(274 days)
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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510(k) Summary For The Magellan LeadCare® Ultra™ Blood Lead Testing System
SUBMITTER/510(K) HOLDER 1.
Magellan Diagnostics, Inc. 101 Billerica Ave, Building 4 North Billerica, MA 01862
AUG 20 2013
Contact Person: Reba Leger Telephone: +1 (978) 248-4811
2. DEVICE NAME
| Proprietary Name: | LeadCare® Ultra™ Blood Lead Testing System |
|---|---|
| Common/Usual Name: | Lead Test System |
| Classification: | Class II |
| Product Code: | DOF |
| 510(k) Number: | K123563 |
3. PREDICATE DEVICE
- · LeadCare® II Blood Lead Testing System (K052549)
DEVICE DESCRIPTION 4.
ક
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
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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 customersupplied 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. Materials supplied in the Test Kit include:
| Quantity | |
|---|---|
| Sensors (8 containers of 24 ea.) | 192 |
| Treatment Reagent Tubes (250μL of 0.34M HCl) | 192 |
| Calibration Button | 1 |
| • Lead Control Level 1 (2mL) | 1 |
| • Lead Control Level 2 (2mL) | 1 |
The controls supplied in the Test Kit are manufactured by Bionostics, Inc. to Magellan's specifications. The controls are cleared under K063398.
5. INDICATIONS FOR USE/ INTENDED USE
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.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE 6. PREDICATE DEVICE
The following table summarizes the similarities and differences between the predicate and the LeadCare Ultra device,
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Similarities/Differences of LeadCare® Ultra™ with Predicate Device
| Feature | LeadCare® II | LeadCare® Ultra™ |
|---|---|---|
| Intended Use | The LeadCare II Blood LeadTesting System is aninstrumented assay to be usedin the quantitation of lead inwhole human blood. TheLeadCare II System is suitablefor use in a Physician's officelaboratory (POL). | The LeadCare Ultra BloodLead Testing System isdesigned to quantitativelymeasure the amount of lead in awhole blood sample. TheLeadCare Ultra Blood LeadTesting System is intended forin vitro (external) use only. Thetest kit components aredesigned for use only with theLeadCare Ultra Blood LeadTesting System.This test system is forprescription use only. Thissystem is not intended for pointof care use. |
| Methodology | Anodic Stripping Voltammetry | Same |
| Throughput | 1 sample at a time | 6 samples at a time |
| Sensor (test strip) | Screen printed sensors withconductive inks; plastic spacerand lid; capillary fill | Same |
| Active TestElectrode area | Thin layer of colloidal gold inan inert polymer matrix | Same |
| Calibration | Electronic calibration button | Same |
| Blood Collection | Fingerstick or venipuncture | Same |
| Sample Matrix | Whole blood collected inEDTA or heparin; fresh up to24 hours from time of draw | Whole blood collected inEDTA or heparin; up to 72hours from time of draw |
| Treatment Reagent | Dilute hydrochloric acidsolution in water | Dilute hydrochloric acidsolution in water with inertcarbon particles |
| Sample Handling | Uses transfer dropper totransfer sample from reagenttube to sensor | Uses pipet to transfer samplefrom reagent tube to sensor |
| Check for SensorLot Expiration | Checks sensor lot expirationdate passed in on the calibrationbutton | Same |
| Internal Self-Test | Self-test checks electronic functions of analyzer each time it is turned ON | Self-test checks electronic functions of analyzer each time it is turned ON and on each channel following a sensor insertion |
| Sensor Connector | Makes electrical contact with sensor. Sensor insertion detection. | Same |
| Unit of Measure | Results displayed in micrograms of lead per deciliter of whole blood (µg/dL) | Same |
| Displayed Result | Lead result is displayed until new sensor is inserted | Lead results displayed via User Interface and stored in computer |
| Reportable Range Controls | 3.3 – 65 µg/dL2 levels of external liquid controls | 1.9 – 65 µg/dLSame |
| Power Source | AC Adapter or 4 AA batteries | AC Adapter |
| Test Time | 3 minutes | Same |
| Software | Software is in the form of firmware only, installed onto the analyzer's microprocessor. All functions (analyzer control, User Interface display control, blood lead algorithm calculation) are executed by this firmware | Software is in the form of firmware installed onto the analyzer's microprocessor, and .NET based software installed onto an accompanying computer workstation with Windows 7 Embedded POS Ready operating system. The firmware is used for the low level control of the analyzer only. The software on the computer workstation is used to run the system User Interface software and perform the blood lead algorithm calculations, receiving raw data from the firmware |
| Lead Test Algorithm | ASV routine; Pb peak identified and quantified; blood Pb result assigned using lookup tables | Same |
| User Interface | Alphanumeric display, 4 lines by 20 characters allows useful messages to guide users through procedure | Graphical user interface with messages and graphics to guide users through procedure |
| System OperatingRange | Temperature range of 54° to97°F (12° to 36°C); RelativeHumidity 12%-80% non-condensing to accommodatefield portability | Temperature range of 60° to82°F (16° to 28°C); RelativeHumidity 12%-80% non-condensing to accommodatetypical laboratory use |
| Limit of Detection | 3.3 µg/dL | 1.9 µg/dL |
.
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SUMMARY OF NON-CLINICAL AND CLINICAL PERFORMANCE TESTING AS BASIS 7. FOR SUBSTANTIAL EQUIVALENCE
A. Non-Clinical Results
Precision
The LeadCare Ultra Precision Study was performed using bovine blood standards at lead concentrations of 4.5, 6.4, 10.8, 24.4, 44.2, and 62.1 ug/dL. Eighty (80) data points were collected per concentration level over a 20 day period. Samples were prepped two times per day and each sample was run in duplicate on alternating channels such that all channels were used equally during the study. For concentrations of 4.5, 6.4 and 62.1 ug/dL, three sensor lots were utilized. For the remaining concentrations, one representative sensor lot was used. The combined data set is shown.
LeadCare Ultra Precision Data
| Mean,µg/dL | WR SD,µg/dL | Total SD,µg/dL | WR CV | Total CV | 95%CI forWR SD,µg/dL | 95%CI forTotal 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 |
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Linearity
Linearity assessments were performed on three Sensor lots using nine donor blood samples spiked with lead to concentrations of 2-5 ug/dL, 5-10 ug/dL, 15-25 ug/dL, 25-35 ug/dL, 35-45 ug/dL, 45-55 ug/dL & 55-65 ug/dL. The concentrations used span the claimed measuring range of the LeadCare Ultra System. Linearity was evaluated by performing polynomial regression and determining whether higher order coefficients were statistically significant as per CLSI EP6-A Section 5.32.
The Linear Regression results for each of the three Sensor lots are as follows:
| 1208A | 1211B | 1305A |
|---|---|---|
| Y = 1.04x - 1.17 | Y = 1.10x - 1.71 | Y = 1.04x - 0.58 |
| R2 = 0.997 | R2 = 0.996 | R2 = 0.998 |
| Sy.x = 1.41 | Sy.x = 1.64 | Sy.x = 1.05 |
For each of the three lots, the average of the LeadCare Ultra replicates was analyzed against the average reference method (GFAAS) results using polynomial regression analysis. The (p) values for the higher order coefficients of the polynomial regressions were calculated for three lots of Sensors. All p values were greater than 0.05, demonstrating no statistically significant nonlinearity for the range 1 - 66 ug/dL.
Random error was evaluated by estimating precision from replicates. These precision data met the precision goals.
Analysis of samples from 1.9 ug/dL to 65 ug/dL was performed to demonstrate linearity across the claimed measuring range. Quadratic and Cubic regression results are shown in the table below:
| QuadraticRegression | Cubic Regression | ||
|---|---|---|---|
| Quad Coefficientp value | Quad Coefficientp value | Cubic Coefficientp value | |
| Lot | 0.13 | 0.39 | 0.27 |
| 1208A | 0.13 | 0.39 | 0.27 |
| 1211B | 0.85 | 0.60 | 0.58 |
| 1305A | 0.69 | 0.22 | 0.20 |
Quadratic and Cubic Regression Data (range 1.9 ug/dL - 65 ug/dL)
The LeadCare Ultra system demonstrated linearity for three lots across the claimed analytical range of 1.9-65 ug/dL.
Linearity was also demonstrated for each of the six channels on the LeadCare Ultra analyzer. Replicate data on each channel met precision goals.
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Limit of Blank, Limit of Detection & Limit of Quantification
The limit of blank LoB was determined by running 70 replicates of a near blank NIST blood sample, 0.3 ug/dL, over 5 days. Samples were analyzed using two Sensor lots across all Analyzer channels.
The LoB was calculated to be 1.5 ug/dL.
Replicates of the low samples were run on the LeadCare Ultra Analyzer over five days. Seventy (70) data points were collected using all channels of the Analyzer. Two Sensor lots were used.
The LoD was calculated to be 1.9 ug/dL.
The limit of quantification LoQ was calculated using the Total Error equation: Total Error LoO = absolute (Bias) + (2 x SD). The bias of 58 samples that contained lead concentrations between 1 and 6 ug/dL, according to GFAAS, was calculated to be 0.02 µg/dL.
The Standard Deviation at the LoD (1.9 µg/dL) is calculated to be 0.25 µg/dL. Based on the equation above, the Total Error LoQ is calculated to be:
Total Error LoQ = 0.02 + (2 x 0.25) Total Error LoQ = 0.52
The LoQ is equal to the LoD (1.9 ug/dL).
Matrix Comparison
Matrix Comparisons were made for the following blood collection devices:
- K3EDTA, K2EDTA Vacutainers
- Sodium Heparin Vacutainers .
- Micro-capillary tubes with K2EDTA .
Linear Regression Results of LeadCare Ultra compared to GFAAS met the acceptance criteria, defined as average bias within ±2 ug/dL in the concentration range 1.9 to 10 µg/dL and ±10% for concentrations above 10 µg/dL.
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Image /page/7/Picture/0 description: The image shows the logo for Magellan Diagnostics. The word "Magellan" is in a large, bold, sans-serif font. Below the word "Magellan" is the word "Diagnostics" in a smaller, sans-serif font. The word "Diagnostics" is in all caps, and each letter is in a separate black box.
| GFAAS,µg/dL | PredictedUltraµg/dL | Bias,µg/dL | PercentBias |
|---|---|---|---|
| 1.9 | 1.7 | -0.2 | -10.3% |
| 5 | 5.0 | 0.0 | -0.6% |
| 10 | 10.2 | 0.2 | 2.4% |
| 20 | 20.8 | 0.8 | 3.9% |
| 30 | 31.3 | 1.3 | 4.4% |
| 40 | 41.8 | 1.8 | 4.6% |
| 50 | 52.4 | 2.4 | 4.8% |
| 60 | 62.9 | 2.9 | 4.9% |
| 65 | 68.2 | 3.2 | 4.9% |
Micro-capillary tubes with K2EDTA (N=72 tubes)
K3EDTA, K2EDTA and Sodium Heparin Vacutainers (N=39 vacutainers each)
| GFAAS | Calculated EDTA Bias | Calculated Heparin Bias | ||
|---|---|---|---|---|
| µg/dL | µg/dL | Percent Bias | µg/dL | Percent Bias |
| 0 | -0.02 | --- | 0.03 | --- |
| 5 | -0.05 | -1.02% | 0.16 | 3.20% |
| 10 | -0.08 | -0.80% | 0.29 | 2.93% |
| 15 | -0.11 | -0.72% | 0.43 | 2.84% |
| 20 | -0.14 | -0.69% | 0.56 | 2.80% |
| 25 | -0.17 | -0.67% | 0.69 | 2.77% |
| 30 | -0.20 | -0.65% | 0.83 | 2.75% |
| 35 | -0.22 | -0.64% | 0.96 | 2.74% |
| 40 | -0.25 | -0.63% | 1.09 | 2.73% |
| 45 | -0.28 | -0.63% | 1.23 | 2.72% |
| 50 | -0.31 | -0.62% | 1.36 | 2.72% |
| 55 | -0.34 | -0.62% | 1.49 | 2.71% |
| 60 | -0.37 | -0.61% | 1.63 | 2.71% |
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Sensor Lot Calibration and Traceability
Calibration of sensor lots, traceable to NIST Standard Reference Material 955c (Lead in Caprine Blood) is performed using four concentrations of control samples. The control samples are used to calibrate a GFAAS instrument, used for comparison with the LeadCare Ultra system. 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.
B. Clinical Results
Method Comparison
The LeadCare Ultra method comparison study was conducted at two sites. Samples collected in EDTA vacutainers, were run in duplicate on GFAAS, the reference method and once on the LeadCare Ultra system. Three hundred ninety four (394) results were generated and 148 were within the claimed analytical range of 1.9-65 ug/dL.
The average of the two GFAAS results was plotted against the LeadCare Ultra result for each sample. Regression analysis for the 148 results is presented.
Image /page/8/Figure/7 description: The image is a scatter plot comparing two different measurement techniques, Ultra and GFAAS, both in units of µg/dL. The x-axis represents GFAAS measurements, while the y-axis represents Ultra measurements. The data points, labeled as 'Series 1', show a positive correlation between the two methods. A linear regression line, described by the equation y = 0.9892x + 0.0662, is fitted to the data, indicating a strong linear relationship between the two measurement techniques.
LeadCare Ultra Results vs. GFAAS average. (R2 = 0.978; N=148 data points).
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The predicted bias for various lead concentrations (LeadCare Ultra) across the analytical range are shown below:
| GFAAS,µg/dL | PredictedUltra, µg/dL | Average Bias,µg/dL | PercentBias |
|---|---|---|---|
| 1.9 | 1.9 | 0.05 | 2.4% |
| 5 | 5.0 | 0.01 | 0.2% |
| 10 | 10.0 | -0.04 | -0.4% |
| 20 | 19.9 | -0.15 | -0.7% |
| 30 | 29.7 | -0.26 | -0.9% |
| 40 | 39.6 | -0.36 | -0.9% |
| 50 | 49.5 | -0.47 | -0.9% |
| 60 | 59.4 | -0.58 | -1.0% |
| 65 | 64.4 | -0.63 | -1.0% |
LeadCare Ultra Average Bias from GFAAS
The clinical data met the acceptance criteria, defined as average bias within the range of ±2 µg/dL in the concentration range 1.9 to 10 µg/dL and ±10% for concentrations above 10 ug/dL.
SUMMARY OF OTHER INFORMATION 8.
This submission included a comparison of intended use statements, proposed product labeling, environmental testing and software validation.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information provided in this 510(k), Magellan believes that the proposed LeadCare Ultra Application is substantially equivalent to the previously cleared predicate product. The proposed device raises no new issues of safety and effectiveness. The non-clinical and clinical testing performed demonstrates that the proposed device met all the specifications and is suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circle, following its curvature.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
Magellan Diagnostics, Inc. C/O Stuart Naylor 101 Billerica Ave, Building 4 NORTH BILLERICA MA 01862-1271
Re: K123563
Trade/Device Name: LeadCare® Ultra™ Blood Lead Testing System Regulation Number: 21 CFR 862.3550 Regulation Name: Lead test system Regulatory Class: II Product Code: DOF Dated: July 10, 2013 Received: July 11, 2013
Dear Stuart Naylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
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the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123563
Device Name: LeadCare Ultra Blood Lead Testing System
Indications for Use:
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.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123563 510(k)
§ 862.3550 Lead test system.
(a)
Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.(b)
Classification. Class II.