510(k) · Cleared
Recalled · 2008Ubit-IR300 Infrared Spectrometry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otsuka Pharmaceutical Co., Ltd. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Cleared on Dec 21, 2001 as substantially equivalent to K974322 (Europa Scientific, Ltd., 1997) after a 71-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 2001
- Review
- 71 days
- Class
- Class I
- Product code
- JJQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974322 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK974322 Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997
- This deviceK013371 Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK052716 Rapirun H. Pylori Antibody Detection KitOtsuka Pharmaceutical Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK041148 Pocone Infrared SpectrophotometerOtsuka Pharmaceutical Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK014225 Breathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc. · 2002 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K052716Rapirun H. Pylori Antibody Detection KitOtsuka Pharmaceutical Co., Ltd. · 2006 · cites it directly0descendants
- K041148Pocone Infrared SpectrophotometerOtsuka Pharmaceutical Co., Ltd. · 2004 · cites it directly0descendants
- K014225Breathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974322 | Abca-NT Gas Isotope Ratio Mass Spectrometer System | Europa Scientific, Ltd. | 1997 | — |
| 0 (this device) | K013371 | Ubit-IR300 Infrared Spectrometry System | Otsuka Pharmaceutical Co., Ltd. | 2001 | — |
| +1 | K052716 | Rapirun H. Pylori Antibody Detection Kit | Otsuka Pharmaceutical Co., Ltd. | 2006 | — |
| +1 | K041148 | Pocone Infrared Spectrophotometer | Otsuka Pharmaceutical Co., Ltd. | 2004 | — |
| +1 | K014225 | Breathtek - Ubit Ubt for H. Pylori | Meretek Diagnostics, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
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 JJQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K974322 | Abca-NT Gas Isotope Ratio Mass Spectrometer SystemSummary page 1…13C-Urea Breath Test Classification Name: Urea Breath Test 3. Predicate Devices e ABCA-NT Gas Isotope Ratio Mass Spectrometer (GIRMS) System Europa Scientific Limited K974322 Otsuka Pharmaceutical Co., Ltd. 510(k) December 17, 2001 Additional Information for K013371 Page C-1 4, DEVICE D… | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 18, 2008 | Not classified | Z-1749-2008 | Nonconforming Material/Component | Medical device power supply may overheat and cause smoke to be emitted from the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JJQ devicesJJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJQ
FDA has decided no JJQ device since 2007.
Median 510(k) review, days · JJQ
Too few JJQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JJQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJQ
20in 2025
MAUDE reports naming product code JJQ, 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 | 1 |
| 2008 | 0 | — | 2 | 4 |
| 2009 | 0 | — | 1 | 10 |
| 2010 | 0 | — | 0 | 46 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 63 |
| 2014 | 0 | — | 0 | 69 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 1 | 22 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 20 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013371: Ubit-IR300 Infrared Spectrometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013371
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026