# K014225: Breathtek - Ubit Ubt for H. Pylori

- Pathway: 510(k) (Special)
- Applicant: Meretek Diagnostics, Inc.
- Decided: Jan 17, 2002 after 22 days
- Product code: MSQ (Test, Urea (Breath Or Blood))
- Device class: 1
- Regulation: 21 CFR 866.3110
- 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: 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). Our OCR of the scanned summary read “K013371” beside “510(k)”; FDA’s K013371 is the only number that fits it and carries the summary’s name for the device. Summary page 4.

## Recalls of this device
- May 2, 2007 · Not classified · Z-0003-2008: Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

## Indications for use
The BreathTek™ - UBiT® UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy. For these purposes, the test utilizes the UBIT IR spectrophotometer for the measurement of the ratio of 13CO; to 12COzcontent in breath gas. For administration by health care professionals. To be administered under a physician’s supervision.

Source page: https://510kreport.com/device/K014225
Methodology: https://510kreport.com/methodology