# K974322: Abca-NT Gas Isotope Ratio Mass Spectrometer System

- Pathway: 510(k) (Traditional)
- Applicant: Europa Scientific, Ltd.
- Decided: Dec 16, 1997 after 29 days
- Product code: DOP (Mass Spectrometer, Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Consolidated Nier Model 21-201 Isotope Ratio Mass Spectrometer (IRMS): named in the summary without a submission number

## Most influential descendants
- K013371: Ubit-IR300 Infrared Spectrometry System (2001), 3 descendants of its own
- 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
- K992163: Abca Gas Isotope Ratio Mass Spectrometer Systems (1999), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K974322
Methodology: https://510kreport.com/methodology