Cleared Traditional

K855238 - BIOTEL (TM)/UTI

K855238 is an FDA 510(k) clearance for BIOTEL (TM)/UTI, manufactured by American Diagnostic Corp.. The device is a Class 1 Chemistry device with product code JMT cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K855238 · American Diagnostic Corp. · Chemistry device
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May 1986
Decision
129d
Days
Class 1
Risk

K855238 is an FDA 510(k) clearance for the BIOTEL (TM)/UTI. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by American Diagnostic Corp. (Wheaton, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 129 days - within the typical 510(k) review window.

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 American Diagnostic Corp. devices

FDA 510(k) Submission Details - K855238

510(k) Number K855238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1985
Decision Date May 09, 1986
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
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.