifestream Technologies, Inc. · Chemistry device
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Dec 1999
Decision
206d
Days
Class 1
Risk

K993096 is an FDA 510(k) clearance for the PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM 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 December 20, 1999 after a review of 206 days - an extended review 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: 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 - K993096

510(k) Number K993096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date December 20, 1999
Days to Decision 206 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
118d slower than avg
Panel avg: 88d · This submission: 206d
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 185
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