510(k) · Cleared

Cleared

Rapirun H. Pylori Antibody Detection Kit

K052716510(k) TraditionalCleared Nov 16, 2006413-day reviewClass I21 CFR 866.3110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Otsuka Pharmaceutical Co., Ltd. · LYR Helicobacter Pylori

Cleared on Nov 16, 2006 as substantially equivalent to K984544 (Enteric Products, Inc., 1999) and 4 other predicates after a 413-day review. Its family tree reaches back 2 generations to 1997.

Decided: Nov 16, 2006
Review: 413 days
Class: Class I
Product code: LYR
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K974322 (1997). 6 ancestors in all, the oldest K944159 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK974322 Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997
1 generation backK013371 Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 2001 · Recalled
This deviceK052716 Rapirun H. Pylori Antibody Detection KitOtsuka Pharmaceutical Co., Ltd. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K974322	Abca-NT Gas Isotope Ratio Mass Spectrometer System	Europa Scientific, Ltd.	1997	—
−1	K013371	Ubit-IR300 Infrared Spectrometry System	Otsuka Pharmaceutical Co., Ltd.	2001	1
0 (this device)	K052716	Rapirun H. Pylori Antibody Detection Kit	Otsuka Pharmaceutical Co., Ltd.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1999	1	0
2003	1	0

FIG. 1 — Lineage of K052716, 1997–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LYR device

#1 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K984544	The Aptus (Automated) Application of the HM-Cap Eia Kit. an Enzyme Linked Immunosorbent… Summary page 1 …tion Namc: Campylobacterpylon 3. PREDICATE DEVICES * HM-CAPTM I. pylori Enzyme Immunoassay Test Enteric Products, Inc. K984544, K955085, K944159 * UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd.…	Enteric Products, Inc.	1999	—
*	K955085	HM-Cap Eia Test (Modification) Summary page 1 …: Campylobacterpylon 3. PREDICATE DEVICES * HM-CAPTM I. pylori Enzyme Immunoassay Test Enteric Products, Inc. K984544, K955085, K944159 * UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd. K013371…	Schiff & Co.	1996	—
*	K944159	HM-Cap Eia Kit Summary page 1 …mpylobacterpylon 3. PREDICATE DEVICES * HM-CAPTM I. pylori Enzyme Immunoassay Test Enteric Products, Inc. K984544, K955085, K944159 * UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd. K013371…	Schiff & Co.	1995	—
*	K013371	Ubit-IR300 Infrared Spectrometry System Summary page 1 …ic Products, Inc. K984544, K955085, K944159 * UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd. K013371 * Instant-View H. pylori Rapid Test Alfa Scientific Designs, Inc. K024360 Otsuka Pharma…	Otsuka Pharmaceutical Co., Ltd.	2001	1
*	K024360	Instant-View H. Pylori One Step Rapid Test Summary page 1 …Otsuka Pharmaceutical Co., Ltd. K013371 * Instant-View H. pylori Rapid Test Alfa Scientific Designs, Inc. K024360 Otsuka Pharmaceutical Co., Ltd. 510(k) September 28, 2005 RAPIRUN H.pylori Antibody Detection Kit…	Alfa Scientific Designs, Inc.	2003	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
1 of the 6 ancestors has a recall of any class.

How does its category compare?

All LYR devices

LYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYR

2in 2023

2007high 4 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYR

86in 2018

2007high 86 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYR

2in 2025

2007high 3 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYR

2in 2023

2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code LYR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	2	0
2009	0	—	0	0
2010	0	—	1	1
2011	0	—	0	2
2012	2	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	2	—	0	2
2016	2	—	0	4
2017	0	—	0	1
2018	4	86	0	0
2019	1	—	0	0
2020	1	—	0	4
2021	0	—	0	1
2022	0	—	3	0
2023	2	—	1	2
2024	0	—	0	0
2025	0	—	2	0
2026	0	—	0	—

What is it indicated for?

The RAPIRUN H pylori Antibody Detection Kit is a rapid immunocbromatographic assay, intended for the qualitative detection of antibodies against Ilelicobacterpylori(H.pylon) in urine to aid in the diagnosis of H pylori infection. The RAPIRUN Kit is suitable for use in both point-of-carc and clinical laboratory settings.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052716: Rapirun H. Pylori Antibody Detection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052716

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026