Cleared Traditional

K943027 - CHOLESTEROL QVET

K943027 is an FDA 510(k) clearance for CHOLESTEROL QVET, manufactured by Prisma Systems. The device is a Class 1 Toxicology device with product code CHH cleared through the Traditional 510(k) pathway after a 214-day FDA review.

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

FDA 510(k) Submission Details - K943027

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.

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 137
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K943027.
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · Boehringer Mannheim Corp. · Mar 1996
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · Data Medical Associates, Inc. · Aug 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995
ROCHE REAGENT
K941573 · Roche Diagnostic Systems, Inc. · Oct 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · Randox Laboratories, Ltd. · Jan 1994
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · Em Diagnostic Systems, Inc. · Dec 1993