(122 days)
The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors is intended to be used for the measurement of pH, pCO2, pO2, Na *, K , Ca , Cl , Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na , K , C * , Cl , Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations.
Measurements of blood gases (PCO2, PO2) 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 {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.
Potassium (K ) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (Ca) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst),adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Chloride (Cl`) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Urea nitrogen (an end-product of nitrogen metabolism) measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The OPTI® CCA-TS2 is a modified model of the legally marketed OPTI® CCA-TS analyzer system. The OPTI® CCA-TS2 analyzer system uses the same technology and operating principles to perform the same intended uses as the OPTI® CCA-TS cleared with K993837. Optical fluorescence and reflectance technology is used to perform the parameter measurements outlined in the intended use. The technology is the same as that employed in previous models of OPTI products.
The OPTI® CCA-TS2 analyzer is sold separately from disposable cassettes containing sensors that interact with an in-vitro blood or plasma/serum sample aspirated into the cassette by the analyzer system. The disposable cassettes are designed and manufactured by OPTI Medical Systems, Inc. for exclusive use with OPTI Analyzers. The parameters reported by the analyzer system are determined by the sensors contained within each cassette style. Various styles of cassettes are available to report up to six combinations of blood gases, electrolytes and metabolites for each sample aspirated into the cassette. Each cassette style is bar-coded with calibration information determined for each lot of cassettes prior to release.
The OPTI® CCA-TS2 is a critical care analyzer designed to measure various blood gas, electrolyte, and metabolite parameters. The submission aims to demonstrate that the OPTI® CCA-TS2 is substantially equivalent to its predicate device, the OPTI® CCA-TS ([K993837](https://510k.innolitics.com/search/K993837)), despite hardware and software updates. The core of the device's functionality, specifically the cassettes and their sensors, remains unchanged.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OPTI® CCA-TS2 are based on demonstrating functional equivalence and performance comparability to the predicate device, OPTI® CCA-TS ([K993837](https://510k.innolitics.com/search/K993837)). This is primarily assessed through:
- Method Comparison: Statistical correlation (Slope, Intercept, Correlation Coefficient R²) between the
OPTI® CCA-TS2and theOPTI® CCA-TSfor all measured parameters across their intended ranges. The expectation is that theOPTI® CCA-TS2should produce results that are highly correlated and show minimal systematic bias (slope close to 1, intercept close to 0) when compared to the predicate. - Precision/Reproducibility: Evaluation of within-run, between-run, and between-day precision (Standard Deviation and %CV) using quality control solutions and spiked whole blood samples, in accordance with CLSI guideline EP5-A2. The device's precision should be within acceptable limits for a clinical laboratory setting.
- Linearity/Reportable Range: Demonstrating that the
OPTI® CCA-TS2provides accurate measurements across the claimed reportable ranges, with linearity assessed by comparing results to the predicate device using linearity solutions and whole blood samples. The correlation (R²) should indicate strong linearity. - Safety and EMC: Compliance with applicable electrical safety (IEC 61010-1, IEC 62133 Ed. 2.0 b:2012) and electromagnetic compatibility (IEC 61326-2-6) standards.
- Software Verification and Validation: Ensuring that software changes did not adversely impact measurement performance.
Here's a summary of the reported device performance, focusing on method comparison and linearity, as these directly address the equivalence to the predicate:
| Parameter | Sample Type | Range (Predicate) | Slope (95% Confidence) | Intercept | Correlation Coefficient (R²) | Acceptance Status |
|---|---|---|---|---|---|---|
| Method Comparison (OPTI CCA-TS2 vs. Predicate) | ||||||
| pH | Whole Blood | 6.927 to 7.705 pH units | 0.97 (0.97 to 0.98) | 0.18 | 0.998 | Met |
| pH (dry sensor) | Whole Blood | 6.961 to 7.648 pH units | 1.00 (0.98 to 1.01) | 0.04 | 0.996 | Met |
| Na+ | Whole Blood | 109.0 to 179.4 mmol/L | 0.99 (0.98 to 0.99) | 1.57 | 0.999 | Met |
| K+ | Whole Blood | 0.9 to 8.1 mmol/L | 1.01 (1.00 to 1.01) | -0.01 | 0.999 | Met |
| Ca++ | Whole Blood | 0.28 to 2.21 mmol/L | 1.00 (0.99 to 1.01) | 0.00 | 0.999 | Met |
| Cl- | Whole Blood | 64.4 to 145.7 mmol/L | 0.98 (0.97 to 0.99) | 0.87 | 0.999 | Met |
| Glucose | Whole Blood | 69.4 to 361.3 mg/dL | 0.99 (0.95 to 1.02) | -0.44 | 0.983 | Met |
| BUN (urea) | Whole Blood | 5.5 to 103.2 mg/dL | 1.01 (1.00 to 1.02) | -0.20 | 0.999 | Met |
| pCO2 | Whole Blood | 14.3 to 198.9 mmHg | 0.97 (0.97 to 0.98) | 0.87 | 0.999 | Met |
| pCO2 (dry) | Whole Blood | 14.7 to 87.9 mmHg | 1.00 (0.99 to 1.02) | -1.13 | 0.995 | Met |
| pO2 | Whole Blood | 13.5 to 639.3 mmHg | 0.98 (0.98 to 0.98) | -1.82 | 0.999 | Met |
| pO2 (dry) | Whole Blood | 10.7 to 656.6 mmHg | 0.99 (0.99 to 1.00) | 0.36 | 0.999 | Met |
| Lactate | Whole Blood | 0.7 to 13.8 mmol/L | 1.01 (0.99 to 1.03) | 0.08 | 0.994 | Met |
| tHb | Whole Blood | 7.7 to 21.2 g/dL | 1.01 (0.99 to 1.03) | -0.09 | 0.996 | Met |
| SO2 | Whole Blood | 71.5 to 99.9 % | 1.03 (1.01 to 1.06) | -3.54 | 0.992 | Met |
| Method Comparison (Plasma/Serum - OPTI CCA-TS2 vs. Predicate) | ||||||
| pH | Plasma/Serum | 6.814 to 7.741 pH units | 0.97 (0.97 to 0.98) | 0.21 | 0.999 | Met |
| Na+ | Plasma/Serum | 104.1 to 176.7 mmol/L | 0.98 (0.98 to 0.99) | 1.91 | 0.998 | Met |
| K+ | Plasma/Serum | 1.60 to 7.45 mmol/L | 0.99 (0.99 to 1.00) | 0.02 | 0.999 | Met |
| Ca++ | Plasma/Serum | 0.39 to 2.75 mmol/L | 0.98 (0.98 to 0.99) | 0.02 | 0.999 | Met |
| Cl- | Plasma/Serum | 64.7 to 146.1 mmol/L | 0.97 (0.96 to 0.97) | 2.50 | 0.999 | Met |
| BUN (urea) | Plasma/Serum | 5.4 to 92.9 mg/dL | 1.03 (1.01 to 1.05) | -0.53 | 0. | Met |
| Glucose | Plasma/Serum | 35.9 to 288.6 mg/dL | 1.00 (0.98 to 1.01) | -2.32 | 0.997 | Met |
| Linearity (OPTI CCA-TS2 vs. Predicate) | ||||||
| pH (60μL sample) | Whole Blood | 6.391 to 8.044 pH units | 0.97 (0.96 to 0.97) | 0.26 | 0.999 | Met |
| pH (120 μL) | Whole Blood | 6.404 to 8.011 pH units | 0.98 (0.97 to 0.98) | 0.16 | 1.000 | Met |
| pH (dry sensor) | Whole Blood | 6.477 to 7.915 pH units | 0.99 (0.98 to 1.00) | 0.09 | 0.998 | Met |
| PCO2 (60μL sample) | Whole Blood | 6.2 to 256.6 mmHg | 0.98 (0.98 to 0.99) | 0.65 | 1.000 | Met |
| PCO2 (120μL) | Whole Blood | 7.4 to 205.7 mmHg | 0.98 (0.98 to 0.99) | 0.45 | 1.000 | Met |
| PCO2 (dry) | Whole Blood | 2.2 to 207.9 mmHg | 1.01 (1.00 to 1.02) | -1.19 | 0.999 | Met |
| PO2 (60μL sample) | Whole Blood | 6.8 to 711.2 mmHg | 0.99 (0.99 to 1.00) | -3.10 | 0.999 | Met |
| PO2 (120μL) | Whole Blood | 8.9 to 707.0 mmHg | 0.99 (0.98 to 0.99) | -2.57 | 1.000 | Met |
| PO2 (dry) | Whole Blood | 9.1 to 656.6 mmHg | 0.99 (0.99 to 1.00) | 0.43 | 0.999 | Met |
| Sodium (Na+) | Whole Blood | 93.4 to 204.4 mmHg | 1.00 (0.99 to 1.01) | -0.18 | 1.000 | Met |
| Potassium (K+) | Whole Blood | 0.39 to 10.09 mmol/L | 1.00 (1.00 to 1.01) | 0.00 | 1.000 | Met |
| Calcium (Ca++) | Whole Blood | 0.158 to 3.372 mmol/L | 0.99 (0.99 to 0.99) | 0.01 | 1.000 | Met |
| Chloride (Cl-) | Whole Blood | 42.9 to 175.0 mmol/L | 0.99 (0.98 to 1.00) | -0.21 | 0.999 | Met |
| Glucose | Whole Blood | 12.5 to 455.6 mg/dL | 1.02 (1.00 to 1.05) | -4.19 | 0.991 | Met |
| BUN (urea) | Whole Blood | 2.63 to 142.93 mg/dL | 1.00 (0.99 to 1.01) | 0.08 | 0.999 | Met |
| Lactate | Whole Blood | 0.17 to 17.81 mmol/L | 1.04 (1.02 to 1.06) | -0.02 | 0.996 | Met |
| tHb | Whole Blood | 4.37 to 26.13 g/dL | 0.99 (0.98 to 1.01) | 0.10 | 0.998 | Met |
| SO2 | Whole Blood | 55.5 to 99.9 % | 0.96 (0.94 to 0.98) | 3.23 | 0.991 | Met |
| Linearity (CVC123 - OPTI CCA-TS2 vs. Predicate) | ||||||
| pH (60μL sample) | CVC123 | 6.915 to 7.638 pH units | 0.98 (0.98 to 0.99) | 0.14 | 1.000 | Met |
| pH (120 μL) | CVC123 | 6.912 to 7.646 pH units | 0.96 (0.96 to 0.97) | 0.26 | 0.999 | Met |
| pH (dry sensor) | CVC123 | 6.971 to 7.631 pH units | 0.98 (0.97 to 0.99) | 0.16 | 0.999 | Met |
| PCO2 (60μL sample) | CVC123 | 13.9 to 85.8 mmHg | 0.98 (0.97 to 0.99) | 0.35 | 1.000 | Met |
| PCO2 (120μL) | CVC123 | 13.3 to 90.5 mmHg | 0.98 (0.98 to 0.99) | 0.88 | 0.999 | Met |
| PCO2 (dry) | CVC123 | 15.9 to 87.8 mmHg | 0.99 (0.98 to 1.00) | -0.04 | 1.000 | Met |
| PO2 (60μL sample) | CVC123 | 62.7 to 451.0 mmHg | 0.97 (0.97 to 0.98) | 0.29 | 0.999 | Met |
| PO2 (120μL) | CVC123 | 60.9 to 487.1 mmHg | 0.98 (0.97 to 0.99) | 0.90 | 0.999 | Met |
| PO2 (dry) | CVC123 | 60.8 to 476.3 mmHg | 0.98 (0.97 to 0.99) | 2.55 | 1.000 | Met |
| Sodium (Na+) | CVC123 | 116.2 to 163.8 mmol/L | 1.01 (0.99 to 1.02) | -0.68 | 0.998 | Met |
| Potassium (K+) | CVC123 | 1.19 to 6.98 mmol/L | 0.99 (0.99 to 1.00) | 0.10 | 1.000 | Met |
| Calcium (Ca++) | CVC123 | 0.20 to 2.67 mmol/L | 1.01 (1.00 to 1.02) | -0.00 | 0.999 | Met |
| Chloride (Cl-) | CVC123 | 85.9 to 135.0 mmol/L | 0.96 (0.94 to 0.98) | 2.93 | 0.998 | Met |
| Glucose | CVC123 | 81.8 to 303.6 mg/dL | 0.98 (0.94 to 1.03) | 1.87 | 0.993 | Met |
| Lactate | CVC123 | 0.77 to 15.3 mmol/L | 1.03 (1.00 to 1.06) | -0.14 | 0.995 | Met |
Precision Results for OPTI CCA-TS2 (using quality control solutions and whole blood)
The precision data (Standard Deviation and %CV) are presented in extensive tables within the document for all parameters across various levels of controls and whole blood. These values generally show low variability, indicating good precision. For example, Total %CV for most parameters in quality control solutions and whole blood samples are well below 5-10%, which is typically considered acceptable for clinical chemistry analytes.
Key Findings: The study concludes that the method comparison, linearity, and precision data demonstrate that the OPTI® CCA-TS2 device is safe, effective, and substantially equivalent to the OPTI® CCA-TS predicate device. The correlation coefficients (R²) are consistently high (>0.98 for most parameters, often >0.99), and slopes are close to 1 with intercepts close to 0, indicating excellent agreement between the new device and the predicate.
2. Sample Sizes Used for the Test Set and Data Provenance
The sample sizes for the test set vary by parameter and type of study (method comparison vs. linearity).
-
Method Comparison:
- Whole Blood Samples: Number of samples (n) ranges from 45 to 144 for individual parameters (e.g., Lactate: n=45, pO2: n=144). These were measured across three
OPTI CCA-TS2analyzers and threeOPTI CCA-TSanalyzers. - Plasma/Serum Samples: Number of samples (n) ranges from 45 to 108 for individual parameters (e.g., Cl-: n=45, pH: n=108).
- Point-of-Care (POC) Sites: Method comparison studies in whole blood samples were repeated at 4 different POC sites. The exact number of samples tested at each POC site is not specified beyond indicating they were "very similar to the results obtained at the internal site."
- Whole Blood Samples: Number of samples (n) ranges from 45 to 144 for individual parameters (e.g., Lactate: n=45, pO2: n=144). These were measured across three
-
Precision/Reproducibility:
- Quality Control Solutions (OPTI Check): Testing was performed over "at least 10 days, 4 runs per day, with a minimum of 2 OPTI CCA-TS2 analyzers." This translates to a minimum of 80 measurements per level per parameter (10 days * 4 runs/day * 2 analyzers). Since three levels were tested for each parameter, this would be
80 * 3 = 240minimum measurements per parameter. (Individual table 'Days run' states 20 per day but this usually means 20 individual runs across all analyzers over 10 days not 20 days per day, so it will be 20 * 4 * 2 = 160 per level.) - Whole Blood Samples (Within-Run Precision): 10 repeats at each of three levels of spiked or diluted whole blood, on one
OPTI CCA-TS2analyzer. This means 30 measurements per parameter (10 repeats * 3 levels).
- Quality Control Solutions (OPTI Check): Testing was performed over "at least 10 days, 4 runs per day, with a minimum of 2 OPTI CCA-TS2 analyzers." This translates to a minimum of 80 measurements per level per parameter (10 days * 4 runs/day * 2 analyzers). Since three levels were tested for each parameter, this would be
-
Linearity/Reportable Range:
- Whole Blood and CVC123 (Aqueous Linearity Solutions):
- Whole Blood Samples: Number of samples (n) ranges from 55 to 90 for individual parameters (e.g., Lactate: n=55, PO2: n=90).
- CVC123 Solutions: Number of samples (n) ranges from 18 to 60 for individual parameters (e.g., Glucose: n=18, PCO2/PO2 120μL: n=60).
- These were run on "two (2)
OPTI CCA-TSand two (2)OPTI CCA-TS2analyzers."
- Whole Blood and CVC123 (Aqueous Linearity Solutions):
Data Provenance: The studies were conducted in-house at OPTI Medical Systems, Inc. for method comparison, precision, and linearity. Additionally, method comparison studies were performed at 4 different Point-of-Care (POC) sites. The data are prospective, as they were collected specifically for this submission to evaluate the performance of the new OPTI® CCA-TS2 device against its predicate. No specific country of origin is mentioned for the patient samples, but the internal site is implied to be in the USA (given the applicant's address and submission to FDA).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This submission does not involve human interpretation of medical images or data where "experts" would establish ground truth in the typical sense (e.g., radiologists, pathologists). Instead, this is a medical device for in-vitro diagnostic (IVD) measurement of blood parameters.
The "ground truth" here is established by:
- The predicate device's measurements: The
OPTI® CCA-TSdevice, which is already legally marketed and cleared (K993837), serves as the reference for method comparison studies. Its measurements are assumed to be the established "truth" against which the new device's performance is gauged for substantial equivalence. - Reference materials/standards: For traceability, the document states that parameters are calibrated and tested using "primary and secondary standards that are traceable to NIST or other recognized standards" (e.g., NIST traceable phosphate buffer for pH, NIST SRM 956A for Na, K, Ca, Cl, NIST SRM 965 for Glucose, NIST SRM 909 for BUN). These national/international metrological standards represent the highest level of ground truth for analytical measurements.
- Aqueous quality control solutions (OPTI Check, CVC123): These commercially prepared and validated solutions have known target values for the analytes and are used to assess precision and linearity.
Therefore, there were no "experts" in the context of human readers providing annotations for machine learning. The ground truth relies on established analytical methods and certified reference materials.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD device measuring physiological parameters, there is no "adjudication method" in the sense of resolving discrepancies between multiple human reviewers or between human reviewers and an AI output. The comparison is directly between the new device's readings and the predicate device's readings or values from certified reference materials. Discrepancies would be analyzed statistically (e.g., regression analysis, bias plots) rather than resolved through an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CADe (Computer-Aided Detection/Diagnosis) devices where human readers interpret medical images or data, and the AI's assistance is evaluated for its impact on reader performance.
The OPTI® CCA-TS2 is an in-vitro diagnostic instrument for direct measurement of analytes. Its performance is evaluated against a predicate device and known standards, not in terms of how it assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the primary studies in this submission are standalone performance evaluations of the OPTI® CCA-TS2 device. The device is intended to provide direct, quantitative measurements.
The "standalone" performance is demonstrated through:
- Method comparison studies: Directly comparing the
OPTI® CCA-TS2measurements to those of theOPTI® CCA-TSpredicate device, without any human intervention influencing the measurement results themselves. - Precision/Reproducibility studies: Assessing the device's inherent variability.
- Linearity studies: Verifying the device's accuracy across its measurement range.
The "algorithms" referred to in the document relate to the internal computational methods the device uses to calculate parameter values from sensor signals. The important point mentioned is that "No changes were made to the algorithms used to calculate parameter values" from the predicate device, implying that the core measurement logic is identical.
7. The Type of Ground Truth Used
The ground truth used for validating the OPTI® CCA-TS2 device's performance is primarily:
- Predicate Device Measurements: The
OPTI® CCA-TSanalyzer (K993837) serves as the comparator, with its measurements representing the established "truth" for demonstrating substantial equivalence. - Certified Reference Materials/Standards: For traceability and fundamental accuracy checks, the device's parameters are linked to NIST (National Institute of Standards and Technology) traceable standards or other recognized standards (e.g., NIST traceable phosphate buffer for pH, NIST SRM 956A for various electrolytes).
- Aqueous Quality Control Solutions with known values (OPTI Check, CVC123): These materials provide stable and characterized analyte concentrations for precision and linearity testing.
- Spiked or Diluted Whole Blood Samples: For precision and linearity, whole blood samples were prepared to achieve specific analyte levels across the measurement range.
There is no "expert consensus," "pathology," or "outcomes data" ground truth as typically understood in fields like imaging or disease diagnosis. The ground truth is analytical and metrological.
8. The Sample Size for the Training Set
This submission does not mention a "training set" in the context of machine learning (AI). The OPTI® CCA-TS2 device is an analytical instrument with established measurement principles (optical fluorescence and reflectance technology) and algorithms that were already developed and cleared for the predicate device. The changes were primarily hardware and software architecture updates to prevent obsolescence and improve manufacturing.
The "algorithms used to calculate parameter values" for OPTI® CCA-TS were developed earlier, and no changes to these algorithms were made for OPTI® CCA-TS2. Thus, there isn't a new AI model being "trained" for this specific submission. The data presented here are for performance verification of the updated device, not for training a new algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for a newly developed AI algorithm relevant to this 510(k) submission. The established algorithms and measurement principles stem from the predicate device, which would have undergone its own validation based on established analytical chemistry and medical device standards. The current submission focuses on demonstrating equivalence of the updated hardware/software with the pre-existing, validated measurement algorithms and sensor technology.
{0}------------------------------------------------
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
-
- 510(k) Number K131126
i
- 510(k) Number K131126
ਪਤ
く
-
- Applicant: OPTI Medical Systems, Inc.
-
- Contact: Len Owens, VP Quality and Regulatory Affairs OPTI Medical Systems, Inc. 235 Hembree Park Drive, Roswell, GA 30076 Office: (770) 688-1658; Fax: (770) 510-4445 Email:len.owens@optimedical.com
-
- Date prepared: June 14, 2013
-
- Proprietary and Established Names OPTI® CCA-TS2
6. Regulatory Information
| Product Code Name | Regulation | Product Code | Class | Classification Panel |
|---|---|---|---|---|
| ACID, LACTIC, ENZYMATIC METHOD | 862.1450 | KHP | I | CHEMISTRY (75) |
| ELECTRODE MEASUREMENT, BLOOD GASES(PCO₂, PO₂) AND BLOOD PH | 862.1120 | CHL | II | CHEMISTRY (75) |
| SYSTEM, HEMOGLOBIN, AUTOMATED | 864.5620 | GKR | II | HEMATOLOGY (81) |
| OXIMETER, WHOLE BLOOD | 864.7500 | GLY | II | HEMATOLOGY (81) |
| ELECTRODE, ION SPECIFIC, POTASSIUM | 862.1600 | CEM | II | CHEMISTRY (75) |
| ELECTRODE, ION SPECIFIC, CALCIUM | 862.1145 | JFP | II | CHEMISTRY (75) |
| ELECTRODE, ION SPECIFIC, SODIUM | 862.1665 | JGS | II | CHEMISTRY (75) |
| ELECTRODE, ION SPECIFIC, CHLORIDE | 862.1170 | CGZ | II | CHEMISTRY (75) |
| ELECTRODE, ION SPECIFIC, UREA NITROGEN | 862.1770 | CDS | II | CHEMISTRY (75) |
| GLUCOSE OXIDASE, GLUCOSE | 862.1345 | CGA | II | CHEMISTRY (75) |
7. Purpose of Submission
OPTI Medical has designed and tested a new model (OPTI® CCA-TS2) of the OPTI® Critical Care Analyzer (OPTI® CCA-TS) previously cleared.for use with K993837 for the IVD measurement of pH, pCO2, pO2, Na , K , Ca* , Clucose, BUN (urea), tHb and SO2 and cleared for use with K093280 for lactate when used with OPTI cassettes containing the blood sample and sensors designed to interact with the analyzer to measure the parameters. Changes were made to the analyzer only in order to update the electronic hardware to prevent obsolescence as electronics evolve, to modify the software to operate the analyzer with modified hardware, and change the software architecture to accommodate the hardware changes and provide for modular programming in the future. No changes were made to the algorithms used to calculate parameter values. Other modifications were made to the analyzer as outlined in the table below to update the look of the new model and improve manufacturing and shipping efficiencies.
OPTI Medical conducted studies to ensure that the OPTI® CCA-TS2 model analyzer reports equivalent results when used with the same cassettes as the OPTI® CCA-TS model analyzer predicate. The
AUG 2 2 2013
1
{1}------------------------------------------------
performance tests completed are summarized here. Please note that since cassettes and the sensors used in the cassettes are unchanged from the cleared analyzer, testing specific to the cassette and the sensor chemistry such as interference studies and limit of detection studies were not repeated in this submission.
8. Predicate Device
OPTI® CCA-TS Critical Care Analyzer (K993837).
9. Device Description
The OPTI® CCA-TS2 is a modified model of the legally marketed OPTI® CCA-TS analyzer system. The OPTI® CCA-TS2 analyzer system uses the same technology and operating principles to perform the same intended uses as the OPTI® CCA-TS cleared with K993837. Optical fluorescence and reflectance technology is used to perform the parameter measurements outlined in the intended use. The technology is the same as that employed in previous models of OPTI products.
The OPTI® CCA-TS2 analyzer is sold separately from disposable cassettes containing sensors that interact with an in-vitro blood or plasma/serum sample aspirated into the cassette by the analyzer system. The disposable cassettes are designed and manufactured by OPTI Medical Systems, Inc. for exclusive use with OPTI Analyzers. The parameters reported by the analyzer system are determined by the sensors contained within each cassette style. Various styles of cassettes are available to report up to six combinations of blood gases, electrolytes and metabolites for each sample aspirated into the cassette. Each cassette style is bar-coded with calibration information determined for each lot of cassettes prior to release.
10. Intended Use
The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors is intended to be used for the measurement of pH, pCO2, pO2, Na *, K , Ca **, Cl , Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na *, K , Ca * , Cl , Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations.
- . Measurements of blood gases (PCO2, PO2) 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 (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.
- Potassium (K') measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
- . Calcium (Ca*) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
- . Sodium (Na*) measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
- Chloride (Cl ) measurements are used in the diagnosis and treatment of electrolyte and .
{2}------------------------------------------------
metabolic disorders such as cystic fibrosis and diabetic acidosis.
- Urea nitrogen (an end-product of nitrogen metabolism) measurements are used in the . diagnosis and treatment of certain renal and metabolic diseases.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate . metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
11. Indications for Use
Same as Intended Use above.
12. Substantial Equivalence Information
Both the OPTI CCA-TS2 system and the predicate OPTI CCA-TS system use identical disposable cassettes containing electrolyte sensors to measure and report in-vitro results. The CCA-TS2 model is designed to use the same technology as that employed in the CCA-TS model with updated electronics and other changes to reduce manufacturing costs and add features desired by end users.
A comparison of the similarities and differences between the devices in provided in the following tables:
| Feature | Candidate:OPTI CCA-TS2 Analyzer | Predicate:OPTI CCA-TS Analyzer (K993837) |
|---|---|---|
| Intended use | The OPTI® CCA-TS2 system when used withdisposable cassettes containing parameterspecific sensors is intended to be used for themeasurement of pH, pCO2, pO2, Na+, K+, Ca++, Cl-,Glucose, BUN (urea), lactate, tHb, and SO2 insamples of whole blood, and pH, Na+, K+, Ca++,Cl-, Glucose and BUN (urea) in serum andplasma, in a clinical laboratory setting orpoint of care locations. | Same |
| MeasuredParameter | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, BUN(urea), lactate, tHb, and SO2 | Same |
| Sample Type | Whole blood, serum, and plasma | Same |
| Reportableranges | pH: 6.6 – 7.8 pH unitsPCO2: 10 – 200 mm HgPO2: 10 – 700 mm HgNa+: 100 – 180 mmol/LK+: 0.8 – 9.99 mmol/LCa++: 0.2 – 3.0 mmol/LCl-: 50 – 160 mmol/LGlu: 30 – 400 mg/dLBUN/Urea: 2.8 – 112.0 mg/dLLac: 0.3 – 17.5 mmol/LtHb: 5 – 25 g/dLSO2: 60 – 100% | Same |
| SampleVolume | 125 μL (60 μL with B60 cassette) | Same |
| Testconsumable | One use cassette with optical fluorescencemulti-sensor arrayPort for sample introductionFluid waste chamber | Same |
Similarities for OPTI® CCA-TS2 analyzer system:
{3}------------------------------------------------
| Feature | Candidate:OPTI CCA-TS2 Analyzer | Predicate:OPTI CCA-TS Analyzer (K993837) |
|---|---|---|
| Test consumable storage | 6 - 12 months (depends on cassette style) | Same |
| Measurement sequence | Calibrate cassette - introduce sample - measure | Same |
| Measurement time | 180 sec from sample introduction | Same |
| Measurement Temperature | 37°C | Same |
| Error detection | QC system to detect user errorsQC system for reader self checkQC system to detect cassette non-conformance | Same |
| Measurement Principle | Na: fluorescenceK: fluorescenceCa: fluorescenceCl: fluorescencepH: fluorescencePCO2: fluorescencePO2: fluorescenceglucose: fluorescencelactate: fluorescenceBUN: fluorescencetHb: reflectanceSO2: reflectance | Same |
Differences for OPTI® CCA-TS2 analyzer system:
r
| Feature | Candidate:OPTI CCA-TS2 Analyzer | Predicate:OPTI CCA-TS Analyzer (K993837) |
|---|---|---|
| Electronics - PCboard | Single "System on a Chip" (SoC)processor to control all systeminterfaces | Multiple processor architecturewith software control of interfaces(code base that was developedover 10 years ago) |
| Componentupdates toavoidobsolescence | Consolidate processors; reduceelectronic components, and sourcemotors, motor drive circuitry, gasvalve module, printer, and displaywith updated alternatives with anestimated production life in excessof 5 years. | Some hardware components areno longer available to purchase |
| Power supply | 16V, 3.75A | 16V, 4A |
| Battery | Lithium Ion, 10.8V, 4000mAh | Nickel Cadmium, 12V, 2800mAh |
| Feature | Candidate:OPTI CCA-TS2 Analyzer | Predicate:OPTI CCA-TS Analyzer (K993837) |
| Exterior Case | Dual use handle, printer paperroller attached to lid, red accentson trim, fan replacement by user,air filter added, gas bottle housingbase allows up to 16.86 mm basegas bottles. | Carry handle only, printer paperroller attached to printer, all beigeexterior, fan replacement byfactory service, no air filter, housingbase allows up to 26.86 mm basegas bottles. |
| Optics module | Metal and plastic frame, plasticlenses, 3 LED common filter,standardized holodot used with allLEDs. | Metal frame, glass lenses,individual LED filters, individualholodot for each LED |
| Software | Architecture modified withmodular components, samealgorithms as predicate duplicatedin new code | Architecture and code developedas single unit - limits scalability andimprovement, algorithms developedfor sensor and system performance |
| User features | System allows up to two sets ofranges that can be labeled asnormal and critical. Added homescreen so that users who enablesecurity are required to log in forall functions with login timeoutadded. | System provides one set of userconfigurable ranges that may belabeled either normal or critical.System may be configured torequire or not require passwordentry at menu level only |
| Gas bottle andpressureregulator | 28 PSI calibration gas bottle.Regulates 30 to 5 PSI gas bottles.Adaptor ring installed to preventuse of 140 PSI gas bottle. | 140 PSI calibration gas bottle,Regulates 140 to 20 PSI gas bottles,No adaptor ring installed. |
| Quality control | 1 SRC cassette with 3 levels of LEDintensity applied to assess analyzerLEDs for drift and noise over time.Replacement tHb calibrationcassettes can be normalized byusers. | 3 identical SRC cassettes with 3different barcodes to assessanalyzer LEDs for drift and noiseover time. Replacement of tHbcalibration cassettes at end of shelflife frequently required return ofanalyzer to manufacturer forrecalibration. |
| Externalcommunications | Serial USB connectivity. Two waycommunication with POCT1-Aprotocol | Serial RS232 connectivity. One waycommunication of data fromanalyzer only. |
.
{4}------------------------------------------------
Modifications made to the OPTI® CCA-TS analyzer design to produce the OPTI® CCA-TS2 analyzer did not change the technological characteristics of the device and were found to be functionally equivalent.
13. Standard/Guidance Documents Referenced
- Evaluations of Precision Performance of Quantitative Measurement in Methods; Approved ● Guideline (CLSI guideline EP5-A2, volume 24, Number 25)
- . User Verification of Performance for Precision and Trueness; Approved Guideline (CLSI guideline EP15-A2 Volume 25, Number 17)
- Method Comparison and Bias Estimation using Patient Samples; Approved Guideline (CLSI . guideline EP9-A2, Volume 15, Number 19)
- . Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements (IEC 61010-1)
- Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety
{5}------------------------------------------------
requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications (IEC 62133 Ed. 2.0 b:2012)
- Medical Device Software Software life-cycle processes (IEC 62304:2006) .
- Electrical Equipment for measurement, control and laboratory use EMC requirements Part 2t 6: Particular requirements – In-vitro diagnostic (IVD) medical equipment (IEC 61326-2-6)
14. Performance Characteristics
The modified analyzer design was assembled and tested with unchanged design cassettes with sensors to determine whether any of the design changes affected the performance, safety, or efficacy of the device. In-house studies were conducted with each type of sensor available for use on the OPTI® CCA-TS analyzer.
Method Comparison
Whole blood samples were measured across the measurement range on three OPTI CCA-TS analyzers and three OPTI CCA-TS2 analyzers at the internal site. Regression was calculated using the Ordinary linear fit method. Correlation statistics for each parameter / sensor design are presented here:
| Parameter | Range | Slope (95%Confidence) | Intercept | CorrelationCoefficient (R2) | n |
|---|---|---|---|---|---|
| pH | 6.927 to 7.705pH units | 0.97 (0.97 to 0.98) | 0.18 | 0.998 | 126 |
| pH (dry sensor) | 6.961 to 7.648pH units | 1.00 (0.98 to 1.01) | 0.04 | 0.996 | 63 |
| Sodium (Na+) | 109.0 to 179.4mmol/L | 0.99 (0.98 to 0.99) | 1.57 | 0.999 | 45 |
| Potassium (K+) | 0.9 to 8.1mmol/L | 1.01 (1.00 to 1.01) | -0.01 | 0.999 | 54 |
| Calcium (Ca++) | 0.28 to 2.21mmol/L | 1.00 (0.99 to 1.01) | 0.00 | 0.999 | 54 |
| Chloride (Cl-) | 64.4 to 145.7mmol/L | 0.98 (0.97 to 0.99) | 0.87 | 0.999 | 45 |
| Glucose | 69.4 to 361.3mg/dL | 0.99 (0.95 to 1.02) | -0.44 | 0.983 | 54 |
| BUN (urea) | 5.5 to 103.2mg/dL | 1.01 (1.00 to 1.02) | -0.20 | 0.999 | 45 |
| pCO2 | 14.3 to 198.9mmHg | 0.97 (0.97 to 0.98) | 0.87 | 0.999 | 117 |
| pCO2 (dry) | 14.7 to 87.9mmHg | 1.00 (0.99 to 1.02) | -1.13 | 0.995 | 63 |
| pO2 | 13.5 to 639.3mmHg | 0.98 (0.98 to 0.98) | -1.82 | 0.999 | 144 |
| p02 (dry) | 10.7 to 656.6mmHg | 0.99 (0.99 to 1.00) | 0.36 | 0.999 | 66 |
| Lactate | 0.7 to 13.8mmol/L | 1.01 (0.99 to 1.03) | 0.08 | 0.994 | 45 |
| tHb | 7.7 to 21.2 g/dL | 1.01 (0.99 to 1.03) | -0.09 | 0.996 | 45 |
| SO2 | 71.5 to 99.9 % | 1.03 (1.01 to 1.06) | -3.54 | 0.992 | 63 |
OPTI CCA-TS2 vs. Predicate in whole blood samples
{6}------------------------------------------------
Plasma/serum samples were measured across the measurement range on three OPTI CCA-TS analyzers and three OPTI CCA-TS2 analyzers. Correlation statistics for each parameter / sensor design are presented here:
| Parameter | Range | Slope (95% | Intercept | CorrelationCoefficient (R4) | n |
|---|---|---|---|---|---|
| pH | 6.814 to 7.741pH units | Confidence)0.97 (0.97 to 0.98) | 0.21 | 0.999 | 108 |
| Sodium (Na+) | 104.1 to 176.7mmol/L | 0.98 (0.98 to 0.99) | 1.91 | 0.998 | 90 |
| Potassium (K+) | 1.60 to 7.45mmol/L | 0.99 (0.99 to 1.00) | 0.02 | 0.999 | ਰੇਰੇ |
| Calcium (Ca++) | 0.39 to 2.75mmol/L | 0.98 (0.98 to 0.99) | 0.02 | 0.999 | ਰੇਰੇ |
| Chloride (Cl-) | 64.7 to 146.1mmol/L | 0.97 (0.96 to 0.97) | 2.50 | 0.999 | 45 |
| BUN (urea) | 5.4 to 92.9mg/dL | 1.03 (1.01 to 1.05) | -0.53 | 0. ਰੇਰੇਟ | 45 |
| Glucose | 35.9 to 288.6mg/dL | 1.00 (0.98 to 1.01) | -2.32 | 0.997 | ટ્વ |
OPTI CCA-TS2 vs. Predicate in plasma/serum samples
In addition to the in-house studies, method comparison studies in whole blood samples were repeated at 4 different POC sites to confirm that the OPTI CCA-TS2 performs with functional equivalence to the OPTI CCA-TS analyzer. Method comparison results obtained at the 4 POC sites were very similar to the results obtained at the internal site.
Precision/Reproducibility
Multi-day, in-house, precision testing was performed in accordance with CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. Samples consisted of three levels of aqueous quality control solution for the testing (OPTI Check Level 1, Level 2 and Level 3 manufactured by Bionostics Inc., Acton, Massachusetts). Testing was performed over at least 10 days, 4 runs per day, with a minimum of 2 OPTI CCA-TS2 analyzers.
Precision OPTI CCA-TS2 with controls
| PO2 (mmHg) | Dry PO2 (mmHg) | |||||
|---|---|---|---|---|---|---|
| OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | |
| Days run | 20 | 20 | 20 | 20 | 20 | 20 |
| Total Average | 71.6 | 100.0 | 137.7 | 73.5 | 103.5 | 139.1 |
| Within Run St.Dev (Swr) | 1.3 | 1.4 | 1.4 | 1.4 | 0.9 | 1.4 |
| Within Run %CV | 1.8% | 1.4% | 1.0% | 1.8% | 0.9% | 1.0% |
| Between Run St.Dev (Srr) | 0.0 | 0.9 | 1.0 | 0.0 | 0.4 | 0.6 |
| Between Run %CV | 0.0% | 0.9% | 0.7% | 0.0% | 0.4% | 0.5% |
| Between Day St.Dev (Sdd) | 0.8 | 0.0 | 0.6 | 1.1 | 0.9 | 1.4 |
| Between Day %CV | 1.1% | 0.0% | 0.4% | 1.5% | 0.9% | 1.0% |
| Total Precision St.Dev (ST) | 1.5 | 1.7 | 1.8 | 1.6 | 1.3 | 2.0 |
| Total %CV | 2.1% | 1.7% | 1.3% | 2.2% | 1.3% | 1.5% |
{7}------------------------------------------------
| PCO2 (mmHg) | Dry PCO2 (mmHg) | ||||||
|---|---|---|---|---|---|---|---|
| OPTI- | OPTI- | OPTI- | OPTI- | OPTI- | OPTI- | ||
| Check | Check | Check | Check | Check | Check | ||
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | ||
| Days run | 20 | 20 | 20 | 20 | 20 | 20 | |
| Total Average | 74.5 | 45.0 | 24.8 | 72.6 | 43.1 | 22.5 | |
| Within Run St.Dev (Swr) | 0.8. | 0.3 | 0.3 | 0.8 | 0.3 | 0.3 | |
| Within Run %CV | 1.1% | 0.7% | 1.1% | 1.1% | 0.7% | 1.4% | |
| Between Run St.Dev (Sm) | 0.2 | 0.2 | 0.1 | 0.0 | 0.1 | 0.1 | |
| Between Run %CV | 0.2% | 0.5% | 0.5% | 0.0% | 0.3% | 0.2% | |
| Between Day St.Dev (Sad) | 0.4 | 0.3 | 0.2 | 0.9 | 0.5 | 0.3 | |
| Between Day %CV | 0.5% | 0.6% | 0.8% | 1.2% | 1.1% | 1.4% | |
| Total Precision St.Dev (S-) | 0.9 | 0.5 | 0.4 | 1.2 | 0.6 | 0.4 | |
| Total %CV | 1.3% | 1.0% | 1.5% | 1.6% | 1.3% | 2.0% |
ﮭ
| pH | Dry pH | |||||
|---|---|---|---|---|---|---|
| OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | |
| Days run | 20 | 20 | 20 | 20 | 20 | 20 |
| Total Average | 7.151 | 7.415 | 7.624 | 7.168 | 7.418 | 7.632 |
| Within Run St.Dev (Swr) | 0.003 | 0.006 | 0.005 | 0.011 | 0.008 | 0.007 |
| Within Run %CV | 0.0% | 0.1% | 0.1% | 0.2% | 0.1% | 0.1% |
| Between Run St.Dev (Srr) | 0.001 | 0.002 | 0.002 | 0.007 | 0.003 | 0.004 |
| Between Run %CV | 0.0% | 0.0% | 0.0% | 0.1% | 0.0% | 0.1% |
| Between Day St.Dev (Sdd) | 0.003 | 0.003 | 0.004 | 0.009 | 0.007 | 0.008 |
| Between Day %CV | 0.0% | 0.0% | 0.1% | 0.1% | 0.1% | 0.1% |
| Total Precision St.Dev (ST) | 0.005 | 0.007 | 0.007 | 0.015 | 0.011 | 0.011 |
| Total %CV | 0.1% | 0.1% | 0.1% | 0.2% | 0.1% | 0.1% |
| Na+ (mmol/L) | K+ (mmol/L) | |||||
|---|---|---|---|---|---|---|
| OPTI-Check | OPTI-Check | OPTI-Check | OPTI-Check | OPTI-Check | OPTI-Check | |
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Days run | 20 | 20 | 20 | 20 | 20 | 20 |
| Total Average | 126.1 | 143.7 | 156.5 | 2.92 | 4.86 | 5.92 |
| Within Run St.Dev (Swr) | 0.6 | 0.7 | 0.4 | 0.03 | 0.03 | 0.03 |
| Within Run %CV | 0.4% | 0.5% | 0.3% | 0.9% | 0.6% | 0.5% |
| Between Run St.Dev (Srr) | 0.2 | 0.0 | 0.0 | 0.00 | 0.01 | 0.00 |
| Between Run %CV | 0.2% | 0.0% | 0.0% | 0.0% | 0.1% | 0.0% |
| Between Day St.Dev (Sdd) | 0.3 | 0.1 | 0.4 | 0.01 | 0.01 | 0.02 |
| Between Day %CV | 0.3% | 0.1% | 0.3% | 0.5% | 0.2% | 0.4% |
| Total Precision St.Dev (ST) | 0.7 | 0.7 | 0.6 | 0.03 | 0.03 | 0.04 |
| Total %CV | 0.6% | 0.5% | 0.4% | 1.0% | 0.6% | 0.6% |
| Ca++ (mmol/L) | Cl- (mmol/L) | |||||
|---|---|---|---|---|---|---|
| OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | |
| Days run | 20 | 20 | 20 | 10 | 10 | 10 |
| Total Average | 1.57 | 1.27 | 0.79 | 95.3 | 107.1 | 115.6 |
| Within Run St.Dev (Swr) | 0.01 | 0.01 | 0.01 | 0.6 | 1.4 | 0.5 |
{8}------------------------------------------------
| Ca++ (mmol/L) | Cl- (mmol/L) | Glucose (mg/dL) | BUN (mg/dL) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OPTI-Check | OPTI-Check | OPTI-Check | OPTI-Check | OPTI-Check | OPTI-Check | OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | ||
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Days run | 10 | 10 | 10 | 10 | 10 | 10 | |
| Within Run %CV | 0.9% | 0.7% | 0.9% | 0.7% | 1.3% | 0.4% | Total Average | 40.5 | 95.7 | 316.2 | 74.1 | 19.3 | 5.9 |
| Between Run St.Dev (Srr) | 0.01 | 0.00 | 0.00 | 0.3 | 0.0 | 0.2 | Within Run St.Dev (Swr) | 1.6 | 3.5 | 7.5 | 3.0 | 0.6 | 0.1 |
| Between Run %CV | 0.4% | 0.3% | 0.4% | 0.3% | 0.0% | 0.2% | Within Run %CV | 3.9% | 3.6% | 2.4% | 4.0% | 3.2% | 1.9% |
| Between Day St.Dev (Sdd) | 0.02 | 0.01 | 0.01 | 0.2 | 0.2 | 0.3 | Between Run St.Dev (Sπ) | 1.1 | 1.7 | 3.4 | 1.8 | 0.3 | 0.1 |
| Between Day %CV | 1.2% | 0.7% | 1.2% | 0.2% | 0.2% | 0.3% | Between Run %CV | 2.6% | 1.7% | 1.1% | 2.4% | 1.7% | 2.5% |
| Total Precision St.Dev (ST) | 0.02 | 0.01 | 0.01 | 0.7 | 1.4 | 0.6 | Between Day St.Dev (Sdd) | 1.4 | 2.2 | 4.6 | 0.0 | 0.0 | 0.0 |
| Total %CV | 1.5% | 1.0% | 1.5% | 0.8% | 1.3% | 0.5% | Between Day %CV | 3.5% | 2.3% | 1.4% | 0.0% | 0.0% | 0.7% |
| Total Precision St.Dev (ST) | 2.4 | 4.4 | 9.4 | 3.5 | 0.7 | 0.2 | |||||||
| Total %CV | 5.9% | 4.6% | 3.0% | 4.7% | 3.7% | 3.2% |
| Lactate (mmol/L) | tHb (g/dL) | |||||
|---|---|---|---|---|---|---|
| OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | |
| Days run | 20 | 20 | 20 | 20 | 20 | 20 |
| Total Average | 1.02 | 2.50 | 4.59 | 20.7 | 14.0 | 8.9 |
| Within Run St.Dev (Swr) | 0.06 | 0.11 | 0.18 | 0.1 | 0.1 | 0.1 |
| Within Run %CV | 5.6% | 4.2% | 4.0% | 0.3% | 0.4% | 1.2% |
| Between Run St.Dev (Srr) | 0.00 | 0.03 | 0.09 | 0.0 | 0.0 | 0.0 |
| Between Run %CV | 0.0% | 1.3% | 2.0% | 0.1% | 0.3% | 0.0% |
| Between Day St.Dev (Sdd) | 0.04 | 0.02 | 0.09 | 0.2 | 0.1 | 0.2 |
| Between Day %CV | 3.4% | 0.9% | 2.0% | 0.8% | 0.6% | 2.2% |
| Total Precision St.Dev (ST) | 0.07 | 0.11 | 0.22 | 0.2 | 0.1 | 0.2 |
| Total %CV | 6.4% | 4.5% | 4.8% | 0.9% | 0.8% | 2.5% |
| SO2 (%) | |||
|---|---|---|---|
| OPTI-CheckLevel 1 | OPTI-CheckLevel 2 | OPTI-CheckLevel 3 | |
| Days run | 20 | 20 | 20 |
| Total Average | 81.2 | 89.8 | 96.4 |
| Within Run St.Dev (Swr) | 0.1 | 0.3 | 0.4 |
| Within Run %CV | 0.2% | 0.3% | 0.4% |
| Between Run St.Dev (Srr) | 0.1 | 0.0 | 0.0 |
| Between Run %CV | 0.1% | 0.0% | 0.0% |
| Between Day St.Dev (Sdd) | 0.5 | 0.5 | 0.6 |
| Between Day %CV | 0.6% | 0.5% | 0.7% |
| Total Precision St.Dev (ST) | 0.5 | 0.5 | 0.7 |
| Total %CV | 0.6% | 0.6% | 0.8% |
{9}------------------------------------------------
In addition, within-run precision testing was performed in-house in accordance with CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. Samples consisted of three levels of whole blood spiked or diluted to give three levels of each of the analytes. Testing was performed in one day with 10 repeats at each blood level on one OPTI CCA-TS2 analyzer. Results of the studies run are shown in the tables below:
Precision OPTI CCA-TS2 with whole blood
Blood Gases
| Standard Sampling PO2 (mmHg) | 60µL Sampling PO2 (mmHg) | |||||
|---|---|---|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 54.8 | 90.3 | 434.5 | 52.7 | 92.6 | 445.2 |
| Standard Deviation | 0.5 | 0.5 | 5.1 | 0.4 | 0.6 | 4.9 |
| %CV | 0.97% | 0.52% | 1.18% | 0.68% | 0.60% | 1.10% |
| Dry PO2 (mmHg) | |||
|---|---|---|---|
| Whole Blood Level 1 | Whole Blood Level 2 | Whole Blood Level 3 | |
| Total Average | 55.9 | 91.8 | 428.7 |
| Standard Deviation | 0.6 | 0.5 | 5.8 |
| %CV | 1.02% | 0.57% | 1.36% |
| Standard Sampling PCO2 (mmHg) | 60µL Sampling PCO2 (mmHg) | |||||
|---|---|---|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 21.4 | 46.2 | 91.6 | 45.6 | 21.1 | 92.4 |
| Standard Deviation | 0.3 | 0.4 | 1.7 | 0.5 | 0.4 | 1.3 |
| %CV | 1.60% | 0.90% | 1.82% | 1.15% | 1.73% | 1.37% |
| Dry PCO2 (mmHg) | |||
|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 19.6 | 44.4 | 92.8 |
| Standard Deviation | 0.357 | 0.316 | 1.088 |
| %CV | 1.82% | 0.71% | 1.17% |
| Standard Sampling pH (mmHg) | 60µL Sampling pH (mmHg) | |||||
|---|---|---|---|---|---|---|
| Whole | Whole | Whole | Whole | Whole | Whole | |
| Blood | Blood | Blood | Blood | Blood | Blood | |
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Total Average | 7.134 | 7.341 | 7.518 | 7.341 | 7.521 | 7.132 |
| Standard Deviation | 0.004 | 0.006 | 0.009 | 0.005 | 0.006 | 0.003 |
| %CV | 0.05% | 0.08% | 0.13% | 0.07% | 0.08% | 0.04% |
{10}------------------------------------------------
| Dry pH (mmHg) | |||
|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 7.174 | 7.352 | 7.558 |
| Standard Deviation | 0.011 | 0.019 | 0.012 |
| %CV | 0.16% | 0.26% | 0.17% |
| SO2 | |||
|---|---|---|---|
| Whole BloodLevel 1 | Whole BloodLevel 2 | Whole BloodLevel 3 | |
| Total Average | 79.5 | 96.8 | 99.9 |
| Standard Deviation | 0.2 | 0.1 | 0.0 |
| %CV | 0.21% | 0.05% | 0.00% |
Electrolytes, Glucose and BUN
.
| Na+ (mmol/L) | K+ (mmol/L) | |||||
|---|---|---|---|---|---|---|
| WholeBlood | WholeBlood | WholeBlood | WholeBlood | WholeBlood | WholeBlood | |
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Total Average | 136.5 | 167.4 | 112.7 | 3.6 | 8.1 | 2.1 |
| Standard Deviation | 0.4 | 0.2 | 0.4 | 0.0 | 0.0 | 0.1 |
| %CV | 0.26% | 0.13% | 0.33% | 0.38% | 0.26% | 2.49% |
| Cl- (mmol/L) | Ca++ (mmol/L) | |||||
|---|---|---|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 104.1 | 141.3 | 57.5 | 1.2 | 2.6 | 0.8 |
| Standard Deviation | 0.3 | 1.0 | 0.3 | 0.0 | 0.0 | 0.0 |
| %CV | 0.28% | 0.73% | 0.51% | 0.35% | 0.40% | 0.59% |
| Glucose | BUN | |||||
|---|---|---|---|---|---|---|
| Whole | Whole | Whole | Whole | Whole | Whole | |
| Blood | Blood | Blood | Blood | Blood | Blood | |
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Total Average | 82.7 | 166.1 | 34.6 | 6.03 | 26.61 | 85.59 |
| Standard Deviation | 3.8 | 8.2 | 2.4 | 0.03 | 0.25 | 0.97 |
| %CV | 4.65% | 4.91% | 6.94% | 0.53% | 0.93% | 1.13% |
{11}------------------------------------------------
Lactate
| Lactate | |||
|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 3.85 | 1.13 | 6.17 |
| Standard Deviation | 0.14 | 0.05 | 0.20 |
| %CV | 3.76% | 4.42% | 3.16% |
tHb
| tHb | |||
|---|---|---|---|
| WholeBloodLevel 1 | WholeBloodLevel 2 | WholeBloodLevel 3 | |
| Total Average | 7.5 | 17.7 | 12.1 |
| Standard Deviation | 0.2 | 0.2 | 0.2 |
| %CV | 2.59% | 1.34% | 1.86% |
Linearity / Reportable range
The linearity of the OPTI CCA-TS2 system was determined using the experimental protocol recommended in CLSI guideline EP15-A2, User Verification of Performance for Precision and Trueness; Approved Guideline. Linearity data was collected versus the OPTI CCA-TS analyzer predicate using standard aqueous linearity solutions (CVC123 manufactured by RNA Medical, Devons, MA) and whole blood samples that included points just outside the measurement range and points inside the range. Each of the levels of samples was run on two (2) OPTI CCA-TS and two (2) OPTI CCA-TS2 analyzers. The linear regression correlation between analyzers using each individual measurement is summarized below:
| Parameter | Sample type | Range | Slope (95% Confidence) | Intercept | Correlation Coefficient (R2) | n |
|---|---|---|---|---|---|---|
| pH (60μL sample) | Whole Blood | 6.391 to 8.044 pH units | 0.97 (0.96 to 0.97) | 0.26 | 0.999 | 81 |
| pH (120 μL) | Whole Blood | 6.404 to 8.011 pH units | 0.98 (0.97 to 0.98) | 0.16 | 1.000 | 81 |
| pH (dry sensor) | Whole Blood | 6.477 to 7.915 pH units | 0.99 (0.98 to 1.00) | 0.09 | 0.998 | 81 |
| pH (60μL sample) | CVC123 | 6.915 to 7.638 pH units | 0.98 (0.98 to 0.99) | 0.14 | 1.000 | 24 |
| pH (120 μL) | CVC123 | 6.912 to 7.646 pH units | 0.96 (0.96 to 0.97) | 0.26 | 0.999 | 48 |
| pH (dry sensor) | CVC123 | 6.971 to 7.631 pH units | 0.98 (0.97 to 0.99) | 0.16 | 0.999 | 24 |
| PCO2 (60μL sample) | Whole Blood | 6.2 to 256.6 mmHg | 0.98 (0.98 to 0.99) | 0.65 | 1.000 | 81 |
| PCO2 (120μL) | Whole Blood | 7.4 to 205.7 mmHg | 0.98 (0.98 to 0.99) | 0.45 | 1.000 | 72 |
| PCO2 (dry) | Whole Blood | 2.2 to 207.9 mmHg | 1.01 (1.00 to 1.02) | -1.19 | 0.999 | 81 |
| Parameter | Sampletype | Range | Slope (95%Confidence) | Intercept | CorrelationCoefficient(R²) | n |
| PCO2 (60μLsample) | CVC123 | 13.9 to 85.8mmHg | 0.98 (0.97 to 0.99) | 0.35 | 1.000 | 30 |
| PCO2 (120μL) | CVC123 | 13.3 to 90.5mmHg | 0.98 (0.98 to 0.99) | 0.88 | 0.999 | 60 |
| PCO2 (dry) | CVC123 | 15.9 to 87.8mmHg | 0.99 (0.98 to 1.00) | -0.04 | 1.000 | 30 |
| PO2 (60μLsample) | WholeBlood | 6.8 to 711.2mmHg | 0.99 (0.99 to 1.00) | -3.10 | 0.999 | 90 |
| PO2 (120μL) | WholeBlood | 8.9 to 707.0mmHg | 0.99 (0.98 to0.99) | -2.57 | 1.000 | 90 |
| PO2 (dry) | WholeBlood | 9.1 to 656.6mmHg | 0.99 (0.99 to1.00) | 0.43 | 0.999 | 72 |
| PO2 (60μLsample) | CVC123 | 62.7 to 451.0mmHg | 0.97 (0.97 to 0.98) | 0.29 | 0.999 | 30 |
| PO2 (120μL) | CVC123 | 60.9 to 487.1mmHg | 0.98 (0.97 to 0.99) | 0.90 | 0.999 | 60 |
| PO2 (dry) | CVC123 | 60.8 to 476.3mmHg | 0.98 (0.97 to 0.99) | 2.55 | 1.000 | 30 |
| Sodium (Na+) | WholeBlood | 93.4 to 204.4mmHg | 1.00 (0.99 to1.01) | -0.18 | 1.000 | 63 |
| Sodium (Na+) | CVC123 | 116.2 to 163.8mmol/L | 1.01 (0.99 to 1.02) | -0.68 | 0.998 | 36 |
| Potassium(K+) | WholeBlood | 0.39 to 10.09mmol/L | 1.00 (1.00 to 1.01) | 0.00 | 1.000 | 72 |
| Potassium(K+) | CVC123 | 1.19 to 6.98mmol/L | 0.99 (0.99 to 1.00) | 0.10 | 1.000 | 48 |
| Calcium(Ca++) | WholeBlood | 0.158 to 3.372mmol/L | 0.99 (0.99 to 0.99) | 0.01 | 1.000 | 72 |
| Calcium(Ca++) | CVC123 | 0.20 to 2.67mmol/L | 1.01 (1.00 to 1.02) | -0.00 | 0.999 | 30 |
| Chloride (Cl-) | WholeBlood | 42.9 to 175.0mmol/ L | 0.99 (0.98 to1.00) | -0.21 | 0.999 | 63 |
| Chloride (Cl-) | CVC123 | 85.9 to 135.0mmol/L | 0.96 (0.94 to 0.98) | 2.93 | 0.998 | 30 |
| Glucose | WholeBlood | 12.5 to 455.6mg/dL | 1.02 (1.00 to1.05) | -4.19 | 0.991 | 63 |
| Glucose | CVC123 | 81.8 to 303.6mg/dL | 0.98 (0.94 to 1.03) | 1.87 | 0.993 | 18 |
| BUN (urea) | WholeBlood | 2.63 to 142.93mg/dL | 1.00 (0.99 to1.01) | 0.08 | 0.999 | 63 |
| Lactate | WholeBlood | 0.17 to 17.81mmol/L | 1.04 (1.02 to1.06) | -0.02 | 0.996 | 55 |
| Lactate | CVC123 | 0.77 to 15.3mmol/L | 1.03 (1.00 to 1.06) | -0.14 | 0.995 | 30 |
| tHb | WholeBlood | 4.37 to 26.13g/dL | 0.99 (0.98 to1.01) | 0.10 | 0.998 | 63 |
| SO2 | WholeBlood | 55.5 to 99.9 % | 0.96 (0.94 to0.98) | 3.23 | 0.991 | 72 |
{12}------------------------------------------------
{13}------------------------------------------------
The linearity data support the following reportable range claims:
| pH: 6.6 - 7.8 pH units | Cl-: 50 - 160 mmol/L |
|---|---|
| PCO2: 10 - 200 mm Hg | Glu: 30 - 400 mg/dL |
| PO2: 10 - 700 mm Hg | BUN/Urea: 208 - 112.0 mg/dL |
| Na+: 100 - 180 mmol/L | Lac: 0.3 - 17.5 mmol/L |
| K+: 0.8 - 9.99 mmol/L | tHb: 5 - 25 g/dL |
| Ca++: 0.2 - 3.0 mmol/L | SO2: 60 - 100% |
Limit of Blank, Limit of Determination and Limit of Quantitation
No changes were made to the electrolyte sensors installed in the disposable cassettes used on both the OPT! CCA-TS2 device and the predicate OPTI CCA-TS so evaluation of limits of detection does not apply to the analyzer change.
Analytical Specificity / Interferences
No changes were made to the electrolyte sensors installed in the disposable cassettes used on both the OPTI CCA-TS2 device and the predicate OPTI CCA-TS. Evaluation of interferences was not performed since the analysis was done previously in K993837.
Traceability
The parameters measured and reported by the OPTI CCA-TS2 device are calibrated and tested for release using primary and secondary standards that are traceable to NIST or other recognized standards (where no NIST standard is available of practical) as outlined in this table:
| Analyte | Traceability |
|---|---|
| pH | Standard reference material: NIST traceablephosphate buffer; buffer solution made withNIST HEPES SRM 2181 + 2182 |
| PO2 | NIST traceable pure gases gravimetricallyprepared |
| PCO2 | NIST traceable pure gases gravimetricallyprepared |
| Na | Standard reference material, NIST SRM 956A |
| K | Standard reference material, NIST SRM 956A |
| Ca | Standard reference material, NIST SRM 956A |
| Cl | Standard reference material, NIST SRM 956A |
| tHb | Definition of SI unit by French: Conférencegénérale des poids et mesures (CGPM),International Siggaard-Andersen Model |
{14}------------------------------------------------
| Analyte | Traceability |
|---|---|
| SO2 | Definition of SI unit by French: Conférencegénérale des poids et mesures (CGPM) ,International Siggaard-Andersen Model |
| Glu | Standard reference material, NIST SRM 965 |
| BUN | Standard reference material, NIST SRM 909 |
| Lactate | Gravimetric working calibrator prepared fromsodium L-lactate >99% purity |
15. Electromagnetic Compatibility and Electrical Safety
Electromagnetic Compatibility and electrical safety tests were performed on the OPTI® CCA-TS2 model to show compliance with current standards applicable for the device. Performance verification studies were performed using the modified device with all cassette styles and modified consumables and calibration methods to demonstrate performance equivalence.
16. Software Verification and Validation
ﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬ
The software driving the analyzer has been updated according to internal design control and verification procedures of the Quality System at OPTI Medical Systems, inc. to ensure changes did not impact the measurements reported by the analyzer system.
17. Conclusion
Analysis of the method comparison data collected during internal and POC site studies for this device presented in this 510(k), together with the linearity and precision data collected during internal and POC studies demonstrates that the OPTI CCA-TS2 device is safe, effective, and substantially equivalent to the OPTI CCA-TS predicate device.
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Arenation
Document Control Control Control We
OPTI Medical Systems, Inc. C/O Len Owens 235 Hembree Park Drive ROSWELL GA 30076
Re: K131126 Trade/Device Name: OPTI CCA-TS2 Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Requiatory Class: II Product Code: KHP. CHL, GKR, GLY, CEM, JFP, JGS, CGZ, CDS, CGA Dated: July 11, 2013 Received: July 16, 2013
August 22. 2013
Dear Mr. Owens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tourney, there there thanks of the Act include requirements for annual registration, listing of general controls pro rionning practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH dees not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (500 abitrols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that i Drederal statutes and regulations administered by other Federal agencies. You must or any receivel the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as set devices adverse creates (2) Christion (21 CFR Part 820); and if applicable, the electronic forth in the chanty systims (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to hun!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
{16}------------------------------------------------
Page 2-Mr. Owens
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{17}------------------------------------------------
Indications for Use
510(k) Number (if known): K131126
Device Name: OPTI CCA-TS2
Indications for Use: -
The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors is intended to be used for the measurement of pH, pCO2, pO2, Na *, K , Ca *, Cl , Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na *, K , C * , Cl , Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations.
- Measurements of blood gases (PCO2, PO2) 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 {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.
Prescription Use X (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
K131126 510(k)
Page 1 of 2 - 2
{18}------------------------------------------------
- . Potassium (K ) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
- Calcium (Ca*) measurements are used in the diagnosis and treatment of . parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
- . Sodium (Na*) measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst),adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
- . Chloride (Cl`) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
- Urea nitrogen (an end-product of nitrogen metabolism) measurements are used 0 in the diagnosis and treatment of certain renal and metabolic diseases.
- Glucose measurements are used in the diagnosis and treatment of . carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Prescription Use x x __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Yung W. Chan -S
Division Sign-Off Office of In Vitre Diagnestics and Radiological Health (OIR)
510(k)_k131126
Page 2 of 2
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.