(318 days)
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No
The document describes a standard blood gas, metabolite, and electrolyte analyzer using traditional sensor technologies (electrochemical, ion-selective electrodes, enzyme/amperometric). There is no mention of AI or ML in the device description, intended use, or performance studies. The "Quality Management System (QMS)" is described as an "electronic monitoring approach," which is not indicative of AI/ML.
No.
The document states that the device is intended for "in vitro diagnostic use," meaning it analyzes samples outside the body to aid in diagnosis, not to directly treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals... for quantitative determination of pH, PCO2, PO2, Hct, Na+. K-, CL-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood." Furthermore, it details how measurements of these parameters are "used in the diagnosis and treatment of" various medical conditions and disturbances.
No
The device is a physical analyzer that measures blood gas, metabolite, and electrolyte levels using sensors and a flow path integrated into a replaceable microsensor card. It processes whole blood specimens and includes hardware components like a peristaltic pump, sampling probe, and waste collection bag. While it is microprocessor-based, the core function relies on physical measurement of biological samples, not solely on software processing of data.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage..."
- Purpose: The device is used for the "quantitative determination of pH, PCO2, PO2, Hct, Na+. K-, CL-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood." These measurements are used in the "diagnosis and treatment" of various medical conditions, which is a core function of IVD devices.
- Sample Type: The device analyzes "heparinized whole blood," which is a biological specimen taken from the human body, a characteristic of IVD testing.
- Associated Consumables: The description also includes associated consumables like quality controls, calibrators, and linearity standards, all of which are explicitly stated as being for "in vitro diagnostic use."
The entire description aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.
PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
iCa: Calcium 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).
Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lac: Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.
Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.
Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na*, K*, Cl*, iCa, Glucose, and Lactate, using the Stat Profile Prime CCS Analyzer.
Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.
Product codes (comma separated list FDA assigned to the subject device)
CHL, JGS, CEM, JFP, CGZ, CGA, GKF, JIX, JJS, KHP
Device Description
The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.
Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flow path and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose) and Lac (Lactate). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.
The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:
- traditional sensor technology to measure blood pO2
- ion selective electrode technology to measure pH, pCO2, blood sodium, potassium, chloride, and ionized calcium
- enzyme/Amperometric technology for glucose measurements
Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.
Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge agueous solutions allow for 2 point calibration of each parameter as follows: - Calibrator A pH, PCO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 500 mL)
- Calibrator B pH, PO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 250 mL)
- Calibrator F PCO2, PO2 (Volume > 720 mL)
- Reference Solution KCI (Volume > 300 mL)
The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, Cl, iCa, Glucose (Glu) and Lactate. The solutions are equilibrated with known levels of 02, CO2, and N2. Each ampule contains 1.7 ml volume.
The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, Glucose (Glu) and Lactate. The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl. iCa. Glucose (Glu) and Lactate. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels: - Control 1: Acidosis, with High Electrolyte, Low Normal Glu, and Lactate
- Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu, and Lactate
- Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, and Lactate
Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, Lactate, K+, and Cl-. Each ampule contains 1.8 ml volume.
The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.
Measured Parameters:
The Stat Profile Prime CCS Analyzer measures pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu and Lactate (Note: Glucose and Lactate are optional).
Calculated Parameters: - pH, PCO2, PO2 (corrected to patient temperature)
- Bicarbonate level (HCO3-)
- Total Carbon Dioxide (TCO2)
- Base Excess of the blood (BE-b)
- Base Excess of extracellular fluid (BE-ecf)
- Standard Bicarbonate Concentration (SBC)
- Oxygen Content (O2Ct)
- Oxygen Capacity (O₂Cap)
- Alveolar Oxygen (A)
- Arterial Alveolar Oxygen Tension Gradient (AaDO2)
- Arterial Alveolar Oxygen Tension Ratio (a/A)
- Respiratory Index (RI)
- P50
- PO2/FIO2 ratio
- Oxygen Saturation (SO2%)
- Hemoqlobin
- Anion Gap
- Normalized Calcium, nCa
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
health care professionals in clinical laboratory settings and for point-of-care usage
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)
Summary of Performance Testing:
Testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile pHOx Ultra Analyzer System.
In this submission, only Lactate data for detection limit. Iinearity, and interference/specificity was reviewed and cleared. Performance data for all other analytes was presented and reviewed in the predicate device submission (K131703 - Stat Profile Prime CCS Analyzer).
Method Comparison:
Method comparison studies were performed. A minimum of 150 whole blood specimens were analyzed for each parameter in syringe collection devices. Some samples were altered in order to achieve the hard-to-find sample range. The samples were analyzed on each of the Stat Profile Prime CCS analyzers and on each of the pHOx Ultra analyzers. The Stat Profile Prime CCS results for each analyzer were compared to the average of the 2 results from the pHOx Ultra comparative method.
Table 1: Syringe method comparison study results vs. the predicate device (Stat Profile pHOx Ultra)
pH: Total # samples 172, Sample range tested 6.523 - 7.862 pH units, Slope 0.9976, Intercept 0.0099, r 0.9985
pCO2: Total # samples 179, Sample range tested 3.4 - 200.0 mmHg, Slope 0.9854, Intercept 0.9344, r 0.9977
pO2: Total # samples 167, Sample range tested 29.5 - 593.2 mmHg, Slope 0.9897, Intercept 1.4508, r 0.9988
Hct: Total # samples 174, Sample range tested 12 - 70%, Slope 1.0445, Intercept -1.9271, r 0.9889
Na: Total # samples 180, Sample range tested 85.5 - 195.7 mmol/L, Slope 1.0189, Intercept -2.2841, r 0.9955
K: Total # samples 179, Sample range tested 1.11 - 19.75 mmol/L, Slope 1.0163, Intercept -0.0371, r 0.9996
iCa: Total # samples 181, Sample range tested 0.25 - 2.48 mmol/L, Slope 0.9880, Intercept 0.0457, r 0.9974
Cl: Total # samples 186, Sample range tested 52.8 - 189.3 mmol/L, Slope 1.0003, Intercept 1.0158, r 0.9955
Glu: Total # samples 185, Sample range tested 39 - 474 mg/dL, Slope 1.0007, Intercept -2.6844, r 0.9892
Lac: Total # samples 182, Sample range tested 0.4 - 17.8, Slope 0.9841, Intercept -0.0937, r 0.9974
Whole blood patient samples were evaluated to demonstrate that syringe sample mode and capillary sample mode are equivalent. The syringe sample was analyzed directly using the syringe mode. After the measurement, samples were transferred from the syringe into the capillary tube and then analyzed using the capillary mode. Approximately 100 whole blood samples were analyzed for each parameter. The capillary test result was compared to the syringe test result and linear regression analysis was performed.
Table 2: Method Comparison Results - Capillary vs. Syringe
pH: total # samples 100, sample range tested 6.787 - 7.683, Slope 1.0094, Intercept -0.0721, r 0.9988
pCO2: total # samples 100, sample range tested 17.7 - 111.0, Slope 1.0026, Intercept -0.4347, r 0.9989
pO2: total # samples 100, sample range tested 25.5 - 435.2, Slope 0.9942, Intercept 2.1791, r 0.9996
Hct: total # samples 100, sample range tested 14 - 69, Slope 1.0013, Intercept 0.0485, r 0.9963
Na: total # samples 100, sample range tested 85.0 - 198.1, Slope 0.9995, Intercept -0.1711, r 0.9978
K: total # samples 100, sample range tested 2.70 - 19.37, Slope 0.9966, Intercept 0.0934, r 0.9996
iCa: total # samples 98, sample range tested 0.33 - 2.51, Slope 1.0228, Intercept -0.0603, r 0.9855
Cl: total # samples 100, sample range tested 55.8 - 197.1, Slope 0.9897, Intercept 0.1776, r 0.9997
Glu: total # samples 100, sample range tested 17 - 488, Slope 0.9855, Intercept -0.4734, r 0.9998
Lac: total # samples 100, sample range tested 1.1 - 18.1, Slope 1.0034, Intercept -0.0120, r 0.9994
Specificity / Interference Testing Protocol:
Li-heparin whole blood samples were used in the interference study. For the initial testing, each interferent was spiked at 20 times the recommended concentration by CLSI EP-7 A2. Each sample containing interferent was evaluated against the same whole blood sample without the interferent. If interference was observed, a dose response study was performed at two analytes concentrations (low and high) to determine the highest substance concentration where no interference was observed. The sponsor's definition of significant interference is ±10% bias for Lactate.
Determination of Limit of Detection: Limit of Detection was determined by obtaining the standard deviation of sample measurements from repeated measurements of samples with a relevant low concentration. Three blood samples with low level lactate concentration were used to estimate the limit of detection.
Table 5: Lactate Limit of Detection
Lac: LoB 2.70 mg/dL (0.30 mmol/L), LoD 3.60 mg/dL (0.40 mmol/L), LoQ 3.60 mg/dL (0.40 mmol/L), Average Total Error 0.13, Acceptance Criteria for Total Error ≤ 0.3, Claimed Measurement Range 3.6 - 178.6 mg/dL (0.4 - 20.0 mmol/L)
Lactate Linearity: Samples were prepared by tonometering, spiking or diluting whole blood to span the analytical measurement range for lactate. Each blood level sample was analyzed in triplicate on each of the three (3) test analyzers and on the pHOx Ultra analyzers. The pHOx Ultra analyzers were used to establish the target value of each blood level for lactate.
Table 6: Lactate Linearity Results (Individual Analyzer Performance Data)
Analyzer #1: total # levels 11, Specimen range 0.2 - 24.9, Analyze r #1, Slope 0.9946, Intercept 0.1178, r 0.9992
Analyzer #2: total # levels 11, Specimen range 0.2 - 24.7, Analyze r #2, Slope 0.9920, Intercept 0.1431, r 0.9994
Analyzer #3: total # levels 11, Specimen range 0.2 - 24.8, Analyze r #3, Slope 0.9911, Intercept 0.2117, r 0.9993
Point-of-Care:
A Point-of-Care study was conducted to demonstrate that the system was safe and effective for use in the POC setting. The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer. The Stat Profile Prime CCS Analyzer was evaluated by point-of-care (POC) personnel in 3 POC sites including a cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU) and a trauma/neuro intensive care unit. A total of 43 respiratory therapy and 10 Nursing POC personnel participated from the 3 POC settings over the study. The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized. All testing was performed using discarded blood gas specimens.
Combined data from all 3 POC settings is summarized in Tables 7 and 8.
Table 7: Prime CCS: POC v Trained Healthcare Professional (THP) - Syringe Mode
pH: Total # specimens 234, Whole Blood Range 6.874 - 7.665, Slope 0.983, Intercept 0.116, r 0.997
PCO2 mmHg: Total # specimens 230, Whole Blood Range 4.1 - 195.5, Slope 1.007, Intercept 0.750, r 0.998
PO2 mmHg: Total # specimens 234, Whole Blood Range 15.2 - 714.5, Slope 1.005, Intercept -0.094, r 0.999
Hct %: Total # specimens 222, Whole Blood Range 12 - 70, Slope 0.997, Intercept 0.395, r 0.985
Na mmol/L: Total # specimens 229, Whole Blood Range 83.2 - 192.3, Slope 1.020, Intercept -2.540, r 0.998
K mmol/L: Total # specimens 231, Whole Blood Range 1.10 - 18.80, Slope 0.974, Intercept 0.110, r 0.999
iCa mmol/L: Total # specimens 234, Whole Blood Range 0.26 - 2.55, Slope 1.001, Intercept 0.004, r 0.999
Cl mmol/L: Total # specimens 234, Whole Blood Range 53.0 - 188.7, Slope 1.000, Intercept -0.020, r 0.999
Glu mg/dL: Total # specimens 233, Whole Blood Range 17 - 478, Slope 0.989, Intercept 1.517, r 0.998
Lac mmol/L: Total # specimens 233, Whole Blood Range 0.6 - 19.5, Slope 1.018, Intercept -0.093, r 0.998
Table 8: Prime CCS: POC v Trained Healthcare Professional (THP) - Capillary Mode
pH: Total # specimens 173, Whole Blood Range 6.881 - 7.780, Slope 0.962, Intercept 0.275, r 0.997
PCO2 mmHg: Total # specimens 170, Whole Blood Range 3.2 - 181.4, Slope 0.989, Intercept 0.899, r 0.998
PO2 mmHg: Total # specimens 173, Whole Blood Range 22.8 - 597.3, Slope 0.979, Intercept 3.141, r 0.999
Hct %: Total # specimens 157, Whole Blood Range 13 - 68, Slope 0.978, Intercept 0.399, r 0.984
Na mmol/L: Total # specimens 169, Whole Blood Range 83.2 - 197.0, Slope 1.010, Intercept -1.258, r 0.997
K mmol/L: Total # specimens 168, Whole Blood Range 1.15 - 19.47, Slope 1.006, Intercept -0.025, r 0.998
iCa mmol/L: Total # specimens 173, Whole Blood Range 0.32 - 2.45, Slope 0.977, Intercept 0.029, r 0.996
Cl mmol/L: Total # specimens 173, Whole Blood Range 55.9 - 188.1, Slope 1.007, Intercept -0.710, r 0.997
Glu mg/dL: Total # specimens 173, Whole Blood Range 15 - 484, Slope 1.004, Intercept 0.036, r 0.999
Lac mmol/L: Total # specimens 173, Whole Blood Range 0.6 - 18.4, Slope 1.019, Intercept -0.127, r 0.998
Total Imprecision Performance:
The total imprecision data included in the following table was obtained from different POC site personnel running 3 levels of Stat Profile Prime External Quality Control material (Levels 1-3) in duplicate each day for a total of 20 runs on 3 Stat Profile Prime CCS analyzers. The protocol was based upon methods described in CLSI "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second edition," CLSI EP5-A2. The test data is representative of the expected total imprecision between analyzer performance obtainable by POC personnel using the Stat Profile Prime CCS analyzer using external quality control materials.
Table 9: Prime CCS: Total Imprecision Results – Combined – External Controls
All values below are N=120.
Level 1:
pH: Pooled Mean 7.144, Within Run SD (Sr) 0.004, Within Run %CV 0.06, Total Imprecision SD(St) 0.007, Total Imprecision %CV 0.10
PCO2: Pooled Mean 64.6, Within Run SD (Sr) 0.8, Within Run %CV 1.3, Total Imprecision SD(St) 1.5, Total Imprecision %CV 2.3
PO2: Pooled Mean 56.2, Within Run SD (Sr) 1.8, Within Run %CV 3.2, Total Imprecision SD(St) 2.6, Total Imprecision %CV 4.7
Hct: Pooled Mean 33, Within Run SD (Sr) 0.5, Within Run %CV 1.6, Total Imprecision SD(St) 0.6, Total Imprecision %CV 1.9
Na: Pooled Mean 163.6, Within Run SD (Sr) 0.6, Within Run %CV 0.4, Total Imprecision SD(St) 1.1, Total Imprecision %CV 0.7
K: Pooled Mean 5.69, Within Run SD (Sr) 0.05, Within Run %CV 0.9, Total Imprecision SD(St) 0.08, Total Imprecision %CV 1.4
Cl: Pooled Mean 128.2, Within Run SD (Sr) 0.3, Within Run %CV 0.2, Total Imprecision SD(St) 1.3, Total Imprecision %CV 1.0
iCa: Pooled Mean 1.56, Within Run SD (Sr) 0.007, Within Run %CV 0.5, Total Imprecision SD(St) 0.023, Total Imprecision %CV 1.5
Glu: Pooled Mean 81.0, Within Run SD (Sr) 1.1, Within Run %CV 1.4, Total Imprecision SD(St) 1.4, Total Imprecision %CV 1.8
Lac: Pooled Mean 1.0, Within Run SD (Sr) 0.02, Within Run %CV 2.0, Total Imprecision SD(St) 0.02, Total Imprecision %CV 2.0
Level 2:
pH: Pooled Mean 7.368, Within Run SD (Sr) 0.002, Within Run %CV 0.03, Total Imprecision SD(St) 0.005, Total Imprecision %CV 0.07
PCO2: Pooled Mean 42.5, Within Run SD (Sr) 0.4, Within Run %CV 1.0, Total Imprecision SD(St) 0.8, Total Imprecision %CV 2.0
PO2: Pooled Mean 98.0, Within Run SD (Sr) 0.9, Within Run %CV 1.0, Total Imprecision SD(St) 2.2, Total Imprecision %CV 2.3
Hct: Pooled Mean 51, Within Run SD (Sr) 0.5, Within Run %CV 0.9, Total Imprecision SD(St) 0.6, Total Imprecision %CV 1.2
Na: Pooled Mean 139.7, Within Run SD (Sr) 0.5, Within Run %CV 0.3, Total Imprecision SD(St) 1.0, Total Imprecision %CV 0.7
K: Pooled Mean 3.73, Within Run SD (Sr) 0.02, Within Run %CV 0.5, Total Imprecision SD(St) 0.05, Total Imprecision %CV 1.3
Cl: Pooled Mean 102.1, Within Run SD (Sr) 0.2, Within Run %CV 0.2, Total Imprecision SD(St) 0.4, Total Imprecision %CV 0.4
iCa: Pooled Mean 1.00, Within Run SD (Sr) 0.005, Within Run %CV 0.5, Total Imprecision SD(St) 0.009, Total Imprecision %CV 0.9
Glu: Pooled Mean 203.0, Within Run SD (Sr) 2.2, Within Run %CV 1.1, Total Imprecision SD(St) 4.9, Total Imprecision %CV 2.4
Lac: Pooled Mean 2.8, Within Run SD (Sr) 0.05, Within Run %CV 1.8, Total Imprecision SD(St) 0.06, Total Imprecision %CV 2.1
Level 3:
pH: Pooled Mean 7.562, Within Run SD (Sr) 0.008, Within Run %CV 0.11, Total Imprecision SD(St) 0.009, Total Imprecision %CV 0.12
PCO2: Pooled Mean 25.1, Within Run SD (Sr) 0.7, Within Run %CV 2.7, Total Imprecision SD(St) 1.3, Total Imprecision %CV 5.2
PO2: Pooled Mean 140.8, Within Run SD (Sr) 1.2, Within Run %CV 0.9, Total Imprecision SD(St) 3.2, Total Imprecision %CV 2.3
Hct: Pooled Mean 65, Within Run SD (Sr) 0.5, Within Run %CV 0.8, Total Imprecision SD(St) 0.7, Total Imprecision %CV 1.0
Na: Pooled Mean 117.6, Within Run SD (Sr) 0.3, Within Run %CV 0.2, Total Imprecision SD(St) 0.5, Total Imprecision %CV 0.4
K: Pooled Mean 1.87, Within Run SD (Sr) 0.01, Within Run %CV 0.5, Total Imprecision SD(St) 0.02, Total Imprecision %CV 1.1
Cl: Pooled Mean 87.0, Within Run SD (Sr) 0.4, Within Run %CV 0.5, Total Imprecision SD(St) 0.9, Total Imprecision %CV 1.1
iCa: Pooled Mean 0.55, Within Run SD (Sr) 0.004, Within Run %CV 0.7, Total Imprecision SD(St) 0.007, Total Imprecision %CV 1.3
Glu: Pooled Mean 318.0, Within Run SD (Sr) 4.2, Within Run %CV 1.3, Total Imprecision SD(St) 9.0, Total Imprecision %CV 2.8
Lac: Pooled Mean 7.1, Within Run SD (Sr) 0.1, Within Run %CV 0.7, Total Imprecision SD(St) 0.12, Total Imprecision %CV 1.7
Low Hematocrit:
Hct: Pooled Mean 19, Within Run SD (Sr) 0.4, Within Run %CV 2.2, Total Imprecision SD(St) 0.5, Total Imprecision %CV 2.6
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Lactate Interference:
Glycolic acid: 0.0 mmol/L, No interference observed. 0.25 mmol/L, Bias of 11.7%
Hydroxyurea: 0.0 mg/dL, No interference observed. 0.2 mg/dL, Bias of 20.1%
Lactate Limit of Detection/Quantitation:
LoB: 2.70 mg/dL / 0.30 mmol/L
LoD: 3.60 mg/dL / 0.40 mmol/L
LoQ: 3.60 mg/dL / 0.40 mmol/L
Average Total Error: 0.13
Acceptance Criteria for Total Error: ≤ 0.3
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.
K131703 - Nova Stat Profile Prime CCS Analyzer System
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.
Not Found
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).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
NOVA BIOMEDICAL CORPORATION PAUL MACDONALD CHIEF QUALITY AND REGULATORY AFFAIRS OFFICER 200 PROSPECT ST WALTHAM MA 02454
Re: K141907 Trade/Device Name: Stat Profile® Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp and Nova Linearity Standard Set A Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, GKF, KHP, JIX, JJS Dated: April 24, 2015 Received: April 27, 2015
Dear Mr. Paul Macdonald:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does 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 may be subject to additional controls. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Katherine Serrano -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
2
Indications for Use
510(k) Number (if known) K141907
Device Name
Stat Profile® Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/ CCS,Stat Profile Prime Calibrator Cartridge CCS/CCS Comp, Nova Linearity Standard Set A
Indications for Use (Describe)
The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, PCO2, PO2, Hct, Na+. K-, CL-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.
PC02,P02,pH: Whole blood measurement of certain gases in whole blood,or pH of whole blood,is used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states,such as anemia and erythrocytosis (an increase in the number of red cells).
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism,diabetes insipidus, adrenal hypertension, Addison's disease,dehydration,or diseases involving electrolyte imbalance.
K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
iCa: Calcium 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).
Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus,neonatal hypoglycemia,and idiopathic hypoglycemia,and of pancreatic islet cell carcinoma.
Lac: Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients lactic acidosis.
The Stat Profile Prime Auto QC Cartridge CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.
The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.
The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glucose and Lactate using the Stat Profile Prime CCS Analyzer.
Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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: | K141907 |
|---|---|
| 510(k) Owner: | Nova Biomedical Corporation |
| Registration Number: | 1219029 |
| Address: | 200 Prospect St. |
| Waltham, MA 02454 | |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Paul W. MacDonald |
| Date Prepared: | 22 May, 2015 |
Proprietary Name: Stat Profile® Prime CCS Analyzer System, Stat Profile Prime Auto QC cartridges CCS, Ampuled Control ABG/CCS, Calibrator Cartridge CCS/CCS Comp, and the Nova Linearity Standard Set A
Common or Usual Name: Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer
Classification Name: Multiple
| Classification Names: | Class No. | Reg. No. | Class |
|---|---|---|---|
| Blood Gases and Blood pH system | 75CHL | 862.1120 | II |
| Sodium Test System | 75JGS | 862.1665 | II |
| Potassium Test System | 75CEM | 862.1600 | II |
| Calcium Test System | 75JFP | 862.1145 | II |
| Chloride Test System | 75CGZ | 862.1170 | II |
| Glucose Test System | 75CGA | 862.1345 | II |
| Instrument, Hematocrit, Automated | 81GKF | 864.5600 | II |
| Lactic Acid Test System | 75KHP | 862.1450 | I |
| Calibrators | 75JIX | 862.1150 | II |
| Quality Control Materials | 75JJS | 862.1660 | I |
Product Codes: CHL, JGS, CEM, JFP, CGZ, CGA, GKF, JIX, JJS, KHP
Predicate Device: K131703 - Nova Stat Profile Prime CCS Analyzer System (including controls, calibrators and linearity standards)
Device Description:
The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.
Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flow path and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose) and Lac (Lactate). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.
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The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:
- traditional sensor technology to measure blood pO2 ●
- ion selective electrode technology to measure pH, pCO2, blood sodium, potassium, chloride, and ionized calcium
- enzyme/Amperometric technology for glucose measurements
Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.
Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge agueous solutions allow for 2 point calibration of each parameter as follows:
- Calibrator A pH, PCO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 500 mL) ●
- Calibrator B pH, PO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 250 mL) .
- Calibrator F PCO2, PO2 (Volume > 720 mL) ●
- Reference Solution KCI (Volume > 300 mL) .
The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, Cl, iCa, Glucose (Glu) and Lactate. The solutions are equilibrated with known levels of 02, CO2, and N2. Each ampule contains 1.7 ml volume.
The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, Glucose (Glu) and Lactate. The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl. iCa. Glucose (Glu) and Lactate. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:
- . Control 1: Acidosis, with High Electrolyte, Low Normal Glu, and Lactate
- Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu, and Lactate ●
- . Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, and Lactate
Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, Lactate, K+, and Cl-. Each ampule contains 1.8 ml volume.
The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.
Measured Parameters:
The Stat Profile Prime CCS Analyzer measures pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu and Lactate (Note: Glucose and Lactate are optional).
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Calculated Parameters:
- pH, PCO2, PO2 (corrected to patient temperature) ●
- Bicarbonate level (HCO3-) ●
- . Total Carbon Dioxide (TCO2)
- Base Excess of the blood (BE-b)
- Base Excess of extracellular fluid (BE-ecf) .
- Standard Bicarbonate Concentration (SBC) ●
- Oxygen Content (O2Ct) ●
- . Oxygen Capacity (O₂Cap)
- Alveolar Oxygen (A) .
- Arterial Alveolar Oxygen Tension Gradient (AaDO2) ●
- Arterial Alveolar Oxygen Tension Ratio (a/A) .
- Respiratory Index (RI)
- . P50
- PO2/FIO2 ratio .
- Oxygen Saturation (SO2%) .
- Hemoqlobin
- . Anion Gap
- Normalized Calcium, nCa ●
Intended Use:
The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, PO2, Hct, Na*, K*, Clr, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.
| PCO2,
PO2,
pH | Whole blood measurement of certain gases in whole blood, or pH of whole blood, is
used in the diagnosis and treatment of life-threatening acid-base disturbances. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hct | Whole blood measurements of the packed red cell volume of a blood sample are used
to distinguish normal from abnormal states, such as anemia and erythrocytosis (an
increase in the number of red cells). |
| Na+ | Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes
insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving
electrolyte imbalance. |
| K+ | Potassium Measurement is used to monitor electrolyte balance in the diagnosis and
treatment of disease conditions characterized by low or high potassium levels. |
| Cl- | Chloride measurement is used in the diagnosis and treatment of electrolyte and
metabolic disorders such as cystic fibrosis and diabetic acidosis. |
| iCa | Calcium 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). |
| Glu | Glucose measurement is used in the diagnosis and treatment of carbohydrate
metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and
idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. |
| Lac | Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients
suspected of having lactic acidosis. |
Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.
7
Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.
Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na*, K*, Cl*, iCa, Glucose, and Lactate, using the Stat Profile Prime CCS Analyzer.
Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.
Summary of the Technological Characteristics:
The Stat Profile Prime CCS Analyzer is substantially equivalent to the previously cleared for market Stat Profile Prime CCS Analyzer System in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the internal and external controls and the calibration cartridge are the same for the tested parameters. The linearity standards for use with the Stat Profile Prime CCS Analyzer are identical to those cleared for use with the predicate Stat Profile Prime CCS Analyzer System.
Summary of Performance Testing:
Testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile pHOx Ultra Analyzer System.
In this submission, only Lactate data for detection limit. Iinearity, and interference/specificity was reviewed and cleared. Performance data for all other analytes was presented and reviewed in the predicate device submission (K131703 - Stat Profile Prime CCS Analyzer).
Method Comparison
Method comparison studies were performed. A minimum of 150 whole blood specimens were analyzed for each parameter in svringe collection devices. Some samples were altered in order to achieve the hard-to-find sample range. The samples were analyzed on each of the Stat Profile Prime CCS analyzers and on each of the pHOx Ultra analyzers. The Stat Profile Prime CCS results for each analyzer were compared to the average of the 2 results from the pHOx Ultra comparative method.
Table 1: Syringe method comparison study results vs. the predicate device (Stat Profile pHOx Ultra)
| Test
Parameter | Total #
samples | Sample range tested | Slope | Intercept | r |
|-------------------|--------------------|------------------------|--------|-----------|--------|
| pH | 172 | 6.523 - 7.862 pH units | 0.9976 | 0.0099 | 0.9985 |
| pCO2 | 179 | 3.4 - 200.0 mmHg | 0.9854 | 0.9344 | 0.9977 |
| pO2 | 167 | 29.5 - 593.2 mmHg | 0.9897 | 1.4508 | 0.9988 |
| Hct | 174 | 12 - 70% | 1.0445 | -1.9271 | 0.9889 |
| Na | 180 | 85.5 - 195.7 mmol/L | 1.0189 | -2.2841 | 0.9955 |
| K | 179 | 1.11 - 19.75 mmol/L | 1.0163 | -0.0371 | 0.9996 |
| iCa | 181 | 0.25 - 2.48 mmol/L | 0.9880 | 0.0457 | 0.9974 |
| Cl | 186 | 52.8 - 189.3 mmol/L | 1.0003 | 1.0158 | 0.9955 |
| Glu | 185 | 39 - 474 mg/dL | 1.0007 | -2.6844 | 0.9892 |
| Lac | 182 | 0.4 - 17.8 | 0.9841 | -0.0937 | 0.9974 |
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Whole blood patient samples were evaluated to demonstrate that syringe sample mode and capillary sample mode are equivalent. The syringe sample was analyzed directly using the syringe mode. After the measurement, samples were transferred from the syringe into the capillary tube and then analyzed using the capillary mode. Approximately 100 whole blood samples were analyzed for each parameter. The capillary test result was compared to the syringe test result and linear regression analysis was performed. Results are summarized in the table below.
| Parameter | total #
samples | sample range
tested | Slope | Intercept | r |
|----------------|--------------------|------------------------|--------|-----------|--------|
| pH
pH units | 100 | 6.787 - 7.683 | 1.0094 | -0.0721 | 0.9988 |
| pCO2
mmHg | 100 | 17.7 - 111.0 | 1.0026 | -0.4347 | 0.9989 |
| pO2
mmHg | 100 | 25.5 - 435.2 | 0.9942 | 2.1791 | 0.9996 |
| Hct
% | 100 | 14 - 69 | 1.0013 | 0.0485 | 0.9963 |
| Na
mmol/L | 100 | 85.0 - 198.1 | 0.9995 | -0.1711 | 0.9978 |
| K
mmol/L | 100 | 2.70 - 19.37 | 0.9966 | 0.0934 | 0.9996 |
| iCa
mmol/L | 98 | 0.33 - 2.51 | 1.0228 | -0.0603 | 0.9855 |
| Cl
mmol/L | 100 | 55.8 - 197.1 | 0.9897 | 0.1776 | 0.9997 |
| Glu
mg/dL | 100 | 17 - 488 | 0.9855 | -0.4734 | 0.9998 |
| Lac
mmol/L | 100 | 1.1 - 18.1 | 1.0034 | -0.0120 | 0.9994 |
Table 2: Method Comparison Results - Capillary vs. Syringe
Specificity / Interference Testing Protocol:
Li-heparin whole blood samples were used in the interference study. For the initial testing, each interferent was spiked at 20 times the recommended concentration by CLSI EP-7 A2. Each sample containing interferent was evaluated against the same whole blood sample without the interferent. If interference was observed, a dose response study was performed at two analytes concentrations (low and high) to determine the highest substance concentration where no interference was observed. The sponsor's definition of significant interference is ±10% bias for Lactate. The following table represents substances that were tested without demonstrating a significant interference on test results:
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| Interfering Substance | Highest Concentration Tested |
|---|---|
| Acetaminophen | 20.0 mg/dL |
| Acetoacetate | 2.0 mmol/L |
| Acetylsalicylic acid | 3.62 mmol/L |
| Ammonium Chloride | 107.0 µmol/L |
| Ascorbic Acid | 50 mg/dL |
| Benzylkonium Chloride | 10.0 mg/L |
| BetaHydroxybutyrate | 2.0 mmol/L |
| Bilirubin | 20.0 mg/dL |
| D-Galactose | 1.0 mmol/L |
| Dobutamine | 2.0 mg/dL |
| Dopamine Hydrochloride | 5.87 µmol/L |
| EDTA | 3.4 µmol/L |
| Ethanol | 86.8 mmol/L |
| Fluoride | 105 µmol/L |
| Glucose | 1,000 mg/dL |
| Glucosamine | 30.0 µmol/L |
| Hemoglobin | 2.0 g/L |
| Heparin | 100 IU/mL |
| Ibuprofen | 2.4 mmol/L |
| Intralipid | 10.0 mg/mL |
| Maltose | 13.0 mmol/L |
| Mannose | 1.0 mmol/L |
| Potassium Thiocyanate | 2,064 µmol/L |
| Pyruvate | 309 µmol/L |
| Salicylic Acid | 4.34 mmol/L |
| Sodium Bromide | 37.5 mmol/L |
| Sodium Citrate | 12.0 mmol/L |
| Sodium Oxalate | 500 mg/dL |
| Thiocyanate | 6.8 mmol/L |
| Urea | 40.0 mg/dL |
| Uric Acid | 1.4 mmol/L |
| Xylose | 25.0 mg/dL |
Table 3: Substances Tested for Lactate Interference
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The following table represents substances that were tested that demonstrated a significant interference on test results:
| Parameter | Interfering
Substance | Concentration of
interfering substance | Interference |
|-----------|--------------------------|-------------------------------------------|--------------------------|
| Lactate | Glycolic acid | 0.0 mmol/L | No interference observed |
| | | 0.25 mmol/L | Bias of 11.7% |
| | Hydroxyurea | 0.0 mg/dL | No interference observed |
| | | 0.2 mg/dL | Bias of 20.1% |
Table 4: Lactate Interfering Substances
Determination of Limit of Detection: Limit of Detection was determined by obtaining the standard deviation of sample measurements from repeated measurements of samples with a relevant low concentration. Three blood samples with low level lactate concentration were used to estimate the limit of detection.
Table 5: Lactate Limit of Detection
| Limit of Detection | ||||||
|---|---|---|---|---|---|---|
| LoB | LoD | LoQ | Average | |||
| Total Error | Acceptance | |||||
| Criteria for | ||||||
| Total Error | Claimed | |||||
| Measurement | ||||||
| Range | ||||||
| Lac | 2.70 mg/dL | |||||
| 0.30 mmol/L | 3.60 mg/dL | |||||
| 0.40 mmol/L | 3.60 mg/dL | |||||
| 0.40 mmol/L | 0.13 | ≤ 0.3 | 3.6 - 178.6 mg/dL | |||
| 0.4 - 20.0 mmol/L |
Lactate Linearity: Samples were prepared by tonometering, spiking or diluting whole blood to span the analytical measurement range for lactate. Each blood level sample was analyzed in triplicate on each of the three (3) test analyzers and on the pHOx Ultra analyzers. The pHOx Ultra analyzers were used to establish the target value of each blood level for lactate.
Table 6: Lactate Linearity Results
| Individual Analyzer Performance Data | ||||||
|---|---|---|---|---|---|---|
| Parameter | total # | |||||
| levels | Specimen | |||||
| range | Analyze | |||||
| r | Slope | Intercept | r | |||
| Lac | 11 | 0.2 - 24.9 | #1 | 0.9946 | 0.1178 | 0.9992 |
| 0.2 - 24.7 | #2 | 0.9920 | 0.1431 | 0.9994 | ||
| 0.2 - 24.8 | #3 | 0.9911 | 0.2117 | 0.9993 |
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Point-of-Care
A Point-of-Care study was conducted to demonstrate that the system was safe and effective for use in the POC setting. The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer. The Stat Profile Prime CCS Analyzer was evaluated by point-of-care (POC) personnel in 3 POC sites including a cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU) and a trauma/neuro intensive care unit. A total of 43 respiratory therapy and 10 Nursing POC personnel participated from the 3 POC settings over the study. The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized. All testing was performed using discarded blood gas specimens.
Combined data from all 3 POC settings is summarized in Tables 7 and 8.
| Parameter | Total #
specimens | Whole Blood
Range | Slope | Intercept | r |
|------------|----------------------|----------------------|-------|-----------|-------|
| рн | 234 | 6.874 - 7.665 | 0.983 | 0.116 | 0.997 |
| PCO2 mmHg | 230 | 4.1 - 195.5 | 1.007 | 0.750 | 0.998 |
| PO2 mmHg | 234 | 15.2 - 714.5 | 1.005 | -0.094 | 0.999 |
| Hct % | 222 | 12 - 70 | 0.997 | 0.395 | 0.985 |
| Na mmol/L | 229 | 83.2 - 192.3 | 1.020 | -2.540 | 0.998 |
| K mmol/L | 231 | 1.10 - 18.80 | 0.974 | 0.110 | 0.999 |
| iCa mmol/L | 234 | 0.26 - 2.55 | 1.001 | 0.004 | 0.999 |
| Cl mmol/L | 234 | 53.0 - 188.7 | 1.000 | -0.020 | 0.999 |
| Glu mg/dL | 233 | 17 - 478 | 0.989 | 1.517 | 0.998 |
| Lac mmol/L | 233 | 0.6 - 19.5 | 1.018 | -0.093 | 0.998 |
Table 7: Prime CCS: POC v Trained Healthcare Professional (THP) - Svringe Mode
Table 8: Prime CCS: POC v Trained Healthcare Professional (THP) - Capillary Mode
| Parameter | Total #
specimens | Whole Blood
Range | Slope | Intercept | r |
|------------|----------------------|----------------------|-------|-----------|-------|
| pH | 173 | 6.881 - 7.780 | 0.962 | 0.275 | 0.997 |
| PCO2 mmHg | 170 | 3.2 - 181.4 | 0.989 | 0.899 | 0.998 |
| PO2 mmHg | 173 | 22.8 - 597.3 | 0.979 | 3.141 | 0.999 |
| Hct % | 157 | 13 - 68 | 0.978 | 0.399 | 0.984 |
| Na mmol/L | 169 | 83.2 - 197.0 | 1.010 | -1.258 | 0.997 |
| K mmol/L | 168 | 1.15 - 19.47 | 1.006 | -0.025 | 0.998 |
| iCa mmol/L | 173 | 0.32 - 2.45 | 0.977 | 0.029 | 0.996 |
| Cl mmol/L | 173 | 55.9 - 188.1 | 1.007 | -0.710 | 0.997 |
| Glu mg/dL | 173 | 15 - 484 | 1.004 | 0.036 | 0.999 |
| Lac mmol/L | 173 | 0.6 - 18.4 | 1.019 | -0.127 | 0.998 |
Total Imprecision Performance
The total imprecision data included in the following table was obtained from different POC site personnel running 3 levels of Stat Profile Prime External Quality Control material (Levels 1-3) in duplicate each day for a total of 20 runs on 3 Stat Profile Prime CCS analyzers. The protocol was based upon methods described in CLSI "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second edition," CLSI EP5-A2. The test data is representative of the expected total imprecision between analyzer performance obtainable by POC personnel using the Stat Profile Prime CCS analyzer using external quality control materials.
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| Combined Total Imprecision Data - Level 1 | ||||||
|---|---|---|---|---|---|---|
| Parameter | Pooled | |||||
| Mean | N | Within Run SD (Sr) | Within Run %CV | Total Imprecision SD(St) | Total Imprecision %CV | |
| pH | 7.144 | 120 | 0.004 | 0.06 | 0.007 | 0.10 |
| PCO2 | 64.6 | 120 | 0.8 | 1.3 | 1.5 | 2.3 |
| PO2 | 56.2 | 120 | 1.8 | 3.2 | 2.6 | 4.7 |
| Hct | 33 | 120 | 0.5 | 1.6 | 0.6 | 1.9 |
| Na | 163.6 | 120 | 0.6 | 0.4 | 1.1 | 0.7 |
| K | 5.69 | 120 | 0.05 | 0.9 | 0.08 | 1.4 |
| Cl | 128.2 | 120 | 0.3 | 0.2 | 1.3 | 1.0 |
| iCa | 1.56 | 120 | 0.007 | 0.5 | 0.023 | 1.5 |
| Glu | 81.0 | 120 | 1.1 | 1.4 | 1.4 | 1.8 |
| Lac | 1.0 | 120 | 0.02 | 2.0 | 0.02 | 2.0 |
| Combined Total Imprecision Data - Level 2 | ||||||
| pH | 7.368 | 120 | 0.002 | 0.03 | 0.005 | 0.07 |
| PCO2 | 42.5 | 120 | 0.4 | 1.0 | 0.8 | 2.0 |
| PO2 | 98.0 | 120 | 0.9 | 1.0 | 2.2 | 2.3 |
| Hct | 51 | 120 | 0.5 | 0.9 | 0.6 | 1.2 |
| Na | 139.7 | 120 | 0.5 | 0.3 | 1.0 | 0.7 |
| K | 3.73 | 120 | 0.02 | 0.5 | 0.05 | 1.3 |
| Cl | 102.1 | 120 | 0.2 | 0.2 | 0.4 | 0.4 |
| iCa | 1.00 | 120 | 0.005 | 0.5 | 0.009 | 0.9 |
| Glu | 203.0 | 120 | 2.2 | 1.1 | 4.9 | 2.4 |
| Lac | 2.8 | 120 | 0.05 | 1.8 | 0.06 | 2.1 |
| Combined Total Imprecision Data - Level 3 | ||||||
| pH | 7.562 | 120 | 0.008 | 0.11 | 0.009 | 0.12 |
| PCO2 | 25.1 | 120 | 0.7 | 2.7 | 1.3 | 5.2 |
| PO2 | 140.8 | 120 | 1.2 | 0.9 | 3.2 | 2.3 |
| Hct | 65 | 120 | 0.5 | 0.8 | 0.7 | 1.0 |
| Na | 117.6 | 120 | 0.3 | 0.2 | 0.5 | 0.4 |
| K | 1.87 | 120 | 0.01 | 0.5 | 0.02 | 1.1 |
| Cl | 87.0 | 120 | 0.4 | 0.5 | 0.9 | 1.1 |
| iCa | 0.55 | 120 | 0.004 | 0.7 | 0.007 | 1.3 |
| Glu | 318.0 | 120 | 4.2 | 1.3 | 9.0 | 2.8 |
| Lac | 7.1 | 120 | 0.1 | 0.7 | 0.12 | 1.7 |
| Combined Total Imprecision Data - Low Hematocrit | ||||||
| Hct | 19 | 120 | 0.4 | 2.2 | 0.5 | 2.6 |
Table 9: Prime CCS: Total Imprecision Results – Combined – External Controls
13
| Table 10: Comparison of Predicate and Proposed devices | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -------------------------------------------------------- |
| Characteristic | Predicate: K131703 Stat Profile Prime CCS Analyzer | Proposed: Stat Profile Prime CCS Analyzer | |
|---|---|---|---|
| Indication For Use | The Stat Profile Prime CCS Analyzer System is intended for in vitro | ||
| diagnostic use by health care professionals in clinical laboratory | |||
| settings for the quantitative determination of pH, PCO2, PO2, Hct, | |||
| Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood. | The Stat Profile Prime CCS Analyzer System is | ||
| intended for in vitro diagnostic use by health care | |||
| professionals in clinical laboratory settings and for | |||
| point-of-care usage for the quantitative determination of | |||
| pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), | |||
| and Lac (Lactate) in heparinized whole blood. | |||
| PCO2, | |||
| PO2, | |||
| pH | Whole blood measurement of blood gases is used in the | ||
| diagnosis and treatment of life-threatening acid-base | |||
| disturbances in critically ill patients with numerous metabolic | |||
| and pulmonary diseases. | Same | ||
| Hct | Whole blood measurements of hematocrit are used to | ||
| estimate that red blood cells are present in sufficient | |||
| quantity to carry oxygen and carbon dioxide. | Same | ||
| Na+ | Sodium measurement is used in the diagnosis and | ||
| treatment of aldosteronism, diabetes insipidus, adrenal | |||
| hypertension, Addison's disease, dehydration, or diseases | |||
| involving electrolyte imbalance. | Same | ||
| K+ | Potassium Measurement is used to monitor electrolyte | ||
| balance in the diagnosis and treatment of disease | |||
| conditions characterized by low or high potassium levels. | Same | ||
| Cl- | Chloride measurement is used in the diagnosis and | ||
| treatment of electrolyte and metabolic disorders such as | |||
| cystic fibrosis and diabetic acidosis. | Same | ||
| iCa | Ionized Calcium measurement is used in the diagnosis and | ||
| treatment of hypertension, renal disease, and vitamin D | |||
| related disorders. Also useful in the diagnosis and treatment | |||
| of patients with increased total protein and/or albumin | |||
| levels, as in dehydration. | Same | ||
| Characteristic | Predicate: K131703 Stat Profile Prime CCS Analyzer | Proposed: Stat Profile Prime CCS Analyzer | |
| Glu | Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. | Same | |
| Lac | Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis. | Same | |
| Acceptable Samples | Lithium heparinized whole blood from syringes, open tubes, small cups, and capillary tubes. | Same | |
| Sample Volumes | 100µL (syringe and capillary) | Same | |
| Measurement Range | |||
| pH | 6.500-8.000 | Same | |
| PCO2 | 3.0 -200 mmHg | Same | |
| PO2 | 5-765 mmHg | Same | |
| Hct | 12%-70% | Same | |
| Na+ | 80-200 mmol/L | Same | |
| K+ | 1.0-20.0 mmol/L | Same | |
| Cl- | 50-200 mmol/L | Same | |
| iCa (Ca++) | 0.20-2.70 mmol/L | Same | |
| Glu | 15-500 mg/dL | Same | |
| Lac | 0.3-20.0 mmol/L | Same | |
| Principles of Measurement | |||
| pH | Hydrogen ion-selective sensor | Same | |
| Characteristic | Predicate: K131703 Stat Profile Prime CCS Analyzer | Proposed: Stat Profile Prime CCS Analyzer | |
| PCO2 | Severinghaus-type sensor | Same | |
| PO2 | Polarographic Clark-type sensor | Same | |
| Hct | Impedance sensor | Same | |
| Na+ | Sodium ion-selective sensor | Same | |
| K+ | Potassium ion-selective sensor | Same | |
| Cl- | Chloride ion-selective sensor | Same | |
| iCa (Ca++) | Calcium ion-selective sensor | Same | |
| Glu | Glucose Oxidase Enzymatic sensor | Same | |
| Lac | Lactate Oxidase Enzymatic sensor | Same | |
| Touch Screen | 5.7" VGA full color display with LED backlight and integrated touch | ||
| panel | Same | ||
| Menu | Fully configurable test menu based on above sensors | Same | |
| Bar Code Scanner | Internal Integrated 1D/2D | Same | |
| Printer | 2" Roll, Thermal Transfer | Same | |
| Pump | Peristaltic Pump w/ Pressure Plate, TPE Tubing (Pharmed BPT) | Same | |
| Analog Board | Precision low level analog front end w/ amperometric and | ||
| potentiometric amplifiers, air detector circuitry and temperature | |||
| control circuitry | Same |
14
15
16
| Characteristic | Predicate: K131703 Stat Profile Prime Calibrator Cartridge CCS | Proposed: Stat Profile Prime Calibrator
Cartridge CCS |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The Stat Profile Prime Calibrator Cartridge CCS is intended for the
calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glucose using the
Stat Profile Prime CCS Analyzer. | The Stat Profile Prime Calibrator Cartridge CCS
is intended for the calibration of pH, PCO2, PO2,
Hct, Na+, K+, Cl-, iCa, Glucose (Glu), and Lactate
(Lac) using the Stat Profile Prime CCS Analyzer. |
| Settings | Clinical Laboratories | Clinical Laboratories and/or Point Of Care |
| Configuration | 2 level calibration standards per analyte, and reference solution | Same |
| Packaging | Liquid in Mylar bags inside cardboard container. Includes a waste
collection bag. Self-contained, disposable packaging. | Same |
| Characteristic | Predicate: K131703 Stat Profile Prime Auto QC Cartridge CCS | Proposed: Stat Profile Prime Auto QC Cartridge CCS |
|---|---|---|
| Indication For Use | The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer. | Same |
| Settings | Clinical Laboratories | Clinical Laboratories and/or Point Of Care |
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Cartridge: Solution in Mylar bags inside cardboard container. Includes a waste collection bag. Self-contained, disposable packaging. | Same |
| Characteristic | Predicate: K131703 Stat Profile Prime Ampuled Control ABG/CCS | Proposed: Stat Profile Prime Ampuled
Control ABG/CCS |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication For Use | The Stat Profile Prime Ampuled Control ABG/CCS is a quality control
material intended for in vitro diagnostic use by healthcare professionals for
monitoring the performance of Stat Profile Prime CCS Analyzer. | Same |
| Settings | Clinical Laboratories | Clinical Laboratories and/or Point Of Care |
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Ampules: Each glass ampule contains 1.7 ml volume. | Same |
17
| Characteristic | Predicate: K131703 Linearity Standard Set A | Proposed: Linearity Standard Set A |
|---|---|---|
| Indication For Use | The Linearity Standard Set A is intended for in vitro diagnostic use with | |
| Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, | ||
| estimate test imprecision, and detect systematic analytical deviations that | ||
| may arise from calibrator cartridge or analytical instrument variation. | Same | |
| Settings | Clinical Laboratories | Clinical Laboratories and/or Point Of Care |
| Configuration | 4 level aqueous solutions in glass ampules. Contain electrolyte, metabolite | |
| and gas solutions. | Same | |
| Packaging | Ampules: Each glass ampule contains 1.8 ml volume | Same |
Conclusion:
The results of software validation and perfication testing confirmed that the Stat Profile Prime CCS Analyzer is safe and effective for its intended purpose and that the Stat Profile Prime CCS Analyzer System is substantially equivalent to the Profile Prine CCS Analyzer System (K131703).