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510(k) Data Aggregation
(274 days)
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
The LeadCare® Ultra™ Blood Lead Testing System is designed to quantitatively measure the amount of lead in a whole blood sample. The LeadCare® Ultra™ Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use only with the LeadCare® Ultra™ Blood Lead Testing System.
This test system is for prescription use only. This system is not intended for point of care use.
The LeadCare Ultra System Blood Lead Testing System is an in vitro diagnostic device that relies on electrochemistry (Anodic Stripping Voltammetry or ASV) and a unique sensor to detect lead in whole blood. Most lead is carried within red blood cells. When a sample of whole blood is mixed with Treatment Reagent (a dilute solution of hydrochloric acid), the red blood cells are lysed and the lead becomes available for detection. When a test is run, the Analyzer applies an electrical potential that causes the lead to collect on the Sensor. After three minutes, the Analyzer measures the amount of lead on the Sensor and displays the result in micrograms per deciliter (ug/dL).
The multi-channel LeadCare Ultra Analyzer performs up to six blood lead tests simultaneously and uploads the completed test results to the Computer. Test results are stored in the Computer in unique sample records, along with sample ID, comments, test conditions, Sensor lot number, and user ID. The Analyzer is also equipped with a Calibration Button Reader. This Reader allows for the download of all calibration information, analytical test parameters, and date code information for any given Sensor lot. These actions can be accomplished by simply touching the appropriate Calibration Button to the Reader.
The system's Computer is dedicated to running only blood lead analyses, and sits on a stand directly behind the monitor. The Computer serves as the user interface for entering patient ID information using a keyboard or barcode reader. It also performs data analysis after blood lead measurements are processed by the firmware embedded in the Analyzer. The Computer stores the patient results (and allows for retrieval of stored results) and it allows connectivity via USB ports to a customer-supplied printer and Laboratory Information Management System (LIMS). Peripherals for the computer are a monitor, keyboard, barcode reader and mouse.
The analyzer is used in conjunction with a LeadCare Ultra Blood Lead Test Kit.
Here's a breakdown of the acceptance criteria and study information for the Magellan LeadCare® Ultra™ Blood Lead Testing System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Not explicitly stated as a numerical criterion for the combined data set. However, the text mentions "These precision data met the precision goals" in the Linearity section, implying internal precision goals were established and met. | See "LeadCare Ultra Precision Data" table below for detailed results. |
| Linearity | Higher order coefficients in polynomial regression should not be statistically significant (p-value > 0.05). | All p-values for higher order coefficients were > 0.05 for 1-66 ug/dL. |
| Limit of Blank (LoB) | Not explicitly stated, but determined. | LoB calculated to be 1.5 ug/dL. |
| Limit of Detection (LoD) | Not explicitly stated, but determined. | LoD calculated to be 1.9 ug/dL. |
| Limit of Quantification (LoQ) | Not explicitly stated, but determined through Total Error equation. | LoQ calculated to be 1.9 ug/dL, equal to LoD. |
| Matrix Comparison | Average bias within ±2 ug/dL for concentrations 1.9 to 10 µg/dL, and ±10% for concentrations above 10 µg/dL. | Met acceptance criteria for K3EDTA, K2EDTA, Sodium Heparin, and micro-capillary tubes with K2EDTA. |
| Method Comparison (Clinical) | Average bias within ±2 µg/dL for concentrations 1.9 to 10 µg/dL, and ±10% for concentrations above 10 ug/dL. | Met acceptance criteria. |
LeadCare Ultra Precision Data:
| Mean, µg/dL | WR SD, µg/dL | Total SD, µg/dL | WR CV | Total CV | 95%CI for WR SD, µg/dL | 95%CI for Total SD, µg/dL |
|---|---|---|---|---|---|---|
| 4.5 | 0.36 | 0.49 | 8.0% | 10.9% | 0.32 to 0.42 | 0.45 to 0.55 |
| 6.4 | 0.55 | 0.60 | 8.7% | 9.4% | 0.49 to 0.63 | 0.55 to 0.67 |
| 10.8 | 0.79 | 0.90 | 7.4% | 8.3% | 0.65 to 1.03 | 0.78 to 1.08 |
| 24.4 | 1.20 | 1.43 | 4.9% | 5.9% | 0.99 to 1.54 | 1.22 to 1.73 |
| 44.2 | 1.55 | 1.62 | 3.5% | 3.7% | 1.28 to 1.99 | 1.40 to 1.93 |
| 62.1 | 1.90 | 3.19 | 3.1% | 5.1% | 1.69 to 2.18 | 2.91 to 3.54 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study (Test Set): 80 data points per concentration level (4.5, 6.4, 10.8, 24.4, 44.2, and 62.1 ug/dL), collected over a 20-day period. Samples were bovine blood standards.
- Linearity Study (Test Set): Nine donor blood samples per sensor lot, spiked to various concentrations. Tested on three sensor lots.
- Limit of Blank (Test Set): 70 replicates of a near blank NIST blood sample (0.3 ug/dL) over 5 days.
- Limit of Detection (Test Set): 70 data points from replicates of low samples over 5 days.
- Limit of Quantification (Test Set): 58 samples with lead concentrations between 1 and 6 ug/dL.
- Matrix Comparison Study (Test Set):
- Micro-capillary tubes with K2EDTA: N=72 tubes.
- K3EDTA, K2EDTA and Sodium Heparin Vacutainers: N=39 vacutainers each.
- Blood type/source: Not explicitly stated if human or bovine for matrix comparison, but given the context of blood collection devices, it's implied to be human blood or blood mimicking human blood characteristics.
- Method Comparison Study (Clinical Test Set): 394 results, with 148 within the claimed analytical range (1.9-65 ug/dL). Samples collected in EDTA vacutainers.
- Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective for the purpose of device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no human experts used to establish ground truth for the test set in the traditional sense of clinical adjudication. The ground truth was established by:
- Reference Method: Graphite Furnace Atomic Absorption Spectrometry (GFAAS) was used as the reference method for determining actual lead concentrations in blood samples for linearity, matrix comparison, and method comparison studies.
- NIST Standard Reference Material: NIST Standard Reference Material 955c (Lead in Caprine Blood) was used for calibration and traceability, implying a highly standardized, non-expert determined ground truth.
4. Adjudication Method for the Test Set
Not applicable. This device measures a biochemical marker (lead concentration) where ground truth is established by a quantitative reference method (GFAAS or NIST standards), not by human expert consensus or adjudication of qualitative findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) quantitative blood lead testing system, not an imaging device or a system requiring human interpretation for diagnostic performance. Therefore, comparing human readers with and without AI assistance is not relevant to this technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone (algorithm/device only) performance evaluations. The device quantitatively measures lead levels, and its performance is evaluated against a reference method (GFAAS), not against human interpretation within a diagnostic workflow.
7. The Type of Ground Truth Used
The primary type of ground truth used was:
- Reference Method Measurement: Graphite Furnace Atomic Absorption Spectrometry (GFAAS) results, considered the gold standard for lead measurement.
- NIST Standard Reference Material: NIST 955c (Lead in Caprine Blood) for calibration and traceability.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. Given that the device relies on electrochemistry and Anodic Stripping Voltammetry (ASV), the "training" would typically refer to the development and calibration of the electrochemical algorithm and sensor technology rather than statistical model training on a separate dataset. The document mentions:
- "Calibration of sensor lots, traceable to NIST Standard Reference Material 955c (Lead in Caprine Blood) is performed using four concentrations of control samples."
- "As part of the calibration, blood samples spiked at 8 concentrations are analyzed by both the LeadCare Ultra system and GFAAS, run in duplicate on 2 separate days."
These calibration/development activities are analogous to how a training set might be used in other contexts, but the exact number of samples exclusively for this purpose beyond what's stated for calibration is not quantified separately as a "training set."
9. How the Ground Truth for the Training Set Was Established
As noted above, for the development and calibration of the device:
- NIST Standard Reference Material 955c: Used for traceability and to establish the true concentrations of control samples.
- GFAAS Instrument Calibration: A GFAAS instrument was calibrated using these NIST-traceable control samples.
- Spiked Blood Samples: Blood samples spiked at 8 concentrations were analyzed by both the LeadCare Ultra system and the calibrated GFAAS to refine and establish the device's algorithm and performance characteristics.
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