DIASORIN LIAISON CMV IGM/IGG

K040290 · Diasorin S.P.A · LFZ · Jun 1, 2005 · Microbiology

Device Facts

• Record ID: K040290
• Device Name: DIASORIN LIAISON CMV IGM/IGG
• Applicant: Diasorin S.P.A
• Product Code: LFZ · Microbiology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

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. 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.

Device Story

LIAISON® CMV IgG and IgM assays are chemiluminescent immunoassays (CLIA) performed on the LIAISON® Analyzer. Input: human serum samples. Principle: indirect CLIA using magnetic particles coated with hCMV antigen; mouse monoclonal antibody-isoluminol conjugate; starter reagents induce flash chemiluminescence. Analyzer measures light signal (RLU) via photomultiplier; signal intensity correlates with antibody concentration. Used in clinical laboratories by trained personnel. Output: qualitative determination of hCMV IgG or IgM antibodies. Healthcare providers use results to assess CMV serological status or diagnose acute infection, facilitating clinical management of patients.

Clinical Evidence

Clinical trials conducted at multiple US and European sites compared LIAISON® assays against predicate ELISA methods. IgG assay: 320 prospective samples (98.13% agreement), 202 pregnancy samples (99.01% agreement), 100 retrospective samples (100% agreement). IgM assay: 1499 prospective samples (90.79% agreement), 200 pregnancy samples (98.50% agreement), 100 retrospective samples (97.0% agreement). Reproducibility studies (4 sites, 9-sample panels) showed acceptable precision. Interference studies confirmed no significant impact from hemolysis, lipemia, or icterus. Cross-reactivity testing evaluated potential interference from related viruses and autoimmune conditions.

Technological Characteristics

CLIA technology; magnetic particles (solid phase) coated with hCMV antigen; mouse monoclonal antibody-isoluminol derivative conjugate; photomultiplier detection of RLU; automated processing on LIAISON® Chemiluminescence Analyzer; serum sample matrix; includes buffer with goat IgG to human IgG (IgM assay) to reduce interference.

Indications for Use

Indicated for qualitative detection of IgG or IgM antibodies to human cytomegalovirus (hCMV) in human serum to aid in determining serological status (IgG) or diagnosing acute infection (IgM).

Regulatory Classification

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.

Predicate Devices

• DiaSorin CMV IqG ELISA Kit (K955361)
• Diamedix Is-CMV IgM Capture ELISA Kit (K001767)

Submission Summary (Full Text)

{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 [phone] Fax [phone] E-mail: [e-mail]

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% |

{2}------------------------------------------------

| 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 | within<br>run | within<br>run | between<br>run | between<br>run | between<br>site | between<br>site | 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 of<br>Samples | Positive<br>LIAISON® CMV<br>IgG 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. Ikeda<br>Regulatory Affairs/Quality Systems Manager<br>DiaSorin Inc.<br>1951 Northwestern Avenue<br>P.O. Box 285<br>Stillwater, MN 55082-0285<br>Phone [phone]<br>Fax [phone]<br>E-mail: [e-mail] |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE:<br>Trade Name: | DiaSorin LIAISON® CMV IgM |
| Common Names/Descriptions: | Immunoassay for the detection of IgM antibodies to<br>human Cytomegalovirus (hCMV) |
| Classification Names: | ENZYME LINKED IMMUNOABSORBENT ASSAY,<br>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% |

{6}------------------------------------------------

| 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 | within<br>run | within<br>run | run | run | site | between between between between overall overall<br>site | | |
|-------|----|---------|---------------|---------------|-------|-------|-------|---------------------------------------------------------|-------|--------|
| 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 of<br>Samples | Positive<br>LIAISON® CMV<br>IgM 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).

{9}------------------------------------------------

#### Page 2 -

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 [phone]. 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 [phone] or [phone] 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

{10}------------------------------------------------

# Indications for Use

510(k) Number (if known):

K040290

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)________________________________________________________________________________________________________________________________________________________________________

{11}------------------------------------------------

# Indications for Use

LIAISON® CMV IgG

510(k) Number (if known):

K040290

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