(318 days)
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.
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.
Here's a summary of the acceptance criteria and the study details for the Stat Profile® Prime CCS Analyzer System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each parameter (e.g., a specific bias range for method comparison). Instead, it presents the results of equivalency studies against a predicate device and within the device itself (capillary vs. syringe, POC vs. trained healthcare professional). The implication is that the performance shown in these tables met the internal acceptance criteria for substantial equivalence to the predicate and for safe and effective use.
I will formulate a table focusing on the Method Comparison and Point-of-Care (POC) vs. Trained Healthcare Professional (THP) studies, as these directly compare the device's performance to established methods or user groups. The "Acceptance Criteria" column will represent the implicit expectation of strong correlation (high 'r' value, slope near 1, intercept near 0) for substantial equivalence and reliable performance.
| Parameter (Analyte) | Study Type | Acceptance Criteria (Implicit) | Reported Device Performance (Slope, Intercept, r) |
|---|---|---|---|
| pH | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 (strong correlation) | 0.9976, 0.0099, 0.9985 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0094, -0.0721, 0.9988 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.983, 0.116, 0.997 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.962, 0.275, 0.997 | |
| PCO2 | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9854, 0.9344, 0.9977 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0026, -0.4347, 0.9989 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.007, 0.750, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.989, 0.899, 0.998 | |
| PO2 | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9897, 1.4508, 0.9988 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9942, 2.1791, 0.9996 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.005, -0.094, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.979, 3.141, 0.999 | |
| Hct | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0445, -1.9271, 0.9889 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0013, 0.0485, 0.9963 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.997, 0.395, 0.985 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.978, 0.399, 0.984 | |
| Na+ | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0189, -2.2841, 0.9955 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9995, -0.1711, 0.9978 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.020, -2.540, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.010, -1.258, 0.997 | |
| K+ | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0163, -0.0371, 0.9996 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9966, 0.0934, 0.9996 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.974, 0.110, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.006, -0.025, 0.998 | |
| iCa | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9880, 0.0457, 0.9974 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0228, -0.0603, 0.9855 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.001, 0.004, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.977, 0.029, 0.996 | |
| Cl- | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0003, 1.0158, 0.9955 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9897, 0.1776, 0.9997 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.000, -0.020, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.007, -0.710, 0.997 | |
| Glu | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0007, -2.6844, 0.9892 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9855, -0.4734, 0.9998 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.989, 1.517, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.004, 0.036, 0.999 | |
| Lac | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9841, -0.0937, 0.9974 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0034, -0.0120, 0.9994 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.018, -0.093, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.019, -0.127, 0.998 | |
| Lactate Limit of Detection (LoD) | Total Error ≤ 0.3 (mmol/L) | 0.13 (mmol/L) | |
| Lactate Linearity (r value for individual analyzer) | r ≈ 1 | 0.9992, 0.9994, 0.9993 (for 3 analyzers) | |
| General | Interference Testing (Lactate) | Bias < ±10% for non-interfering substances | Various substances tested with no significant interference. Glycolic acid (0.25 mmol/L) showed 11.7% bias, Hydroxyurea (0.2 mg/dL) showed 20.1% bias. |
| Total Imprecision (e.g., pH Level 1) | Low SD and %CV | pH: 0.007 SD, 0.10% CV | |
| Total Imprecision (e.g., Lac Level 1) | Low SD and %CV | Lac: 0.02 SD, 2.0% CV |
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison (vs. Predicate):
- Sample Size: A minimum of 150 whole blood specimens for each parameter (ranging from 167 for pO2 to 186 for Cl).
- Data Provenance: Not explicitly stated, but the samples were whole blood specimens. Given the context of seeking FDA clearance in the US, it's highly probable the data was collected within the United States. It used a predicate device (Stat Profile pHOx Ultra) for comparison, implying a retrospective comparison against results obtained from the predicate or concurrently with the predicate. The statement "Some samples were altered in order to achieve the hard-to-find sample range" suggests a controlled, laboratory-based study, likely prospective for the new device.
- Capillary vs. Syringe Equivalency:
- Sample Size: Approximately 100 whole blood samples for each parameter (ranging from 98 for iCa to 100 for others).
- Data Provenance: Not explicitly stated, but implies a controlled, likely prospective study comparing two sampling modes on the same device.
- Point-of-Care (POC) vs. Trained Healthcare Professional (THP):
- Sample Size:
- Syringe Mode: Ranged from 222 (Hct) to 234 (pH, PO2, iCa, Cl) specimens.
- Capillary Mode: Ranged from 157 (Hct) to 173 (pH, PO2, iCa, Cl, Glu, Lac) specimens.
- Data Provenance: The study was conducted in 3 POC sites (cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU), and a trauma/neuro intensive care unit). All testing used "discarded blood gas specimens." This implies a prospective study using real-world patient samples collected at these clinical sites.
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Method Comparison: The predicate device, Stat Profile pHOx Ultra, was used as the comparative method. The "ground truth" for the new device's performance was established by comparing its results to the average of two results from the pHOx Ultra comparative method. This means the "experts" were the established and validated measurement capabilities of the predicate device, not human experts in interpreting results.
- Capillary vs. Syringe: The "ground truth" for comparison was the syringe sample results from the same new device.
- Point-of-Care (POC) vs. Trained Healthcare Professional (THP): The "ground truth" for comparison was the results obtained by "Trained Healthcare Professionals" (THP) also using the new device. The qualifications for THP are simply stated as "trained Healthcare Professionals." While the POC personnel included 43 respiratory therapy and 10 Nursing POC personnel from 3 POC settings, the specific qualifications of the "Trained Healthcare Professionals" are not detailed.
4. Adjudication Method for the Test Set
- Method Comparison: The ground truth involved the average of 2 results from the predicate device (pHOx Ultra). If these two results were the reference method, it implies an internal comparison against a standard, not an adjudication process among human readers.
- Capillary vs. Syringe & POC vs. THP: These studies involved direct comparison between two measurements from different methods/users. There's no mention of a separate adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that interprets images or provides a diagnosis. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is essentially a standalone performance study for an automated in vitro diagnostic device. The device itself (its sensors and integrated system) performs the measurements. The comparison studies (Method Comparison, Capillary vs. Syringe) evaluate the analytical performance of the algorithm/device itself.
- The POC study implicitly evaluates the human-in-the-loop aspect for correct operation of the device by different user groups, but the measurement itself is performed by the standalone instrument.
7. The Type of Ground Truth Used
- Established Reference Method/Predicate Device: For the method comparison, the "ground truth" was established by the predicate device (Stat Profile pHOx Ultra), which is itself a legally marketed and presumably validated medical device. For Lactate linearity, the pHOx Ultra analyzers were used to establish the "target value" of each blood level.
- Internal Device Consistency: For the capillary vs. syringe study, the syringe measurement mode on the new device served as the reference for the capillary mode.
- Trained Professional Reference: For the Point-of-Care study, the measurements taken by "Trained Healthcare Professionals" using the new device served as the reference for measurements taken by POC personnel.
8. The Sample size for the training set
The document describes performance testing for substantial equivalence, not the development or training of an algorithm for the device. Therefore, a "training set" in the context of machine learning or AI is not applicable to this submission. The device relies on traditional sensor technology and measurement algorithms, which are engineered and validated rather than "trained" with data sets in the AI sense.
9. How the ground truth for the training set was established
As there is no explicit "training set" mentioned or implied for an AI algorithm, this question is not applicable to the information provided. The "ground truth" for the device's development and validation would have been established through a combination of engineering specifications, chemical/electrical standards, and established reference methods/materials for each analyte.
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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
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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, isused 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 usedto distinguish normal from abnormal states, such as anemia and erythrocytosis (anincrease in the number of red cells). |
| Na+ | Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetesinsipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involvingelectrolyte imbalance. |
| K+ | Potassium Measurement is used to monitor electrolyte balance in the diagnosis andtreatment of disease conditions characterized by low or high potassium levels. |
| Cl- | Chloride measurement is used in the diagnosis and treatment of electrolyte andmetabolic 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 muscularcontractions or spasms). |
| Glu | Glucose measurement is used in the diagnosis and treatment of carbohydratemetabolism disturbances including diabetes mellitus, neonatal hypoglycemia, andidiopathic hypoglycemia, and of pancreatic islet cell carcinoma. |
| Lac | Lactate (lactic acid) measurement is used to evaluate the acid-base status of patientssuspected 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.
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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)
| TestParameter | 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 rangetested | Slope | Intercept | r |
|---|---|---|---|---|---|
| pHpH units | 100 | 6.787 - 7.683 | 1.0094 | -0.0721 | 0.9988 |
| pCO2mmHg | 100 | 17.7 - 111.0 | 1.0026 | -0.4347 | 0.9989 |
| pO2mmHg | 100 | 25.5 - 435.2 | 0.9942 | 2.1791 | 0.9996 |
| Hct% | 100 | 14 - 69 | 1.0013 | 0.0485 | 0.9963 |
| Nammol/L | 100 | 85.0 - 198.1 | 0.9995 | -0.1711 | 0.9978 |
| Kmmol/L | 100 | 2.70 - 19.37 | 0.9966 | 0.0934 | 0.9996 |
| iCammol/L | 98 | 0.33 - 2.51 | 1.0228 | -0.0603 | 0.9855 |
| Clmmol/L | 100 | 55.8 - 197.1 | 0.9897 | 0.1776 | 0.9997 |
| Glumg/dL | 100 | 17 - 488 | 0.9855 | -0.4734 | 0.9998 |
| Lacmmol/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 | InterferingSubstance | Concentration ofinterfering 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 | AverageTotal Error | AcceptanceCriteria forTotal Error | ClaimedMeasurementRange | |
| Lac | 2.70 mg/dL0.30 mmol/L | 3.60 mg/dL0.40 mmol/L | 3.60 mg/dL0.40 mmol/L | 0.13 | ≤ 0.3 | 3.6 - 178.6 mg/dL0.4 - 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 | Specimenrange | Analyzer | 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 BloodRange | 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 BloodRange | 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 | PooledMean | 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
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| 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 vitrodiagnostic use by health care professionals in clinical laboratorysettings 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 isintended for in vitro diagnostic use by health careprofessionals in clinical laboratory settings and forpoint-of-care usage for the quantitative determination ofpH, 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 thediagnosis and treatment of life-threatening acid-basedisturbances in critically ill patients with numerous metabolicand pulmonary diseases. | Same | |
| Hct | Whole blood measurements of hematocrit are used toestimate that red blood cells are present in sufficientquantity to carry oxygen and carbon dioxide. | Same | |
| Na+ | Sodium measurement is used in the diagnosis andtreatment of aldosteronism, diabetes insipidus, adrenalhypertension, Addison's disease, dehydration, or diseasesinvolving electrolyte imbalance. | Same | |
| K+ | Potassium Measurement is used to monitor electrolytebalance in the diagnosis and treatment of diseaseconditions characterized by low or high potassium levels. | Same | |
| Cl- | Chloride measurement is used in the diagnosis andtreatment of electrolyte and metabolic disorders such ascystic fibrosis and diabetic acidosis. | Same | |
| iCa | Ionized Calcium measurement is used in the diagnosis andtreatment of hypertension, renal disease, and vitamin Drelated disorders. Also useful in the diagnosis and treatmentof patients with increased total protein and/or albuminlevels, 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 touchpanel | 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 andpotentiometric amplifiers, air detector circuitry and temperaturecontrol circuitry | Same |
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| Characteristic | Predicate: K131703 Stat Profile Prime Calibrator Cartridge CCS | Proposed: Stat Profile Prime CalibratorCartridge CCS |
|---|---|---|
| Indication For Use | The Stat Profile Prime Calibrator Cartridge CCS is intended for thecalibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glucose using theStat Profile Prime CCS Analyzer. | The Stat Profile Prime Calibrator Cartridge CCSis 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 wastecollection 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 AmpuledControl ABG/CCS |
|---|---|---|
| Indication For Use | The Stat Profile Prime Ampuled Control ABG/CCS is a quality controlmaterial intended for in vitro diagnostic use by healthcare professionals formonitoring 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 |
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| 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 withStat Profile Prime CCS Analyzers to verify calibration, analytical linearity,estimate test imprecision, and detect systematic analytical deviations thatmay 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, metaboliteand 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).
§ 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.