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510(k) Data Aggregation
(63 days)
JLB
The Piccolo MetLyte 7 Reagent Disc, used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use:
Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass.
Creatinine The creatinine assay is used for the quantitation of creatinine in human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.
Glucose The glucose assay is used for the quantitation of glucose in human heparinized whole blood, heparinized plasma, or serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including adult and juvenile diabetes mellitus and hypoglycemia.
Potassium The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
Total Carbon Dioxide The total carbon dioxide assay is used for the quantitation of total carbon dioxide in human heparinized whole blood, heparinized plasma, or serum. Total carbon dioxide measurements are used in the diagnosis and treatment of primary MetLyte 7 alkalosis and primary respiratory alkalosis and acidosis.
Urea Nitrogen The urea nitrogen assay is used for the quantitation of urea nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.
The Piccolo MetLyte 7 Reagent Disc is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.
The provided text describes the acceptance criteria and study results for the Piccolo MetLyte 7 Reagent Disc for Creatine Kinase, Potassium, and Total Carbon Dioxide tests.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Performance Characteristics" sections in Tables 1-3, where the new device's performance (Piccolo® Point-of-Care Chemistry Analyzer) is compared to legally marketed predicate devices. The studies aim to show substantial equivalence.
| Analyte | Performance Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Piccolo) |
|---|---|---|---|
| Creatine Kinase | Intended Use | quantitative determination of creatine kinase | quantitative analysis of creatine kinase |
| Methodology | isoenzymes | isoenzymes | |
| Sample Type | serum | whole blood, plasma, serum | |
| Sensitivity | 0.0001 A/min/U/L | 0.0001 A/min/U/L | |
| Reagents | liquid mono reagent | dry test-specific reagent beads | |
| Temperature | 37°C | 37°C | |
| Calibration | pre-set calibration | bar code with disc-specific calibration data | |
| Assay Range | 0 - 2,000 U/L | 5 - 5,000 U/L | |
| Accuracy: Corr. Coeff. | (Not explicitly stated for predicate) | 0.967 | |
| Accuracy: Slope | (Not explicitly stated for predicate) | 1.194 | |
| Accuracy: Intercept | (Not explicitly stated for predicate) | -24.983 | |
| Accuracy: SEE | (Not explicitly stated for predicate) | 9.050 | |
| Accuracy: R-Square | (Not explicitly stated for predicate) | 0.934 | |
| Potassium | Intended Use | quantitative determination of potassium | quantitative analysis of potassium |
| Methodology | ion-selective electrodes | enzymatic activation | |
| Sample Type | whole blood, plasma, serum, urine | whole blood, plasma, serum | |
| Sensitivity | 0.58 (mmol/L)/(mV) | 0.024 A/min/mmol/L | |
| Reagents | N/A (for KNA™ 2) | dry, test specific reagent beads | |
| Temperature | 37° C | 37° C | |
| Calibration | automatic 1 point calibration every 2 hrs; 2 point calibration every 8 hrs | bar code with disc-specific calibration data | |
| Assay Range | 1.0 - 99.9 mmol/L | 1.5 - 8.5 mmol/L | |
| Accuracy: Corr. Coeff. | (Not explicitly stated for predicate) | 0.969 | |
| Accuracy: Slope | (Not explicitly stated for predicate) | 0.863 | |
| Accuracy: Intercept | (Not explicitly stated for predicate) | 0.573 | |
| Accuracy: SEE | (Not explicitly stated for predicate) | 0.141 | |
| Accuracy: R-Square | (Not explicitly stated for predicate) | 0.939 | |
| Total Carbon Dioxide | Intended Use | quantitative determination of total carbon dioxide | quantitative analysis of total carbon dioxide |
| Methodology | enzymatic using phosphoenol pyruvate carbo-xylase and malate dehydrogenase | enzymatic | |
| Sample Type | serum and plasma | whole blood, plasma, serum | |
| Sensitivity | 0.0427 A/mmol/L | 0.0037 A/min/mmol/L | |
| Reagents | liquid substrate reagent 1 and liquid enzyme reagent 2 | dry test-specific reagent beads | |
| Temperature | 37° C | 37° C | |
| Calibration | Roche calibrator serum every 6 months | bar code with disc-specific calibration data | |
| Assay Range | 0 - 40 mmol/L | 5 - 40 mmol/L | |
| Accuracy: Corr. Coeff. | (Not explicitly stated for predicate) | 0.947 | |
| Accuracy: Slope | (Not explicitly stated for predicate) | 0.903 | |
| Accuracy: Intercept | (Not explicitly stated for predicate) | 2.444 | |
| Accuracy: SEE | (Not explicitly stated for predicate) | 0.837 | |
| Accuracy: R-Square | (Not explicitly stated for predicate) | 0.900 | |
| Linearity | Creatine Kinase | Statistically linear at 99% significance level | F-Ratio: 0.11, Slope: 1.00, Intercept: -7.45, Corr. Coeff.: 1.00 |
| Potassium | Statistically linear at 99% significance level | F-Ratio: 0.37, Slope: 1.05, Intercept: 0.03, Corr. Coeff.: 1.00 | |
| Total Carbon Dioxide | Statistically linear at 99% significance level | F-Ratio: 0.88, Slope: 1.09, Intercept: -0.71, Corr. Coeff.: 0.97 | |
| Precision | Within-Run & Total CV Ratio | (Not explicitly stated, but expected to be low) | Creatine Kinase: CV 1.5-2.0%, Potassium: CV 5.2-6.3%, Total Carbon Dioxide: CV 8.6-10.7% |
2. Sample Size Used for the Test Set and Data Provenance
- Creatine Kinase (Accuracy): n = 47 samples
- Potassium (Accuracy): n = 58 samples
- Total Carbon Dioxide (Accuracy): n = 60 samples
- Linearity: The number of data points for the linearity analysis is not explicitly stated, only the F-ratio, slope, intercept, and correlation coefficient.
- Precision: n = 120 (results pooled from 6 instruments each running 20 discs) for both within-run and total precision for each analyte.
- Sample Type Comparison: A study was conducted, but the sample size is not specified.
Data Provenance: The document implies these are prospective studies conducted by Abaxis, Inc. No information on the country of origin of the data is provided, but the company is based in Sunnyvale, CA, USA. The data is for assessing the performance of the new device against predicate devices (retrospective comparison to predicate characteristics, but prospective data collection for the new device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves chemical analysis on a diagnostic device, not interpretation of images or patient data by human experts to establish ground truth. The "ground truth" for accuracy studies is typically the established reference method or the predicate device's results.
4. Adjudication Method for the Test Set
Not applicable, as this is a device performance study relying on quantitative measurements, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic device, not human reader performance with or without AI assistance.
6. Standalone Performance
Yes, the studies describe the standalone performance of the Piccolo MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer. The accuracy, linearity, and precision results presented are for the algorithm (device) only.
7. Type of Ground Truth Used
The ground truth for the accuracy studies appears to be the measurements obtained from the existing legally marketed predicate devices (COBAS FARATM Chemistry System for Creatine Kinase and Total Carbon Dioxide, and Radiometer KNA™ 2 Sodium-Potassium Analyzer for Potassium). For linearity and precision, the ground truth would be ideal linear performance and expected variability of control materials, respectively.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" as it would for a machine learning algorithm. For an in vitro diagnostic device like this, the "development" or "calibration" data is implicitly used to establish the disc-specific calibration data that is embedded in a barcode. The accuracy, linearity, and precision studies represent independent validation or testing.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated in terms of a "training set" ground truth. The device relies on "bar code with disc-specific calibration data." This implies the calibration data (which serves a similar role to a training set for the device's operational parameters) would have been established through a process of running known concentration standards. The details of this process and the ground truth used for it are not provided in this summary.
Ask a specific question about this device
(26 days)
JLB
The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.
Not Found
This document is a 510(k) clearance letter from the FDA for the Olympus CK-MB Reagent, not a study report or a detailed technical specification. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use, which is the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.
Therefore, I cannot provide the requested information from the given input.
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