Cleared Traditional

K943028 - HDL QVET

K943028 is an FDA 510(k) clearance for HDL QVET, manufactured by Prisma Systems. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K943028 · Prisma Systems · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
163d
Days
Class 1
Risk

K943028 is an FDA 510(k) clearance for the HDL QVET. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 163 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Prisma Systems devices

FDA 510(k) Submission Details - K943028

510(k) Number K943028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date December 07, 1994
Days to Decision 163 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
75d slower than avg
Panel avg: 88d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 52
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K943028.
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · Roche Diagnostic Systems, Inc. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · Randox Laboratories, Ltd. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · Beckman Instruments, Inc. · Oct 1993
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · Technicon Instruments Corp. · Nov 1991
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · Immunotech Corp. · Mar 1990