# K052027: Opti Lion Electrolyte Analyzer, Model GD7200

- Pathway: 510(k) (Traditional)
- Applicant: Osmetech, Inc.
- Decided: Sep 29, 2005 after 64 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861087 (1986). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974784: Avl Opti Critical Care Analyzer, Avl Scientific Corp. (1998) Summary page 1.
- K984299: Avl Opti Critical Care Analyzer, Avl Scientific Corp. (1998) Summary page 1.
- K852473: Ion-Specific Electrode Option for Cobas Fara, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K945915: Avl Omni Analyzer, Avl Scientific Corp. (1995) Summary page 1.
- K990092: Avl Omni Modular Analyzer, Avl Scientific Corp. (1999) Summary page 1.
- K895317: Avl Model 995HB PH/Blood Gas Analyzer, Avl Scientific Corp. (1990) Summary page 1.
- K972673: Avl 9181 Electrolyte Analyzer, Avl Scientific Corp. (1997). Our reading of the summary gave K972763, FDA’s number for Hemaprompt (Aerscher Diagnostics). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AVL 9180”.
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Recalls of this device
- Aug 9, 2013 · Class II · Z-0029-2014: OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a d
- Mar 15, 2011 · Not classified · Z-2558-2011: The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
- Apr 20, 2009 · Not classified · Z-1083-2010: Outer box labeling shows an incorrect storage temperature range.
- Jul 18, 2007 · Not classified · Z-0119-2008: Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequ

## Indications for use
The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma as appropriate in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

Source page: https://510kreport.com/device/K052027
Methodology: https://510kreport.com/methodology