Search Results
Found 3 results
510(k) Data Aggregation
(288 days)
Re: K142705
Trade/Device Name: LeadCare® Plus™ Blood Lead Testing System Regulation Number: 21 CFR 862.3550
|
| Regulatory section:
Classification:
Product Code:
Panel: | 21 CFR 862.3550
The LeadCare® Plus™ Blood Lead Testing System is intended for the quantitative measurement of lead in a whole blood sample. The LeadCare Plus Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are for use with both the LeadCare Plus and LeadCare Ultra® Blood Lead Testing Systems.
This test system is for prescription use only. This system is not intended for point of care use.
The LeadCare Plus Blood Lead Testing System is a new instrument to the LeadCare line of instruments. The predicate, LeadCare Ultra, is a 6-channel analyzer which has the same intended use as the LeadCare Plus. The LeadCare Plus instrument is a one-channel version of this system. The LeadCare Plus Analyzer is used in conjunction with the same test kit components, including: sensors, control materials, and single-use packaged reagent tubes as utilized with the predicate device, LeadCare Ultra. The single-channel LeadCare Plus analyzer is an in vitro diagnostic device that relies on electrochemistry (Anodic Stripping Voltammetry or ASV).
The analyzer is a low voltage potentiostat that runs on AC power or batteries and has dimensions of 9"x6.5"x3.5". It is equipped with a Liquid Crystal Display (LCD) Screen, Sensor Connector and Calibration Button reader. The Screen displays instructions for the blood lead assay, result, lot code and error messages. The Calibration Button reader allows for the download of all calibration information, analytical test parameters, and lot code information for any given Sensor lot.
For measurement of lead, the whole blood sample is pipetted to a packaged reagent tube. Upon mixing, the red blood cells are ruptured and the lead is released from the proteins and becomes labile and available for electrochemical detection. After the sample mixture is applied to the sensor, the analyzer applies an electrical potential that causes the lead to reduce (collect) on the sensor. After three minutes, the analyzer applies potentials that cause the lead to oxidize back into solution. The current produced is measured and the amount of lead in the sample is calculated. The analytical result is displayed on the screen in micrograms per deciliter (ug/dL).
Here's an analysis of the acceptance criteria and study details for the LeadCare® Plus™ Blood Lead Testing System, based on the provided document:
1. Table of Acceptance Criteria & Reported Device Performance
The document implicitly defines acceptance criteria through the reported performance metrics that demonstrate substantial equivalence to the predicate device and the reference method. Explicit, pre-defined numerical acceptance criteria are not always stated as "acceptance criteria" but are demonstrated by the device meeting statistical thresholds or showing strong correlation.
| Performance Metric | Acceptance Criteria (Implicit/Demonstrated) | Reported Device Performance |
|---|---|---|
| Precision | Within-run and Total CVs demonstrating acceptable variability for blood lead testing. | Reported: |
| - Mean 3.1 µg/dL: WR CV 14.1%, Total CV 15.6% | ||
| - Mean 5.1 µg/dL: WR CV 8.5%, Total CV 9.6% | ||
| - Mean 11.7 µg/dL: WR CV 5.3%, Total CV 6.0% | ||
| - Mean 24.7 µg/dL: WR CV 3.2%, Total CV 4.0% | ||
| - Mean 45.4 µg/dL: WR CV 3.5%, Total CV 3.7% | ||
| - Mean 59.1 µg/dL: WR CV 3.2%, Total CV 4.0% | ||
| Linearity (vs. LeadCare Plus) | Strong linear relationship, R² close to 1.0. | Reported: |
| Higher order coefficients not statistically significant (CLSI EP06-A Section 5.32). | - Lot 1312B/021214U: Y = 1.11x - 1.49, R² = 0.998 | |
| - Lot 1310A/041014U: Y = 1.08x - 0.803, R² = 0.997 | ||
| Limit of Blank (LoB) | Stated as 1.5 µg/dL (matching predicate). | Calculated Average LoB: 0.98 µg/dL (claimed 1.5 µg/dL) |
| Limit of Detection (LoD) | Stated as 1.9 µg/dL (matching predicate). | Calculated Average LoD: 1.2 µg/dL (claimed 1.9 µg/dL) |
| Limit of Quantification (LoQ) | Stated as 1.9 µg/dL (matching predicate). | Calculated Average LoQ: 1.6 µg/dL (claimed 1.9 µg/dL), Total Error at LoQ 18% |
| Method Comparison (vs. LeadCare Ultra) | Strong linear correlation, slope near 1.0, intercept near 0, R² close to 1.0. | Reported: Slope 0.985, Intercept -0.10, R² 0.994 |
| Method Comparison (vs. GFAAS) | Strong linear correlation, slope near 1.0, intercept near 0, R value close to 1.0. | Reported: Slope 1.029, Intercept -0.98, R 0.994 |
| Matrix Comparison (Micro-capillary tubes vs. GFAAS) | Strong linear correlation, slope near 1.0, intercept near 0, R² close to 1.0. | Reported: Slope 1.018, Intercept 0.023, R² 0.983 |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Study: 80 data points per concentration level (6 concentrations), for a total of 480 individual measurements. The samples included bovine blood standards and an additional human blood sample. Blood matrix information suggests samples were from human donors (for linearity, LoD/LoQ, and method comparison) or bovine (for LoB and some precision).
- Linearity Study: Nine donor blood samples per Sensor/Reagent Lot Pair (concentrations ranging from 0-70 ug/dL). One whole blood, unadulterated in K2EDTA vacutainers, was also included.
- Limit of Blank (LoB) Study: 60 replicates of near blank bovine blood samples.
- Limit of Detection (LoD) & Limit of Quantification (LoQ) Study: 60 replicates of 10 different whole blood samples (human, collected in K2EDTA vacutainers).
- Method Comparison Study: 284 clinical samples were generated, and 169 were within the reportable range of 1.9 - 65 µg/dL for comparison against LeadCare Ultra and GFAAS. These were whole blood samples collected in K2EDTA vacutainers.
- Matrix Comparison Study (Micro-capillary tubes): 23 native patient samples and 27 contrived (spiked) blood samples, totaling 50 samples.
Data Provenance: The document does not explicitly state the country of origin for the human or bovine blood samples. The studies appear to be prospective as they were specifically designed and executed to evaluate the performance of the LeadCare Plus device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes the Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) as the reference method (ground truth) for the Method Comparison and Matrix Comparison studies. For the other studies (Precision, Linearity, LoB/LoD/LoQ), the "ground truth" is typically established by the spiked concentrations or the inherent characteristic of the controls/samples used.
- Number of Experts: Not applicable in the context of GFAAS being the reference method. GFAAS is an analytical instrument-based method, and its results are considered the objective ground truth for lead concentration.
- Qualifications of Experts: Not relevant as the ground truth is an analytical measurement, not an expert visual/cognitive assessment. The technicians operating the GFAAS system would be qualified laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. The ground truth (GFAAS) is an objective analytical measurement, not a subjective interpretation requiring adjudication among human readers.
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 is an in vitro diagnostic device for quantitative measurement of lead, not an imaging or diagnostic AI device that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this entire submission focuses on the standalone performance of the LeadCare® Plus™ Blood Lead Testing System. It is an automated analytical device that provides a quantitative result. The performance metrics presented (precision, linearity, LoB/LoD/LoQ, and method comparisons) all reflect the device's algorithmic and instrument performance without direct human interpretation being part of the measurement output itself. The comparison is made against existing analytical methods (LeadCare Ultra and GFAAS).
7. The Type of Ground Truth Used
The primary ground truth used for performance evaluation, especially for accuracy claims, is objective analytical measurement by Graphite Furnace Atomic Absorption Spectroscopy (GFAAS). GFAAS is a highly accurate and widely accepted reference method for determining elemental concentrations, including lead in blood.
8. The Sample Size for the Training Set
This document does not specify a separate "training set" in the context of machine learning. The LeadCare Plus system is based on electrochemistry (Anodic Stripping Voltammetry or ASV) and operates on a defined algorithm, not a machine learning model that requires a distinct training and test set with ground truth labels. The development and internal validation of the ASV algorithm would have used various samples, but these are not explicitly termed a "training set" in the sense of AI/ML.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device relying on a "training set" in the typical sense, this question is not directly applicable. The device's underlying principles and algorithm are based on established electrochemical theories and analytical chemistry, with development and optimization based on known concentrations of lead and robust calibration protocols.
Ask a specific question about this device
(274 days)
Re: K123563
Trade/Device Name: LeadCare® Ultra™ Blood Lead Testing System Regulation Number: 21 CFR 862.3550
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.
Ask a specific question about this device
(20 days)
01824
Re: K052549 Trade/Device Name: LeadCare® II Blood Lead Testing System Regulation Number: 21 CFR 862.3550
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.
Ask a specific question about this device
Page 1 of 1