(122 days)
No
The document describes a standard medical device using established optical fluorescence and reflectance technology for measuring various parameters in blood, serum, and plasma. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The performance studies focus on traditional metrics like correlation coefficients and precision, not metrics typically associated with AI/ML model evaluation.
No.
The device is for diagnostic purposes, measuring various analytes in blood and serum/plasma to aid in the diagnosis and treatment of conditions, but it does not provide therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that measurements performed by the device "are used in the diagnosis and treatment" of various conditions, such as "life-threatening acid-base disturbances," "lactic acidosis," "parathyroid disease," and "diabetes mellitus." This directly indicates the device's role in diagnosing medical conditions.
No
The device description clearly states it is an "analyzer system" that uses "optical fluorescence and reflectance technology" and interacts with "disposable cassettes containing sensors." This indicates a hardware component is essential to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is 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". These are measurements performed on biological samples in vitro (outside the body).
- Clinical Context: The intended use also specifies that these measurements are used "in the diagnosis and treatment of life-threatening acid-base disturbances" and various other disease conditions. This clearly indicates a diagnostic purpose.
- Device Description: The device description explains that the system uses "disposable cassettes containing sensors that interact with an in-vitro blood or plasma/serum sample aspirated into the cassette". This further confirms that the analysis is performed on samples outside the body.
- Care Setting: The intended user/care setting is "clinical laboratory setting or point of care locations", which are typical environments for IVD devices.
The device fits the definition of an In Vitro Diagnostic device as it is intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / 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 , 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KHP, CHL, GKR, GLY, CEM, JFP, JGS, CGZ, CDS, CGA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory setting or point of care locations.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
Whole blood samples:
- Measured across the measurement range on three OPTI CCA-TS analyzers and three OPTI CCA-TS2 analyzers at the internal site.
- Regression calculated using the Ordinary linear fit method.
- Sample size: pH (126), pH (dry sensor) (63), Sodium (Na+) (45), Potassium (K+) (54), Calcium (Ca++) (54), Chloride (Cl-) (45), Glucose (54), BUN (urea) (45), pCO2 (117), pCO2 (dry) (63), pO2 (144), p02 (dry) (66), Lactate (45), tHb (45), SO2 (63).
- Key Results: Correlation Coefficients (R2) ranged from 0.983 to 0.999 across all parameters, indicating strong correlation between the two analyzer models. Slope values were close to 1 and intercept values close to 0, which further demonstrates equivalence.
Plasma/serum samples:
- Measured across the measurement range on three OPTI CCA-TS analyzers and three OPTI CCA-TS2 analyzers.
- Sample size: pH (108), Sodium (Na+) (90), Potassium (K+) (90), Calcium (Ca++) (90), Chloride (Cl-) (45), BUN (urea) (45), Glucose (60).
- Key Results: Correlation Coefficients (R2) ranged from 0.997 to 0.999 across all parameters, indicating strong correlation.
Method comparison studies were also repeated at 4 different POC sites consistently showing functional equivalence to the OPTI CCA-TS analyzer.
Precision/Reproducibility:
Multi-day, in-house, precision testing:
- Performed in accordance with CLSI EP5-A2.
- Samples: Three levels of aqueous quality control solution (OPTI Check Level 1, Level 2 and Level 3 manufactured by Bionostics Inc., Acton, Massachusetts).
- Protocol: Performed over at least 10 days, 4 runs per day, with a minimum of 2 OPTI CCA-TS2 analyzers.
- Key Results: Detailed tables are provided for PO2, Dry PO2, PCO2, Dry PCO2, pH, Dry pH, Na+, K+, Ca++, Cl-, Glucose, BUN, Lactate, tHb, and SO2 showing Within-Run St.Dev and %CV, Between-Run St.Dev and %CV, Between-Day St.Dev and %CV, and Total Precision St.Dev and %CV for each level. All %CV values are very low, demonstrating high precision.
Within-run precision testing (whole blood):
- Performed in-house in accordance with CLSI EP5-A2.
- Samples: Three levels of whole blood spiked or diluted to give three levels of each of the analytes.
- Protocol: Performed in one day with 10 repeats at each blood level on one OPTI CCA-TS2 analyzer.
- Key Results: Detailed tables are provided for PO2 (Standard and 60µL Sampling, Dry), PCO2 (Standard and 60µL Sampling, Dry), pH (Standard and 60µL Sampling, Dry), SO2, Na+, K+, Cl-, Ca++, Glucose, BUN, Lactate, and tHb showing Total Average, Standard Deviation, and %CV. All %CV values are low, indicating good within-run precision.
Linearity / Reportable Range:
- Determined using the experimental protocol recommended in CLSI guideline EP15-A2.
- Data collected versus the OPTI CCA-TS analyzer predicate using standard aqueous linearity solutions (CVC123 manufactured by RNA Medical, Devons, MA) and whole blood samples.
- Included points just outside and inside the measurement range.
- Protocol: Each level of samples was run on two (2) OPTI CCA-TS and two (2) OPTI CCA-TS2 analyzers.
- Key Results: Linear regression correlation between analyzers using each individual measurement showed high R2 values (0.991 to 1.000) and slopes close to 1, supporting the claimed reportable ranges for all parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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
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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 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. | Same |
| Measured
Parameter | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, BUN
(urea), lactate, tHb, and SO2 | Same |
| Sample Type | Whole blood, serum, and plasma | Same |
| Reportable
ranges | pH: 6.6 – 7.8 pH units
PCO2: 10 – 200 mm Hg
PO2: 10 – 700 mm Hg
Na+: 100 – 180 mmol/L
K+: 0.8 – 9.99 mmol/L
Ca++: 0.2 – 3.0 mmol/L
Cl-: 50 – 160 mmol/L
Glu: 30 – 400 mg/dL
BUN/Urea: 2.8 – 112.0 mg/dL
Lac: 0.3 – 17.5 mmol/L
tHb: 5 – 25 g/dL
SO2: 60 – 100% | Same |
| Sample
Volume | 125 μL (60 μL with B60 cassette) | Same |
| Test
consumable | One use cassette with optical fluorescence
multi-sensor array
Port for sample introduction
Fluid 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 errors
QC system for reader self check
QC system to detect cassette non-conformance | Same |
| Measurement Principle | Na: fluorescence
K: fluorescence
Ca: fluorescence
Cl: fluorescence
pH: fluorescence
PCO2: fluorescence
PO2: fluorescence
glucose: fluorescence
lactate: fluorescence
BUN: fluorescence
tHb: reflectance
SO2: reflectance | Same |
Differences for OPTI® CCA-TS2 analyzer system:
r
| Feature | Candidate:
OPTI CCA-TS2 Analyzer | Predicate:
OPTI CCA-TS Analyzer (K993837) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electronics - PC
board | Single "System on a Chip" (SoC)
processor to control all system
interfaces | Multiple processor architecture
with software control of interfaces
(code base that was developed
over 10 years ago) |
| Component
updates to
avoid
obsolescence | Consolidate processors; reduce
electronic components, and source
motors, motor drive circuitry, gas
valve module, printer, and display
with updated alternatives with an
estimated production life in excess
of 5 years. | Some hardware components are
no 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 paper
roller attached to lid, red accents
on trim, fan replacement by user,
air filter added, gas bottle housing
base allows up to 16.86 mm base
gas bottles. | Carry handle only, printer paper
roller attached to printer, all beige
exterior, fan replacement by
factory service, no air filter, housing
base allows up to 26.86 mm base
gas bottles. |
| Optics module | Metal and plastic frame, plastic
lenses, 3 LED common filter,
standardized holodot used with all
LEDs. | Metal frame, glass lenses,
individual LED filters, individual
holodot for each LED |
| Software | Architecture modified with
modular components, same
algorithms as predicate duplicated
in new code | Architecture and code developed
as single unit - limits scalability and
improvement, algorithms developed
for sensor and system performance |
| User features | System allows up to two sets of
ranges that can be labeled as
normal and critical. Added home
screen so that users who enable
security are required to log in for
all functions with login timeout
added. | System provides one set of user
configurable ranges that may be
labeled either normal or critical.
System may be configured to
require or not require password
entry at menu level only |
| Gas bottle and
pressure
regulator | 28 PSI calibration gas bottle.
Regulates 30 to 5 PSI gas bottles.
Adaptor ring installed to prevent
use 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 LED
intensity applied to assess analyzer
LEDs for drift and noise over time.
Replacement tHb calibration
cassettes can be normalized by
users. | 3 identical SRC cassettes with 3
different barcodes to assess
analyzer LEDs for drift and noise
over time. Replacement of tHb
calibration cassettes at end of shelf
life frequently required return of
analyzer to manufacturer for
recalibration. |
| External
communications | Serial USB connectivity. Two way
communication with POCT1-A
protocol | Serial RS232 connectivity. One way
communication of data from
analyzer 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 | Correlation
Coefficient (R2) | n |
|-----------------|----------------------------|---------------------------|-----------|---------------------------------|-----|
| pH | 6.927 to 7.705
pH units | 0.97 (0.97 to 0.98) | 0.18 | 0.998 | 126 |
| pH (dry sensor) | 6.961 to 7.648
pH units | 1.00 (0.98 to 1.01) | 0.04 | 0.996 | 63 |
| Sodium (Na+) | 109.0 to 179.4
mmol/L | 0.99 (0.98 to 0.99) | 1.57 | 0.999 | 45 |
| Potassium (K+) | 0.9 to 8.1
mmol/L | 1.01 (1.00 to 1.01) | -0.01 | 0.999 | 54 |
| Calcium (Ca++) | 0.28 to 2.21
mmol/L | 1.00 (0.99 to 1.01) | 0.00 | 0.999 | 54 |
| Chloride (Cl-) | 64.4 to 145.7
mmol/L | 0.98 (0.97 to 0.99) | 0.87 | 0.999 | 45 |
| Glucose | 69.4 to 361.3
mg/dL | 0.99 (0.95 to 1.02) | -0.44 | 0.983 | 54 |
| BUN (urea) | 5.5 to 103.2
mg/dL | 1.01 (1.00 to 1.02) | -0.20 | 0.999 | 45 |
| pCO2 | 14.3 to 198.9
mmHg | 0.97 (0.97 to 0.98) | 0.87 | 0.999 | 117 |
| pCO2 (dry) | 14.7 to 87.9
mmHg | 1.00 (0.99 to 1.02) | -1.13 | 0.995 | 63 |
| pO2 | 13.5 to 639.3
mmHg | 0.98 (0.98 to 0.98) | -1.82 | 0.999 | 144 |
| p02 (dry) | 10.7 to 656.6
mmHg | 0.99 (0.99 to 1.00) | 0.36 | 0.999 | 66 |
| Lactate | 0.7 to 13.8
mmol/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 | Correlation
Coefficient (R4) | n |
|----------------|----------------------------|------------------------------------|-----------|---------------------------------|------|
| pH | 6.814 to 7.741
pH units | Confidence)
0.97 (0.97 to 0.98) | 0.21 | 0.999 | 108 |
| Sodium (Na+) | 104.1 to 176.7
mmol/L | 0.98 (0.98 to 0.99) | 1.91 | 0.998 | 90 |
| Potassium (K+) | 1.60 to 7.45
mmol/L | 0.99 (0.99 to 1.00) | 0.02 | 0.999 | ਰੇਰੇ |
| Calcium (Ca++) | 0.39 to 2.75
mmol/L | 0.98 (0.98 to 0.99) | 0.02 | 0.999 | ਰੇਰੇ |
| Chloride (Cl-) | 64.7 to 146.1
mmol/L | 0.97 (0.96 to 0.97) | 2.50 | 0.999 | 45 |
| BUN (urea) | 5.4 to 92.9
mg/dL | 1.03 (1.01 to 1.05) | -0.53 | 0. ਰੇਰੇਟ | 45 |
| Glucose | 35.9 to 288.6
mg/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- | ||||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 3 | OPTI- | |||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 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- | ||||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 3 | OPTI- | |||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 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- | ||||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 3 | OPTI- | |||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 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- | ||||||||||||
| Check | |||||||||||||
| Level 1 | OPTI- | ||||||||||||
| Check | |||||||||||||
| Level 2 | OPTI- | ||||||||||||
| Check | |||||||||||||
| Level 3 | OPTI- | ||||||||||||
| Check | |||||||||||||
| Level 1 | OPTI- | ||||||||||||
| Check | |||||||||||||
| Level 2 | OPTI- | ||||||||||||
| Check | |||||||||||||
| Level 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- | ||||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 3 | OPTI- | |||||
| Check | ||||||
| Level 1 | OPTI- | |||||
| Check | ||||||
| Level 2 | OPTI- | |||||
| Check | ||||||
| Level 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- | |||
| Check | |||
| Level 1 | OPTI- | ||
| Check | |||
| Level 2 | OPTI- | ||
| Check | |||
| Level 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) | |||||
|---|---|---|---|---|---|---|
| Whole | ||||||
| Blood | ||||||
| Level 1 | Whole | |||||
| Blood | ||||||
| Level 2 | Whole | |||||
| Blood | ||||||
| Level 3 | Whole | |||||
| Blood | ||||||
| Level 1 | Whole | |||||
| Blood | ||||||
| Level 2 | Whole | |||||
| Blood | ||||||
| Level 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) | |||||
|---|---|---|---|---|---|---|
| Whole | ||||||
| Blood | ||||||
| Level 1 | Whole | |||||
| Blood | ||||||
| Level 2 | Whole | |||||
| Blood | ||||||
| Level 3 | Whole | |||||
| Blood | ||||||
| Level 1 | Whole | |||||
| Blood | ||||||
| Level 2 | Whole | |||||
| Blood | ||||||
| Level 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) | |||
|---|---|---|---|
| Whole | |||
| Blood | |||
| Level 1 | Whole | ||
| Blood | |||
| Level 2 | Whole | ||
| Blood | |||
| Level 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) | |||
|---|---|---|---|
| Whole | |||
| Blood | |||
| Level 1 | Whole | ||
| Blood | |||
| Level 2 | Whole | ||
| Blood | |||
| Level 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 Blood | |||
| Level 1 | Whole Blood | ||
| Level 2 | Whole Blood | ||
| Level 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) | |||||
|---|---|---|---|---|---|---|
| Whole | ||||||
| Blood | Whole | |||||
| Blood | Whole | |||||
| Blood | Whole | |||||
| Blood | Whole | |||||
| Blood | Whole | |||||
| Blood | ||||||
| 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) | |||||
|---|---|---|---|---|---|---|
| Whole | ||||||
| Blood | ||||||
| Level 1 | Whole | |||||
| Blood | ||||||
| Level 2 | Whole | |||||
| Blood | ||||||
| Level 3 | Whole | |||||
| Blood | ||||||
| Level 1 | Whole | |||||
| Blood | ||||||
| Level 2 | Whole | |||||
| Blood | ||||||
| Level 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 | |||
|---|---|---|---|
| Whole | |||
| Blood | |||
| Level 1 | Whole | ||
| Blood | |||
| Level 2 | Whole | ||
| Blood | |||
| Level 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 | |||
|---|---|---|---|
| Whole | |||
| Blood | |||
| Level 1 | Whole | ||
| Blood | |||
| Level 2 | Whole | ||
| Blood | |||
| Level 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 | Sample | |||||
| type | Range | Slope (95% | ||||
| Confidence) | Intercept | Correlation | ||||
| Coefficient | ||||||
| (R²) | n | |||||
| PCO2 (60μL | ||||||
| sample) | CVC123 | 13.9 to 85.8 | ||||
| mmHg | 0.98 (0.97 to 0.99) | 0.35 | 1.000 | 30 | ||
| PCO2 (120μL) | CVC123 | 13.3 to 90.5 | ||||
| mmHg | 0.98 (0.98 to 0.99) | 0.88 | 0.999 | 60 | ||
| PCO2 (dry) | CVC123 | 15.9 to 87.8 | ||||
| mmHg | 0.99 (0.98 to 1.00) | -0.04 | 1.000 | 30 | ||
| PO2 (60μL | ||||||
| sample) | Whole | |||||
| Blood | 6.8 to 711.2 | |||||
| mmHg | 0.99 (0.99 to 1.00) | -3.10 | 0.999 | 90 | ||
| PO2 (120μL) | Whole | |||||
| Blood | 8.9 to 707.0 | |||||
| mmHg | 0.99 (0.98 to | |||||
| 0.99) | -2.57 | 1.000 | 90 | |||
| PO2 (dry) | Whole | |||||
| Blood | 9.1 to 656.6 | |||||
| mmHg | 0.99 (0.99 to | |||||
| 1.00) | 0.43 | 0.999 | 72 | |||
| PO2 (60μL | ||||||
| sample) | CVC123 | 62.7 to 451.0 | ||||
| mmHg | 0.97 (0.97 to 0.98) | 0.29 | 0.999 | 30 | ||
| PO2 (120μL) | CVC123 | 60.9 to 487.1 | ||||
| mmHg | 0.98 (0.97 to 0.99) | 0.90 | 0.999 | 60 | ||
| PO2 (dry) | CVC123 | 60.8 to 476.3 | ||||
| mmHg | 0.98 (0.97 to 0.99) | 2.55 | 1.000 | 30 | ||
| Sodium (Na+) | Whole | |||||
| Blood | 93.4 to 204.4 | |||||
| mmHg | 1.00 (0.99 to | |||||
| 1.01) | -0.18 | 1.000 | 63 | |||
| Sodium (Na+) | CVC123 | 116.2 to 163.8 | ||||
| mmol/L | 1.01 (0.99 to 1.02) | -0.68 | 0.998 | 36 | ||
| Potassium | ||||||
| (K+) | Whole | |||||
| Blood | 0.39 to 10.09 | |||||
| mmol/L | 1.00 (1.00 to 1.01) | 0.00 | 1.000 | 72 | ||
| Potassium | ||||||
| (K+) | CVC123 | 1.19 to 6.98 | ||||
| mmol/L | 0.99 (0.99 to 1.00) | 0.10 | 1.000 | 48 | ||
| Calcium | ||||||
| (Ca++) | Whole | |||||
| Blood | 0.158 to 3.372 | |||||
| mmol/L | 0.99 (0.99 to 0.99) | 0.01 | 1.000 | 72 | ||
| Calcium | ||||||
| (Ca++) | CVC123 | 0.20 to 2.67 | ||||
| mmol/L | 1.01 (1.00 to 1.02) | -0.00 | 0.999 | 30 | ||
| Chloride (Cl-) | Whole | |||||
| Blood | 42.9 to 175.0 | |||||
| mmol/ L | 0.99 (0.98 to | |||||
| 1.00) | -0.21 | 0.999 | 63 | |||
| Chloride (Cl-) | CVC123 | 85.9 to 135.0 | ||||
| mmol/L | 0.96 (0.94 to 0.98) | 2.93 | 0.998 | 30 | ||
| Glucose | Whole | |||||
| Blood | 12.5 to 455.6 | |||||
| mg/dL | 1.02 (1.00 to | |||||
| 1.05) | -4.19 | 0.991 | 63 | |||
| Glucose | CVC123 | 81.8 to 303.6 | ||||
| mg/dL | 0.98 (0.94 to 1.03) | 1.87 | 0.993 | 18 | ||
| BUN (urea) | Whole | |||||
| Blood | 2.63 to 142.93 | |||||
| mg/dL | 1.00 (0.99 to | |||||
| 1.01) | 0.08 | 0.999 | 63 | |||
| Lactate | Whole | |||||
| Blood | 0.17 to 17.81 | |||||
| mmol/L | 1.04 (1.02 to | |||||
| 1.06) | -0.02 | 0.996 | 55 | |||
| Lactate | CVC123 | 0.77 to 15.3 | ||||
| mmol/L | 1.03 (1.00 to 1.06) | -0.14 | 0.995 | 30 | ||
| tHb | Whole | |||||
| Blood | 4.37 to 26.13 | |||||
| g/dL | 0.99 (0.98 to | |||||
| 1.01) | 0.10 | 0.998 | 63 | |||
| SO2 | Whole | |||||
| Blood | 55.5 to 99.9 % | 0.96 (0.94 to | ||||
| 0.98) | 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 traceable |
| phosphate buffer; buffer solution made with | |
| NIST HEPES SRM 2181 + 2182 | |
| PO2 | NIST traceable pure gases gravimetrically |
| prepared | |
| PCO2 | NIST traceable pure gases gravimetrically |
| prepared | |
| 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: Conférence |
| générale des poids et mesures (CGPM), | |
| International Siggaard-Andersen Model |
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| Analyte | Traceability |
|---|---|
| SO2 | Definition of SI unit by French: Conférence |
| générale 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 from |
| sodium 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.
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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!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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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
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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)
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- . 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
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