(179 days)
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No
The device description details a standard immunoassay process using electrochemiluminescence detection and a calibration curve. There is no mention of AI or ML in the intended use, device description, or any other section.
No
This device is an immunoassay kit for in vitro diagnostic use, intended to determine IgG antibodies for the assessment of immune status and as an aid in diagnosing primary infection, not to treat a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the assay is "intended for use as an aid in diagnosis of primary infection," which directly indicates its role as a diagnostic device.
No
The device description clearly outlines a complex immunoassay process involving reagents, microparticles, electrodes, and a photomultiplier, indicating a hardware-based system. While software is likely used for data analysis and instrument control, the core functionality relies on physical and chemical reactions and hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Elecsys Toxo IgG immunoassay is "for the in vitro quantitative determination of IgG antibodies to Toxoplasma gondi in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay process involving sample incubation, reagent addition, and detection using an analyzer. This is typical of an IVD.
- Performance Studies: The inclusion of performance studies like "Method Comparison" with metrics like "Negative Agreement" and "Positive Agreement" are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K993319 VIDAS TOXO IgG II Test System) is a regulatory requirement for demonstrating substantial equivalence to a legally marketed IVD.
All of these elements strongly indicate that this device is intended for use outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
(1) The Elecsys Toxo IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to Toxoplasma gondi in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as an aid in the assessment of immune status and as an aid in the diagnosis of primary infection. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl Toxo IgG is used for quality control of the Elecsys Toxo IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes
LGD, JJX
Device Description
(1) The Elecsys Toxo IgG Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. In the first incubation, 10 µL of sample, a biotinylated recombinant T. gondii- specific antigen, and a T. gondii-specific recombinant antigen labeled with a ruthenium complex a form a sandwich complex. Then, after addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. A human serum-based calibrator is provided with the test kit, and the recommended control material is PreciControl Toxo IgG.
(2) The Elecsys Precicontrol Toxo IgG contains two levels of human serum with Toxo IgG antibodies.
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
Not Found
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
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Summary of Performance Studies
Method Comparison:
US Routine Clinical Specimens
Negative Agreement: 93.4 % (310/332) 90.1%-95.8%
Positive Agreement 100 % (183/183) 98.0% - 100.0%
European Site Prospective study results:
Negative Agreement: 91.1% (288/316) 87.5 - 94.0 %
Positive Agreement: 99.3% (151/152) 96.4-100.0%
European Site Frozen sample results:
Negative Agreement: 68.1 (32/47) 52.9 -80.9%
Positive Agreement: 9999.7% (378/379) 98.5-100.0
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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
Elecsys Toxo IgG Test System
510(k) Summary
(07350)
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3723 |
| Contact Person: Theresa A. Bush | |
| Date PreparedJune 6, 2008 | |
| Device Name | |
| Proprietary name: (1) Elecsys Toxo IgG Immunoassay (2) Elecsys PreciControl Toxo IgG | |
| Common name: (1) Toxoplasma IgG assay (2) PreciControl Toxo IgG | |
| Classification name: (1) Toxoplasma gondi serological reagents (2) Single (specified) analyte controls (assayed and unassayed) |
1
.
| Device Description | (1) The Elecsys Toxo IgG Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. In the first incubation, 10 µL of sample, a biotinylated recombinant T. gondii- specific antigen, and a T. gondii-specific recombinant antigen labeled with a ruthenium complex a form a sandwich complex. Then, after addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. A human serum-based calibrator is provided with the test kit, and the recommended control material is PreciControl Toxo IgG. (2) The Elecsys Precicontrol Toxo IgG contains two levels of human serum with Toxo IgG antibodies. |
|---|---|
| Intended use | (1) The Elecsys Toxo IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to Toxoplasma gondi in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as an aid in the assessment of immune status and as an aid in the diagnosis of primary infection. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. (2) Elecsys PreciControl Toxo IgG is used for quality control of the Elecsys Toxo IgG immunoassay on the Elecsys and cobas e immunoassay analyzers. |
| Indications for Use | (1) The Elecsys Toxo IgG assay may be used as an aid in the assessment of immune status and as an aid in the diagnosis of primary infection. |
| Substantial equivalence | The Elecsys Toxo IgG Test System is substantially equivalent to the VIDAS TOXO IgG II Test System cleared in K993319 |
510(k) Summary, Continued
Substantial equivalence -
| equivalence |
|---|
| similarities |
ar
.
2
Elecsys Toxo IgG Test System
| Feature | Elecsys Toxo IgG Immunoassay | Predicate Device: VIDAS TOXO
IgG II Test System (K993319) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Toxo IgG immunoassay is for
the in vitro quantitative determination of
IgG antibodies to Toxoplasma gondi in
human serum and Li-heparin, K3-EDTA,
and sodium citrate plasma. This assay is
intended for use as an aid in the assessment
of immune status and as an aid in the
diagnosis of primary infection.
The electrochemiluminescence
immunoassay "ECLIA" is intended for use
on the Elecsys and cobas e immunoassay
analyzers.
NOTE: This assay has not been cleared by
the FDA for blood/plasma donor screening. | The VIDAS Toxo IgG II (TXG) assay
is an automated quantitative test for use
on the VIDAS analyzer for the
measurement of anti-toxoplasma IgG
in human serum using the ELFA
technique (Enzyme Linked
Fluorescence Assay). It is intended for
use as an aid in determination of
immune status. This test is not intended
for use in screening blood donors. |
| Indication for
Use | aid in the assessment of immune status and
as an aid in the diagnosis of primary
infection. | an aid in determination of immune
status |
| Assay Protocol | Electrochemiluminescent Immunoassay | enzyme-linked fluorescent
immunoassay (ELFA) |
| Sample Type | Human serum, lithium heparin plasma,
potassium EDTA plasma and sodium citrate
plasma.
When citrated plasma is used, the values found
are approximately 15% lower | Serum |
| Instrument
Platform | Roche Elecsys 2010/ cobas e 411 and
MODULAR ANALYTICS E170 (Elecsys
module)/ cobas e 601 analyzers. | VIDAS ® Instrument |
| Calibrator | Included in kit | Included in kit |
| Calibrator levels | Two | One |
| Format | Human serum | Human serum |
| Calibrator
Stability | After opening at 2-8C: 8 weeks
On Elecsys 2010/ cobas e 411: up to 5
hours
On E170/ cobas e 601: use only once | Store between 2-8 °C. |
| Calibration
frequency | Once per reagent lot and
• After 1 month when using same
reagent lot
• After 7 days when using same
reagent kit
• As required per QC findings or
pertinent regulations | • Every new reagent lot
• Every 14 days |
| Controls | PreciControl Toxo IgG (sold separately) | Positive and negative control included in kit. |
| Traceability | 3rd International Standard for Anti-
Toxoplasma serum (TOXM) from NIBSC,
UK | WHO standard |
| Reagent Stability | Unopened 2-8°C - up to expiration
Opened 2-8°C - 12 weeks
Onboard- 2 weeks or 12 weeks (if stored
alternately in refrigerator and on the
analyzer- ambient temperature 20-25°C; up
to 84 hours opened in total.) | Unopened kit: Store at 2-8°C. Do not
freeze
After opening: Store at 2-8°C . Pouch
should be immediately resealed with
dessicant ; stable until expiration date |
| Measuring
Range | 0.125-650 IU/mL | Linear up to 250 or 300 IU/mL |
| Precision | Intrassay: (range of values)
Low Control: SD = 0.02-0.05 IU/mL
High Control: 2.02-4.78 CV %
Plasma Samples 1 IU/mL:
CV 1.76-3.09%
Inter-assay:
Low Control: SD 0.047 -0.077 IU/mL
High Control: CV 2.9-5.1 %
Plasma Samples 5 IU/mL:
CV 2.7-5.3% | Within-run:
Negative: SD = 0.25 IU/mL
Low positive: 5.13% CV
High positive: 7.21 % CV
Total:
Negative: SD = 0.43 IU/mL
Low positive: 6.70% CV
High positive: 10.88 % CV |
| Limit of Blank | 0.130 IU/mL | Not stated. |
| Limit of
Detection | 0.175 IU/mL | Not stated. |
3
4
·
:
| Analytical Specificity | 193 specimens were tested representing a variety of disease. Results shown in table: | No crossreactivity or interference due to RF, ANA and EBV. | ||||
|---|---|---|---|---|---|---|
| Cross-reactant | No. tested | Elecsys Toxo IgG/Reference Neg/Neg | Elecsys Toxo IgG/Reference Pos/Neg | Elecsys Toxo IgG/Reference Neg/Pos | Elecsys Toxo IgG/Reference Pos/Pos | |
| AMAf | 15 | 3 | 0 | 0 | 11 | |
| ANAg | 26 | 8 | 1 | 0 | 15 | |
| Chlamydia | 4 | 2 | 0 | 0 | 2 | |
| CMV | 8 | 0 | 0 | 0 | 8 | |
| EBVh | 9 | 4 | 0 | 0 | 4 | |
| Gonorrhea | 5 | 2 | 0 | 0 | 3 | |
| HAV | 10 | 7 | 0 | 0 | 3 | |
| HBV | 23 | 14 | 1 | 0 | 8 | |
| HCVi | 11 | 5 | 0 | 0 | 6 | |
| HIV | 13 | 10 | 1 | 0 | 2 | |
| HSVj | 8 | 1 | 0 | 0 | 6 | |
| Influenza | 16 | 12 | 0 | 0 | 4 | |
| Malaria | 10 | 4 | 0 | 0 | 6 | |
| Parvo B19 | 10 | 9 | 0 | 0 | 1 | |
| Rubella | 10 | 4 | 0 | 0 | 6 | |
| Syphilis | 5 | 3 | 0 | 0 | 2 | |
| TPAH | 3 | 1 | 0 | 0 | 1 | |
| VZV | 7 | 4 | 1 | 0 | 2 | |
| Sub-total | 186 | 93 | 4 | 0 | 89 | |
| Total | 193 | |||||
| f. One sample was repeatedly equivocal by the Elecsys Toxo IgG immunoassay | ||||||
| g. Two samples were repeatedly equivocal by the reference method | ||||||
| h One sample was repeatedly equivocal by the reference method | ||||||
| i One sample was repeatedly equivocal by the Elecsys Toxo IgG immunoassay | ||||||
| j One equivocal sample was not repeated on the reference method | ||||||
| Interferences | The assay is unaffected by icterus (bilirubin $ |