Cleared Traditional

K990931 - EZ-HBT HELICOBACTER BLOOD TEST

K990931 is an FDA 510(k) clearance for EZ-HBT HELICOBACTER BLOOD TEST, manufactured by Metabolic Solutions, Inc.. The device is a Class 1 Microbiology device with product code MSQ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K990931 · Metabolic Solutions, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K990931

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
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
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