OPTI® B-Lac Cassette

K200986 · Opti Medical Systems, Inc. · CHL · Aug 2, 2021 · Clinical Chemistry

Device Facts

• Record ID: K200986
• Device Name: OPTI® B-Lac Cassette
• Applicant: Opti Medical Systems, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

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.

Device Story

OPTI B-Lac cassette is a single-use, disposable consumable for OPTI CCA-TS/TS2 analyzers; measures pH, PO2, PCO2, tHb, and SO2 in sodium heparinized venous blood. Device uses fluorescence optodes for pH, PO2, and PCO2; laser-based optical reflectance for tHb and SO2. Analyzer warms cassette to 37°C, performs automated calibration verification, and aspirates sample. System performs automated diagnostic checks (packaging integrity, temperature, bubble detection, dirty optics). Results displayed on graphical touch screen for clinician use in diagnosis/treatment of acid-base disturbances. Cassette discarded after single use. No hardware changes to analyzer; software updated to implement new PCO2 sensor algorithms.

Clinical Evidence

Bench testing only. Studies included 20-day precision (CLSI EP05-A3), within-run precision, method comparison against tonometry/ABL90 Flex (CLSI EP9-A2), interference testing (CLSI EP7-A2), altitude testing (up to 10,151 ft), and stability testing. Results confirmed performance meets claims for pH, PO2, PCO2, tHb, and SO2.

Technological Characteristics

Single-use cassette with optical fluorescence multi-sensor array for pH, PO2, PCO2; laser-based optical reflectance for tHb and SO2. Operates at 37°C. Dry-calibration for pH; gas mixture calibration for PO2/PCO2. Microprocessor-based analyzer with graphical touch screen. Software-driven; no reagents/waste in analyzer.

Indications for Use

Indicated for in vitro measurement of pH, pO₂, pCO₂, total hemoglobin (tHb), and % oxygen saturation (SO₂) in sodium heparinized venous whole blood samples for patients requiring assessment of acid-base status, hemoglobin content, and oxygen capacity in a clinical laboratory setting.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• Instrumentation Laboratory GEM Premier 4000
• Radiometer ABL90 Flex (K092686)
• OPTI CCA TS2 E-Series Cassettes (K131126)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

k200986

B Applicant

OPTI Medical Systems, Inc.

C Proprietary and Established Names

OPTI® B-Lac Cassette

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHL | Class II | 21 CFR 862.1120 - Blood Gases (pCO_{2}, pO_{2}) And Blood pH Test System | CH - Clinical Chemistry |
| GKR | Class II | 21 CFR 864.5620 - Automated hemoglobin system | HE - Hematology |
| GLY | Class II | 21 CFR 864.7500 - Whole blood hemoglobin assays | HE - Hematology |

## II Submission/Device Overview:

A Purpose for Submission:

Modification of the pCO₂ sensor in an existing device (k093280) following a field corrective action for pCO₂.

B Measurand:

pH, pO₂, pCO₂, total hemoglobin (tHb) and oxygen saturation (SO₂).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Type of Test:

Quantitative - using optical fluorescence and reflectance technology.

III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) 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.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

D Special Instrument Requirements:

OPTI CCA-TS/TS2 Analyzers

IV Device/System Characteristics:

A Device Description:

The OPTI® B-Lac cassette is a disposable, single use cassette that contains four sensors for in vitro quantitative measurements of pO₂, pCO₂, pH and Lactate. The cassette includes additional laser-based measurements of total hemoglobin (tHb) and SO₂. The pO₂, pH, tHb, and SO₂ sensors were not modified from the previous clearance (k093280). The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date.

B Principle of Operation:

The OPTI® B-Lac cassette uses fluorescence optodes to measure the intensity of light emitted from fluorescent dyes exposed to specific analytes. The concentration of the analyte is determined by the calculation of the difference in fluorescence measured at a defined calibration point and that measured with the unknown concentration of analyte. The principles of

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measurement of $\mathrm{pO}_2$ , $\mathrm{pCO}_2$ and $\mathrm{pH}$ for the B-Lac cassette are similar to those used with existing cassette styles that are used on the OPTI CCA-TS/TS2 (k984299).

# V Substantial Equivalence Information:

# A Predicate Device Name(s):

ABL90 FLEX Series, OPTI CCA-TS2

# B Predicate 510(k) Number(s):

k092686, k131126

# C Comparison with Predicate(s):

Device Comparison Table: pH, pO2, pCO2 and tHb

| Device & Predicate Device(s): | k200986 | k092686 |
| --- | --- | --- |
| Device Trade Name | OPTI® B-Lac Cassette | ABL90 FLEX |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended to be used for in vitro measurements of pH, pO2, pCO2 and tHb (total hemoglobin) in heparinized venous whole blood samples. | Same |
| Measured Parameter | pH, pO2, pCO2 and tHb (total hemoglobin) | Same |
| Measurement Temperature | 37 °C | Same |
| General Device Characteristic Differences | | |
| Sample Type | Sodium heparin venous blood | Arterial and venous whole blood with heparin anticoagulant |
| Test Environment | Clinical laboratory setting | Laboratory environment, near patient or point-of-care (POC) setting |
| Measurement Principle | pH: fluorescence pO2: fluorescence pCO2: fluorescence tHb: Optical reflectance | pH: electrochemistry pO2: optical pCO2: electrochemistry ctHb: spectrophotometry |

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Device Comparison Table: SO₂

| Device & Predicate Device(s): | k200986 | k092686 |
| --- | --- | --- |
| | measurement. | |
| Reportable Ranges | pH: 6.818 - 7.8
pO₂: 10 - 700 mmHg
pCO₂: 10 - 200 mmHg
mmol/L
tHb: 5.0 – 24 g/L | pH: 6.818 – 7.797
pO₂: 30.1 - 488 mmHg
pCO₂: 15.4 – 98.3 mmHg
tHb: 0.1 – 24 g/dL |
| Sample Volume | 125 μL | 65 – 150 μL |
| Measurement Time | 180 s from sample introduction | 35 s |
| Test Consumable Storage | Refrigerated storage (2 – 8°C) until expiry date including max 28 days at room temperature | Sensor Pack: 2 – 8°C storage until expiry date
Fluid Pack: 2 – 25°C storage until expiry date |
| Device & Predicate Device(s): | k200986 | k131126 |
| --- | --- | --- |
| Device Trade Name | OPTI® B-Lac cassette | OPTI CCA TS2 E-Series Cassettes |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended to be used for in vitro measurements of oxygen saturation (SO₂), in heparinized venous whole blood samples. | Same. |
| Reportable Ranges | SO₂: 60% - 100% | Same |
| Sample Volume | 125 μL | Same |
| Measurement Time | 180 s from sample introduction | Same |
| General Device Characteristic Differences | | |
| Sample type | Whole blood (sodium heparinized, venous) | Whole blood, serum, and plasma (heparinized, venous or arterial) |
| Test Environment | Clinical laboratory setting | Clinical laboratory setting or POC locations |
| Test Consumable Storage | Refrigerated storage (2 – 8°C) until expiry date | Room temperature storage (4 – 30°C) until |

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| Device & Predicate Device(s): | k200986 | k131126 |
| --- | --- | --- |
| | including max 28 days at room temperature. | expiration date |

# VI Standards/Guidance Documents Referenced:

CLSI EP5-A3 - Evaluations of Precision Performance of Quantitative Measurement in Methods; Approved Guideline – Third Edition

CLSI EP6-A – Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

CLSI EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition

CLSI EP17-A2 – Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition

# VII Performance Characteristics (if/when applicable):

## A Analytical Performance:

### 1. Precision/Reproducibility:

In-House Within Run Precision Evaluation:

Within run precision testing was performed using venous whole blood manipulated to three different levels (tonometered for gases, spiked or diluted for tHb) and three levels of aqueous quality control solutions (OPTI Check Level 1, 2 and 3) following the experimental protocol recommended in the CLSI guideline EP05-A3. The samples were run in multiple replicates on three separate lots of B-Lac cassettes. Each lot was run on one OPTI CCA-TS and one OPTI CCA-TS2 analyzer for pH, pCO₂, pO₂, tHb, and SO₂.

The data supported that the performance in venous whole blood in clinical laboratory settings as demonstrated in k093280 for pO₂, pH, tHb, and SO₂ has not changed. A summary of the within-run precision results for one representative lot for pCO₂ is presented in the tables below:

Venous whole blood:

pCO₂

| Sample Description | OPTI CCA TS | | | | OPTI CCA TS2 | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Mean (mm Hg) | N | SD | %CV | Mean (mm Hg) | N | SD | %CV |
| Level 1 | 14.9 | 9 | 0.5 | 3.69 | 16.0 | 9 | 0.9 | 5.74 |
| Level 2 | 38.3 | 10 | 0.7 | 1.77 | 39.5 | 10 | 1.0 | 2.42 |
| Level 3 | 75.6 | 10 | 2.3 | 3.11 | 78.4 | 10 | 2.4 | 3.11 |

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Aqueous controls:

$\mathbf{pCO_2}$

| Sample Description | OPTI CCA TS | | | | OPTI CCA TS2 | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Mean (mm Hg) | N | SD | %CV | Mean (mm Hg) | N | SD | %CV |
| Level 1 | 22.1 | 10 | 1.4 | 6.30 | 22.9 | 10 | 0.9 | 3.93 |
| Level 2 | 40.1 | 8 | 1.0 | 2.40 | 41.4 | 8 | 1.2 | 2.91 |
| Level 3 | 65.7 | 9 | 1.3 | 1.95 | 67.1 | 9 | 1.3 | 1.86 |

In-House Multi-Day Precision Testing:

A 20-Day precision study was performed using three levels of aqueous quality control solutions, following the experimental protocol recommended in the CLSI guideline EP05-A3. Typical within-run, between-day and total precision were determined from four runs per day over 20 days on three lots of B-Lac cassettes. Each lot of cassette was run on one OPTI CCA-TS and one OPTI-CCA-TS2 analyzer. The data supported that the performance in venous whole blood in clinical laboratory settings as demonstrated in k093280 for $\mathsf{pO}_2$ , pH, tHb, and $\mathrm{SO}_2$ has not changed. A summary of the multi-day precision results for one representative lot for $\mathsf{pCO}_2$ is presented in the tables below:

$\mathbf{pCO_2}$

| Sample Description | Mean (mm Hg) | N | Within-Run | | Between Day | | Between-Instrument | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Level 1 | 25.9 | 160 | 1.55 | 6.0 | 0.00 | 0.0 | 0.19 | 0.7 | 1.56 | 6.0 |
| Level 2 | 41.3 | 160 | 0.54 | 1.3 | 0.00 | 0.0 | 0.28 | 0.7 | 0.63 | 1.5 |
| Level 3 | 68.5 | 160 | 2.04 | 3.0 | 0.00 | 0.0 | 0.50 | 0.7 | 2.14 | 3.1 |

2. Linearity:

To evaluate the linearity of the B-Lac $\mathrm{pCO_2}$ , $\mathrm{pO_2}$ , $\mathrm{pH}$ , $\mathrm{tHb}$ and $\mathrm{SO_2}$ , venous whole blood samples from different donors collected in sodium heparin tubes were tonometered with a range of $\% \mathrm{CO_2}$ and $\% \mathrm{O_2}$ gas mixtures to generate samples with $\mathrm{pCO_2}$ , $\mathrm{pO_2}$ , $\mathrm{pH}$ , and $\mathrm{SO_2}$ values spanning the claimed measuring ranges. Venous whole blood was manipulated (centrifuged and spiked with red blood cells or diluted with plasma, then tonometered with $6\%$ $\mathrm{CO_2} / 12\%$ $\mathrm{O_2}$ gas) to obtain tHb values spanning the claimed measuring range. Testing was performed using three different lots of B-Lac cassettes with three replicate measurements being taken for each lot for each sample, on one CCA-TS analyzer and one CCA-TS2 analyzer. The concentrations for $\mathrm{pH}$ and $\mathrm{tHb}$ were assigned using the ABL90 FLEX analyzer. For $\mathrm{pO_2}$ and $\mathrm{pCO_2}$ the concentrations were assigned by tonometry as well as using the ABL90 FLEX analyzer. The $\mathrm{SO_2}$ concentration was assigned using the OPTI CCA TS/TS2 E Series Cassette.

The data supported that the performance in venous whole blood in clinical laboratory settings as demonstrated in k093280 for $\mathrm{pO}_2$ , pH, tHb, and $\mathrm{SO}_2$ has not changed. For the $\mathrm{pCO}_2$ sensor, the results of the linear regression analysis per instrument type are presented in the table below:

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pCO2

| Instrument | Value Assignment | Slope | Intercept | R² |
| --- | --- | --- | --- | --- |
| OPTI CCA-TS | Tonometry | 0.980 | -0.73 | 0.999 |
| | ABL90 FLEX | 1.035 | -3.75 | 0.996 |
| OPTI CCA-TS2 | Tonometry | 0.999 | -2.09 | 0.999 |
| | ABL90 FLEX | 1.030 | -2.70 | 0.999 |

The linearity study results support that the assays are linear across the following claimed reportable ranges:

| Parameter | Reportable Range |
| --- | --- |
| pCO₂ | 10-200 mm Hg |
| pO₂ | 10-700 mm Hg |
| pH | 6.818-7.8 |
| tHb | 5-24 g/dL |
| SO₂ | 60-100% |

## 3. Analytical Specificity/Interference:

The B-Lac cassette was evaluated to determine the potential interference of endogenous and exogenous substances. The study used human venous whole blood samples and was conducted for all the analytes at two concentration levels (see table below). For pH, pCO₂, pO₂, tHb and SO₂, two different analyte levels were generated by tonometering with different gas mixtures. For tHb, the low level sample was generated by dilution with plasma. All the samples were spiked with the potential interferents (test samples) and were measured against the samples that were not spiked (control samples). The sponsor states that interferences were considered to be non-significant if the bias between the test and control samples were as follows:

| Parameter | Maximum allowed difference (analyte level) |
| --- | --- |
| pCO₂ | 2.5 mmHg (83 mm Hg) or 4% (17 mm Hg) |
| pO₂ | 2.5 mmHg (48 mm Hg) or 4% (416 mmHg) |
| pH | 0.02 (7.17 or 7.52) |
| tHb | 0.6 g/dL (<10 g/dL or 12-18 g/dL) |
| SO₂ | 3% (70.9% or 99.9%) |

The table below summarizes the results of the interference testing performed:

| Substance | Highest concentration tested | Interference | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | pH | pCO₂ (mmHg) | pO₂ (mmHg) | tHb (g/dL) | SO₂ (%) |
| Acetaminophen | 1.66 mmol/L | No | No | No | No | No |
| Acetylsalicylic acid | 3.33 mmol/L | N/A | No | No | No | No |

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| Substance | Highest concentration tested | Interference | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | pH | pCO₂ (mmHg) | pO₂ (mmHg) | tHb (g/dL) | SO₂ (%) |
| Ascorbic acid | 0.23 mmol/L | No | No | No | No | No |
| β-hydroxybutyric acid | 16.03 mmol/L | No | No | No | Yes | No |
| Bilirubin | 0.26 mmol/L | No | No | No | No | No |
| Cardiogreen | 0.0065 mmol/L | No | No | No | Yes | Yes |
| Cysteine (hydrochloride hydrate) | 6.41 mmol/L | N/A | No | No | No | No |
| Ethanol | 86.8 mmol/L | No | No | No | No | No |
| Evans Blue | 0.0104 mmol/L | No | No | Yes | Yes | Yes |
| Glycolic acid | 10 mmol/L | N/A | No | No | No | Yes |
| Halothane | 0.759 mmol/L | No | No | No | No | No |
| Ibuprofen | 2.43 mmol/L | N/A | No | No | No | No |
| Intralipid | 1% | No | No | No | Yes | No |
| Methylene Blue | 0.125 mmol/L | No | No | Yes | Yes | Yes |
| Sodium Chloride | 20 mmol/L | No | No | No | Yes | No |
| Glucose | 22.22 mM | N/A | N/A | N/A | N/A | N/A |
| Hydroxyurea | 0.5 mM | N/A | N/A | N/A | N/A | N/A |
| Pyruvic acid | 0.24 mM | N/A | N/A | N/A | N/A | N/A |

The substances that were found to have significant interference are listed in the Operator's manuals. In addition, for pH, the labeling includes the following limitation for fluorescein, which was tested in a separate study not reviewed in this submission:

"At the interferent concentration tested (1.064 mM), the pH will be suppressed. However, for lower concentrations, the pH may show a bias."

4. Assay Reportable Range:

Please see the linearity study above.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Traceability for all analytes was previously described and reviewed in k093280.

Total hemoglobin (tHb) shelf-life stability studies were reviewed and considered acceptable to support the claims previously cleared in k093280.

6. Detection Limit:

Linearity studies were used to support the lower end of the measuring range for pH, pCO₂, pO₂, tHb and SO₂ (see section VII.A.2 above).

7. Assay Cut-Off:

Not applicable.

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# B Comparison Studies:

1. Method Comparison with Predicate Device:

A method comparison study was conducted using native venous whole blood samples collected in sodium heparin blood collection tubes. A small percentage (&lt;10%) manipulated blood samples (tonometered, spiked or diluted) were added to cover the measurement ranges. This method comparison study was carried out using three different lots of B-Lac cassettes on both OPTI CCA-TS and OPTI CCA-TS2 instruments. Each blood sample was tested in singlicate across three CCA-TS and three CCA-TS2 analyzers with one cassette lot per analyzer. Each sample was also tested on predicate instruments with the ABL90 FLEX used for pH, pCO₂, pO₂ and tHb and OPTI CCA E-series cassettes for SO₂.

The results on the OPTI CCA-TS and OPTI CCA-TS2 instrument types were analyzed separately. The data supported that the performance in venous whole blood in clinical laboratory settings as demonstrated in k093280 for pO₂, pH, tHb and SO₂ has not changed. The linear regression analysis for the first sample measurement for pCO₂ is presented in the tables below:

B-Lac/OPTI CCA-TS Test System

| Parameter | Comparator method | Slope | Intercept | R² |
| --- | --- | --- | --- | --- |
| pCO₂ | ABL90 Flex | 0.950 | 1.316 | 0.978 |

B-Lac/OPTI CCA-TS2 Test System

| Parameter | Comparator method | Slope | Intercept | R² |
| --- | --- | --- | --- | --- |
| pCO₂ | ABL90 Flex | 1.003 | -0.122 | 0.999 |

2. Matrix Comparison:

Not applicable. For use with sodium heparinized venous whole blood samples only.

C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable.

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D Clinical Cut-Off:

Not applicable.

E Expected Values/Reference Range:

The following reference ranges were included in the labeling. The sponsor also noted that each facility should establish its own reference ranges.

| Parameter | Units | Range | Reference Source |
| --- | --- | --- | --- |
| pCO_{2} | mmHg | 30.0-50.0 | Tietz^{1} |
| pO_{2} | mmHg | 70.0-700.0 | Tietz^{1} |
| pH | pH units | 7.35-7.45 | Tietz^{1} |
| tHb | g/dL | 12.0-17.0 | Tietz^{1} |
| SO_{2} | % | 95.0-98.0 | Henry^{2} |

1 Tietz; Burtis C, et al (Eds.), Textbook of Clinical Chemistry and Molecular Diagnostics, 4th Ed., (Elsevier Saunders, 2006).
2 J. B. Henry, Clinical Diagnosis and Management by Laboratory Methods, 19th Ed., 1996.

F Other Supportive Instrument Performance Characteristics Data:

1. Method Comparison at Altitude:

A method comparison at altitude study was conducted to evaluate the performance of the B-Lac cassette pCO₂, pO₂ and pH sensors and measured tHb and SO₂ parameters against the ABL90 FLEX Analyzer at a range of altitudes. Both contrived venous whole blood samples and aqueous control materials were used in the study and testing was conducted at two clinical sites (1080 feet and 10151 feet altitude) for venous whole blood samples and at four clinical sites (ranging from 75 feet – 10551 altitude) for aqueous control samples. The results of the study supported the performance of the B-Lac cassette for all parameters up to 10151 feet altitude.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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