# K992163: Abca Gas Isotope Ratio Mass Spectrometer Systems

- Pathway: 510(k) (Special)
- Applicant: Pdz-Europa, Ltd.
- Decided: Jul 13, 1999 after 18 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
Longest line of descent: 1 generation back to K974322 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The ABCA 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/K992163
Methodology: https://510kreport.com/methodology