Cleared Traditional

K981345 - CHOLESTRON PRO II CHOLESTEROL TEST

K981345 is an FDA 510(k) clearance for CHOLESTRON PRO II CHOLESTEROL TEST, manufactured by Lifestream Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K981345 · Lifestream Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
170d
Days
Class 1
Risk

K981345 is an FDA 510(k) clearance for the CHOLESTRON PRO II CHOLESTEROL TEST. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Lifestream Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 1, 1998 after a review of 170 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 Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981345

510(k) Number K981345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1998
Decision Date October 01, 1998
Days to Decision 170 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 88d · This submission: 170d
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 182
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K981345.
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K982469 · Elan Pharma, Inc. · Aug 1998
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
K981181 · Actimed Laboratories, Inc. · Aug 1998
CARESIDE ANALYZER
K982118 · Exigent Diagnostics, Inc. · Jul 1998