Cleared Traditional

K973000 - ALIMENTERICS LARA (TM) BREATH TEST SYSTEM

K973000 is an FDA 510(k) clearance for ALIMENTERICS LARA (TM) BREATH TEST SYSTEM, manufactured by Alimenterics, Inc.. The device is a Class 1 Microbiology device with product code MSQ cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K973000 · Alimenterics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
198d
Days
Class 1
Risk

K973000 is an FDA 510(k) clearance for the ALIMENTERICS LARA (TM) BREATH TEST SYSTEM. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Alimenterics, Inc. (Morris Plains, US). The FDA issued a Cleared decision on February 26, 1998 after a review of 198 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alimenterics, Inc. devices

FDA 510(k) Submission Details - K973000

510(k) Number K973000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date February 26, 1998
Days to Decision 198 days
Submission Type Traditional
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
96d slower than avg
Panel avg: 102d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

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 10
Devices cleared under the same product code (MSQ) and FDA review panel - the closest regulatory comparables to K973000.
BREATHID HP SYSTEM
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THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · Meretek Diagnostics, Inc. · Oct 1997