LEADCARE II BLOOD LEAD TESTING SYSTEM

K052549 · Esa Biosciences, Inc. · DOF · Oct 6, 2005 · Clinical Toxicology

Device Facts

• Record ID: K052549
• Device Name: LEADCARE II BLOOD LEAD TESTING SYSTEM
• Applicant: Esa Biosciences, Inc.
• Product Code: DOF · Clinical Toxicology
• Decision Date: Oct 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3550
• Device Class: Class 2

Indications for Use

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 Story

LeadCare® II Blood Lead Testing System quantifies lead in venous or capillary whole blood samples. System components include an analyzer, disposable sensors, reagent vials, and a calibration button. Operation involves mixing blood with treatment reagent (dilute hydrochloric acid) to release lead from red blood cells; sample is applied to a sensor. Analyzer uses Anodic Stripping Voltammetry (ASV) to collect lead on the sensor, then strips it to generate a current response. The device identifies and quantifies the lead peak, converts it to a blood Pb value (µg/dL), and displays the result. Used in physician office laboratories by clinical staff. Output guides clinical decision-making regarding lead exposure. Benefits include rapid, point-of-care lead testing.

Clinical Evidence

Method comparison study conducted with 108 human blood samples (22 spiked, 86 unspiked) across six analyzers over 5 days. Results compared against graphite furnace atomic absorption spectroscopy (GFAAS). Regression analysis: Y = 1.040x + 0.12, r = 0.996, syx = 1.30. Bias analysis showed average bias from GFAAS of 0.07 µg/dL (0-10 µg/dL range), 4.7% (10.1-25.0 µg/dL range), and 5.0% (25.1-65 µg/dL range).

Technological Characteristics

In vitro diagnostic testing system for blood lead measurement. Features capillary action sample channel, sensor insertion detection, and calibrator-based sensor lot expiration verification. Reagent-based assay.

Indications for Use

Indicated for the quantitative measurement of lead in whole blood.

Regulatory Classification

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.

Predicate Devices

• LeadCare® Blood Lead Testing System (K971640)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K052549

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for Device name change from "ESA LeadCare® Testing System to ESA LeadCare® II Testing System and the use of a testing transfer dropper from the reagent tube to the sensor, the creation of a channel to draw sample to the sensor via capillary action, checks of the sensor lot expiration with the calibrator button, sensor insertion detection and lead results displayed until a new sensor is inserted.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and the measuring range of the assay.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.