Cleared Traditional

K053335 - PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480

K053335 is an FDA 510(k) clearance for PREMIER PLATINUM HPSA PLUS, manufactured by Meridian Bioscience, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K053335 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
99d
Days
Class 1
Risk

K053335 is an FDA 510(k) clearance for the PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 10, 2006 after a review of 99 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K053335

510(k) Number K053335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date March 10, 2006
Days to Decision 99 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
3d faster than avg
Panel avg: 102d · This submission: 99d
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 90
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K053335.
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · Gold Standard Diagnostics · Feb 2012
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
K052716 · Otsuka Pharmaceutical Co., Ltd. · Nov 2006
PYLO-PLUS
K052708 · Arj Medical, Inc. · May 2006
HELICOBACTER PYLORI IGG ELISA
K041238 · Biohit Plc · Dec 2004
IMMUNOCARDSTAT HPSA
K032222 · Meridian Bioscience, Inc. · Dec 2003
PYLORI IGG
K033067 · Trinity Biotech USA · Nov 2003
K053335 · PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
Download PDF FDA Summary Meridian Bioscience, …