K032162 · Beckman Coulter, Inc. · LGD · Aug 8, 2003 · Microbiology
Device Facts
Record ID
K032162
Device Name
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
Applicant
Beckman Coulter, Inc.
Product Code
LGD · Microbiology
Decision Date
Aug 8, 2003
Decision
SESE
Submission Type
Special
Regulation
21 CFR 866.3780
Device Class
Class 2
Indications for Use
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.
Device Story
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay used to detect IgG antibodies to Toxoplasma gondii in human serum. The device utilizes reagent packs, calibrators, QC, substrate, and wash buffer. It is designed for use on Beckman Coulter Access Immunoassay Systems, including the UniCel Dxl 800. The system processes samples to provide qualitative and quantitative results, which are used by clinicians to diagnose infection and assess protective antibody levels in pregnant patients. The modification described involves expanding the platform compatibility to include the Dxl 800 system, maintaining the same reagents and performance specifications as the predicate.
Clinical Evidence
Bench testing only; verification and validation activities performed per design control requirements to confirm performance on the Dxl 800 Access Immunoassay System.
Technological Characteristics
Paramagnetic-particle, chemiluminescent immunoassay. Components include reagent packs, calibrators, QC, substrate, and wash buffer. System is an automated immunoassay analyzer (UniCel Dxl 800).
Indications for Use
Indicated for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum to aid in the diagnosis of infection and determination of protective antibody levels in pregnant women.
Regulatory Classification
Identification
Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.
Predicate Devices
Access Toxo IgG Assay for use on the Access Immunoassay Systems (K951495)
Submission Summary (Full Text)
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SPECIAL 510(k): Device Modification
OIVD Review Memorandum
To: THE FILE
RE: DOCUMENT NUMBER K032162
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, device 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.
Access Toxo IgG Assay, K951495
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
Use of device on new instrument:, Dxl 800 Access@ Immunoassay System
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics has been provided.
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 Enclosed
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. The device is determined substantially equivalent to the previously cleared device.
