Cleared Traditional

K972146 - QUALITROL UNASSAYED H. PYLORI CONTROL S...

K972146 is the FDA 510(k) clearance for QUALITROL UNASSAYED H. PYLORI CONTROL S... by Consolidated Technologies, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K972146 · Consolidated Technologies, Inc. · Microbiology device
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Jul 1997
Decision
29d
Days
Class 1
Risk

K972146 is an FDA 510(k) clearance for the QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on July 8, 1997 after a review of 29 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Consolidated Technologies, Inc. devices

Submission Details

510(k) Number K972146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date July 08, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
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 - LYR Helicobacter Pylori

All 45
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K972146.
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · Zeus Scientific, Inc. · Jul 1998
PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · Jan 1997
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc. · Aug 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996