Cleared Traditional

K933026 - SYNERMED DIRECT BILIRUBIN REAGENT KIT

K933026 is the FDA 510(k) clearance for SYNERMED DIRECT BILIRUBIN REAGENT KIT by Synermed, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K933026 · Synermed, Inc. · Chemistry device
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Oct 1993
Decision
128d
Days
Class 2
Risk

K933026 is an FDA 510(k) clearance for the SYNERMED DIRECT BILIRUBIN REAGENT KIT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on October 28, 1993 after a review of 128 days - within the typical 510(k) review window.

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 Synermed, Inc. devices

Submission Details

510(k) Number K933026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date October 28, 1993
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 172
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K933026.
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
K955880 · Diagnostic Chemicals , Ltd. · Aug 1996
TOTAL BILIRUBIN PROCEDURE
K955300 · Data Medical Associates, Inc. · Dec 1995
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K940570 · Synermed, Inc. · Apr 1994
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
K932159 · Em Diagnostic Systems, Inc. · Sep 1993
TOTAL BILIRUBIN
K931888 · Em Diagnostic Systems, Inc. · Jul 1993
OLYMPUS TOTAL BILIRUBIN REAGENT
K924964 · Olympus Corp. · Dec 1992