(41 days)
No
The summary describes a standard chemiluminescent immunoassay (CLIA) and analyzer, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic assay used to detect antibodies for diagnostic purposes, not to treat a medical condition or disease.
Yes
Explanation: The device is used for the qualitative determination of specific IgG antibodies to Toxoplasma gondii to aid in the assessment of a patient's serological status to infection and to determine immune status, which are diagnostic purposes.
No
The device is an in vitro diagnostic assay that utilizes chemical reactions and a physical analyzer (LIAISON® XL Analyzer) to determine the presence of antibodies. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a patient's health status (serological status to infection and immune status).
- Device Description: The description details a laboratory-based immunoassay method (CLIA) performed on an analyzer. This is a typical setup for an in vitro diagnostic test.
- Sample Type: The assay uses "human serum," which is a biological specimen obtained from a patient.
- Regulatory Statement: The statement "U.S. Federal Law restricts this device to sale by or on the order of a physician" is a common regulatory requirement for IVD devices.
- Performance Studies: The document describes clinical studies using human serum samples to evaluate the performance of the assay in detecting antibodies, which is characteristic of IVD validation.
- Quality Control: The mention of "LIAISON® Control Toxo IgG II (negative and positive)" for monitoring performance is also typical for IVD assays.
N/A
Intended Use / Indications for Use
The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondii and in the determination of immune status of individuals including pregnant women. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
LGD, JJX
Device Description
The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The method for qualitative determination of IgG antibodies to Toxoplasma gondii (anti-Toxo IgG) is an indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Toxoplasma gondii and a conjugate of mouse monoclonal antibodies to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, Toxoplasma gondii antibodies present in diluted calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjuqate reacts with anti-Toxo IgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-Toxo IqG in calibrators, samples or controls. All assay steps and incubations are performed by the LIAISON® XL Analyzer.
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
Individuals including pregnant women.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
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)
A. Prospective:
The prospective populations consist of non-selected subjects sent to the laboratory for Toxoplasma gondii IgG testing (US and European subjects) and pregnant women.
The prospective US population consisted of 204 individuals, 96.1% Female (n=196) and 3.9% Male (n=8) ranging in age from 18 years to 42 years. There were 147 samples from patients where the age was unknown.
- Negative: 183/183 (100.0% Agreement, 98.0 - 100.0% Exact 95% Confidence Interval)
- Positive: 21/21 (100.0% Agreement, 84.5 - 100.0% Exact 95% Confidence Interval)
The prospective European population consisted of 600 individuals. Age and gender for these samples were unknown.
- Negative: 252/267 (94.3% Agreement, 90.9 - 96.6% Exact 95% Confidence Interval)
The prospective population of pregnant women consisted of 202 females with ages ranging from 14 years to 44 years. There were 71 samples from subjects in the 1st trimester, 50 samples from subjects in the second trimester and 81 samples from subjects in the 3rd trimester of pregnancy.
- Negative: 188/188 (100.0% Agreement, 98.0 - 100.0% Exact 95% Confidence Interval)
- Positive: 12/14 (85.7% Agreement, 60.1 - 96.0% Exact 95% Confidence Interval)
B. Retrospective/PreSelected Population:
The retrospective population was defined as pre-selected samples from individuals who had a positive Toxoplasma gondii IgG result by the comparator assay. Forty two (42) samples were included in this study. The 42 individuals from the retrospective population were 95.2% females (n=40) and 4.8% males (n=2) ranging in age from 0 to 47 years.
- Positive: 42/42 (100.0% Agreement, 91.8 - 100.0% Exact 95% Confidence Interval)
The results demonstrate that the LIAISON® Toxo IgG II assay can be used with the LIAISON® XL Analyzer for the qualitative detection of IgG antibodies to Toxoplasma gondii.
C. CDC Panel Study:
The CDC Toxoplasma 1998 Human Serum Panel is comprised of 100 frozen blind specimens (70 Toxoplasma IgG true positive samples and 30 Toxoplasma IgG true negative samples). The panel was tested by LIAISON® Toxo IgG II assay. The results were submitted to the CDC (Reference Immunodiagnostic Lab, Biology and Diagnostic Branch Division of Parasitic Diseases) for data analysis. As communicated by the CDC, the LIAISON® Toxo IgG II assay correctly detected the 70 Toxoplasma IgG true positive samples (100% Sensitivity) and the 30 Toxoplasma IgG true negative samples (100% Specificity).
D. Prevalence:
The observed prevalence of the LIAISON® Toxo IgG II assay was calculated for the prospective populations consisting of the 804 samples from patients sent to the lab for Toxoplasma gondii testing and 202 pregnant women.
The observed prevalence of LIAISON® Toxo IgG II assay for the US population is 10.3%, the European population had a prevalence of 57.0% and pregnant women a prevalence of 5.9%.
Precision/Reproducibility:
Assay precision was evaluated according to CLSI EP5-A2. Six serum samples containing concentrations of analyte prepared to span the range of the assay and the LIAISON® Control Toxo IgG II (positive and negative) were assayed in duplicate in two runs per day over 20 operating days.
The following repeatability results were obtained from the samples tested internally at DiaSorin Inc. in one kit lot.
- Neg Control: N=80, Mean
§ 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
510(k) SUMMARY
| SUBMITTED BY: | Kelly R. Sauer
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5884
Fax (651) 351-5669
Email: kelly.sauer@diasorin.com |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AUG 2 8 2013 | |
| DATE PREPARED: | July 17, 2013 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® Toxo IgG II
LIAISON® Control Toxo IgG II |
| Common Names/Descriptions: | Toxoplasma gondii IgG assay and
Toxoplasma gondii IgG controls |
| Classification Names: | Toxoplasma gondii serological reagents:
Class II, 21 CFR: 866.3780; Microbiology (83) |
| | Single (Specified) analyte controls (assayed
and unassayed): Class I, reserved
21 CFR 862.1660; Clinical Chemistry (75) |
| Product Code: | LGD
JJX |
| PREDICATE DEVICES : | Diamedix Is-Toxoplasma IgG ELISA
Reference K981498 (assay)
DiaSorin LIAISON® Control Rubella IgM
(K122397) |
DEVICE DESCRIPTION:
INTENDED USE:
The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondii and in the determination of immune status of individuals including pregnant women
1
This assay has not been cleared/approved by the FDA for blood/plasma donor screening.
U.S. Federal Law restricts this device to sale by or on the order of a physician.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.
KIT DESCRIPTION:
The method for qualitative determination of IgG antibodies to Toxoplasma gondii (anti-Toxo IgG) is an indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Toxoplasma gondii and a conjugate of mouse monoclonal antibodies to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, Toxoplasma gondii antibodies present in diluted calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjuqate reacts with anti-Toxo IgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-Toxo IqG in calibrators, samples or controls.
All assay steps and incubations are performed by the LIAISON® XL Analyzer.
COMPARISON TO PREDICATE DEVICE:
The DiaSorin LIAISON® Toxo IgG II assay is substantially equivalent in principle and performance to the Diamedix Is-Toxoplasma IgG ELISA (K981498) which was FDA cleared August 21, 1998. The DiaSorin LIAISON Control Toxo II is substantially equivalent in principle to the DiaSorin LIAISON Control Rubella IgM (K122397) which was FDA cleared September 6, 2012.
2
| Characteristic | New Device
DiaSorin LIAISON® Toxo IgG II | Predicate Device
Diamedix Is-Toxoplasma IgG
ELISA (K981498) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LIAISON® Toxo IgG II assay
uses chemiluminescent
immunoassay (CLIA) technology on
the LIAISON® XL Analyzer for the
qualitative determination of specific
IgG antibodies to Toxoplasma
gondii in human serum. The results
of this assay can be used as an aid
in the assessment of the patient's
serological status to infection with
Toxoplasma gondii and in the
determination of immune status of
individuals including pregnant
women.
This assay has not been
cleared/approved by the FDA for
blood/plasma donor screening. U.S.
Federal Law restricts this device to
sale by or on the order of a licensed
practitioner. Assay performance
characteristics have not been
established for
immunocompromised or
immunosuppressed patients, cord
blood, neonatal specimens, or
infants. | The Diamedix Is-Toxoplasma IgG
Test Kit is an enzyme-linked
immunoassay (ELISA) for the
qualitative and quantitative
detection of IgG to Toxoplasma
gondii in human serum. The
results of the assay can be used as
an aid in the assessment of the
patient's immunological response
to infection with T. gondii and in the
determination of immune status of
individuals, including females of
child-bearing age. The evaluation
of paired sera can aid in the
diagnosis of primary or reactivated
infection. This product is not FDA
cleared for use in screening blood
and plasma donors. |
| Measured
Analyte | IgG antibodies to Toxoplasma gondii | Same |
| Reagent Storage | On-board or in refrigerator @ 2-8°C | In refrigerator @ 2-8°C |
| Calibrators | Included with kit | Same |
| Controls | 2 levels (negative and positive) | Same |
| Sample matrix | Human Serum | Same |
| Table 2 : Table of Differences | | |
| Characteristic | New Device
DiaSorin LIAISON® Toxo IgG II | Predicate Device
Diamedix Is-Toxoplasma IgG
ELISA (K981498) |
| Assay Type | Chemiluminescent Immunoassay | Enzyme Immunoassay |
| Calibration
Standarization | E6 (National Health Laboratory,
France, 1987) standardized against
WHO 2nd International Standard | WHO 3rd International Standard |
| Calculation of
Results | Qualitative assay | Qualitative or Quantitative |
| Calibration | Two point verification of stored master
curve | Single point Cut-Off Calibrator
(Qualitative)
Three point - 3 Standards |
| Unit of Measure | IU/mL | Index Value (Qualitative)
IU/mL (Quantitative) |
| Cut-Off | ≥ 8.8 IU/mL | 1.10 Index Value (Qualitative)
50.0 IU/mL (Quantitative) |
| Equivocal Zone | ≥ 7.2 -