510(k) · Cleared
ClearedAbca-NT Gas Isotope Ratio Mass Spectrometer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Europa Scientific, Ltd. · DOP Mass Spectrometer, Clinical Use
Cleared on Dec 16, 1997 after a 29-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Dec 16, 1997
- Review
- 29 days
- Class
- Class I
- Product code
- DOP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK974322 Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997
- Descendant · cites it directly · 3 of its ownK013371 Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK052716 Rapirun H. Pylori Antibody Detection KitOtsuka Pharmaceutical Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK041148 Pocone Infrared SpectrophotometerOtsuka Pharmaceutical Co., Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK014225 Breathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK992163 Abca Gas Isotope Ratio Mass Spectrometer SystemsPdz-Europa, Ltd. · 1999
Most influential descendants
Showing 5 of 5 · See all- K013371Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 2001 · cites it directly3descendants
- K052716Rapirun H. Pylori Antibody Detection KitOtsuka Pharmaceutical Co., Ltd. · 2006 · 2 generations on0descendants
- K041148Pocone Infrared SpectrophotometerOtsuka Pharmaceutical Co., Ltd. · 2004 · 2 generations on0descendants
- K014225Breathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc. · 2002 · 2 generations on0descendants
- K992163Abca Gas Isotope Ratio Mass Spectrometer SystemsPdz-Europa, Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974322 | Abca-NT Gas Isotope Ratio Mass Spectrometer System | Europa Scientific, Ltd. | 1997 | — |
| +1 | K013371 | Ubit-IR300 Infrared Spectrometry System | Otsuka Pharmaceutical Co., Ltd. | 2001 | 1 |
| +2 | K052716 | Rapirun H. Pylori Antibody Detection Kit | Otsuka Pharmaceutical Co., Ltd. | 2006 | — |
| +2 | K041148 | Pocone Infrared Spectrophotometer | Otsuka Pharmaceutical Co., Ltd. | 2004 | — |
| +2 | K014225 | Breathtek - Ubit Ubt for H. Pylori | Meretek Diagnostics, Inc. | 2002 | 1 |
| +1 | K992163 | Abca Gas Isotope Ratio Mass Spectrometer Systems | Pdz-Europa, Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 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 DOP? 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 |
|---|---|---|---|
| * | — | Consolidated Nier Model 21-201 Isotope Ratio Mass Spectrometer (IRMS) Named without a submission number |
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013371 (Otsuka Pharmaceutical Co., Ltd., 2001) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DOP devicesDOP Mass Spectrometer, Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DOP
FDA has decided no DOP device since 2007.
Median 510(k) review, days · DOP
Too few DOP 510(k)s in any year since 2007 to give a median.
Recalls per year · DOP
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DOP
1in 2025
MAUDE reports naming product code DOP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 4 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ABCA-NT is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement of stable isotopes of carbon, nitrogen, and oxygen in gas samples. For this purpose, the system is comprised of a gas sampling module, a gas purification module, and an isotope ratio mass spectrometer which are synchronously coupled by means of an external personal computer which also collects and archives data.
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/K974322 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974322: Abca-NT Gas Isotope Ratio Mass Spectrometer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974322
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026