# K200492: i-STAT CG4+ Cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Apr 9, 2020 after 41 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861087 (1986). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093297: Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube, Epocal, Inc. (2010) Summary page 5.
- K041874: ABL800 Flex, Radiometer Medical Aps (2004) Summary page 5.

## Indications for use
The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point of care or clinical laboratory settings. pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances. Lactate measurements are used in (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

Source page: https://510kreport.com/device/K200492
Methodology: https://510kreport.com/methodology