Cleared Traditional

K972146 - QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS

K972146 is an FDA 510(k) clearance for QUALITROL UNASSAYED H. PYLORI CONTROL S..., manufactured by Consolidated Technologies, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K972146

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

LYR Device Classification - Class 1, General Controls

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 72
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K972146.
SHIELD HELICO-G2 ELISA KIT
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PYLORI DETECT IGG
K973508 · Micro Detect, Inc. · Mar 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998
PYLORISET EIA-G (68926)
K971537 · Orion Diagnostica, Div. Orion Corp. · Jun 1997
KENLOR H. PYLORI CONTROL SERUM
K964014 · Kenlor Industries, Inc. · Mar 1997
ACCUMETER H. PYLORI TEST
K965099 · Chemtrak, Inc. · Feb 1997