(481 days)
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No
The summary describes a standard chemiluminescent immunoassay (CLIA) technology for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond standard assay result processing.
No.
This device is an in vitro diagnostic (IVD) assay designed to detect antibodies to human cytomegalovirus (hCMV) in human serum, providing an aid in the determination of serological status or diagnosis of acute CMV infection. It does not treat or directly impact a patient's health condition.
Yes
Explanation: The device is intended to be used as an "aid in the determination of serological status to CMV" and "an aid in the diagnosis of acute CMV infection", which are diagnostic purposes. It also performs qualitative determination of antibodies, which is a diagnostic measurement.
No
The device description clearly states that the assay uses chemiluminescent immunoassay (CLIA) technology and involves physical components like magnetic particles and conjugates, which are processed by a LIAISON® Chemiluminescence Analyzer. This indicates a hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assays are for the "qualitative determination of IgG/IgM antibodies to human cytomegalovirus (hCMV) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (CMV infection).
- Device Description: The description details a "chemiluminescence immunoassay (CLIA)" method using "magnetic particles" and "conjugates" to detect antibodies in a sample. This is a typical laboratory-based diagnostic test performed on biological specimens.
- Performance Studies: The performance studies involve testing human serum samples and comparing the results to other diagnostic methods (implied by the "Percent Agreement" and the mention of predicate devices). This is characteristic of studies conducted for IVD devices to demonstrate their accuracy and reliability in a clinical setting.
- Predicate Devices: The mention of predicate devices (K955361 DiaSorin CMV IqG ELISA Kit and K001767 Diamedix Is-CMV IgM Capture ELISA Kit) which are also IVD devices, further confirms the classification of this device as an IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® CMV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the diagnosis of acute CMV infection.
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.
Product codes (comma separated list FDA assigned to the subject device)
LFZ
Device Description
DiaSorin LIAISON® CMV IgG: The method for qualititative determination of specific IgG to hCMV is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with hCMV antigen and a conjugate of mouse monoclonal antibody to human IqG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, hCMV antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with hCMV IgG 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 hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of hCMV IgG in calibrators, samples or controls.
DiaSorin LIAISON® CMV IgM: The method for qualititative determination of specific IgM to hCMV is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with hCMV antigen, a buffer of goat IgG to human IgG and a conjugate of mouse monoclonal antibody to human IgM linked to an isoluminol derivative (isoluminolantibody conjugate). During the first incubation, calibrators, samples or controls are diluted with buffer A, which contains goat IgG to human IgG as an absorbent reagent to curb interference from human IgG specific to hCMV or from rheumatoid factor. During the second incubation, hCMV antibodies present in the calibrators, samples or controls bind to the solid phase. During the third incubation, the antibody conjugate reacts with hCMV IgM that is 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 hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of hCMV IgM 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
Human serum
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
DiaSorin LIAISON® CMV IgG:
Comparative Clinical Trials: Conducted at two external US laboratories and at DiaSorin. Testing was performed on repository and prospective samples.
Prospective Samples: 320 samples collected.
Pregnancy Samples: 202 samples collected.
Retrospective Samples: 100 samples from suspected acute CMV infection.
Reproducibility: 9 frozen repository serum samples tested at 4 sites, three replicates per run for ten runs.
Interference: Controlled studies with potentially interfering substances.
Cross-Reactivity: 46 total specimens from a disease panel (EBV, HSV, VZV, Hepatitis A, Parvovirus B19, ANA, RF).
DiaSorin LIAISON® CMV IgM:
Comparative Clinical Trials: Conducted at two external US laboratories and at DiaSorin. Testing was performed on repository and prospective samples.
Prospective Samples: 1499 samples (U.S. 610; European 889).
Pregnancy Samples: 200 samples.
Retrospective Samples: 100 samples from suspected acute CMV infection.
Reproducibility: 9 frozen repository serum samples tested at 4 sites, three replicates per run for ten runs.
Interference: Controlled studies with potentially interfering substances.
Cross-Reactivity: 67 total specimens from a disease panel (EBV, HSV, VZV, HHV6, Hepatitis A, Parvovirus B19, ANA, RF).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DiaSorin LIAISON® CMV IgG:
- Study Type: Comparative Clinical Trials (prospective, pregnancy, retrospective)
- Sample Size: Prospective (320), Pregnancy (202), Retrospective (100)
- Key Results (Agreement with Predicate Device):
- Prospective Samples: Positives 100.0% (178/178), Negatives 96.45% (136/141), Overall 98.13% (314/320).
- Pregnancy Samples: Positives 99.43% (175/176), Negatives 96.15% (25/26), Overall 99.01% (200/202).
- Retrospective Samples: Positives 100.0% (100/100), Negatives N/A, Overall 100.0% (100/100).
- Reproducibility Study: Performed at 4 sites using a coded panel of 9 frozen repository serum samples. Results expressed in U/mL with within-run, between-run, between-site, and overall SD and %CV. Example: for sample CGS1 (mean 0.91 U/mL), overall SD 0.11, %CV 12.29.
- Interference Study: Assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
- Cross-Reactivity Study: None of the 46 specimens tested from disease panel (EBV, HSV, VZV, Hepatitis A, Parvovirus B19, ANA, RF) were positive. No conclusive evidence of cross-reactivity observed, but possibility cannot be excluded due to limited sample availability. Assay interference due to circulating antibodies against HIV, Hepatitis B and Hepatitis C viruses has not been evaluated.
DiaSorin LIAISON® CMV IgM:
- Study Type: Comparative Clinical Trials (prospective, pregnancy, retrospective)
- Sample Size: Prospective (1499), Pregnancy (200), Retrospective (100)
- Key Results (Agreement with Predicate Device):
- Prospective Samples: Positives 90.70% (39/43), Negatives 93.23% (1322/1418), Overall 90.79% (1361/1499).
- Pregnancy Samples: Positives N/A, Negatives 98.50% (197/200), Overall 98.50% (197/200).
- Retrospective Samples: Positives 100.0% (97/97), Negatives 0.0% (0/2), Overall 97.0% (97/100).
- Reproducibility Study: Performed at 4 sites using a coded panel of 9 frozen repository serum samples. Results expressed in AU/mL with within-run, between-run, between-site, and overall SD and %CV. Example: for sample CMS1 (mean 51.5 AU/mL), overall SD 5.97, %CV 11.59.
- Interference Study: Assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
- Cross-Reactivity Study: Two out of 67 specimens tested from disease panel (EBV, HSV, VZV, HHV6, Hepatitis A, Parvovirus B19, ANA, RF) were positive (Parvovirus B19 IgM: 2/17). Possibility of cross-reactivity cannot be excluded due to limited sample availability. Assay interference due to circulating antibodies against HIV, Hepatitis B and Hepatitis C viruses has not been evaluated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DiaSorin LIAISON® CMV IgG:
- Prospective Samples:
- Percent Agreement Positives: 100.0% (178/178)
- Percent Agreement Negatives: 96.45% (136/141)
- Overall Percent Agreement: 98.13% (314/320)
- Pregnancy Samples:
- Percent Agreement Positives: 99.43% (175/176)
- Percent Agreement Negatives: 96.15% (25/26)
- Overall Percent Agreement: 99.01% (200/202)
- Retrospective Samples:
- Percent Agreement Positives: 100.0% (100/100)
- Percent Agreement Negatives: N/A
- Overall Percent Agreement: 100.0% (100/100)
DiaSorin LIAISON® CMV IgM:
- Prospective Samples:
- Percent Agreement Positives: 90.70% (39/43)
- Percent Agreement Negatives: 93.23% (1322/1418)
- Overall Percent Agreement: 90.79% (1361/1499)
- Pregnancy Samples:
- Percent Agreement Positives: N/A
- Percent Agreement Negatives: 98.50% (197/200)
- Overall Percent Agreement: 98.50% (197/200)
- Retrospective Samples:
- Percent Agreement Positives: 100.0% (97/97)
- Percent Agreement Negatives: 0.0% (0/2)
- Overall Percent Agreement: 97.0% (97/100)
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 CMV IqG ELISA Kit (K955361), Diamedix Is-CMV IgM Capture ELISA Kit (K001767)
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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§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
0
JUN 1 - 2005
6.0 510 (k) SUMMARY
SUBMITTED BY:
David M. Ikeda Requlatory Affairs/Quality Systems Manager DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5592 Fax (651) 351-5669 E-mail: david.ikeda@diasorin.com
Immunoassay for the detection of IgG antibodies to
ENZYME LINKED IMMUNOABSORBENT ASSAY,
NAME OF DEVICE: Trade Name:
Common Names/Descriptions:
Classification Names:
Product Code:
LFZ
CYTOMEGALOVIRUS
PREDICATE DEVICE:
DiaSorin CMV IqG ELISA Kit (K955361)
DiaSorin LIAISON® CMV IgG
human Cytomegalovirus (hCMV)
DEVICE DESCRIPTION:
INTENDED USE: The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV. LIAISON® Control CMV IgG kit is used in conjunction with LIAISON® CMV IgG immunoassay for monitoring substantial reagent failure.
KIT DESCRIPTION: The method for qualititative determination of specific IgG to hCMV is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with hCMV antigen and a conjugate of mouse monoclonal antibody to human IqG linked to an isoluminol derivative (isoluminol-antibody conjugate).
During the first incubation, hCMV antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with hCMV IgG 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 hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of hCMV IgG in calibrators, samples or controls.
1
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external US laboratories and at DiaSorin. Testing was performed on repository and prospective samples as laboratories and at DiaSolin. Testing was penomicul on reposition and comparison assay delified "below." The "damplo" tren" trial sites per the manufacturers' instructions for use.
| LIAISON® CMV IgG | CMV IgG ELISA | |||
|---|---|---|---|---|
| Negative | Equivocal | Positive | Total | |
| Negative ( |