Cleared Special

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI (K000316) - FDA 510(k) Clearance

Class I Microbiology device.

K000316 · Meretek · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
23d
Days
Class 1
Risk

K000316 is an FDA 510(k) clearance for the MERETEK UBT_LITE BREATH TEST FOR H. PYLORI. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Meretek (Nashville, US). The FDA issued a Cleared decision on February 24, 2000 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Meretek devices

Submission Details

510(k) Number K000316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2000
Decision Date February 24, 2000
Days to Decision 23 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MSQ Test, Urea (breath Or Blood)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.

Regulatory Peers - MSQ Test, Urea (breath Or Blood)

All 16
Devices cleared under the same product code (MSQ) and FDA review panel - the closest regulatory comparables to K000316.
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K173777 · Exalenz Bioscience , Ltd. · Mar 2018