Cleared Traditional

K946116 - URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD

K946116 is an FDA 510(k) clearance for URISTRIP REAGENT STRIPS TEST FOR PROTEIN, manufactured by Chemtech Labs, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K946116 · Chemtech Labs, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
96d
Days
Class 2
Risk

K946116 is an FDA 510(k) clearance for the URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Chemtech Labs, Inc. (Gurnee, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Chemtech Labs, Inc. devices

FDA 510(k) Submission Details - K946116

510(k) Number K946116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date March 21, 1995
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 56
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K946116.
DIA SCREEN 10 WAY REAGENT STRIPS
K961375 · Genesis Labs, Inc. · Jun 1996
FIRST CHOICE GLUCOSE URINE TEST STRIPS
K953661 · Polymer Technology Intl. · Jun 1996
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · Teco Diagnostics · Mar 1995
URINE REAGENT STRIP-3 PARAMETERS
K940469 · Teco Diagnostics · Sep 1994
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · American Diagnostic Corp. · Mar 1987