Cleared Traditional

K954968 - HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

K954968 is an FDA 510(k) clearance for HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST, manufactured by Tcpi, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K954968 · Tcpi, Inc. · Chemistry device
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Jul 1996
Decision
273d
Days
Class 2
Risk

K954968 is an FDA 510(k) clearance for the HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Tcpi, Inc. (Beverly, US). The FDA issued a Cleared decision on July 26, 1996 after a review of 273 days - an extended review 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: 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 Tcpi, Inc. devices

FDA 510(k) Submission Details - K954968

510(k) Number K954968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1995
Decision Date July 26, 1996
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 88d · This submission: 273d
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 49
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K954968.
MEDI-TEST COMBI 11
K991927 · Macherey-Nagel-Duren · Sep 1999
DBEST REAGENT STRIP FOR URINALYSIS
K973142 · Ameritek, Inc. · Oct 1997
CLINISTRIP
K970250 · Teco Diagnostics · Apr 1997
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