Cleared Traditional

K002011 - GLUTARTEST 1 REAGENT STRIP

K002011 is an FDA 510(k) clearance for GLUTARTEST 1 REAGENT STRIP, manufactured by Integrated Biomedical Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSY cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K002011 · Integrated Biomedical Technology, Inc. · Gastroenterology & Urology device
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Jan 2001
Decision
203d
Days
Class 2
Risk

K002011 is an FDA 510(k) clearance for the GLUTARTEST 1 REAGENT STRIP. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Integrated Biomedical Technology, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 22, 2001 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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.

View all Integrated Biomedical Technology, Inc. devices

FDA 510(k) Submission Details - K002011

510(k) Number K002011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date January 22, 2001
Days to Decision 203 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 130d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSY Device Classification - Class 2, Special Controls

Product Code MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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.

Regulatory Peers - MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Devices cleared under the same product code (MSY) and FDA review panel - the closest regulatory comparables to K002011.
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K080712 · Serim Research Corp. · May 2008