Cleared Traditional

K943000 - ALBUMIN QVET

K943000 is an FDA 510(k) clearance for ALBUMIN QVET, manufactured by Prisma Systems. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K943000 · Prisma Systems · Chemistry device
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Dec 1994
Decision
173d
Days
Class 2
Risk

K943000 is an FDA 510(k) clearance for the ALBUMIN QVET. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 - K943000

510(k) Number K943000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 13, 1994
Days to Decision 173 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
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 80
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K943000.
ALBG
K981468 · Abbott Laboratories · May 1998
TRACE COBAS MIRA RANGE
K952488 · Trace Scientific , Ltd. · Oct 1995
DMA ALBUMIN PROCEDURE
K946355 · Data Medical Associates, Inc. · Mar 1995
EMDS ALBUMIN (ALB) TEST
K935179 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS ALBUMIN REAGENT
K924368 · Olympus Corp. · Feb 1993
ALBUMIN TEST
K923959 · Em Diagnostic Systems, Inc. · Dec 1992