# K013371: Ubit-IR300 Infrared Spectrometry System

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka Pharmaceutical Co., Ltd.
- Decided: Dec 21, 2001 after 71 days
- Product code: JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974322 (1997). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974322: Abca-NT Gas Isotope Ratio Mass Spectrometer System, Europa Scientific, Ltd. (1997) Summary page 1.

## Most influential descendants
- K052716: Rapirun H. Pylori Antibody Detection Kit (2006), 0 descendants of its own
- K041148: Pocone Infrared Spectrophotometer (2004), 0 descendants of its own
- K014225: Breathtek - Ubit Ubt for H. Pylori (2002), 0 descendants of its own

## Recalls of this device
- Jan 18, 2008 · Not classified · Z-1749-2008: Medical device power supply may overheat and cause smoke to be emitted from the device.

## Indications for use
The UBIiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in '*CO: content in breath CO. gas by infrared spectroscopic analysis. ~ The system consists of the UBIiT-IR800 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags. The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek '*C-urea breath tests for the detection of Helicobacter pylori (H. pylors) infection. The UBiT-IR800 System is suitable for use in both clinical laboratory and point-of-care settings.

Source page: https://510kreport.com/device/K013371
Methodology: https://510kreport.com/methodology