K Number
K131441
Device Name
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
Manufacturer
Date Cleared
2013-08-09

(81 days)

Product Code
Regulation Number
866.3780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples. It is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. The LIAISON Control Toxo IgM II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON Toxo IgM II assay on the LIAISON® XL Analyzer.
Device Description
The method for qualitative determination of specific IgM to Toxoplasma gondii is an antibody capture chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with IgG (mouse, monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgM, Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody coniugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen and the immune complex thus formed reacts with IgM already bound to the solid phase. After the incubations, the 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 hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of Toxoplasma gondii IgM concentration present in calibrators, samples or controls. All assay steps and incubations are performed by the LIAISON® XL Analyzer.
More Information

Not Found

No
The device description and performance studies focus on standard immunoassay technology and statistical analysis of results, with no mention of AI or ML algorithms.

No
The device is an in-vitro diagnostic test intended to aid in the diagnosis of Toxoplasma gondii infection, not to treat or cure a condition.

Yes

The LIAISON® Toxo IgM II assay is explicitly stated to be "intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection." This directly indicates its role in diagnosis.

No

The device is a laboratory 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 it's for the "qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a medical condition (Toxoplasma gondii infection).
  • Device Description: The description details a "chemiluminescence immunoassay (CLIA)" method that uses reagents to detect specific antibodies in the sample. This is a typical in vitro diagnostic technique.
  • Sample Type: The assay uses "human serum samples," which are biological specimens taken from a patient.
  • Purpose: The assay is intended "as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection." This directly relates to providing diagnostic information.
  • Control: The description mentions "LIAISON Control Toxo IgM II (negative and positive)" which are used as "assayed quality control samples to monitor the performance of the LIAISON Toxo IgM II assay." Quality controls are standard components of IVD systems to ensure the accuracy and reliability of the test results.

All these elements align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples. It is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening.
The LIAISON Control Toxo IgM II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON Toxo IgM II assay on the LIAISON® XL Analyzer.

Product codes (comma separated list FDA assigned to the subject device)

LGD

Device Description

The method for qualitative determination of specific IgM to Toxoplasma gondii is an antibody capture chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with IgG (mouse, monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgM, Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody coniugate).

During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen and the immune complex thus formed reacts with IgM already bound to the solid phase. After the incubations, the 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 hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of Toxoplasma gondii IgM concentration present 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

14 years to 44 years

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

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Prospective and Retrospective studies were performed to evaluate the performance of the LIAISON® Toxo IgM II assay among individuals who were sent to the lab for Toxoplasma gondii IgM testing, pregnant women (Prospective) and on frozen or repository samples from individuals with a positive Toxoplasma gondii IgM result by the comparator assay (Retrospective).

A. Prospective:
The prospective populations consist of non-selected subjects sent to the laboratory for Toxoplasma gondii IgM testing (US and European subjects) and pregnant women.

  • Prospective US Population: 204 individuals (96.1% Female, 3.9% Male) ranging in age from 18 years to 42 years. 147 samples from patients where age was unknown.
  • Prospective European Population: 600 individuals. Age and gender unknown.
  • Pregnant Women Population: 201 females aged 14 to 44 years. 70 samples from 1st trimester, 50 from 2nd trimester, 81 from 3rd trimester.

Comparison Results:

  • Prospective US Population Comparison:
    • Negative: 203/203 (100.0% agreement, 95% CI: 98.2 - 100.0%)
    • Positive: 0/1 (NA)
  • Prospective European Population Comparison:
    • Negative: 499/506 (98.9% agreement, 95% CI: 97.1 - 99.4%)
    • Positive: 93/94 (98.9% agreement, 95% CI: 94.3 - 99.7%)
  • Pregnant Women Population Comparison:
    • Negative: 194/197 (98.5% agreement, 95% CI: 94.1 - 99.1%)
    • Positive: 1/4 (25.0% agreement, 95% CI: 4.6 - 70.0%)

B. Retrospective/PreSelected Population:
Defined as pre-selected samples from individuals who had a positive Toxoplasma gondii IgM result by the comparator assay.

  • Sample size: 33 samples. 93.9% Females (n=31), 6.1% Males (n=2), age 15 to 47 years.
  • Retrospective Population Comparison:
    • Positive: 33/33 (100.0% agreement, 95% CI: 89.7 - 99.9%)

Key results: The results demonstrate that the LIAISON® Toxo IgM II assay can be used with the LIAISON® XL Analyzer for the qualitative detection of IgM antibodies to Toxoplasma qondii.

C. CDC Panel Study:

  • Panel: CDC Toxoplasma 1998 Human Serum Panel (100 frozen blind specimens: 32 Toxoplasma IgM true positive, 65 Toxoplasma IgM true negative, 3 dilutions of 3 true Toxoplasma IgM positive samples).
  • Testing: Tested by LIAISON® Toxo IqM II assay at site #3.
  • Results: LIAISON® Toxo IgM II assay correctly detected the 32 Toxoplasma IgM true positive samples (100% agreement) and the 65 Toxoplasma IgM true negative samples (100% agreement).

D. Prevalence:

  • Observed prevalence: Calculated for the prospective populations (804 samples from patients sent for Toxoplasma gondii testing and 201 pregnant women).
  • Results: US population 0%, European population 16.7%, pregnant women 1.5%.

PRECISION:

  • Study: Repeatability assessed at one site using two kit controls and seven serum samples prepared to span the measuring range.
  • Sample size for each sample ID: 80 replicates.
  • Results: Showed %CV ranging from 2.00% to 11.00% for Total variability across different samples.

REPRODUCIBILITY:

  • Study: Reproducibility assessed across three testing sites using two kit controls and 7 serum samples prepared to span the measuring range.
  • Sample size for each sample ID: 480 replicates.
  • Results: Showed %CV ranging from 9.00% to 13.7% for Total variability across different samples.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" section for Percent Agreement and Confidence Intervals based on comparison studies.
Sensitivity, Specificity, PPV, NPV are not explicitly stated, but can be inferred from the agreement data against comparator assays / CDC panel.

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.

K001707

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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).

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K131441

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

SUBMITTED BY:

Sandra Zimniewicz Regulatory/Clinical Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5711 Fax (651) 351-5669 Email: sandra.zimniewicz@diasorin.com

AUG 09 2013

NAME OF DEVICE:

Trade Name:

LIAISON® Control Toxo IgM II
Common Names/Descriptions:Toxoplasma IgM Assay and Toxo IgM Controls
Classification Names:Toxoplasma gondii Serological Reagent: Class II , 21 CFR 866.3780; Microbiology (83)
Product Code:LGD
PREDICATE DEVICE:Diamedix Is-Toxoplasma IgM Capture Test System (K001707)

LIAISON® Toxo IgM II

DEVICE DESCRIPTION:

INTENDED USE:

The LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples. It is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening.

1

The LIAISON Control Toxo IgM II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON Toxo IgM II assay on the LIAISON® XL Analyzer.

KIT DESCRIPTION:

The method for qualitative determination of specific IgM to Toxoplasma gondii is an antibody capture chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with IgG (mouse, monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgM, Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody coniugate).

During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen and the immune complex thus formed reacts with IgM already bound to the solid phase. After the incubations, the 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 hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of Toxoplasma gondii IgM concentration present in calibrators, samples or controls.

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

2

COMPARISON TO PREDICATE DEVICE:

Table 1: Table of Similarities
CharacteristicNew Device
DiaSorin LIAISON® Toxo IgM IIPredicate Device
Diamedix Is-Toxoplasma IgM
Capture Test Kit (K001707)
Intended UseThe LIAISON® Toxo IgM II assay
uses chemiluminescent
immunoassay (CLIA) technology
on the LIAISON® Analyzer for the
qualitative determination of IgM
antibodies to Toxoplasma gondii in
human serum specimens. It is
intended for use as an aid in the
presumptive diagnosis of acute or
recent Toxoplasma gondii infection,
including pregnant women. It is
recommended that the LIAISON®
Toxo IgM II assay be performed in
conjunction with a Toxoplasma
gondii IgG assay.
This product has not been
cleared/approved by the FDA for
blood/plasma donor screening.The Diamedix Is-Toxoplasma IgM
Capture Test Kit is a capture
enzyme immunoassay (EIA) for the
presumptive qualitative detection of
IgM antibodies to Toxoplasma
gondii in human serum by capture
enzyme immunoassay. When
performed in conjunction with an
anti-Toxoplasma gondii IgG assay,
the Is-Toxoplasma IgM Capture
assay can be used as an aid in the
presumptive diagnosis of acute,
recent or reactivated Toxoplasma
gondii infection. Performance has
not been established in newborns.
This product has not been
cleared/approved by the FDA for
blood/plasma donor screening.
Measured AnalyteIgM antibodies to Toxoplasma
gondiiIgM antibodies to Toxoplasma
gondii
Reagent StorageOn-board or in refrigerator @ 2-8°CIn refrigerator @ 2-8°C
CalibratorsIncluded with kitIncluded with kit
Controls2 levels (negative and positive)2 levels (negative and positive)
Sample matrixHuman SerumHuman Serum
AntigenToxoplasma gondii, RH strainToxoplasma gondii, RH strain
Capture AntibodyMouse monoclonal anti-human IgMMouse monoclonal anti-human
IgM
Table 2 : Table of Differences
CharacteristicNew Device
DiaSorin LIAISON® Toxo IgM IIPredicate Device
Diamedix Is-Toxoplasma IgM
Capture Test Kit (K001707)
Assay TypeChemiluminescent ImmunoassayEnzyme Immunoassay
CalibrationTwo point verification of stored
master curveSingle point Cut-Off Calibrator
Unit of MeasureAU/mLIndex Value
Cut-Off10.0 AU/mL1.10 Index Value
Equivocal Zone8.0 - 9.9 AU/mL0.90 - 1.09 Index Value
Sample size20 μL2 μL
Sample Handling/
ProcessingAutomatedManual or Automated
Assay Time40 minutes140 minutes
ControlsProvided SeparatelyIncluded with kit
Capture ReagentMagnetic particles coated with IgG
to human IgM (mouse
monoclonal)Microwells coated with mouse
monoclonal anti-human IgM (heavy
chain)
ConjugateMouse monoclonal antibodies to
Toxoplasma gondii conjugated to
an isoluminol derivativeMouse monoclonal anti-Toxoplasma
gondii conjugated to horseradish
peroxidase
Measurement
SystemPhotomultiplier (flash
chemiluminescence reader)Spectrophotometer (EIA microtiter
plate reader)

.

1999 - 1999 - 1999

.

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PERFORMANCE DATA:

COMPARATIVE CLINICAL STUDIES:

Prospective and Retrospective studies were performed to evaluate the performance of the LIAISON® Toxo IgM II assay among individuals who were sent to the lab for Toxoplasma gondii IgM testing, pregnant women (Prospective) and on frozen or repository samples from individuals with a positive Toxoplasma gondii IgM result by the comparator assay (Retrospective).

A. Prospective:

The prospective populations consist of non-selected subjects sent to the laboratory for Toxoplasma gondii IgM testing (US and European subjects) and pregnant women.

The prospective US population consisting of 204 individuals were 96.1% Female (n=196) and 3.9% Male (n=8) ranging in age from 18 years to 42 vears. There were 147 samples from patients where the age was unknown.

The prospective European population consisted of 600 individuals. Age and gender for these samples are unknown.

4

The prospective population of pregnant women consists of 201 females with ages ranging from 14 years to 44 years. There were 70 samples from subjects in the 1st trimester, 50 samples form subjects in the second trimester and 81 samples from subjects in the 3rd trimester of pregnancy.

Prospective US Population Comparison

Percent AgreementExact 95% Confidence Interval
Negative203/203100.0%98.2 - 100.0%
Positive0/1NA1.3 - 84.2%

Prospective European Population Comparison

Percent AgreementExact 95% Confidence Interval
Negative499/50698.9 %97.1 - 99.4%
Positive93/9498.9 %94.3 - 99.7%

Pregnant Women Population Comparison

Percent AgreementExact 95% Confidence Interval
Negative194/19798.5 %94.1 - 99.1%
Positive1/425.0 %4.6 - 70.0%

B. Retrospective/PreSelected Population:

The retrospective population was defined as pre-selected samples from individuals who had a positive Toxoplasma gondii IgM result by the comparator assay. Thirty three (33) samples were included in this study. The 33 individuals from the retrospective population were 93.9% Females (n=31) and 6.1% Males (n=2) ranging in age from 15 to 47 vears.

Retrospective Population Comparison

Percent AgreementExact 95% Confidence Interval
Positive33/33100.0 %89.7 - 99.9%

The results demonstrate that the LIAISON® Toxo IgM II assay can be used with the LIAISON® XL Analyzer for the qualitative detection of IgM antibodies to Toxoplasma qondii.

C. CDC Panel Study:

The CDC Toxoplasma 1998 Human Serum Panel is comprised of 100 frozen blind specimens (32 Toxoplasma IgM true positive samples and 65 Toxoplasma IgM true negative samples and 3 dilutions of 3 true Toxoplasma IgM positive samples). The panel was tested by LIAISON® Toxo IqM II assay at site #3.

The results were submitted to the CDC (Reference Immunodiagnostic Lab, Biology and Diagnostic Branch Division of Parasitic Diseases) for data analysis. As communicated

5

by the CDC, the LIAISON® Toxo IgM II assay correctly detected the 32 Toxoplasma IgM true positive samples (100% agreement) and the 65 Toxoplasma IgM true negative samples (100% agreement).

D. Prevalence:

The observed prevalence of the LIAISON® Toxo IgM II assay was calculated for the prospective populations consisting of the 804 samples from patients sent to the lab for Toxoplasma gondii testing and 201 pregnant women.

The prevalence may vary depending upon geographical location, age, gender, type of test employed, specimen collection and handling procedures as well as clinical history of the patient.

The observed prevalence of LIAISON® Toxo IgM II assay for the US population is 0%, the European population had a prevalence of 16.7% and pregnant women a prevalence of 1.5%.

PRECISION:

Precision was assessed by measuring repeatability at one site using two kit controls and seven serum samples prepared to span the measuring range of the assay. Mean, standard deviation, and coefficient of variation (%CV) were calculated using multiple sources of variability that include within-run, within-day, between-day, and total variability. The following results were obtained from one site with one kit lot assayed in duplicate in two assays per day over 20 operating days.

SampleMeanWithin-RunWithin-DayBetween-DayTotal
Sample IDNAU/mLSD%CVSD%CVSD%CVSD%CV
Negative Control*80The DiaSorin LIAISON® Control Toxo IgM II is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® Toxo IgM II assay on the LIAISON® XL Analyzer.

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ribhi Shawar -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_K131441