(274 days)
No
The description focuses on electrochemical detection and data processing via embedded firmware and a dedicated computer, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is designed to measure the amount of lead in a blood sample, which is a diagnostic function, not a therapeutic one. Therapeutic devices are used for treatment or prevention of disease.
Yes
Documentation states, "The LeadCare Ultra System Blood Lead Testing System is an in vitro diagnostic device".
No
The device description clearly outlines hardware components including an Analyzer, Computer, Monitor, Keyboard, Barcode Reader, Mouse, and Test Kit components (sensor, reagent). While software is involved in data analysis and storage, it is integral to a system that includes significant physical hardware for sample processing and measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the system is "intended for in vitro (external) use only" and is designed to "quantitatively measure the amount of lead in a whole blood sample." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details how the system analyzes a blood sample using electrochemistry to detect lead. This process is performed outside of the body using a biological specimen.
- Predicate Device: The document lists a predicate device (K052549; LeadCare® II Blood Lead Testing System) which is also a blood lead testing system, further indicating that this type of device is classified as an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DOF
Device Description
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. Materials supplied in the Test Kit include:
Sensors (8 containers of 24 ea.) Quantity: 192
Treatment Reagent Tubes (250μL of 0.34M HCl) Quantity: 192
Calibration Button Quantity: 1
Lead Control Level 1 (2mL) Quantity: 1
Lead Control Level 2 (2mL) Quantity: 1
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Whole blood sample
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This test system is for prescription use only. This system is not intended for point of care use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Results
Precision
Study Performed: LeadCare Ultra Precision Study
Sample Size: Eighty (80) data points per concentration level.
Data Source: Bovine blood standards at lead concentrations of 4.5, 6.4, 10.8, 24.4, 44.2, and 62.1 ug/dL.
Key Results: The combined data set for precision is presented, showing within-run SD (WR SD), total SD, WR CV, and Total CV for various lead concentrations. For example, at 4.5 µg/dL, WR SD was 0.36 µg/dL and Total SD was 0.49 µg/dL.
Linearity
Study Performed: Linearity assessments
Sample Size: Not explicitly stated as overall sample size but nine donor blood samples were spiked. Replicates were analyzed.
Data Source: 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.
Key Results: Linear regression results for three Sensor lots (1208A, 1211B, 1305A) showed high R2 values (0.997, 0.996, 0.998 respectively), demonstrating linearity. Polynomial regression analysis showed no statistically significant non-linearity for the range 1 - 66 ug/dL (all p values for higher order coefficients were greater than 0.05). Linearity was also demonstrated for each of the six channels on the LeadCare Ultra analyzer, and replicate data met precision goals.
Limit of Blank, Limit of Detection & Limit of Quantification
LoB Determination: 70 replicates of a near blank NIST blood sample (0.3 ug/dL) run over 5 days using two Sensor lots and all Analyzer channels.
Result: LoB calculated to be 1.5 ug/dL.
LoD Determination: 70 data points from low samples collected using all channels of the Analyzer, over five days, with two Sensor lots.
Result: LoD calculated to be 1.9 ug/dL.
LoQ Calculation: Using the Total Error equation: Total Error LoQ = absolute (Bias) + (2 x SD). Bias of 0.02 µg/dL for 58 samples between 1 and 6 ug/dL (GFAAS). Standard Deviation at the LoD (1.9 µg/dL) is 0.25 µg/dL.
Result: Total Error LoQ = 0.02 + (2 x 0.25) = 0.52. The LoQ is equal to the LoD (1.9 ug/dL).
Matrix Comparison
Matrix Comparisons were made for K3EDTA, K2EDTA Vacutainers, Sodium Heparin Vacutainers, and Micro-capillary tubes with K2EDTA.
Result: 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.
Clinical Results
Method Comparison
Study Type: Method comparison study
Sample Size: Three hundred ninety four (394) results were generated, and 148 were within the claimed analytical range of 1.9-65 ug/dL.
Data Source: Samples collected in EDTA vacutainers.
Protocol: Samples were run in duplicate on GFAAS (reference method) and once on the LeadCare Ultra system. The average of the two GFAAS results was plotted against the LeadCare Ultra result for each sample.
Key Results: Regression analysis for the 148 results showed R2 = 0.978. 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. For example, at 1.9 µg/dL GFAAS, predicted Ultra was 1.9 µg/dL with an average bias of 0.05 µg/dL (2.4% bias). At 65 µg/dL GFAAS, predicted Ultra was 64.4 µg/dL with an average bias of -0.63 µg/dL (-1.0% bias).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Non-Clinical Results
Precision
WR SD, Total SD, WR CV, Total CV
Specific values available in the Precision table for different concentrations.
Linearity
Linear Regression results: Y = 1.04x - 1.17, R2 = 0.997, Sy.x = 1.41 (Lot 1208A)
Y = 1.10x - 1.71, R2 = 0.996, Sy.x = 1.64 (Lot 1211B)
Y = 1.04x - 0.58, R2 = 0.998, Sy.x = 1.05 (Lot 1305A)
Quadratic and Cubic Regression p values for different lots.
Limit of Blank, Limit of Detection & Limit of Quantification
LoB: 1.5 ug/dL
LoD: 1.9 ug/dL
LoQ: 1.9 ug/dL (Total Error LoQ = 0.52)
Matrix Comparison
Bias (µg/dL and Percent Bias) for Micro-capillary tubes with K2EDTA compared to GFAAS.
Calculated EDTA Bias and Calculated Heparin Bias (µg/dL and Percent Bias) compared to GFAAS.
Clinical Results
Method Comparison
R2 = 0.978
Average Bias (µg/dL and Percent Bias) for various lead concentrations compared to GFAAS.
Example: For GFAAS 1.9 µg/dL, Average Bias is 0.05 µg/dL (2.4%).
For GFAAS 65 µg/dL, Average Bias is -0.63 µg/dL (-1.0%).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LeadCare® II Blood Lead Testing System (K052549)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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,
2
Similarities/Differences of LeadCare® Ultra™ with Predicate Device
| Feature | LeadCare® II | LeadCare® Ultra™ |
|---|---|---|
| Intended Use | The LeadCare II Blood Lead | |
| Testing System is an | ||
| instrumented assay to be used | ||
| in the quantitation of lead in | ||
| whole human blood. The | ||
| LeadCare II System is suitable | ||
| for use in a Physician's office | ||
| laboratory (POL). | 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. |
| Methodology | Anodic Stripping Voltammetry | Same |
| Throughput | 1 sample at a time | 6 samples at a time |
| Sensor (test strip) | Screen printed sensors with
conductive inks; plastic spacer
and lid; capillary fill | Same |
| Active Test
Electrode area | Thin layer of colloidal gold in
an inert polymer matrix | Same |
| Calibration | Electronic calibration button | Same |
| Blood Collection | Fingerstick or venipuncture | Same |
| Sample Matrix | Whole blood collected in
EDTA or heparin; fresh up to
24 hours from time of draw | Whole blood collected in
EDTA or heparin; up to 72
hours from time of draw |
| Treatment Reagent | Dilute hydrochloric acid
solution in water | Dilute hydrochloric acid
solution in water with inert
carbon particles |
| Sample Handling | Uses transfer dropper to
transfer sample from reagent
tube to sensor | Uses pipet to transfer sample
from reagent tube to sensor |
| Check for Sensor
Lot Expiration | Checks sensor lot expiration
date passed in on the calibration
button | 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/dL
2 levels of external liquid controls | 1.9 – 65 µg/dL
Same |
| 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 Operating
Range | Temperature range of 54° to
97°F (12° to 36°C); Relative
Humidity 12%-80% non-
condensing to accommodate
field portability | Temperature range of 60° to
82°F (16° to 28°C); Relative
Humidity 12%-80% non-
condensing to accommodate
typical laboratory use |
| Limit of Detection | 3.3 µg/dL | 1.9 µg/dL |
.
3
4
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 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 |
5
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:
| | Quadratic
Regression | Cubic Regression | |
|-------|-----------------------------|-----------------------------|------------------------------|
| | Quad Coefficient
p value | Quad Coefficient
p value | Cubic Coefficient
p 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.
6
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.
7
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 | Predicted
Ultra
µg/dL | Bias,
µg/dL | Percent
Bias |
|-----------------|-----------------------------|----------------|-----------------|
| 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% |
8
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).
9
The predicted bias for various lead concentrations (LeadCare Ultra) across the analytical range are shown below:
| GFAAS,
µg/dL | Predicted
Ultra, µg/dL | Average Bias,
µg/dL | Percent
Bias |
|-----------------|---------------------------|------------------------|-----------------|
| 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)