Search Results
Found 7 results
510(k) Data Aggregation
(55 days)
CEK
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
The HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems, and serum, plasma, and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. The study aimed to demonstrate its substantial equivalence to the SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224) manufactured by Beckman Coulter, Inc.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the comparison to a predicate device and established NCCLS guidelines for precision. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the reported performance demonstrates equivalence, which is the underlying goal for 510(k) submission.
| Metric (Implied Acceptance Criterion: Comparable to Beckman® Reagent) | HiChem® Total Protein Reagent Performance | Beckman® Total Protein Reagent Performance (Predicate) | Discussion |
|---|---|---|---|
| Precision (Within Run %CV): | |||
| Serum 1 (3.8 g/dL) | 1.1% | 1.2% | Comparable |
| Serum 2 (5.9 g/dL) | 0.7% | 0.8% | Comparable |
| Serum 3 (8.0 g/dL) | 0.7% | 0.6% | Comparable |
| CSF 1 (21 mg/dL) | 15.2% | 5.2% | Higher for HiChem® |
| CSF 2 (53 mg/dL) | 3.1% | 2.8% | Comparable |
| Precision (Total %CV): | |||
| Serum 1 (3.8 g/dL) | 1.7% | 1.3% | Comparable |
| Serum 2 (5.9 g/dL) | 1.3% | 1.0% | Comparable |
| Serum 3 (8.0 g/dL) | 1.4% | 1.1% | Comparable |
| CSF 1 (21 mg/dL) | 19.7% | 12.2% | Higher for HiChem® |
| CSF 2 (53 mg/dL) | 4.4% | 5.2% | Comparable |
| Patient Comparison (Linear Regression for Serum/Plasma): | y = 0.2 + 0.970x | N/A (predicate comparison) | Strong correlation (r = 0.988) with the predicate. |
| Patient Comparison (Linear Regression for CSF): | y = -2.8 + 1.010x | N/A (predicate comparison) | Strong correlation (r = 0.995) with the predicate. |
Note: For the CSF 1 precision, the HiChem® reagent shows higher %CVs compared to the Beckman® reagent. However, the strong correlation in the patient comparison for CSF (r = 0.995) suggests that despite higher variability at lower concentrations, the overall agreement with the predicate is very high.
2. Sample Sizes and Data Provenance:
- Precision Test Set:
- Serum and Cerebrospinal Fluid Controls: Each control was assayed 3 times per day for 10 days, resulting in n=60 measurements for each sample (3 assays/day * 10 days * 2 reagents = 60 for HiChem®, 60 for Beckman®, for a total of 120 measurements per sample type).
- Data Provenance: Not explicitly stated, but assumed to be prospective, collected during the study. Country of origin is not specified.
- Patient Comparison Test Set:
- Serum/Plasma Specimens: n=160 adult patients.
- CSF Specimens: n=40 adult patients.
- Data Provenance: Retrospective, collected from adult patients. Country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is an in vitro diagnostic reagent, and its performance is assessed against a predicate device and NCCLS guidelines, not against human expert interpretation or a "ground truth" established by experts in the typical sense of image analysis or diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable, as the "ground truth" is based on quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a device intended for human interpretation or a scenario where human readers would collaborate with AI.
6. Standalone (Algorithm Only) Performance:
Yes, the study presents the standalone performance of the HiChem® Total Protein Reagent. The precision and patient comparison studies demonstrate the reagent's performance in isolation, with measurements obtained directly from the SYNCHRON CX® DELTA System. There is no human-in-the-loop component in the evaluation of this reagent's analytical performance.
7. Type of Ground Truth Used:
The "ground truth" for this study is established by:
- Comparison to a legally marketed predicate device: The SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224) manufactured by Beckman Coulter, Inc. This implicitly serves as the standard for expected performance.
- Quantitative measurements: The accuracy of the reagent is assessed by its correlation with the predicate device using least squares linear regression.
- Internal precision: Assessed against NCCLS publication EP3-T guidelines, indicating repeatability and reproducibility.
8. Sample Size for the Training Set:
Not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set. The performance is evaluated based on its chemical and analytical properties when run on a specified instrument.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(195 days)
CEK
For the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF). For IN VITRO diagnostic use.
Total Protein (Micro) Assay
The provided text is an FDA 510(k) clearance letter for the "Total Protein (Micro) Assay" device. It does not contain information about acceptance criteria, device performance, specific study details, or ground truth establishment.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF) for in vitro diagnostic use. It outlines the regulatory classification, general controls, and other regulatory information but does not include the type of detailed study information requested.
Therefore, I cannot provide the requested table and study details based on the input text.
Ask a specific question about this device
(29 days)
CEK
For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
CareSide™ Total Protein cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure total protein concentration in whole blood, plasma or serum specimens. The CareSide™ Total Protein cartridge, a single use disposable in vitro diagnostic test carridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total protein concentration. The film cartridge (patent pending) contains all reagents necessary to measure total protein concentration. When used in conjunction with the CareSide™ Albumin cartidge on the CareSide™ Analyzer, the analyzer calculates globulin (as the difference between the total protein and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
Here's a summary of the acceptance criteria and study information for the CareSide™ Total Protein device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria / Predicate Performance | CareSide™ Total Protein Performance |
|---|---|---|
| Detection Limit | 2 g/dL | 2 g/dL |
| Reportable Range | 2.0 to 11 g/dL | 2.0 to 11 g/dL |
| Accuracy | Not provided for predicate | Mean recovery 105% |
| Precision | Total CV, 4.5 g/dL: 2.5% (Vitros TP DT) | Total CV, 6.0 g/dL: 7.2% |
| Method Comparison | Not provided for predicate | CareSide™ = 0.9 (Vitros Total Protein DT) + 0.56, r=0.93 |
| Linearity | Not provided for predicate | Mean deviation approx 1%, r² ≥0.99 |
| Interference | Not provided for predicate | No significant interference observed at tested concentrations of Ascorbic Acid (20 mg/dL), Bilirubin (20 mg/dL), Hemoglobin (250 mg/dL), Triglycerides (1500 mg/dL). |
| Specimen Types & Anticoagulants | No clinically significant difference between serum and heparin plasma. Whole blood unsuitable (Vitros TP DT). | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. |
| Expected Values (Reference Range) | 6.3 to 8.2 g/dL (combined male and female, Central 95% interval) (Vitros TP DT) | 6.3 to 8.4 g/dL (combined male and female, Central 95% interval) |
Note on Acceptance Criteria: The document primarily uses the predicate device's performance characteristics or a "not provided" statement as a benchmark. For some metrics like Accuracy, Linearity, and Interference, the CareSide™ device reports its own performance without a direct comparison to a specific quantitative acceptance criterion from the predicate, implying these met general expectations for such a device. The conclusion states the device "performs as well as or better than the legally marketed predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Specific sample sizes for each performance characteristic (accuracy, precision, method comparison, linearity, interference studies) are not explicitly provided in the given text.
- Data Provenance: The studies appear to be clinical performance evaluations conducted by Exigent Diagnostics, Inc. The location and whether they were retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The data presented is quantitative analytical performance, presumably compared against established laboratory methods or reference values, not expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are for analytical performance, not for subjective interpretation or agreement between multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic test for measuring total protein concentration, not a device requiring human interpretation of results in the way an imaging diagnostic device might.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The reported performance characteristics (accuracy, precision, linearity, etc.) represent the performance of the CareSide™ Total Protein cartridge and CareSide™ Analyzer system as a standalone diagnostic device, without human interpretive input beyond following the operational instructions. The device directly measures and reports a quantitative result.
7. The Type of Ground Truth Used
The ground truth for the device's performance (e.g., accuracy, method comparison, linearity) would have been established using:
- Reference Methods: The "Reference Method" is stated as Biuret, which is a widely accepted laboratory method for total protein measurement.
- Predicate Device Data: For comparison, the predicate device (Vitros Total Protein DT Slides) served as a benchmark.
- Standard Calibrators/Controls: For linearity and precision studies, calibrated materials with known concentrations would have been used.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a chemical assay system with a fixed reaction sequence and measurement principle, not a machine learning or AI-based device that would typically involve a "training set" in the conventional sense of AI model development. The system uses a "lot-specific standard curve" for calculation, which implies calibration data for each lot, but this is distinct from training a machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The device operates based on established chemical reactions and calibration curves rather than an AI training process.
Ask a specific question about this device
(18 days)
CEK
Ask a specific question about this device
(163 days)
CEK
Ask a specific question about this device
(153 days)
CEK
Ask a specific question about this device
(82 days)
CEK
Ask a specific question about this device
Page 1 of 1