# K972733: Avl Omni Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Sep 9, 1997 after 50 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946206 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954612: Abl System 625, 615, 605, Radiometer America, Inc. (1995) Summary page 1.
- K960120: Stat Profile Ultra F,G,H,I,J, and K Analyzers, Nova Biomedical Corp. (1996) Summary page 1.
- K946206: Ciba Corning 8-- Series CO-Oximeter, Ciba Corning Diagnostics Corp. (1995) Summary page 1.
- K955793: IL Bgge Blood Gas with Glucose System, Instrumentation Laboratory CO (1996) Summary page 1.

## Recalls of this device
- Dec 29, 2003 · Not classified · Z-0336-04: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Dec 29, 2003 · Not classified · Z-0335-04: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Dec 29, 2003 · Not classified · Z-0337-04: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Dec 15, 2003 · Not classified · Z-0326-04: If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
- Dec 15, 2003 · Not classified · Z-0328-04: If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
- Dec 15, 2003 · Not classified · Z-0327-04: If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

## Indications for use
The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO₂, PO₂, ctHb, HHb, O₂Hb, COHb, MetHb, SulfHb, Na⁺, K⁺, Cl, ionized Ca™, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

Source page: https://510kreport.com/device/K972733
Methodology: https://510kreport.com/methodology