# K200986: OPTI® B-Lac Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Opti Medical Systems, Inc.
- Decided: Aug 2, 2021 after 474 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: 7 generations back to K861087 (1986). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092686: ABL90 Flex Series, Radiometer Medical Aps (2010) Summary page 7.
- K131126: Opti Cca-TS2, Opti Medical Systems, Inc. (2013) Summary page 5.
- (no number) Instrumentation Laboratory GEM Premier 4000: named in the summary without a submission number

## Indications for use
The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, PCO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location. » Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. » Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood. * Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.

Source page: https://510kreport.com/device/K200986
Methodology: https://510kreport.com/methodology