Cleared Traditional

K943924 - CREATININE-PO REAGENT KIT

K943924 is an FDA 510(k) clearance for CREATININE-PO REAGENT KIT, manufactured by Synermed, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K943924 · Synermed, Inc. · Chemistry device
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Sep 1994
Decision
39d
Days
Class 2
Risk

K943924 is an FDA 510(k) clearance for the CREATININE-PO REAGENT KIT. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on September 20, 1994 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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.

FDA 510(k) Submission Details - K943924

510(k) Number K943924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date September 20, 1994
Days to Decision 39 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
50d faster than avg
Panel avg: 89d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 158
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K943924.
CR PERFECT
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CREATININE QVET
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ROCHE REAGENT FOR CREATININE
K941837 · Roche Diagnostic Systems, Inc. · Aug 1994
KODAK EKTACHEM DT SLIDES (URCR)
K934071 · Eastman Kodak Company · Mar 1994
CREATININE-S ASSAY
K934587 · Diagnostic Chemicals , Ltd. · Mar 1994
K943924 · CREATININE-PO REAGENT KIT
Download PDF Synermed, Inc.