(288 days)
Not Found
No
The device description and performance studies focus on electrochemical measurement and standard statistical analysis, with no mention of AI or ML algorithms.
No.
The device is intended for the quantitative measurement of lead in a whole blood sample, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use" section explicitly states that the device is for "quantitative measurement of lead in a whole blood sample," and the "Device Description" identifies it as an "in vitro diagnostic device." These phrases confirm its role in diagnosing a condition (lead levels).
No
The device description clearly details a physical instrument (analyzer) that performs electrochemical measurements and has hardware components like an LCD screen, sensor connector, and calibration button reader. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The LeadCare Plus Blood Lead Testing System is intended for in vitro (external) use only." This is a key characteristic of an IVD.
- Device Description: The "Device Description" section also refers to the device as "an in vitro diagnostic device".
- Function: The device measures lead in a whole blood sample, which is a biological specimen. IVDs are designed to examine specimens derived from the human body to provide information for diagnostic purposes.
- Components: The system includes components like sensors, control materials, and reagent tubes, which are typical for in vitro diagnostic tests.
Therefore, based on the provided information, the LeadCare Plus Blood Lead Testing System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DOF
Device Description
The LeadCare Plus Blood Lead Testing System is a new instrument to the LeadCare line of instruments. 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription use only. 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)
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.
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.
Limit of Blank, Limit of Detection & Limit of Quantification: 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%.
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.
Linear regression analysis for LeadCare Plus vs. LeadCare Ultra: Slope 0.985, Intercept -0.10, R2 0.994, N 169.
Linear regression analysis for LeadCare Plus vs. GFAAS: Slope 1.029, Intercept -0.98, R 0.994, N 169.
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.
Linear regression results of LeadCare Plus vs. GFAAS: Slope 1.018, Intercept 0.023, R2 0.983, Concentration Range 1.9 - 63.1 µg/dL, N 50.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reportable Range: 1.9 – 65 µg/dL
Limit of Detection: 1.9 µg/dL
Numeric Resolution (Result): 0.1 µg/dL
Average LoB: 0.98 µg/dL
Average LoD: 1.2 ug/dL
Average LoQ: 1.6 ug/dL
Total Error at the LoQ: 18%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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
2
Indications for Use
510(k) Number (if known) K142705
Device Name LeadCare® Plus™ Blood Lead Testing System
Indications for Use (Describe)
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.
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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3
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 4 |
| N. Billerica, MA, 01862-1272 | |
| Contact Person: | Reba Daoust |
| Director of QA/RA | |
| Phone Number: | |
| Fax Number: | |
| E-mail: | 978-248-7811 |
| 978-856-2335 | |
| rdaoust@magellandx.com | |
| Device Trade Name: | LeadCare® Plus™ |
| Regulatory section: | |
| Classification: | |
| Product Code: | |
| Panel: | 21 CFR 862.3550 |
| Class II | |
| DOF | |
| Toxicology |
Date Summary Prepared: 06/26/2015
Indications for Use:
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.
Page 1 of 9
4
Device Description and Test Principle:
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).
5
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 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® 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. |
| Methodology | Anodic Stripping Voltammetry | Same |
| Throughput | 6 samples at a time | 1 sample 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; up to 72 hours from time
of draw | Same |
| Treatment Reagent | Dilute hydrochloric acid in water with
inert carbon particles | Same |
| Sample Handling | Uses pipet to transfer sample from
reagent tube to sensor | Same |
| Check for Sensor
Lot Expiration | Checks sensor lot expiration date | Same |
| Internal Self Test | Self Test checks electronic functions of
analyzer each time it is turned ON and
on each channel following a sensor
insertion | Self Test checks electronic functions
every 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 of
lead per deciliter of whole blood
(µg/dL) | Same |
| Displayed Result | Lead results stored in computer | Lead result is displayed until new sensor
is 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 firmware
installed onto the analyzer's
microprocessor | Software is in the form of firmware
only, installed onto the analyzer's
microprocessor |
| | User Interface software, installed on
the computer workstation, displays
results and provides Data
Management capability | Results displayed on LCD screen |
| Lead Test
Algorithm | ASV routine; Pb peak identified and
quantified; blood Pb result assigned
using lookup tables | Same |
| Storage of Results | Computer stores the patient results
and allows for retrieval of stored
results | None |
| Output of Results | Results displayed on screen. Results
can be printed and transferred to a
LIMS 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 with
messages and graphics to guide users
through procedure | Alphanumeric display, 4 lines by 20
characters allows useful messages
to
guide users through procedure |
| System Operating
Range | Temperature range of 16° to 30°C;
(60.8° to 86°F); Relative Humidity
12%-80% non-condensing to
accommodate typical laboratory use | Same |
| Limit of Detection | 1.9 µg/dL | Same |
| Numeric
Resolution (Result) | 0.1 µg/dL | Same |
6
7
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
Page 5 of 9
8
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%.
9
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.
10
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™
11
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.