Cleared Traditional

K925256 - QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL (FDA 510(k) Clearance)

Class I Hematology device.

K925256 · Quantimetrix Corp. · Hematology device
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Mar 1993
Decision
133d
Days
Class 1
Risk

K925256 is an FDA 510(k) clearance for the QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on March 1, 1993 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1660 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K925256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date March 01, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 113d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.