(326 days)
Not Found
Not Found
No
The document describes a standard immunoassay performed on an automated instrument, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic assay used for qualitative measurement of IgM antibodies to Toxoplasma gondii to aid in diagnosis, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the assay is used "to aid in the diagnosis of primary infection," which directly indicates its diagnostic purpose.
No
The device description clearly indicates it is a Microparticle Enzyme Immunoassay (MEIA) which involves physical reagents (polystyrene microparticles, conjugate) and is performed on an automated instrument, indicating a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative measurement of IgM antibodies to Toxoplasma gondii in human serum and plasma... to aid in the diagnosis of primary infection." This clearly indicates it's used to test specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details a "Microparticle Enzyme Immunoassay (MEIA)" which is a laboratory-based test method performed on biological samples.
- Sample Type: It specifies the use of "human serum and plasma," which are biological specimens.
- Performance Studies: The performance studies involve testing "samples from pregnant women, non-pregnant individuals and individuals positive for IgM antibodies to T. gondii," further confirming its use with human biological samples for diagnostic evaluation.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety or suitability of a transfusion or transplantation.
N/A
Intended Use / Indications for Use
The AxSYM Toxo IgM assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to Toxoplasma gondii in human serum and plasma (EDTA, heparin, or sodium citrate) to aid in the diagnosis of primary infection. The AxSYM Toxo IgM assay is not for use with cord blood or neonatal specimens. This product is not FDA cleared for use in testing blood or plasma donors.
Product codes
Not Found
Device Description
The AxSYM Toxo IgM assay is a Microparticle Enzyme Immunoassay (MEIA).
The AxSYM Toxo IgM assay utilizes a rheumatoid neutralization buffer to remove rheumatoid factor interference antibodies.
The solid phase in the AxSYM Toxo IgM assay contains polystyrene microparticles coated with Toxoplasma gondii antigen.
The conjugate in the AxSYM Toxo IgM assay contains goat anti-human IgM antibody conjugated to alkaline phosphatase.
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
Not Found
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)
The AxSYM Toxo IgM assay was compared to the VIDAS Toxo IgM assay using 1,400 samples from pregnant women, non-pregnant individuals and individuals positive for IgM antibodies to T. gondii in two U.S. sites and one European site. Discordant results were resolved by testing with Platelia Toxo IgM (Sanofi) and Abbott IMx Toxo IgM Antibody assay, both of which are legally marketed devices in the United States. Based on this study, the AxSYM Toxo IgM assay showed relative sensitivity of 96.3%, relative specificity of 99.8% and relative agreement of 99.3%. Specimens giving equivocal results were not included in the calculation of relative agreement, relative sensitivity, or relative specificity. Percent CV's on positive panel members and positive control was 6.0% to 10.1%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity of 96.3%, relative specificity of 99.8% and relative agreement of 99.3%. Percent CV's on positive panel members and positive control was 6.0% to 10.1%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The predicate device for determination of substantial equivalence is the bioMerieux VIDAS Toxo-M.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma 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.(b)
Classification. Class II (performance standards).
0
AUG 23 1996
ATTACHMENT A
[510(k)] Summary Of Safety And Effectiveness Information Supporting A
Substantially Equivalent Determination
1
[510(k)] Summary Of Safety And Effectiveness Information Supporting A Substantially Equivalent Determination
The following information as presented in the [510(k)] notification for the AxSYM Toxo IqM assay constitutes data supporting a substantially equivalent determination:
[510(k)] Summary of Device Performance
The AxSYM Toxo IgM assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to Toxoplasma gondii in human serum and plasma (EDTA, heparin, or sodium citrate) to aid in the diagnosis of primary infection. The AxSYM Toxo IgM assay is not for use with cord blood or neonatal specimens. This product is not FDA cleared for use in testing blood or plasma donors.
The predicate device for determination of substantial equivalence is the bioMerieux VIDAS Toxo-M. The VIDAS Toxo IgM (TXM) assay is intended for use with a VIDAS (Vitek ImmunoDiagnostic Assay System) instrument as an automated enzyme-linked fluorescent immunoassay (ELFA) for the qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of toxoplasmosis. It is not intended for use in testing (screening) blood or plasma donors.
In two U.S. sites and one European site, the AxSYM Toxo IgM assay was compared to the VIDAS Toxo IgM assay using 1,400 samples from pregnant women, non-pregnant individuals and individuals positive for IgM antibodies to T. gondii. Discordant results were resolved by testing with Platelia Toxo IgM (Sanofi) and Abbott IMx Toxo IgM Antibody assay, both of which are legally marketed devices in the United States. Based on this study, the AxSYM Toxo IgM assay showed relative sensitivity of 96.3%, relative specificity of 99.8% and relative agreement of 99.3%. Specimens giving equivocal results were not included in the calculation of relative agreement, relative sensitivity, or relative specificity. Percent CV's on positive panel members and positive control was 6.0% to 10.1%.
In conclusion, the AxSYM Toxo IgM Assay is substantially equivalent to the VIDAS Toxo IgM assay for the detection of IgM antibodies to T. gondii in human serum and plasma (EDTA, heparin, or sodium citrate) specimens.
2
[510(k)] Summary Of Technological Comparison
The AxSYM Toxo IgM Antibody assay and the bioMerieux VIDAS Toxo IgM are substantially equivalent in that:
- A. Both are in vitro immunologic test methods.
- B. Both are intended for use in the detection of IgM antibody to T. gondii in human serum.
- C. Both are based on information of immune complexes between T. gondii antigens and antibody.
- D. Both use a polystyrene solid phase.
- E. Both are qualitative assays.
- F. Both use automated immunoassay analyzers.
- G. Both use 4 methylumbelliferyl phosphate (MUP) as the enzyme substrate.
The AxSYM Toxo IgM Antibody assay and the VIDAS Toxo IgM assay differ in that:
- A. The solid phase in the AxSYM Toxo IgM assay contains polystyrene microparticles coated with Toxoplasma gondii antigen. The VIDAS Toxo IgM assay is coated with goat anti-u chain antibodies inside of the SPR (solid phase receptacle).
- B. The conjugate in the AxSYM Toxo IgM assay contains goat anti-human IgM antibody conjugated to alkaline phosphatase. The conjugate in the VIDAS Toxo IgM assay contains an immune complex of T. gondii antigen and anti-P30 mouse monoclonal antibody conjugated to alkaline phosphatase.
- C. Serum and plasma (EDTA, heparin, sodium citrate) specimens may be tested in the AxSYM Toxo IgM assay. The use of plasma specimens has not been validated in the VIDAS Toxo IqM Assay.
- D. The AxSYM Toxo IgM assay utilizes a rheumatoid neutralization buffer to remove rheumatoid factor interference antibodies. The VIDAS Toxo IgM assay does not utilize a buffer for rheumatoid factor interference antibodies.
3
Comparison Of Methods
| Assay Characteristic | AxSYM Toxo IgM Assay | VIDAS Toxo IgM Assay |
|---|---|---|
| Assay Type | Qualitative | Qualitative |
| Antibody Measured | Specific IgM | Specific IgM |
| Assay Principle | MEIA | EIA (ELFA) |
| Solid Phase | polystyrene microparticle | polystyrene solid phase |
| receptacle | ||
| Solid Phase Coating | Toxoplasma antigen, RH | |
| strain derived from HeLa | ||
| cell culture | goat anti-μ chain antibodies | |
| Conjugate | goat anti-human IgM | |
| antibodies conjugated to | ||
| alkaline phosphatase | mouse anti-P30 monoclonal | |
| antibody conjugated to | ||
| alkaline phosphatase | ||
| Specimen | Human serum and plasma | |
| (EDTA, heparin, citrate) | Human serum | |
| Automation | performed on an | |
| automated instrument | performed on an | |
| automated instrument | ||
| Relative Specificity | 99.8% | |
| ( European & U.S. ) | 93.0% - 94.3% ( U.S. ) | |
| 99.4% - 99.6% ( European ) | ||
| Relative Sensitivity | 96.3% | |
| ( European & U.S. ) | 87.9% - 99.5% ( U.S. ) | |
| 97.7% - 100.0% ( European ) |