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.

Device Description

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).

AI/ML Overview

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.

Summary

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July 7, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

MAGELLAN DIAGNOSTICS REBA DAOUST QA/RA MANAGER 101 BILLERICA AVE. BLDG #4 NORTH BILLERICA MA 01862

Re: K142705

Trade/Device Name: LeadCare® Plus™ Blood Lead Testing System Regulation Number: 21 CFR 862.3550 Regulation Name: Lead test system Regulatory Class: II Product Code: DOF Dated: June 26, 2015 Received: June 29, 2015

Dear Reba Daoust:

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 Parts 801 and 809); 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -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) K142705

Device Name LeadCare® Plus™ Blood Lead Testing System

Indications for Use (Describe)

This test system is for prescription use only. This system is not intended for point of care use.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Magellan Diagnostics. The word "Magellan" is written in a large, bold, sans-serif font. Below the word "Magellan" is a blue rectangle with the word "DIAGNOSTICS" written in white, sans-serif letters. The logo is simple and professional.

510(k) Summary

Applicant Contact Information:

Applicant:	Magellan Diagnostics
Address:	101 Billerica Ave., Building 4N. Billerica, MA, 01862-1272
Contact Person:	Reba DaoustDirector of QA/RA
Phone Number:Fax Number:E-mail:	978-248-7811978-856-2335rdaoust@magellandx.com
Device Trade Name:	LeadCare® Plus™
Regulatory section:Classification:Product Code:Panel:	21 CFR 862.3550Class IIDOFToxicology

Date Summary Prepared: 06/26/2015

Indications for Use:

This test system is for prescription use only. This system is not intended for point of care use.

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Device Description and Test Principle:

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Predicate Device:

K123563 LeadCare Ultra®

Substantial Equivalence Information:

The LeadCare Plus Blood Lead Testing System is a single channel version of the predicate device, LeadCare Ultra Blood Lead Testing System, 510(k) K123563. The following table summarizes the similarities and differences between the two devices.

Feature	LeadCare Ultra - Predicate	LeadCare Plus
Intended Use	The LeadCare Ultra® Blood LeadTesting System is designed toquantitatively measure the amount oflead in a whole blood sample. TheLeadCare Ultra Blood Lead TestingSystem is intended for in vitro(external) use only. The test kitcomponents are designed for use onlywith the LeadCare Ultra Blood LeadTesting System.This test system is for prescription useonly. This system is not intended forpoint of care use.	The LeadCare® Plus™ Blood LeadTesting System is intended for thequantitative measurement of lead in awhole blood sample. The LeadCarePlus Blood Lead Testing System isintended for in vitro (external) useonly. The test kit components are foruse with both the LeadCare Plus andLeadCare Ultra Blood Lead TestingSystems.This test system is for prescription useonly. This system is not intended forpoint of care use.
Methodology	Anodic Stripping Voltammetry	Same
Throughput	6 samples at a time	1 sample at a time
Sensor (test strip)	Screen printed sensors withconductive inks; plastic spacer and lid;capillary fill	Same
Active TestElectrode area	Thin layer of colloidal gold in an inertpolymer matrix	Same
Calibration	Electronic calibration button	Same
Blood Collection	Fingerstick or venipuncture	Same
Sample Matrix	Whole blood; up to 72 hours from timeof draw	Same
Treatment Reagent	Dilute hydrochloric acid in water withinert carbon particles	Same
Sample Handling	Uses pipet to transfer sample fromreagent tube to sensor	Same
Check for SensorLot Expiration	Checks sensor lot expiration date	Same
Internal Self Test	Self Test checks electronic functions ofanalyzer each time it is turned ON andon each channel following a sensorinsertion	Self Test checks electronic functionsevery time the analyzer is turned ON
Sensor Connector	Makes electrical contact with sensor.	Same
Feature	LeadCare Ultra - Predicate	LeadCare Plus
Unit of Measure	Results displayed in micrograms oflead per deciliter of whole blood(µg/dL)	Same
Displayed Result	Lead results stored in computer	Lead result is displayed until new sensoris inserted
Reportable Range	1.9 – 65 µg/dL	Same
Controls	2 levels of external liquid controls	Same
Power Source	AC Adapter or batteries	Same
Test Time	3 minutes	Same
Software	Software is in the form of firmwareinstalled onto the analyzer'smicroprocessor	Software is in the form of firmwareonly, installed onto the analyzer'smicroprocessor
	User Interface software, installed onthe computer workstation, displaysresults and provides DataManagement capability	Results displayed on LCD screen
Lead TestAlgorithm	ASV routine; Pb peak identified andquantified; blood Pb result assignedusing lookup tables	Same
Storage of Results	Computer stores the patient resultsand allows for retrieval of storedresults	None
Output of Results	Results displayed on screen. Resultscan be printed and transferred to aLIMS accessible location	Result displayed on screen
Audible Tones	Beep at power up; at beginning of test;at end of test; after calibration	Same
User Interface	Graphical user interface withmessages and graphics to guide usersthrough procedure	Alphanumeric display, 4 lines by 20characters allows useful messagestoguide users through procedure
System OperatingRange	Temperature range of 16° to 30°C;(60.8° to 86°F); Relative Humidity12%-80% non-condensing toaccommodate typical laboratory use	Same
Limit of Detection	1.9 µg/dL	Same
NumericResolution (Result)	0.1 µg/dL	Same

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Summary of Non-Clinical and Clinical Performance Testing as Basis for Substantial Equivalence:

A. Non-Clinical Results

Precision

The Precision Study was performed using bovine blood standards at lead concentrations of 3.1, 5.1, 11.7, 24.7 and 45.4 µg/dL. An additional human blood sample at lead concentration of 59.1 µg/dL was also included to challenge the high end of the range. Eighty (80) data points were collected per concentration level over a 20 day period using two Sensor/Reagent Lot Pairs following CLSI EP05-A2 guidelines. Samples were prepped two times per day. The LeadCare Plus precision passed the pre-defined acceptance criteria.

The combined data set is shown: Summarized ANOVA Results for Both Sensor/Reagent Lot Pairs

Mean,	WR* SD,	Total SD,	WR	Total
µg/dL	µg/dL	µg/dL	CV	CV
3.1	0.44	0.49	14.1%	15.6%
5.1	0.44	0.50	8.5%	9.6%
11.7	0.64	0.71	5.3%	6.0%
24.7	0.80	1.00	3.2%	4.0%
45.4	1.61	1.71	3.5%	3.7%
59.1	1.89	2.42	3.2%	4.0%

*WR = within run

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Linearity

Linearity assessments were performed on two Sensor/Reagent Lot Pairs using nine donor blood samples, spiked with lead to concentrations of 0-2 ug/dL, 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, 65-70 ug/dL. One whole blood, unadulterated in K2EDTA vacutainers, was also included.

Linearity was evaluated by performing polynomial regressions and determining whether higher order coefficients were statistically significant as per CLSI EP06-A Section 5.32.

The Linear Regression results for each of the two Sensor/Reagent Lot Pairs are as follows:

1312B/021214U	1310A/041014U
Y = 1.11x - 1.49	Y = 1.08x - 0.803
R2 = 0.998	R2 = 0.997

Limit of Blank, Limit of Detection & Limit of Ouantification

The Limits of Blank, Detection and Quantification were established using the Total Error Analysis Method and by following the CLSI EP17-A2 guidelines.

The Limit of Blank (LoB) was determined by running 60 replicates of near blank bovine blood samples, over 5 days. Samples were analyzed using two Sensor/Reagent Lot Pairs.

The average LoB was calculated to be 0.98 µg/dL.

The Limit of Detection (LoD) and Limit of Quantification (LoQ) were determined by running 60 replicates of 10 different whole blood samples, collected in K2EDTA vacutainers. The replicates were run, using two Sensor/Reagent Lot Pairs on LeadCare Plus analyzers over five days.

The average LoD was calculated to be 1.2 ug/dL.

The Limit of Quantification LoQ was calculated using the Total Error equation:

Total Error LoQ = absolute (Bias) + (2 x SD)

The average LoQ was calculated to be 1.6 ug/dL.

The Total Error at the LoQ was 18%.

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Obtained LoB, LoD, and LoQ values for the LeadCare Plus differ slightly from those obtained for the LeadCare Ultra (See K123563). For product family consistency between LeadCare Plus and LeadCare Ultra, the claimed values for LoB, LoD and LoQ of the LeadCare Plus are provided in the table below and are identical to the values obtained for the LeadCare Ultra:

	LeadCare Plus
LoB	1.5 µg/dL
LoD	1.9 µg/dL
LoQ	1.9 µg/dL

Interference

See K123563 for interference information.

B. Clinical Results

Method Comparison

The Method Comparison Study was conducted at one site with two Sensor/Reagent Lot Pairs; two labs; two users and two stations of six LeadCare Plus analyzers. To determine accuracy, based on CLSI EP09-A3, clinical samples were run on the LeadCare Plus systems and the results were compared to the predicate method, LeadCare Ultra and to the reference method, Graphite Furnace Atomic Absorption Spectroscopy (GFAAS).

Whole blood samples collected in K2EDTA Vacutainers, were run singly on the LeadCare Plus and predicate device, LeadCare Ultra; and in duplicate on the reference method, GFAAS. Two hundred eighty four (284) results were generated and 169 were within range of 1.9 - 65 µg/dL.

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The linear regression analysis for LeadCare Plus vs. LeadCare Ultra is shown below:

Slope	Intercept	R2	N
0.985	-0.10	0.994	169

A graph of the actual LeadCare Plus Results vs. LeadCare Ultra is as follows:

Image /page/10/Figure/3 description: This image is a scatter plot comparing LeadCare Plus and LeadCare Ultra, both measured in micrograms per deciliter (µg/dL). The x-axis represents LeadCare Ultra values, ranging from 0 to 70 µg/dL, while the y-axis represents LeadCare Plus values, also ranging from 0 to 70 µg/dL. The data points are clustered along a diagonal line, indicating a positive correlation between the two measurement methods. The trend line suggests that as LeadCare Ultra values increase, LeadCare Plus values also tend to increase.

The Linear Regression Results of LeadCare Plus vs. GFAAS is shown below:

Slope	Intercept	R	N
1.029	-0.98	0.994	169

A graph of the actual LeadCare Plus results vs. GFAAS is shown below:

Image /page/10/Figure/7 description: This image is a scatter plot comparing LeadCare Plus and GFAAS measurements, both in µg/dL. The x-axis represents GFAAS measurements ranging from 0 to 70 µg/dL, while the y-axis represents LeadCare Plus measurements over the same range. The data points show a strong positive correlation between the two measurement methods, with a dotted line indicating a trend. Most of the data points are clustered along the trend line, indicating agreement between LeadCare Plus and GFAAS.

Page 8 of 9

Section 5 Traditional 510(k) LeadCare® Plus™

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Matrix Comparison

Matrix Comparisons were made for the Micro-capillary tubes with K2EDTA. The bloods had lead concentrations that spanned the range 1.9 to 63.1 ug/dL, based on GFAAS. Twenty three results were obtained from native patient samples. Twenty seven results were obtained with contrived blood samples, spiked with lead.

The Linear Regression Results of LeadCare Plus vs. GFAAS is shown below:

Slope	Intercept	R2	Concentration Range, μg/dL	N
1.018	0.023	0.983	1.9 - 63.1	50

See K123563 for other Matrix Comparison results using:

K3EDTA, K2EDTA Vacutainers ●
Sodium Heparin Vacutainers ●

Conclusions:

The LeadCare Plus System 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 summarized demonstrates that the LeadCare Plus met all the specifications and is suitable for its intended use.

Regulation Number and Section

§ 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.