Cleared Traditional

LITH A TEST TM (K830091) - FDA 510(k) Clearance

Class I Hematology device.

K830091 · Lenal Creative Approaches, Inc. · Hematology device
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Feb 1983
Decision
35d
Days
Class 1
Risk

K830091 is an FDA 510(k) clearance for the LITH A TEST TM. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Lenal Creative Approaches, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1983 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1550 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lenal Creative Approaches, Inc. devices

Submission Details

510(k) Number K830091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date February 15, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEN Dye-indicator, Ph (urinary, Non-quantitative)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
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.