(319 days)
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IMx Toxo IgG Antibody assay, Platelia Toxo IgG
No
The description details a standard immunoassay (MEIA) 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 quantitative measurement of antibodies to aid in determining immune status, not for treating a condition.
Yes
Explanation: The intended use of the device is to aid in the determination of immune status by quantitatively measuring IgG antibodies to Toxoplasma gondii, which is a diagnostic purpose.
No
The device description clearly states it is a Microparticle Enzyme Immunoassay (MEIA) that uses physical components like polystyrene microparticles, antigens, and conjugates, and is performed on an automated instrument. This indicates it is a hardware-based assay system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of IgG antibodies to Toxoplasma gondii in human serum or plasma... to aid in the determination of immune status." This involves testing biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "Microparticle Enzyme Immunoassay (MEIA)" which is a laboratory technique performed on biological samples.
- Sample Type: It specifies the use of "human serum or plasma," which are biological specimens.
- Purpose: The purpose is to "aid in the determination of immune status," which is a diagnostic goal.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The AxSYM Toxo IqG Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of IgG antibodies to Toxoplasma gondii in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status. This product is not FDA cleared for use in testing blood or plasma donors.
Product codes
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Device Description
The AxSYM Toxo IgG antibody assay is a Microparticle Enzyme Immunoassay (MEIA) that quantitatively measures IgG antibodies to Toxoplasma gondii. It utilizes polystyrene microparticles coated with Toxoplasma gondii antigen (RH strain derived from HeLa cell cultures) as the solid phase. The assay uses goat anti-human IgG antibody conjugated to alkaline phosphatase as the conjugate and 4-Methylumbelliferyl Phosphate (MUP) as the enzyme substrate. The assay is performed on an automated instrument.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
In two U.S. sites and one European site, the AxSYM Toxo IgG Antibody assay was compared to the VIDAS Toxo IgG Antibody assay using 1400 specimens from pregnant women and random low risk individuals. Discordant results were resolved by testing with IMx Toxo IgG Antibody assay and Platelia Toxo IgG, both of which are legally marketed devices. Discordant results were also resolved by the Sabin-Feldman dye test, a reference laboratory method for the determination of antibody to Toxoplasma gondii in human serum.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison study:
Sample size: 1400 specimens.
Key results: Based on this study, the AxSYM Toxo IqG showed relative sensitivity of 99.66%. relative specificity of 99.10% and relative agreement of 99.34%. 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 were 7.6% to 12 7%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity: 99.66%
Relative specificity: 99.10%
Relative agreement: 99.34%
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 IgG assav.
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.
IMx Toxo IgG Antibody assay, Platelia Toxo IgG
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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 presented in the [510(k)] notification for the AxSYM Toxo IgG antibody assay constitutes data supporting a substantially equivalent determination:
[510(k) ]Summary of Device Performance
The AxSYM Toxo IqG Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of IgG antibodies to Toxoplasma gondii in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status. 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 IgG assav.
The VIDAS Toxo IgG (TXG) assay is intended for use with a VIDAS (Vitek_ ImmunoDiagnostic Assay System) instrument as a semi-quantitative automated enzyme-linked fluorescent immunoassay (ELFA). It is intended for use in determination of Toxoplasma gondii immunological experience from a single serum sample, or as an aid in the diagnosis of T. gondii recent infection or reactivation through evaluation of paired sera for a significant increase in T. aondii-specific lgG. 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 IgG Antibody assay was compared to the VIDAS Toxo IgG Antibody assay using 1400 specimens from pregnant women and random low risk individuals. Discordant results were resolved by testing with IMx Toxo IgG Antibody assay and Platelia Toxo IgG, both of which are legally marketed devices. Discordant results were also resolved by the Sabin-Feldman dye test, a reference laboratory method for the determination of antibody to Toxoplasma gondii in human serum. This method was first developed in 1948 and is still considered the most sensitive and specific method for the detection of IgG antibodies to toxoplasma. Based on this study, the AxSYM Toxo IqG showed relative sensitivity of 99.66%. relative specificity of 99.10% and relative agreement of 99.34%. 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 were 7.6% to 12 7%.
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In conclusion, the AxSYM Toxo IgG antibody assay is substantially equivalent to the bioMerieux VIDAS Toxo IgG antibody assay for the detection of IgG antibodies to toxoplasmosis in human serum and plasma (EDTA, heparin, or sodium citrate) samples.
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[510(k)] Summary Of Technological Comparison
The AxSYM Toxo IgG Antibody Assay and the VIDAS Toxo IgG Antibody assay are substantially equivalent in that:
- A. Both are in vitro immunologic test methods.
- B. Both are intended for use in the detection of IgG antibody to Toxoplasmosis qondii in human serum.
- C. Both are based on the formation of immune complexes between Toxoplasmosis qondii antigens and antibody.
- D. Both are quantitative assays.
- E. Both use automated immunoassay analyzers.
- F. Both use a polystyrene solid phase.
- G. Both use an anti-human IgG antibody conjugated to alkaline phosphatase.
- H. Both use 4-Methylumbelliferyl Phosphate (MUP) as the enzyme substrate.
The AxSYM Toxo IgG Antibody Assay and VIDAS Toxo IgG Antibody assay ** differ in that:
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- The solid phase in the AxSYM Toxo IgG assay is polystyrene microparticles coated with Toxoplasmosis gondii antigen (RH strain derived from HeLa cell cultures). The solid phase for the VIDAS Toxo IgG assay consists of Toxoplasmosis gondii antigen coated to the inside of the SPR (solid phase receptacle).
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- The conjugate in the AxSYM Toxo IgG assay uses goat anti-human IgG antibody. The conjugate in the VIDAS Toxo IgG assay uses mouse monoclonal anti-human IgG antibody.
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- Plasma (EDTA, heparin, sodium citrate) specimens may be tested in the AxSYM Toxo IgG assay. The use of plasma specimens has not been validated in the VIDAS Toxo IgG assay
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Comparison of Methods
| Assay Characteristics
Assay Type | AXSYM Toxo IgG
Quantitative | VIDAS Toxo IgG
Quantitative |
|------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------|
| Antibody Measured | Specific IgG | Specific IgG |
| Assay Principle | MEIA | EIA(ELFA) |
| Solid Phase | polystyrene microparticles | polystyrene solid phase
receptacle |
| Solid Phase Coating | Toxo antigen, RH strain
derived from HeLa cell
cultures | Toxo antigen, RH strain |
| Conjugate | goat anti-human IgG
conjugated to
alkaline phosphatase | mouse monoclonal
anti-human IgG
conjugated to
alkaline phosphatase |
| Specimen | Human serum and
plasma (EDTA,
heparin, sodium citrate) | Human serum |
| Automation | Performed on an
automated instrument | Performed on an
automated instrument |
| Relative Specificity | 99.1%
(European & US) | 97.8% (European study)
97.9% (U.S. study) |
| Relative Sensitivity
(final interpretation) | 99.6%
(European & US) | 98.4% (European study)
96.0% (U.S. study) |