Cleared Traditional

K990873 - DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE

K990873 is an FDA 510(k) clearance for DBEST URINARY TRACT INFECTION TEST KIT ..., manufactured by Ameritek, Inc.. The device is a Class 1 Chemistry device with product code JMT cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K990873 · Ameritek, Inc. · Chemistry device
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Sep 1999
Decision
169d
Days
Class 1
Risk

K990873 is an FDA 510(k) clearance for the DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 169 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1510 - 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 Ameritek, Inc. devices

FDA 510(k) Submission Details - K990873

510(k) Number K990873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1999
Decision Date September 01, 1999
Days to Decision 169 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
81d slower than avg
Panel avg: 88d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

JMT Device Classification - Class 1, General Controls

Product Code JMT Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1510
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JMT Diazo (colorimetric), Nitrite (urinary, Non-quant)

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