# K041148: Pocone Infrared Spectrophotometer

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka Pharmaceutical Co., Ltd.
- Decided: Jul 15, 2004 after 73 days
- Product code: MSQ (Test, Urea (Breath Or Blood))
- 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013371: Ubit-IR300 Infrared Spectrometry System, Otsuka Pharmaceutical Co., Ltd. (2001) Summary page 1.

## Indications for use
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek "3C-urea breath tests for the detection of Helicobacterpylori (H.pylori) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.

Source page: https://510kreport.com/device/K041148
Methodology: https://510kreport.com/methodology