# K093280: Opti Cca-TS, B-Lac Cassette Model BP7561

- Pathway: 510(k) (Traditional)
- Applicant: Opti Medical Systems, Inc.
- Decided: Jan 7, 2011 after 444 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: 6 generations back to K801848 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061974: Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit, Instrumentation Laboratory CO (2006) Summary page 2.

## Recalls of this device
- Jul 3, 2012 · Class II · Z-2440-2012: The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).

## Indications for use
The OPTI CCA-TS B-Lac cassette is intended to be used for in vitro measurements of pH, PCO 2, P02, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (502) in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point-of-care locations. Measurements of blood gases (PCO 2, P02) and blood PH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Total hemoglobin measurement is used to determine the hemoglobin content of human blood. Oxygen saturation measurement is used to determine the oxygen capacity of the hemoglobin.

Source page: https://510kreport.com/device/K093280
Methodology: https://510kreport.com/methodology