# K052716: Rapirun H. Pylori Antibody Detection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka Pharmaceutical Co., Ltd.
- Decided: Nov 16, 2006 after 413 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974322 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984544: The Aptus (Automated) Application of the HM-Cap Eia Kit. an Enzyme Linked Immunosorbent Assay for the Detection of the S, Enteric Products, Inc. (1999) Summary page 1.
- K955085: HM-Cap Eia Test (Modification), Schiff & Co. (1996) Summary page 1.
- K944159: HM-Cap Eia Kit, Schiff & Co. (1995) Summary page 1.
- K013371: Ubit-IR300 Infrared Spectrometry System, Otsuka Pharmaceutical Co., Ltd. (2001) Summary page 1.
- K024360: Instant-View H. Pylori One Step Rapid Test, Alfa Scientific Designs, Inc. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K052716
Methodology: https://510kreport.com/methodology