Cleared Traditional

K942949 - BILIRUBIN (DIRECT) QVET

K942949 is an FDA 510(k) clearance for BILIRUBIN (DIRECT) QVET, manufactured by Prisma Systems. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K942949 · Prisma Systems · Chemistry device
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Nov 1994
Decision
152d
Days
Class 2
Risk

K942949 is an FDA 510(k) clearance for the BILIRUBIN (DIRECT) QVET. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 152 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 - K942949

510(k) Number K942949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date November 22, 1994
Days to Decision 152 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
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 178
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K942949.
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
K955880 · Diagnostic Chemicals , Ltd. · Aug 1996
TOTAL BILIRUBIN PROCEDURE
K955300 · Data Medical Associates, Inc. · Dec 1995
BILIRUBIN(TOTAL) QVET
K942999 · Prisma Systems · Dec 1994
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K940570 · Synermed, Inc. · Apr 1994
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K933026 · Synermed, Inc. · Oct 1993
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
K932159 · Em Diagnostic Systems, Inc. · Sep 1993