Cleared Traditional

URI-TEST 3, INLAB REAGENT STRIPS-URINAL (K831498) - FDA 510(k) Clearance

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

K831498 · Laprol Scientific, Inc. · Chemistry device
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Jun 1983
Decision
42d
Days
Class 2
Risk

K831498 is an FDA 510(k) clearance for the URI-TEST 3, INLAB REAGENT STRIPS-URINAL. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Laprol Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laprol Scientific, Inc. devices

Submission Details

510(k) Number K831498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date June 22, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K831498.
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · Behring Diagnostics, Inc. · Oct 1986
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · Miles Laboratories, Inc. · Sep 1983
BIOSTRIP G
K820594 · Helena Laboratories · May 1982
9-WAY URINE TEST WITH ASCORBIC
K771755 · Miles Laboratories, Inc. · Oct 1977
MEGA-DIASTIX
K761310 · Miles Laboratories, Inc. · Mar 1977