510(k) · Cleared
Recalled · Class II · 2012Opti Cca-TS, B-Lac Cassette Model BP7561
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opti Medical Systems, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jan 7, 2011 as substantially equivalent to K061974 (Instrumentation Laboratory CO, 2006) after a 444-day review. Its family tree reaches back 6 generations to 1980. It has been recalled once.
- Decided
- Jan 7, 2011
- Review
- 444 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801848 (1980). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 5 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 4 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 3 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 2 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 1 generation backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- This deviceK093280 Opti Cca-TS, B-Lac Cassette Model BP7561Opti Medical Systems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −5 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −4 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −3 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −2 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −1 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| 0 (this device) | K093280 | Opti Cca-TS, B-Lac Cassette Model BP7561 | Opti Medical Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4…Summary page 2…zers and 'Point of Care' analyzers. Specifically, the sensors in the 8-Lac cassette are shown to be equivalent to the Instrument Laboratory Co. GEM Premier 4000 [K061974] for the measurement of blood gases and ph, total hemoglobin, oxygen saturation, and lactic acid. Non-clinical studies were… | 2006 |
| † | K993837 | Avl Opti Critical Care Analyzer | 1999 |
| † | K984299 | Avl Opti Critical Care Analyzer | 1998 |
| † | K974784 | Avl Opti Critical Care Analyzer | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2012 | Class II | Z-2440-2012 | Process design | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K061974.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
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.…
Read the full statement (123 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093280: Opti Cca-TS, B-Lac Cassette Model BP7561.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026