Cleared Special

K000316 - MERETEK UBT_LITE BREATH TEST FOR H. PYLORI

K000316 is an FDA 510(k) clearance for MERETEK UBT_LITE BREATH TEST FOR H. PYLORI, manufactured by Meretek. The device is a Class 1 Microbiology device with product code MSQ cleared through the Special 510(k) pathway after a 23-day FDA review.

K000316 · Meretek · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K000316

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

MSQ Device Classification - Class 1, General Controls

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.
POCONE INFRARED SPECTROPHOTOMETER
K041148 · Otsuka Pharmaceutical Co., Ltd. · Jul 2004
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225 · Meretek Diagnostics, Inc. · Jan 2002
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · Oridion Medical 1987 , Ltd. · Jul 2001
EZ-HBT HELICOBACTER BLOOD TEST
K990931 · Metabolic Solutions, Inc. · Sep 1999
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000 · Alimenterics, Inc. · Feb 1998
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · Meretek Diagnostics, Inc. · Oct 1997
K000316 · MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
Download PDF FDA Summary Meretek