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).

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the European Space Agency (ESA). The logo consists of the letters "esa" in a sans-serif font. Below the letters, there is the text "EUROPEAN SPACE AGENCY" in a smaller font size. The logo is in black and white.

510(k) summary of safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.

The assigned 510(k) number is: KOS 2549

Submitter's Information

ESA Biosciences Inc 22 Alpha Road Chelmsford, MA 01824 USA

Contact: Harold Asp, Quality Assurance Manager Phone: (978) 250-7000 Fax: (978) 250-7090

Date Summary Prepared: September 15, 2005

Device Name

Product Name: LeadCare® II Blood Lead Testing System Classification Name: Atomic Absorption, Lead Common/Usual Name: Anodic Stripping Voltammetry (ASV) Proprietary Name: LeadCare® II Blood Lead Testing System Product Code: DOF

Predicate Device

Substantial Equivalence to ESA Bioscience Inc. (formerly ESA Inc.) LeadCare® Blood Lead Testing System. (K971640)

Device Description

Section 7 pass 1 of 4

ESA BIOSCIENCES, INC. ESA INTERNATIONAL, INC

22 Alpha Road Chelmsford, MA 01824.417 United States (978) 250-7000 Fax (978) 250-7090 www.esainc.com

ESA LABORATORIES, INC

22 Alpha Road Chelmsford, MA 01824-4171 United Stutes (978) 250-7150 Fax (978) 250-717 ?

ESA ANALYTICAL, LTD

Brook Farm, Dorto Aylesbury, Buckinghamshire H018 9NH England 41 23938 844) 239382

CYPRESS SYSTEMS

A Division of ESA Biosciences, Inc 2300 West 31st Street, Suite A lawrence, KS 66047 United States (800) 235-2436 Fax (785) 832 0406 www.cypressssystems.com

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the European Space Agency (ESA). The logo consists of a stylized bird-like figure on the left and the letters "esa" on the right. The logo is in black and white and appears to be slightly pixelated.

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.

1. 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).
1. Comparison to Predicate Device
  The LeadCare® II Bllod Lead Testing System is a modification of the LeadCare® Blood Lead Testing System and is substantially equivalent to it. The table below summarizes the similarities and differences.

Feature	LeadCare® System	LeadCare® II System
Intended Use	An Instrumented assay to beUsed in the quantitation ofLead in human whole blood.The LeadCare®System issuitable for use inPhysician's OfficeLaboratory Environment(POL)	Same as LeadCare®.
Methodology	Anodic StrippingVoltmmetry (ASV)	Same as LeadCare®.
Sample Matrix	Fresh human whole blood	Same as LeadCare®.
Blood Collection	Skin puncture orvenipuncture	Same as LeadCare®.
Treatment Reagent	Dilute hydrochloric acidsolution in water	Same as LeadCare®.
Sample handling	Uses 50 µl pipette to transfersample from reagent tube tosensor	Uses 50 µl capillary tube totransfer sample fromreagent tube to sensor
Feature	LeadCare® System	LeadCare® II System
Sensor (Test Strip)	(2)Screen printed conductive inks on an inert polymer substrate. (1) screen printed dielectric ink is for insulation and electrode area definition.	Same as LeadCare®.In addition, a plastic spacer and lid are attached to the sensors to create a channel, which fills via capillary action.
Active Test Electrode area	Test electrode is covered by a thin layer of colloidal gold in an inert polymer matrix	Same as LeadCare®.
Calibration	Electronic calibration button	Same as LeadCare®.
Check for Sensor LotExpiration	None	Checks sensor lot expiration date passed in on the calibration button for that particular lot of sensors.
Internal Self Test	Self test checks electronic functions of analyzer each time it is turned on	Same as LeadCare®.
Sensor Connector	Makes electrical contact with sensor.	Sensor insertion detection and makes electrical contact with sensor.
Unit of Measure	Results displayed in micrograms of lead per deciliter of whole blood (µg/dl of Pb)	Same as LeadCare®.
Displayed Result	Pb result is displayed until the Start button is pressed. Upon power-up after auto shut-off, last result is displayed.	Pb result is displayed until a new sensor is inserted.
Reportable Range	1.4-65 µg/dl of Pb	Same as LeadCare®.
Controls	2 levels of external control	2 levels of external control
Power Source	AC Adapter or one 9 volt battery	AC Adapter or 4 AA batteries
On/Off	Start button acts as On switch; auto shut-off	On/Off switch and auto shut-off
Test Time	3 minutes	Same as LeadCare®.
Initiation of Test	User presses Start button after applying sample.	Analyzer starts the test after confirming enough sample has been added to the sensor.
Pb Test Algorithm	ASV routine; Pb peak identified and quantified; blood Pb result assigned using look-up tables	Same as LeadCare®.
Error Messages	5 error codes	16 error messages
Audible Tones	"Beep" at power-up; at beginning of test; at end of test: after calibration.	Same as LeadCare®.
User Interface	Custom display, limited message capability	Alphanumeric display, 4 lines by 20 characters allows useful messages to guide users through procedure
Feature	LeadCare® System	LeadCare® II System
System Operating Range	Temperature: 54°-97° F (12-36°C) Relative Humidity12%-80% (non condensing)	Same asLeadCare®.
Sensitivity (Limit OfDetection)	1.4 µg/dl Pb	1.5 µg/dl Pb
Display Resolution	0.1 µg/dl Pb	Same asLeadCare®.

Section 7 page 2 of 4

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the ESA logo. The logo consists of a stylized bird-like figure on the left and the letters "esa" on the right. The image is in black and white.

Section 7 page 3 of 4

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the European Space Agency (ESA). The logo consists of a stylized image of a bird in flight on the left, and the letters "esa" in a sans-serif font on the right. The logo is black and white.

1. Discussion of Non-Clinical Performance Data
  A method comparison study was conducted in which 108 human samples were run on six LeadCare II analyzers over 5 days and compared with results run by graphite furnace atomic absorption spectroscopy (GFAAS). Of the 108 samples, 22 were spiked (86 were unspiked).

The results from this study gave the following regression:

Y (LeadCare II) = 1.040 x GFAAS + 0.12, syx =1.30 , r = 0.996

The average LeadCare II bias from reference is shown in Table 1 for three ranges.

Table 1Average LeadCare II average bias from GFA
Leadconcentrationµg/dL	LeadCare IIbias fromGFAAS	LeadCare II% bias fromGFAAS
0 - 10	0.07	-----
10.1 - 25.0	-----	4.7%
25.1 - 65	-----	5.0%

These results are similar to the LeadCare results, which had a regression equation of:

Y (LeadCare I) = 0.992 x GFAAS + 0.94
Since the LeadCare II average biases are well within goals, LeadCare II is substantially equivalent to LeadCare .
1. Conclusions
  In summary, based on comparison with the legally marketed LeadCare® Blood Lead Testing System, the data demonstrates that the LeadCare® II Blood Lead testing System performs as well as the predicate device and do not present new issues of safety and effectiveness.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers. The logo is presented in black and white.

Public Health Service

OCT 6 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Harold Asp Quality Assurance Manager ESA Biosciences Inc. 22 Alpha Road Chelmsford, MA 01824

Re: K052549 Trade/Device Name: LeadCare® II Blood Lead Testing System Regulation Number: 21 CFR 862.3550 Regulation Name: Lead test system Regulatory Class: Class II Product Code: DOF Dated: September 15, 2005 Received: September 16, 2005

Dear Mr. Asp:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{5}------------------------------------------------

Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K05 2549

Device Name: LEADCARE® II BLOOD LEAD TESTING SYSTEM

Indications For Use:

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).

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitto Diagnostic Device Evaluation and nety

510(k) K052549

Page 1 of ___ 1_______________________________________________________________________________________________________________________________________________________________

Section 1 ... / 11

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.