Cleared Traditional

CHOLESTEROL QVET (K943027) - FDA 510(k) Clearance

Class I Toxicology device.

K943027 · Prisma Systems · Toxicology device
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Jan 1995
Decision
214d
Days
Class 1
Risk

K943027 is an FDA 510(k) clearance for the CHOLESTEROL QVET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 214 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1175 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Prisma Systems devices

Submission Details

510(k) Number K943027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date January 27, 1995
Days to Decision 214 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 87d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 229
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K943027.
Lipids
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K232404 · Medicon Hellas S.A · Aug 2024
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K190490 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
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K181373 · Laboratory Corporation of America Holdings · Oct 2018
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K180504 · ACON Laboratories, Inc. · Mar 2018