Cleared Traditional

K972716 - SYNERMED TOTAL BILIRUBIN REAGENT KIT

K972716 is the FDA 510(k) clearance for SYNERMED TOTAL 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 17-day FDA review.

K972716 · Synermed, Inc. · Chemistry device

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Aug 1997

Decision

17d

Days

Class 2

Risk

K972716 is an FDA 510(k) clearance for the SYNERMED TOTAL 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 August 7, 1997 after a review of 17 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synermed, Inc. devices

Submission Details

510(k) Number	K972716 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 21, 1997
Decision Date	August 07, 1997
Days to Decision	17 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

71d faster than avg

Panel avg: 88d · This submission: 17d

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 K972716.

DIRECT BILIRUBIN (DBIL)

K981222 · Abbott Laboratories · Apr 1998

BILIRUBIN-SL (TOTAL) ASSAY

K974874 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1998

SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

K973109 · Synermed, Inc. · Sep 1997

WAKO DIRECT BILIRUBIN V

K970986 · Wako Chemicals USA, Inc. · May 1997

SYNERMED DIRECT BILIRUBIN REAGENT KIT

K963939 · Synermed, Inc. · Dec 1996

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05

K955880 · Diagnostic Chemicals , Ltd. · Aug 1996

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K972716

Synermed, Inc.

Quebec, Canada · CA

MARCIA J ARENTZ

Regulatory profile

45 submissions 45 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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