(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 |
§ 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.