(148 days)
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No
The description details a standard chemiluminescent immunoassay (CLIA) technology for detecting antibodies. There is no mention of AI, ML, or any algorithms beyond basic signal processing to measure relative light units (RLU). The performance studies focus on traditional assay metrics like percent agreement, not metrics typically associated with AI/ML model evaluation.
No.
This device is an in vitro diagnostic (IVD) device used to detect antibodies to Toxoplasma gondii, which aids in diagnosis and immune status assessment rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the results of the 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" and as "an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection." These are clearly diagnostic purposes.
No
The device description clearly outlines a chemiluminescent immunoassay (CLIA) technology that utilizes magnetic particles, reagents, and a LIAISON® Analyzer to perform the assay steps and measure light signals. This involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum" and the "presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum." This indicates the device is used to test human specimens (serum) to provide information about a person's health status (presence of antibodies to Toxoplasma gondii).
- Device Description: The description details a "chemiluminescence immunoassay (CLIA)" method performed on a "LIAISON® Analyzer." This describes a laboratory test method used to analyze biological samples.
- Performance Studies: The document includes detailed performance studies using human serum samples (Comparative Clinical Trials, CDC Panel Study, Reproducibility, Cross-Reactions, Interfering Substances). These studies are typical for demonstrating the performance of an IVD.
- Predicate Device(s): The mention of predicate devices (DiaSorin Toxoplasma IgM ELISA Kit and Diamedix Is-Toxoplasma IgG ELISA Kit) with K numbers indicates that this device is being compared to previously cleared IVDs.
All of these points align with the definition and characteristics 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 state, state of health, or disease or congenital abnormality.
N/A
Intended Use / Indications for Use
The LIAISON® Toxo IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the 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 F.D.A for blood/plasma donor screening.
The LIAISON® Toxo IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON® Toxo IgM can be used as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection. It is recommended that the LIAISON® Toxo IgM assay be performed in conjunction with a Toxoplasma gondii IgG assay.
This assay has not been cleared/approved by the F.D.A for blood/plasma donor screening.
Product codes (comma separated list FDA assigned to the subject device)
LGD
Device Description
The DiaSorin LIAISON® Toxo IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON® Toxo IgM can be used as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection. It is recommended that the LIAISON® Toxo IgM assay be performed in conjunction with a Toxoplasma gondii IgG assay.
The method for qualitative determination of IgM antibodies to Toxoplasma gondii (anti-Toxo IgM) is an anthody capture chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the components of the test are magnetic particles (solid phase) coated with igG to human IgM (mouse, monoclonal), Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in diluted calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen previously added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each incubation, 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 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 IgM in calibrators, samples or controls.
The LIAISON® Toxo IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer (Catolog number 15970) for the 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.
The method for qualitative determination of IgG antibodies to Toxoplasma gondii (anti-Toxo IgG) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. 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 conjugate 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 IgG in calibrators, samples or controls.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Clinical Trials (LIAISON® Toxo IgM):
- Type: Comparative Clinical Trials
- Sample Size: 613 samples from U.S. (200 from pregnant women), 279 from Europe. Total 892 samples.
- Data Source: Samples collected from U.S. and Europe. Testing performed at a hospital, a physician's laboratory, and DiaSorin.
- Key Results (U.S. Prospective samples):
- Positive Percent Agreement: 33.3% (1/3) with 95% CI (0.8 - 90.6%)
- Negative Percent Agreement: 99.8% (408/409) with 95% CI (98.7 - 99.9%)
- Overall Percent Agreement: 99.3% (409/412) with 95% CI (97.9 - 99.9%)
- Key Results (European Prospective samples):
- Positive Percent Agreement: 91.1% (41/45) with 95% CI (78.0 - 97.5%)
- Negative Percent Agreement: 98.7% (223/226) with 95% CI (96.2 - 99.7%)
- Overall Percent Agreement: 94.9% (265/279) with 95% CI (91.7 - 97.3%)
- Key Results (Prospective samples: Pregnant Women):
- Positive Percent Agreement: 33.3% (1/3) with 95% CI (0.8 - 90.6%)
- Negative Percent Agreement: 99.5% (194/195) with 95% CI (97.2 - 99.9%)
- Overall Percent Agreement: 98.5% (195/198) with 95% CI (95.6 - 99.7%)
CDC Panel Study (LIAISON® Toxo IgM):
- Type: CDC Panel Study
- Sample Size: 100 frozen blinded specimens (32 Toxoplasma IgM positive, 3 dilutions of three true Toxoplasma IgM positive, and 65 Toxoplasma IgM negative samples, of which 30 were Toxoplasma IgG negative).
- Key Results: Correctly detected 32 out of 32 IgM positives, 1 out of 3 IgM positive dilutions, and 63 out of 65 IgM negatives.
Reproducibility (LIAISON® Toxo IgM):
- Type: Assay Reproducibility Study
- Sample Size: 9 frozen repository serum samples, tested at two external US laboratories and at DiaSorin. Each sample tested in three replicates per run for ten runs (90 total measurements per sample).
- Key Results: Mean, within-run SD and %CV, between-run SD and %CV, between-site SD and %CV, and overall SD and %CV provided for 9 samples. Overall %CV ranged from 14.21% to 31.48%.
Cross-Reactions (LIAISON® Toxo IgM):
- Type: Cross-reactivity studies
- Sample Size: 112 samples with known antibodies/conditions (HAV, HBc, VZV IgM, Rubella IgM, CMV IgM, VCA IgM, HSV1-2 IgM, ANA, RF, HAMA).
- Key Results: No positive result was found for any of the 112 samples, indicating no cross-reactivity with these agents/conditions.
Interfering Substances (LIAISON® Toxo IgM):
- Type: Controlled studies
- Key Results: Assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
Comparative Clinical Trials (LIAISON® Toxo IgG):
- Type: Comparative Clinical Trials
- Sample Size: 887 prospectively collected samples (613 U.S., 274 Europe). 200 archived samples from pregnant women also processed.
- Key Results (U.S. Prospective samples):
- Positive Percent Agreement: 91.8% (78/85) with 95% CI (83.8 – 96.6%)
- Negative Percent Agreement: 95.3% (304/319) with 95% CI (92.4 - 97.3%)
- Overall Percent Agreement: 93.5% (386/413) with 95% CI (90.6 - 95.6%)
- Key Results (European Prospective samples):
- Positive Percent Agreement: 98.6% (139/141) with 95% CI (94.9 - 99.8%)
- Negative Percent Agreement: 91.3% (116/127) with 95% CI (85.0 - 95.6%)
- Overall Percent Agreement: 94.5% (255/268) with 95% CI (91.9 - 97.4%)
- Key Results (Prospective samples: Pregnant Women):
- Positive Percent Agreement: 96.0% (48/50) with 95% CI (86.3 – 99.5%)
- Negative Percent Agreement: 97.3% (143/147) with 95% CI (91.2 - 99.2%)
- Overall Percent Agreement: 96.5% (190/197) with 95% CI (92.8 - 98.6%)
- Key Results (Retrospective Samples - Sabin Feldman Dye test):
- Positive Percent Agreement: 99.3% (149/150) with 95% CI (96.3 - 99.9%)
- Negative Percent Agreement: 100.0% (0/0) (Note: The calculation (0/0) is presented, but is not interpretable, text gives 92.0 - 100.0 as CI)
- Overall Percent Agreement: 99.5% (49/50) with 95% CI (97.2 - 99.9%)
CDC Panel Study (LIAISON® Toxo IgG):
- Type: CDC Panel Study
- Sample Size: 100 frozen blinded specimens (70 Toxoplasma positive, 30 Toxoplasma negative).
- Key Results: Correctly detected all 70 positive and all 30 negative specimens.
Reproducibility (LIAISON® Toxo IgG):
- Type: Assay Reproducibility Study
- Sample Size: 9 frozen repository serum samples, tested at two external US laboratories and at DiaSorin. Each sample tested in three replicates per run for ten runs (90 total measurements per sample).
- Key Results: Mean, within-run SD and %CV, between-run SD and %CV, between-site SD and %CV, and overall SD and %CV provided for 9 samples. Overall %CV ranged from 5.07% to 8.26%.
Cross-Reactions (LIAISON® Toxo IgG):
- Type: Cross-reactivity studies
- Sample Size: 88 samples with known antibodies/conditions (HAV, HBc, VZV IgG, Rubella IgG, CMV IgG, VCA IgG, HSV1-2 IgG, ANA, RF, HAMA).
- Key Results: No positive result was found for any of the 88 samples, indicating no cross-reactivity with these agents/conditions.
Interfering Substances (LIAISON® Toxo IgG):
- Type: Controlled studies
- Key Results: Assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for detailed percent agreement values (Positive Percent Agreement, Negative Percent Agreement, Overall Percent Agreement) and their 95% confidence intervals.
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.
DiaSorin Toxoplasma IgM ELISA Kit (K963289), Diamedix Is-Toxoplasma IgG ELISA Kit (K981498)
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.
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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).
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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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| SUBMITTED BY: | Mari A. Meyer
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5635
Fax (651) 351-5669
E-mail: mari.meyer@diasorin.com |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE: | |
| Trade Name: | DiaSorin LIAISON® TOXO IgM |
| Common Names/Descriptions: | Immunoassay for the detection of IgM antibodies
Toxoplasma gondii |
| Classification Names: | Enzyme Linked Immunosorbent Assay, Toxoplasma |
| Product Code: | LGD |
| PREDICATE DEVICES: | DiaSorin Toxoplasma IgM ELISA Kit (K963289) |
6.0 510 (k) SUMMARY
INTENDED USE:
DEVICE DESCRIPTION:
The DiaSorin LIAISON® Toxo IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON® Toxo IgM can be used as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection. It is recommended that the LIAISON® Toxo IgM assay be performed in conjunction with a Toxoplasma gondii IgG assay.
This assay has not been cleared/approved by the FDA for blood/plasma screening.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
KIT DESCRIPTION:
The method for qualitative determination of IgM antibodies to Toxoplasma gondii (anti-Toxo IgM) is an anthody capture chemiluminescence immunoassay (CLIA). All assay steps (with the exception of
magnetic particle resuspension) and incubations are performed by the components of the test are magnetic particles (solid phase) coated with igG to human IgM (mouse, monoclonal), Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in diluted calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen previously added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each incubation, 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 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 IgM in calibrators, samples or controls.
1
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS:
OOM ANVE SENTORE Samples were tested – 613 collected from the U.S and 279 collected from Europe. The U.S. collection included 200 samples from pregnant women. The testing was performed at three sites – a hospital, a physician's laboratory, and at DiaSorin. All samples were tested with the LIAISON® Toxo IgG Assay and an enzyme immunoassay, ELISA. Equivocal results were not repeat tested per the manufacturers' recommendations; these results were not included in the calculations of overall agreement.
U.S. Prospective samples:
| DiaSorin Toxo IgM ELISA Results | ||||
|---|---|---|---|---|
| LIAISON® Toxo IgM | ||||
| Results | Positive | Equivocal | Negative | Total |
| Positive (>= 10.0 AU) | 1 | 0 | 0 | 1 |
| Equivocal (8.0 - 9.9 AU) | 1 | 0 | 1 | 2 |
| Negative (= 10 AU) | 41 | 0 | 3 | 44 |
| Equivocal (8.0- 9.9 AU) | 3 | 1 | 0 | 4 |
| Negative ( ro(x) premained issubstantially equivalent (for the indications referenced and nave decembled the actering and arrased predicate devices marketed in interstant for use stated in the encrosule) to regally mancted producal Device Americal Device Ameradments, or to commerce prior to May 28, 1770, the enactinent and early of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). | ||||
| and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that do not require approvide of the general controls provisions of the Act. The You may, therefore, market the device, bacycer to tirements for annual registration, listing of | ||||
| general controls provisions of the Act include requirements for annual registe general controls provisions of the received required of childrens against misbranding and adulteration. |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), , If your device is classified (SCC above) into e. Existing major regulations affecting your device it may be subject to such additional controlial Childring and 800 to 895. In addition, FDA can be found in Thic 21, Code of Peachar regard resgure in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA s Issualities with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemination may your in the Journer Federal agencies. You must light and light or any Federal statutes and regulations administered of registration and listing (21 comply with an the Ace 3 requirements, on and 809); and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good (21 CFR Part 820) CFK Part 807), labeling (21 CFR Patts 60 Parts (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins leter will anow you to oogin manisting of substantial equivalence of your device to a legally premarket notification: "The sults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your devire, If you desire specific infortion and advertising of your device, please contact the Office of In of quostions on the promise Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may odain other general ers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sale, a ton
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
KOS 2499
LIAISON® Toxo IgG Device Name:
The LIAISON® Toxo IgG assay uses chemiluminescent Indications For Use: immunoassay (CLIA) technology on the LIAISON® Analyzer for the 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 F.D.A for blood/plasma donor screening.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sall alany
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052499
Volume l
12
Indications for Use
Kos 24999 510(k) Number (if known):
LIAISON® Toxo IgM Device Name:
- The LIAISON® Toxo IgM assay uses Indications For Use: chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON® Toxo IgM can be used as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection. It is recommended that the LIAISON® Toxo IgM assay be performed in conjunction with a Toxoplasma gondii IgG assay.
This assay has not been cleared/approved by the F.D.A for blood/plasma donor screening.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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