Cleared Traditional

SERIM DIALYSATE MONITOR TEST STRIP (K043031) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043031 · Serim Research Corp. · Gastroenterology & Urology device
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Jun 2005
Decision
222d
Days
Class 2
Risk

K043031 is an FDA 510(k) clearance for the SERIM DIALYSATE MONITOR TEST STRIP. Classified as Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator (product code NTZ), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on June 13, 2005 after a review of 222 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K043031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2004
Decision Date June 13, 2005
Days to Decision 222 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 130d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTZ Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
Definition Device Provides Semiquantitative Indications Of Ph, Bicarbonate Ions, And Glucose In The Final Bicarbonate Dialysate.
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 Gastroenterology & Urology devices follow this clearance model.