Cleared Traditional

K052716 - RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

K052716 is an FDA 510(k) clearance for RAPIRUN H. PYLORI ANTIBODY DETECTION KIT, manufactured by Otsuka Pharmaceutical Co., Ltd.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K052716 · Otsuka Pharmaceutical Co., Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
413d
Days
Class 1
Risk

K052716 is an FDA 510(k) clearance for the RAPIRUN H. PYLORI ANTIBODY DETECTION KIT. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Otsuka Pharmaceutical Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on November 16, 2006 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Otsuka Pharmaceutical Co., Ltd. devices

FDA 510(k) Submission Details - K052716

510(k) Number K052716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date November 16, 2006
Days to Decision 413 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
311d slower than avg
Panel avg: 102d · This submission: 413d
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 74
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K052716.
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
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PYLO-PLUS
K052708 · Arj Medical, Inc. · May 2006
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K053335 · Meridian Bioscience, Inc. · Mar 2006
HELICOBACTER PYLORI IGG ELISA
K041238 · Biohit Plc · Dec 2004