Cleared Traditional

EZ-HBT HELICOBACTER BLOOD TEST (K990931) - FDA 510(k) Clearance

Class I Microbiology device.

K990931 · Metabolic Solutions, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
189d
Days
Class 1
Risk

K990931 is an FDA 510(k) clearance for the EZ-HBT HELICOBACTER BLOOD TEST. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Metabolic Solutions, Inc. (Nashua, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 189 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 Metabolic Solutions, Inc. devices

Submission Details

510(k) Number K990931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date September 24, 1999
Days to Decision 189 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

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
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