Cleared Traditional

K973142 - DBEST REAGENT STRIP FOR URINALYSIS

K973142 is the FDA 510(k) clearance for DBEST REAGENT STRIP FOR URINALYSIS by Ameritek, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K973142 · Ameritek, Inc. · Chemistry device
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Oct 1997
Decision
60d
Days
Class 2
Risk

K973142 is an FDA 510(k) clearance for the DBEST REAGENT STRIP FOR URINALYSIS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on October 20, 1997 after a review of 60 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 Ameritek, Inc. devices

Submission Details

510(k) Number K973142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1997
Decision Date October 20, 1997
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
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 27
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K973142.
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URS-IG (GLUCOSE TEST)
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URISYS 2400 URINE TEST STRIP
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CLINISTRIP
K970250 · Teco Diagnostics · Apr 1997
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · Teco Diagnostics · Mar 1995
URINE REAGENT STRIP-3 PARAMETERS
K940469 · Teco Diagnostics · Sep 1994