ESA Biosciences LeadCare II Control is intended to be used to monitor and evaluate the analytical performance of the ESA Biosciences LeadCare II Analyzer for the measurement of lead in blood. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of lead provided by the controls allow performance monitoring within the clinically important range. For In Vitro Diagnostic Use

Device Description

The ESA LeadCare II Control is customized for use on the ESA Biosciences LeadCare II Lead Analyzer and are used to verify the performance of the LeadCare II analyzers and sensors for the measurement of lead. The control solution is an aqueous solution containing bovine albumin, lead, buffers, preservative and dye in concentrations determined optimal for the LeadCare II system. The product is provided in two distinct levels, in screw capped, glass vials, each containing 2 mL of solution. One set of controls will be packaged with each LeadCare II test kit for use in quality control testing of the sensors, and verification of system performance. LeadCare II Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle. LeadCare II Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.

AI/ML Overview

Here's an analysis of the provided information regarding the LeadCare II Lead Controls device, structured according to your request:

Acceptance Criteria and Study Details for LeadCare II Lead Controls

The provided document describes the LeadCare II Lead Controls, a quality control material intended to monitor the precision and verify the performance of the ESA Biosciences LeadCare II System for measuring lead in blood. The nature of this device (a quality control material) means that its "performance" is primarily defined by its stability, accuracy in its stated lead concentration, and its ability to provide consistent results when used with the LeadCare II analyzer. The acceptance criteria are implicitly tied to maintaining the stated levels and stability.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a quality control material, the "performance" is related to its characteristics and stability rather than diagnostic accuracy metrics like sensitivity or specificity. The document doesn't explicitly state numerical acceptance criteria values for each test, but describes the tests performed to verify specific performance requirements.

Acceptance Criteria Category	Reported Device Performance (as described by tests conducted)
Preservation Efficacy	Tests were conducted to verify preservative efficacy. (No specific results or numerical acceptance criteria provided in this summary.)
Closed Bottle Stability	Tests were conducted to verify closed bottle stability. (No specific results or numerical acceptance criteria provided in this summary.)
Stability After Opening	Tests were conducted to verify stability after opening. (No specific results or numerical acceptance criteria provided in this summary.)
Comparison to Predicate Device	Substantially equivalent in function, safety, and efficacy to the Kaulson Laboratories Heavy Metal Control.
Test Precision and Range	Tests were conducted to verify test precision and range. (No specific results or numerical acceptance criteria provided in this summary.)

2. Sample Size and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample sizes used for the non-clinical tests (preservative efficacy, stability studies, precision, and range).
Data Provenance: The studies were conducted by Bionostics, Inc., located in Devens, MA, USA. The data would therefore be of U.S. origin. The studies are non-clinical tests, likely conducted prospectively as part of product development and validation for the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. The ground truth for a quality control material relates to its manufactured concentration and stability, which are determined through analytical chemistry and stability studies, not by expert consensus on diagnostic images or patient data.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for a quality control material is established through lab-based analytical methods rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is a quality control material, not an AI or diagnostic imaging device that would involve human readers interpreting cases. Therefore, an MRMC study and effects on human reader performance are not relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a consumable quality control material (an aqueous solution), not a software algorithm or AI-powered device. Its "performance" is inherent in its chemical composition and stability characteristics rather than an algorithmic output.

7. Type of Ground Truth Used

The ground truth for this device (LeadCare II Lead Controls) is established through analytical testing and laboratory characterization of the manufactured control solutions. This includes:

Certified lead reference materials: Used to accurately determine the lead concentration in the control solutions.
Stability studies: Monitoring the lead concentration and integrity of the control solutions over time under various conditions to establish shelf-life and in-use stability.
Precision studies: Performed using established laboratory methods on the LeadCare II System itself to demonstrate repeatable results.

8. Sample Size for the Training Set

Not applicable. This device is not a machine learning or AI algorithm, so there is no "training set" in the context of an algorithm learning from data. The product is manufactured and validated based on its chemical properties and performance with the associated analytical system.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device. The ground truth for a quality control material is established through the manufacturing process specifications and subsequent analytical validation, as detailed in point 7.

Summary

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

Image /page/0/Picture/0 description: The image shows the number 1063398 at the top. Below that is the word BIONOSTICS in bold font. There is a crescent moon shape in the middle of the image. The words FERRARIS Quality Solutions are at the bottom right of the image.

510(k) Summary1

DEC - 5 2006

(a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Randy Byrd Chief Technical Officer (978) 772-7070 x 272

Date of preparation of this summary: 8 November 2006

(2) Device trade or proprietary name: LeadCare II Lead Controls Device common or usual name or classification name:
Clinical Toxicology Control Material

CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PANEL
Clinical Toxicology Control Material	862.3280 (D/F)	1	Toxicology

I. Substantial Equivalence

ESA LeadCare II Lead Control is substantially equivalent in function, safety and efficacy to the Kaulson Laboratories Heavy Metal Control currently distributed with the LeadCare II test kits.

Characteristic	New Device	Predicate Device
Name:	LeadCare II Lead Control	Kaulson Labs LeadCare Lead Control
510(k):	--	K830234
Description:	Aqueous solution containing bovine albumin,lead salts, preservatives and dye.	Lyophilized whole bovine blood with pre-measured water for dilution
Intended Use:	LeadCare II Lead Controls are intended foruse as a quality control to monitor theprecision of measurement and verify theperformance of the ESA BiosciencesLeadCare II System at two distinct levelswithin the measurement range.	LeadCare Lead Controls are intended foruse as a quality control to monitor theprecision of measurement and verify theperformance of the ESA BiosciencesLeadCare II System at two distinct levelswithin the measurement range.
Levels:	2	2
Analytes:	Lead	Lead

Comparison of Technological Characteristics with Predicate Device

l This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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

II. Description of the new device

LeadCare II Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle.

LeadCare II Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.

(5) Intended use of the device

LeadCare II Lead Controls are intended for use as a quality control to monitor the precision of measurement and verify the performance of the ESA Biosciences LeadCare II System at two distinct levels within the measurement range.

(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Tests were conducted to verify specific performance requirements:

a) Preservative Efficacy
b) Closed bottle stability
c) Stability after opening
d) Comparison to predicate device
e) Test precision and range
(b) (2) Summary of clinical tests submitted with the premarket notification for the device.

N/A

(b) (3) Conclusions drawn from the clinical and non-clinical trials. Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human figures in the negative space of the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Randy Byrd Chief Technical Officer Bionostics, Inc. 7 Jackson Road Devens, MA 01434

DEC - 5 2006

Re: K063398 Trade/Device Name: ESA Biosciences LeadCare II Lead Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology control material Regulatory Class: Class I, reserved Product Code: DIF Dated: November 8, 2006 Received: November 9, 2006

Dear Mr. Byrd:

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 Mav 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).

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

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,

Alberto G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K063398

Device Name: ESA Biosciences LeadCare II Control

Indications For Use:

For In Vitro Diagnostic Use

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)

Carol Benam

sion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

K063398

Page 1 of

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.