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510(k) Data Aggregation
(243 days)
ESA BIOSCIENCES INC.
The ESA Biosciences Inc. Vitamin D HPLC test is for the quantitative determination of 25-hydroxyvitamin D in human serum or EDTA-plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.
The ESA method is a complete kit for measurement of Total 25(OH)D by HPLC with electrochemical (EC) detection. Specific reagents and solid phase extraction columns are included for sample preparation and are employed with user-supplied standard laboratory equipment (centrifuge, test tubes, pipettes, etc.). A 200µL volume of sample (serum or plasma) is mixed with a precipitation reagent, which contains internal standard (IS). The internal standard is a stable vitamin D analogue that is used to correct for variability in extraction recovery and analytical sample volume. After centrifugation, supernatant is poured onto a pre-conditioned SPE column for rapid extraction of 25(OH)D and IS. SPE columns are washed with 2 different reagents and analytes are eluted with a third reagent. The resulting eluent is diluted before analysis. The prepared sample is analyzed with an isocratic HPLC system using an ESA EC detector (Coulochem® III or CoulArray®) equipped with a dual coulometric EC cell. Calibration is accomplished by direct HPLC analysis of authentic standard solutions (i.e. not taken through the extraction step). Analysis requires a specific guard and analytical column, mobile phase and calibration reagents to allow rapid quantitative analysis. A dual EC cell is used with the first, upstream, cell maintained at a specific potential to oxidatively screen possible interfering sample components. The second, downstream cell is maintained at a potential that is optimized for selective 25(OH)D detection. The dual coulometric EC cell is a rugged detector that provides much higher selectivity than commonly used absorbance detectors. This allows the use of lower sample volumes than are typically required with HPLC-UV methods and is less susceptible to interferences. Analytical run time is less than 12 minutes and Total 25(OH)D sample concentration is automatically determined by single-point internal standard quantitation.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ESA Biosciences Inc. Vitamin D HPLC Test:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a dedicated section with pass/fail thresholds. However, it presents performance characteristics that implicitly serve as the criteria for evaluating the device's suitability. The table below lists these performance metrics and the reported results.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Within-run) | Low %CV for various samples | Sample #1 (Plasma): 2.82% CV |
| Sample #2 (Plasma): 2.31% CV | ||
| Sample #3 (Serum): 2.55% CV | ||
| Sample #4 (Serum): 2.16% CV | ||
| Level 1: 10.6% CV | ||
| Level 2: 6.8% CV | ||
| Precision (Within-device/Total) | Low %CV for various samples | Sample #1 (Plasma): 6.05% CV |
| Sample #2 (Plasma): 5.48% CV | ||
| Sample #3 (Serum): 5.66% CV | ||
| Sample #4 (Serum): 5.43% CV | ||
| Level 1: 12.6% CV | ||
| Level 2: 8.4% CV | ||
| Limit of Detection (LoD) | Defined as concentration with ≤ 5% false negative/positive | 5.0 ng/mL |
| Limit of Quantitation (LoQ) | % CV ≤ 20% at this concentration | 7.0 ng/mL |
| Limit of Blank (LoB) | N/A (reported as a baseline metric) | 2.5 ng/mL |
| Linearity Range | Linear from LoQ to 200 ng/mL with specific bias goals | Linear from 7.0 ng/mL (LoQ) to 200 ng/mL (bias goals: ≤ 3ng/mL bias for ≤ 20 ng/mL; ≤ 7.5% bias for 21-200 ng/mL) |
| Recovery | Expected % recovery around 100% for spiked samples | Plasma: 90-107% mean recovery |
| Serum: 93-105% mean recovery | ||
| Method Comparison (Correlation) | Correlation Coefficient (R) for comparison with reference method (implies r needs to be within an acceptable range, though r |
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(20 days)
ESA BIOSCIENCES INC.
For In Vitro Diagnostic Use Only. The LeadCare® II Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The Leadcare® II System is suitable for use in a physician's office laboratory environment (POL).
The LeadCare® II Blood Lead Testing System is an instrumented assay utilizing electrochemistry and a unique sensor to be used for the quantitation of lead in whole human blood. Testing can be performed on venous or capillary samples. The system is comprised of an analyzer, sensor (single use, disposable), reagent vial (filled with a measured amount of Treatment Reagent) and a calibration button. The system is powered by 4 AA batteries or AC Adapter. A built in self test checks the electronic functions of the analyzer cach time it is turned on. Blood lead controls are available to monitor the precision and accuracy of the system. The methodology of the system is Anodic Stripping Voltammetry (ASV). Most lead is carried in red blood cells. When a sample of whole blood is mixed with Treatment Reagent, the lead in the red blood cells is released and made available for detection. During the Pb test, the analyzer causes the lead to collect on the sensor. After a specified time, the analyzer removes the lead accumulated on the sensor. The current response (a peak shaped curve) is baseline corrected, quantified and converted to a blood Pb value. The analyzer displays the blood Pb level in units of µg/dL. The test electrode is covered by a thin layer of colloidal gold in an inert polymer matrix. The treatment reagent contains a dilute hydrochloric acid solution in water.
Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria but rather demonstrates substantial equivalence to a predicate device by comparing performance metrics. The key performance indicator measured is bias from the reference method (GFAAS).
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (LeadCare II) | Remarks |
|---|---|---|---|
| Regression | Similar to LeadCare I: Y = 0.992x GFAAS + 0.94 | Y = 1.040 x GFAAS + 0.12, syx = 1.30, r = 0.996 | Deemed "similar" and "well within goals" by the submitter. |
| Bias (0-10 µg/dL) | Implied to be acceptable if similar to LeadCare I performance. | 0.07 µg/dL | - |
| % Bias (10.1-25.0 µg/dL) | Implied to be acceptable if similar to LeadCare I performance. | 4.7% | - |
| % Bias (25.1-65 µg/dL) | Implied to be acceptable if similar to LeadCare I performance. | 5.0% | - |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 108 human samples. Of these, 22 were spiked samples, and 86 were unspiked.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it involves samples that were then run on the devices and compared to a reference method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth was established using a gold standard laboratory method, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established using an objective laboratory method (GFAAS), not subjective expert judgment.
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
Not applicable. This device is a blood lead testing system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device's performance was evaluated in standalone mode. The study compared the LeadCare II system's measurements directly against the GFAAS reference method.
7. The Type of Ground Truth Used
The ground truth was established using a laboratory reference method: Graphite Furnace Atomic Absorption Spectroscopy (GFAAS).
8. The Sample Size for the Training Set
Not applicable. This document describes the performance of a medical device (a blood lead testing system), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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