Cleared Traditional

K905217 - FORMASURE TEST REAGENT

K905217 is an FDA 510(k) clearance for FORMASURE TEST REAGENT, manufactured by Di-Chem, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K905217 · Di-Chem, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
140d
Days
Class 2
Risk

K905217 is an FDA 510(k) clearance for the FORMASURE TEST REAGENT. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Di-Chem, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 9, 1991 after a review of 140 days - within the typical 510(k) review window.

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.

View all Di-Chem, Inc. devices

FDA 510(k) Submission Details - K905217

510(k) Number K905217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date April 09, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 130d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - LIF Dialyzer Reprocessing System

All 17
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K905217.
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123 · Serim Research Corp. · Apr 1992
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · Serim Research Corp. · Jun 1991
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · Serim Research Corp. · Jun 1991
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · Serim Research Corp. · Apr 1991
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · Minntech Corp. · Nov 1990
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
K900341 · Serim Research Corp. · Jul 1990