Cleared Traditional

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (K052716) - FDA 510(k) Clearance

Class I Microbiology device.

K052716 · Otsuka Pharmaceutical Co., Ltd. · Microbiology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 102d · This submission: 413d
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 90
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