(481 days)
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.
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 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).
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).
Here's a breakdown of the acceptance criteria and study information for both the LIAISON® CMV IgG and LIAISON® CMV IgM assays, based on the provided text:
LIAISON® CMV IgG Assay
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a predicate device (DiaSorin CMV IgG ELISA Kit K955361) and a general expectation of high agreement. Specific numerical targets for acceptance criteria are not explicitly stated as "acceptance criteria" but rather as "percent agreement" for different sample types.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Prospective Samples | High overall agreement with predicate assay. | Overall Agreement: 98.13% (314/320) |
| High positive agreement with predicate assay. | Positive Agreement: 100.0% (178/178) | |
| High negative agreement with predicate assay. | Negative Agreement: 96.45% (136/141) | |
| Pregnancy Samples | High overall agreement with predicate assay. | Overall Agreement: 99.01% (200/202) |
| High positive agreement with predicate assay. | Positive Agreement: 99.43% (175/176) | |
| High negative agreement with predicate assay. | Negative Agreement: 96.15% (25/26) | |
| Retrospective Samples | High overall agreement with known positive samples. | Overall Agreement: 100.0% (100/100) |
| High positive agreement with known positive samples. | Positive Agreement: 100.0% (100/100) | |
| Reproducibility | Acceptable within-run, between-run, and between-site precision. | Overall %CV values ranged from 7.68% to 22.07%. |
| Interference | No significant interference from common interfering substances. | No effects from hemolysis, lipemia, icterus (within tested limits). |
| Cross-Reactivity | No significant cross-reactivity with related infectious agents. | 0/46 samples showed positive results (with caveats). |
2. Sample Size and Data Provenance for Test Set
-
Sample Sizes:
- Prospective Samples: 320 samples
- Pregnancy Samples: 202 samples
- Retrospective Samples (Suspected Acute CMV Infection): 100 samples
- Reproducibility Panel: 9 frozen repository serum samples (tested 90 times each, 3 replicates per run for 10 runs across 4 sites).
- Interference Studies: Not explicitly stated for specific sample count, but "controlled studies" were performed.
- Cross-Reactivity Panel: 46 samples (from various conditions/organisms).
-
Data Provenance:
- Country of Origin: The clinical trials were conducted at two external US laboratories and at DiaSorin.
- Retrospective or Prospective: Both retrospective (repository) and prospective samples were used.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established by comparison to a "comparison assay" (DiaSorin CMV IgG ELISA Kit). It's implied that the reference method itself effectively serves as the "expert" for establishing the ground truth.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable/not specified. The study compared the new device's results directly against a predicate device (DiaSorin CMV IgG ELISA Kit). There's no indication of an expert adjudication process beyond the results of the predicate assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is an in-vitro diagnostic device (immunoassay), not an imaging or interpretation device that would typically involve human "readers." The performance is measured directly by the assay's output.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done: Yes. The performance metrics presented (percent agreement, reproducibility, interference, cross-reactivity) are all "standalone" in the sense that they describe the device's performance without human interpretation or intervention in the final result determination, other than following the manufacturer's instructions for use. The device directly produces qualitative (Negative, Equivocal, Positive) or quantitative (U/mL) results.
7. Type of Ground Truth Used
- Ground Truth Type: Comparison to a predicate device (DiaSorin CMV IgG ELISA Kit). For the retrospective samples, it refers to "Suspected Acute CMV Infection," implying clinical diagnosis or established serological status.
8. Sample Size for Training Set
- Training Set Sample Size: Not specified. The document describes clinical performance data using test sets, but typically for immunoassay development, specific training set sizes are not disclosed in the same manner as for AI/ML algorithms. The development involved antigen selection and optimization, which indirectly uses data to establish assay parameters.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified in the provided text. For an immunoassay, the "training" aspect would involve optimizing reagent concentrations, incubation times, and cutoff values using a panel of known positive and negative samples, which would have their ground truth established through clinical diagnosis, confirmed infection, or other reference methods (like another established ELISA).
LIAISON® CMV IgM Assay
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a predicate device (Diamedix Is-CMV IgM Capture ELISA Kit K001767) and a general expectation of high agreement. Specific numerical targets for acceptance criteria are not explicitly stated as "acceptance criteria" but rather as "percent agreement" for different sample types.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Prospective Samples | High overall agreement with predicate assay. | Overall Agreement: 90.79% (1361/1499) |
| High positive agreement with predicate assay. | Positive Agreement: 90.70% (39/43) | |
| High negative agreement with predicate assay. | Negative Agreement: 93.23% (1322/1418) | |
| Pregnancy Samples | High overall agreement with predicate assay. | Overall Agreement: 98.50% (197/200) |
| High negative agreement with predicate assay. | Negative Agreement: 98.50% (197/200) | |
| Positive agreement not applicable due to 0 positives. | Positive Agreement: N/A | |
| Retrospective Samples | High overall agreement with known positive samples. | Overall Agreement: 97.0% (97/100) |
| High positive agreement with known positive samples. | Positive Agreement: 100.0% (97/97) | |
| Reproducibility | Acceptable within-run, between-run, and between-site precision. | Overall %CV values ranged from 10.97% to 26.59%. |
| Interference | No significant interference from common interfering substances. | No effects from hemolysis, lipemia, icterus (within tested limits). |
| Cross-Reactivity | No significant cross-reactivity with related infectious agents. | 2/67 samples showed positive results (with caveats). |
2. Sample Size and Data Provenance for Test Set
-
Sample Sizes:
- Prospective Samples: 1499 samples (U.S. 610; European 889)
- Pregnancy Samples: 200 samples
- Retrospective Samples (Suspected Acute CMV Infection): 100 samples
- Reproducibility Panel: 9 frozen repository serum samples (tested 90 times each, 3 replicates per run for 10 runs across 4 sites).
- Interference Studies: Not explicitly stated for specific sample count, but "controlled studies" were performed.
- Cross-Reactivity Panel: 67 samples (from various conditions/organisms).
-
Data Provenance:
- Country of Origin: Clinical trials were conducted at two external US laboratories and at DiaSorin. Prospective samples included both U.S. and European origin.
- Retrospective or Prospective: Both retrospective (repository) and prospective samples were used.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established by comparison to a "comparison assay" (Diamedix Is-CMV IgM Capture ELISA Kit). It's implied that the reference method itself effectively serves as the "expert" for establishing the ground truth.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable/not specified. The study compared the new device's results directly against a predicate device (Diamedix Is-CMV IgM Capture ELISA Kit). There's no indication of an expert adjudication process beyond the results of the predicate assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is an in-vitro diagnostic device (immunoassay), not an imaging or interpretation device that would typically involve human "readers." The performance is measured directly by the assay's output.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done: Yes. The performance metrics presented (percent agreement, reproducibility, interference, cross-reactivity) are all "standalone" in the sense that they describe the device's performance without human interpretation or intervention in the final result determination, other than following the manufacturer's instructions for use. The device directly produces qualitative (Negative, Equivocal, Positive) or quantitative (AU/mL) results.
7. Type of Ground Truth Used
- Ground Truth Type: Comparison to a predicate device (Diamedix Is-CMV IgM Capture ELISA Kit). For the retrospective samples, it refers to "Suspected Acute CMV Infection," implying clinical diagnosis or established serological status.
8. Sample Size for Training Set
- Training Set Sample Size: Not specified. The document describes clinical performance data using test sets, but typically for immunoassay development, specific training set sizes are not disclosed in the same manner as for AI/ML algorithms. The development involved antigen selection and optimization, which indirectly uses data to establish assay parameters.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified in the provided text. For an immunoassay, the "training" aspect would involve optimizing reagent concentrations, incubation times, and cutoff values using a panel of known positive and negative samples, which would have their ground truth established through clinical diagnosis, confirmed infection, or other reference methods (like another established ELISA).
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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 (<0.6 U/mL) | 136 | 0 | 0 | 136 |
| Equivocal (0.6-0.69 U/mL) | 1 | 0 | 0 | 1 |
| Positive (≥ 0.7 U/mL) | 4 | 1 | 178 | 183 |
| Total | 141 | 1 | 178 | 320 |
Prospective Samples: Subjects Sent to Laboratory for CMV Testing:
| Percent Agreement | Exact 95% confidence interval | ||
|---|---|---|---|
| Positives | 100.0% | (178/178) | 97.95 - 100.0% |
| Negatives | 96.45% | (136/141) | 91.92 - 98.84% |
| Overall | 98.13% | (314/320) | 95.96 - 99.31% |
Pregnancy Samples: Subjects Sent to Laboratory for CMV Testing:
| LIAISON® CMV IgG | CMV IgG ELISA | |||
|---|---|---|---|---|
| Negative | Equivocal | Positive | Total | |
| Negative (< 0.6 U/mL) | 25 | 0 | 1 | 26 |
| Equivocal (0.6-0.69 U/mL) | 0 | 0 | 0 | 0 |
| Positive (≥ 0.7 U/mL) | 1 | 0 | 175 | 176 |
| Total | 26 | 0 | 176 | 202 |
| Percent Agreement | Exact 95% confidence interval | ||
|---|---|---|---|
| Positives | 99.43% | (175/176) | 96.88 - 99.99% |
| Negatives | 96.15% | (25/26) | 80.36 - 99.90% |
| Overall | 99.01% | (200/202) | 96.47 - 99.88% |
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| LIAISON® CMV IgG | CMV IgG ELISA | |||
|---|---|---|---|---|
| Negative | Equivocal | Positive | Total | |
| Negative (< 0.6 U/mL) | 0 | 0 | 0 | 0 |
| Equivocal (0.6-0.69 U/mL) | 0 | 0 | 0 | 0 |
| Positive (≥ 0.7 U/mL) | 0 | 0 | 100 | 100 |
| Total | 0 | 0 | 100 | 100 |
| Percent Agreement | Exact 95% confidence interval | |||
| Positives | 100.0% | (100/100) | 96.38 - 100.0% | |
| Negatives | N/A | N/A | ||
| Overall | 100.0% | (100/100) | 96.38 - 100.0% |
Retrospective Samples: Suspected Acute CMV Infection
REPRODUCIBILITY: Reproducibility studies were performed at 4 sites using a coded panel comprised of 9 frozen repository serum samples. The serum panel was prepared to represent from low- to mid-positive analyte level. The same coded panel was tested at all sites, in three replicates per run for ten runs. Results expressed in U/mL are summarized in the following table.
| mean | withinrun | withinrun | betweenrun | betweenrun | betweensite | betweensite | overall | overall | ||
|---|---|---|---|---|---|---|---|---|---|---|
| ID# | N | (U/mL) | S.D. | %CV | S.D. | %CV | S.D. | %CV | S.D. | %CV |
| CGS1 | 90 | 0.91 | 0.04 | 4.84 | 0.11 | 9.39 | 0.06 | 6.55 | 0.11 | 12.29 |
| CGS2 | 90 | 6.09 | 0.57 | 9.69 | 1.24 | 14.57 | 0.85 | 13.93 | 1.34 | 22.07 |
| CGS3 | 90 | 1.59 | 0.10 | 6.05 | 0.14 | 8.21 | 0.07 | 4.60 | 0.16 | 10.31 |
| CG1 | 90 | 1.15 | 0.04 | 3.76 | 0.12 | 5.36 | 0.12 | 10.35 | 0.12 | 10.88 |
| CG2 | 90 | 0.94 | 0.04 | 3.95 | 0.09 | 6.01 | 0.08 | 8.13 | 0.09 | 9.86 |
| CG3 | 90 | 0.84 | 0.04 | 5.01 | 0.09 | 7.24 | 0.08 | 9.41 | 0.10 | 11.46 |
| CG4 | 90 | 0.68 | 0.02 | 3.60 | 0.05 | 5.34 | 0.05 | 6.76 | 0.06 | 8.43 |
| CG5 | 90 | 0.68 | 0.03 | 4.63 | 0.06 | 5.12 | 0.06 | 8.47 | 0.07 | 9.88 |
| CG6 | 90 | 1.17 | 0.07 | 6.02 | 0.06 | 5.17 | 0.03 | 2.20 | 0.09 | 7.68 |
INTERFERENCE: Controlled studies of potentially interfering substances showed that the assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
{3}------------------------------------------------
CROSS-REACTIVITY: The cross-reactivity studies for the LIAISON® CMV IgG assay were designed to evaluate potential interference from IgG immunoglobulins directed against closelydesigned to evaluate potential interformsily (EBV, HSV, VZV), from other organisms that may related member of the norpoo m(Hepatitis A virus, Parvovirus B19) and from other conditions that may result from atypical immune system activity (ANA, rheumatoid factor).
| Organism / condition | Number ofSamples | PositiveLIAISON® CMVIgG Result |
|---|---|---|
| EBV (VCA) IgG | 25 | (0/25) |
| HSV IgG | 2 | (0/2) |
| VZV IgG | 1 | (0/1) |
| Hepatitis A Ig | 1 | (0/1) |
| Parvovirus B19 IgG | 11 | (0/11) |
| ANA | 3 | (0/3) |
| RF | 3 | (0/3) |
| Total | 46 | (0/46) |
None of the 46 total specimens tested from the disease panel was positive. There was no conclusive evidence of cross-reactivity observed, however due to the limited availability of certain samples, the possibility of cross-reactivity cannot be excluded.
WARNING: Assay interference due to circulating antibodies against HIV, Hepatitis B and Hepatitis C viruses has not been evaluated. The user is responsible for establishing cross-reactivity performance with these infectious agents.
CONCLUSION:
The LIAISON® CMV IgG assay showed equivalent performance to the corresponding FDAcleared assay. The DiaSorin LIAISON® CMV IgG assay demonstrated agreement with the comparison method higher then 98% among prospectively collected routine samples, 99% among pregnancy samples and 100% agreement among retrospective selected samples. The amonstrated that LIAISON® CMV IgG assay can be used with the LIAISON® Analyzer for the qualitative detection of IgG antibodies to hCMV and can be intended for use as an aid in the determination of serological status to CMV.
{4}------------------------------------------------
| SUBMITTED BY: | David M. IkedaRegulatory Affairs/Quality Systems ManagerDiaSorin Inc.1951 Northwestern AvenueP.O. Box 285Stillwater, MN 55082-0285Phone (651) 351-5592Fax (651) 351-5669E-mail: david.ikeda@diasorin.com |
|---|---|
| NAME OF DEVICE:Trade Name: | DiaSorin LIAISON® CMV IgM |
| Common Names/Descriptions: | Immunoassay for the detection of IgM antibodies tohuman Cytomegalovirus (hCMV) |
| Classification Names: | ENZYME LINKED IMMUNOABSORBENT ASSAY,CYTOMEGALOVIRUS |
| Product Code: | LFZ |
| PREDICATE DEVICE: | Diamedix Is-CMV IgM Capture ELISA Kit (K001767) |
510 (k) SUMMARY 6.0
DEVICE DESCRIPTION:
INTENDED USE: The LIAISON® CMV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to teomfology on the EMROON VANA serum. It is intended to be used as an aid in the diagnosis of acute CMV infection. LIAISON® Control CMV IgM kit is used in conjunction with LIAISON® CMV IgM immunoassay for monitoring substantial reagent failure.
KIT DESCRIPTION: 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
{5}------------------------------------------------
by a photomultiplier as relative light units (RLU) and is indicative of the presence of hCMV IgM in calibrators, samples or controls.
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 laburatories and at Blaoom. Testing was penomical on reporting and comparison assay (Diamedix Is-CMV IgM Capture ELISA), at the trial sites per the manufacturers' instructions for use.
Prospective Samples: Subjects Sent to Laboratory for CMV Testing (U.S. 610; European 889):
| LIAISON® CMV IgM | CMV IgM ELISA | |||
|---|---|---|---|---|
| Negative | Equivocal | Positive | Total | |
| Negative (< 30 AU/mL) | 1322 | 29 | 4 | 1355 |
| Equivocal (30-34.9 AU/mL) | 22 | 0 | 0 | 22 |
| Positive (≥ 35 AU/mL) | 74 | 9 | 39 | 122 |
| Total | 1418 | 38 | 43 | 1499 |
| Percent Agreement | Exact 95% confidence interval | |
|---|---|---|
| Positives | 90.70% (39/43) | 77.86 - 97.41% |
| Negatives | 93.23% (1322/1418) | 91.80 - 94.48% |
| Overall | 90.79% (1361/1499) | 89.22-92.21% |
Pregnancy Samples: Subjects Sent to Laboratory for CMV Testing:
| LIAISON® CMV IgM | CMV IgM ELISA | |||
|---|---|---|---|---|
| Negative | Equivocal | Positive | Total | |
| Negative (< 30 AU/mL) | 197 | 0 | 0 | 197 |
| Equivocal (30-34.9 AU/mL) | 1 | 0 | 0 | 1 |
| Positive (≥ 35 AU/mL) | 2 | 0 | 0 | 2 |
| Total | 200 | 0 | 0 | 200 |
| Percent Agreement | Exact 95% confidence interval | |
|---|---|---|
| Positives | N/A | N/A |
| Negatives | 98.50% (197/200) | 95.68 - 99.69% |
| Overall | 98.50% (197/200) | 95.68 - 99.69% |
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| LIAISON® CMV IgM | CMV IgM ELISA | |||
|---|---|---|---|---|
| Negative | Equivocal | Positive | Total | |
| Negative (<30 AU/mL) | 0 | 0 | 0 | 0 |
| Equivocal (30-34.9 AU/mL) | 0 | 0 | 0 | 0 |
| Positive (≥ 35 AU/mL) | 2 | 1 | 97 | 100 |
| Total | 2 | 1 | 97 | 100 |
| Percent Agreement | Exact 95% confidence interval | |||
| Positives | 100.0% (97/97) | 96.27 - 100.0% | ||
| Negatives | 0.0% (0/2) | 0 - 85.0% |
Retrospective Samples: Suspected Acute CMV Infection
97.0%
Overall
REPRODUCIBILITY: Reproducibility studies were performed at 4 sites using a coded panel comprised of 9 frozen repository serum samples. The serum panel was prepared to represent from low- to mid-positive analyte level. The same coded panel was tested at all sites, in three replicates per run for ten runs. Results expressed in AU/mL are summarized in the following table.
(97/100)
91.48 - 99.38%
| mean | withinrun | withinrun | run | run | site | between between between between overall overallsite | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| ID# | N | (AU/mL) | S.D. | %CV | S.D. | %CV | S.D. | %CV | S.D. | %CV |
| CMS1 | 90 | 51.5 | 3.32 | 6.33 | 5.09 | 8.43 | 2.87 | 5.57 | 5.97 | 11.59 |
| CMS2 | 90 | 117.6 | 5.77 | 4.87 | 12.43 | 7.59 | 9.05 | 7.70 | 13.33 | 11.34 |
| CMS3* | 90 | <8.0 | 110* | 4.62* | 247* | 4.89* | 260* | 10.77* | 265* | 10.97* |
| CM1 | 90 | 44.7 | 2.12 | 4.61 | 8.08 | 6.32 | 9.10 | 20.36 | 8.27 | 18.50 |
| CM2 | 90 | 40.6 | 1.84 | 4.41 | 6.23 | 6.36 | 6.88 | 16.92 | 6.40 | 15.76 |
| CM3 | 90 | 42.3 | 1.95 | 4.52 | 6.03 | 5.59 | 6.69 | 15.82 | 6.25 | 14.78 |
| CM4 | 90 | 60.7 | 3.85 | 5.37 | 15.66 | 16.70 | 14.68 | 23.39 | 16.14 | 26.59 |
| CM5 | 90 | 56.7 | 2.40 | 4.26 | 9.34 | 7.60 | 9.95 | 17.54 | 9.53 | 16.81 |
| CM6 | 90 | 49.2 | 3.36 | 5.96 | 9.03 | 9.90 | 8.54 | 17.36 | 10.23 | 20.79 |
*The precision calculations for CMS3 are based on RLU data.
INTERFERENCE: Controlled studies of potentially interfering substances showed that the assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
{7}------------------------------------------------
CROSS-REACTIVITY: The cross-reactivity studies for the LIAISON® CMV IgM assay were GROSSHEROTIVET. The oroos fouctive for alow immunoglobulins directed against closelydesigned to evaluate potential interestily (EBV, HSV, VZV, HHV6), from other organisms that related members of the nerped that tamily (Hepatitis A virus, Parvovirus B19) and from other may cause "symptome" offinial ttypical immune system activity (ANA, rheumatoid factor).
| Organism / condition | Number ofSamples | PositiveLIAISON® CMVIgM Result |
|---|---|---|
| EBV IgM | 23 | (0/23) |
| HSV IgM | 2 | (0/2) |
| VZV IgM | 3 | (0/3) |
| HHV6 IgM | 2 | (0/2) |
| Hepatitis A IgM | 2 | (0/2) |
| Parvovirus B19 IgM | 17 | (2/17) |
| ANA Ig | 7 | (0/7) |
| RF | 11 | (0/11) |
| Total | 67 | (2/67) |
Two out of 67 total specimens tested from the disease panel were positive. Due to the limited availability of certain samples, the possibility of cross-reactivity cannot be excluded.
WARNING: Assay interference due to circulating antibodies against HIV, Hepatitis B and Hepatitis C viruses has not been evaluated. The user is responsible for establishing cross-reactivity performance with these infectious agents.
CONCLUSION:
The LIAISON® CMV IgM assay showed equivalent performance to the corresponding FDAche Ell assay. The DiaSorin LIAISON® CMV IgM assay demonstrated agreement with the comparison method higher then 90% among prospectively collected samples, 98% among pregnancy samples and 97% agreement among retrospective selected samples. The results demonstrate that LIAISON® CMV IgM assay can be used with the LIAISON® Analyzer for the qualitative detection of IgM antibodies to CMV and can be intended for use as an aid in the diagnosis of acute CMV infection.
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 - 2005
David Ikeda Manager, Regulatory Affairs & Quality Systems DiaSorin Inc. 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082
K040290 Re: Trade/Device Name: DiaSorin LIAISON® CMV IgG Assay DiaSorin LIAISON® CMV IgM Assay Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LFZ Dated: May 24, 2005 Received: May 25, 2005
Dear Mr. Ikeda:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (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 his icticle witi anow you to orgin marketing of substantial equivalence of your device to a legally premarket notification: "The PDT Imazlig sification 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 device, If you desire specific information acountiving of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may ootan only general mist generational 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,
Sally a Hom
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):
LIAISON® CMV IgM Device Name:
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.
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1_________________________________________________________________________________________________________________________________________________________________
510(k)________________________________________________________________________________________________________________________________________________________________________
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Indications for Use
LIAISON® CMV IgG
510(k) Number (if known):
Device Name:
Indications For 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.
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)
Salz at An
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k)________________________________________________________________________________________________________________________________________________________________________ KO4D290
§ 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).