Cleared Traditional

K952971 - DIA SCREEN REAGENT STRIPS

K952971 is an FDA 510(k) clearance for DIA SCREEN REAGENT STRIPS, manufactured by Genesis Labs, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K952971 · Genesis Labs, Inc. · Chemistry device
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Aug 1995
Decision
45d
Days
Class 2
Risk

K952971 is an FDA 510(k) clearance for the DIA SCREEN REAGENT STRIPS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Genesis Labs, Inc. (Edina, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 45 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 Genesis Labs, Inc. devices

FDA 510(k) Submission Details - K952971

510(k) Number K952971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1995
Decision Date August 11, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 46
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K952971.
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K954968 · Tcpi, Inc. · Jul 1996
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