Cleared Traditional

K974064 - MICRO X RESIDUAL TEST STRIPS

K974064 is an FDA 510(k) clearance for MICRO X RESIDUAL TEST STRIPS, manufactured by Reprocessing Products Corp. The device is a Class 2 Gastroenterology & Urology device with product code MSY cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K974064 · Reprocessing Products Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
406d
Days
Class 2
Risk

K974064 is an FDA 510(k) clearance for the MICRO X RESIDUAL TEST STRIPS. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Reprocessing Products Corp (Maple Grove, US). The FDA issued a Cleared decision on December 7, 1998 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Reprocessing Products Corp devices

FDA 510(k) Submission Details - K974064

510(k) Number K974064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1997
Decision Date December 07, 1998
Days to Decision 406 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 131d · This submission: 406d
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

All 8
Devices cleared under the same product code (MSY) and FDA review panel - the closest regulatory comparables to K974064.
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K971598 · Environmental Test Systems, Inc. · Jul 1997