# K142220: Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Oct 17, 2014 after 66 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061830 (2006). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131703: Nova Stat Profile Prime CCS Analyzer System, Nova Biomedical Corporation (2014) Summary page 4.

## Most influential descendants
- K151982: Stat Profile Prime ABG Analyzer System (2015), 0 descendants of its own

## Recalls of this device
- Jun 19, 2017 · Class II · Z-2732-2017: Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.

## Indications for use
The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood. PCO2, PO2, pH: Whole blood measurement of blood gases is used in the diagnosis and treatment of life threatening acid-base disturbances. Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer. Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer. Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO2, and PO2, using the Stat Profile Prime ABG Analyzer.

Source page: https://510kreport.com/device/K142220
Methodology: https://510kreport.com/methodology