Cleared Traditional

K874909 - MICRO-BUMINTEST REAGENT TABLETS (FDA 510(k) Clearance)

Class I Chemistry device.

K874909 · Miles Laboratories, Inc. · Chemistry device
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Apr 1988
Decision
149d
Days
Class 1
Risk

K874909 is an FDA 510(k) clearance for the MICRO-BUMINTEST REAGENT TABLETS. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on April 28, 1988 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K874909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date April 28, 1988
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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.