Cleared Traditional

LUMAC'S BACTERIURIA SCREENING KIT (K810746) - FDA 510(k) Clearance

Class I Toxicology device.

K810746 · Lumac · Toxicology device
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Jul 1981
Decision
134d
Days
Class 1
Risk

K810746 is an FDA 510(k) clearance for the LUMAC'S BACTERIURIA SCREENING KIT. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Lumac (Mchenry, US). The FDA issued a Cleared decision on July 31, 1981 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2660 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K810746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1981
Decision Date July 31, 1981
Days to Decision 134 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 87d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.