OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561— 510(k) K093280

Clearance details

Applicant

Opti Medical Systems, Inc.

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2009-10-20

Decision date

2011-01-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roswell, GA, US

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Death

20

Malfunction

999

Total

1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2440-2012 — BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), 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. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.Class II·Terminated·OPTI Medical Systems, Inc·20120703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093280.