DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

K052499 · Diasorin S.P.A · LGD · Feb 8, 2006 · Microbiology

Device Facts

• Record ID: K052499
• Device Name: DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
• Applicant: Diasorin S.P.A
• Product Code: LGD · Microbiology
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

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. This assay has not been cleared/approved by the F.D.A for blood/plasma donor screening. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. 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.

Device Story

LIAISON® Toxo IgG and IgM assays are chemiluminescent immunoassays (CLIA) performed on the LIAISON® Analyzer. Input: human serum samples. Principle: antibody capture (IgM) or indirect (IgG) immunoassay using magnetic particles coated with T. gondii antigen and isoluminol-antibody conjugate. Analyzer performs incubation, wash cycles, and starter reagent addition; photomultiplier measures flash chemiluminescence as relative light units (RLU). Output: qualitative determination of anti-Toxo IgG/IgM antibodies. Used in clinical laboratories by trained personnel. Results aid clinicians in assessing immune status or diagnosing recent infection. Benefits: provides automated, standardized serological testing for Toxoplasma gondii.

Clinical Evidence

Performance evaluated via method comparison studies using 887 (IgG) and 892 (IgM) prospective samples. IgG assay showed 93.5% overall agreement with ELISA in US specimens and 96.5% in pregnant women. IgM assay showed 99.3% overall agreement with ELISA in US specimens. CDC Toxoplasma 1998 Human Serum Panel testing: IgG assay correctly identified 70/70 positive and 30/30 negative samples; IgM assay correctly identified 32/32 positive and 63/65 negative samples. Precision studies reported CVs of 5-8% (IgG) and 19-32% (IgM).

Technological Characteristics

Chemiluminescent immunoassay (CLIA) technology. Solid phase: magnetic particles coated with T. gondii antigen (IgG) or anti-human IgM (IgM). Conjugate: mouse monoclonal antibodies to T. gondii (IgM) or human IgG (IgG) linked to isoluminol derivative. Energy source: LIAISON® Analyzer (photomultiplier detection). Form factor: automated kit components. Connectivity: LIAISON® Analyzer platform. Sterilization: N/A (reagents).

Indications for Use

Indicated for qualitative determination of Toxoplasma gondii IgG and IgM antibodies in human serum. IgG assay aids assessment of serological status and immune status, including in pregnant women. IgM assay aids presumptive diagnosis of acute or recent infection. Not for blood/plasma donor screening.

Regulatory Classification

Identification

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma 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.

Predicate Devices

• Is-Toxoplasma IgG ELISA Kit (k981498)
• Toxoplasma IgM ELISA Kit (k963289)

Submission Summary (Full Text)

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| SUBMITTED BY: | Mari A. Meyer<br>Regulatory Affairs Specialist<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: | |
| Trade Name: | DiaSorin LIAISON® TOXO IgM |
| Common Names/Descriptions: | Immunoassay for the detection of IgM antibodies<br>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.

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#### 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<br>Results | Positive | Equivocal | Negative | Total |
| Positive (>= 10.0 AU) | 1 | 0 | 0 | 1 |
| Equivocal (8.0 - 9.9 AU) | 1 | 0 | 1 | 2 |
| Negative (< 8.0 AU) | 1 | 1 | 408 | 410 |
| Total | 3 | 1 | 409 | 413 |

| | Percent Agreement | Exact 95% confidence interval |
|----------|-------------------|-------------------------------|
| Positive | 33.3% (1/3) | 0.8 - 90.6% |
| Negative | 99.8% (408/409) | 98.7 - 99.9% |
| Overall | 99.3% (409/412) | 97.9 - 99.9% |

#### European Prospective sample:

| LIAISON® Toxo IgM<br>Results | DiaSorin Toxo IgM ELISA Results | | | |
|------------------------------|---------------------------------|-----------|----------|-------|
| | Positive | Equivocal | Negative | Total |
| Positive (>= 10 AU) | 41 | 0 | 3 | 44 |
| Equivocal (8.0- 9.9 AU) | 3 | 1 | 0 | 4 |
| Negative (< 8.0 AU) | 1 | 7 | 223 | 231 |
| Total | 45 | 8 | 226 | 279 |

| | Percent Agreement | Exact 95% confidence interval |
|----------|-------------------|-------------------------------|
| Positive | 91.1% (41/45) | 78.0 - 97.5% |
| Negative | 98.7% (223/226) | 96.2 - 99.7% |
| Overall | 94.9% (265/279) | 91.7 - 97.3% |

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Prospective samples: Pregnant Women

| LIAISON® Toxo IgM<br>Results | ELISA Results | | | |
|------------------------------|---------------|-----------|----------|-------|
| | Positive | Equivocal | Negative | Total |
| Positive | 1 | 0 | 1 | 2 |
| Equivocal | 1 | 0 | 0 | 1 |
| Negative | 1 | 2 | 194 | 197 |
| Total | 3 | 2 | 195 | 200 |

| | Percent Agreement | | Exact 95% confidence<br>interval | |
|-----------|-------------------|-----------|----------------------------------|--|
| Positive: | 33.3% | (1/3) | 0.8 - 90.6% | |
| Negative: | 99.5% | (194/195) | 97.2 - 99.9% | |
| Overall: | 98.5% | (195/198) | 95.6 - 99.7% | |

#### CDC PANEL STUDY:

The CDC (Centers for Disease Control and Prevention) Toxoplasma 1998 Human Serum Panel was tested by LIAISON® Toxo IgM assay. The panel is comprised of 100 frozen blinded specimens: 32 Toxoplasma IgM positive, 3 dilutions of three true Toxoplasma IgM positive, and 65 Toxoplasma IgM negative samples. Of the 6 IgM neqative samples 30 were Toxoplasma IgG negative. The data obtained were submitte to the CDC for analysis. The LIAISON® Toxo IgM Assay correctly detected the 32 out of the 32 IgM positives, 1 out of the three IgM positive dilutions, and 63 out of the 65 IgM negatives. Note: These results are presented as means to convey further information on the performance of this assay with a masked, characterized serum panı This does not imply endorsement of the assay by the CDC.

#### REPRODUCIBILITY:

An assay reproducibility study was conducted at two external US laboratories and at DiaSorin. A coded panel comprised of 9 frozen repository serum samples was prepared by DiaSorin and provided to each site for testing by the LIAISON Toxo IgM assay. The panel contained 3 sets of serum samples. The sets were prepared to represent low to mid positive analyte levels. All panel members were divided into aliquots and stored frozen prior to testing. The same coded panel was tested at all three siles, in three replicates per run for ten runs. The results are summarized below.

| ID# | N | mean<br>(AU/mL) | within<br>run<br>S.D. | within<br>run<br>%CV | between<br>run<br>S.D. | between<br>run<br>%CV | between<br>site<br>S.D. | between<br>site<br>%CV | overall<br>sd. | overall<br>%CV |
|------|----|-----------------|-----------------------|----------------------|------------------------|-----------------------|-------------------------|------------------------|----------------|----------------|
| TMS1 | 90 | 33.1 | 3.08 | 9.18 | 9.12 | 12.54 | 6.04 | 18.26 | 7.57 | 22.89 |
| TMS2 | 90 | 19.7 | 1.30 | 6.88 | 5.06 | 9.36 | 3.94 | 19.99 | 3.92 | 19.91 |
| TMS3 | 90 | 847 | 47.1 | 5.71 | 187 | 8.52 | 91.9 | 10.87 | 120.3 | 14.21 |
| TM1 | 90 | 24.4 | 1.70 | 6.65 | 7.38 | 10.33 | 6.23 | 25.48 | 6.10 | 24.96 |
| TM2 | 90 | 34.0 | 2.08 | 5.74 | 12.26 | 9.77 | 11.49 | 33.78 | 10.71 | 31.48 |
| TM3 | 90 | 26.7 | 1.95 | 7.17 | 7.55 | 8.20 | 6.03 | 25.57 | 6.04 | 22.63 |
| TM4 | 90 | 25.9 | 1.65 | 6.14 | 8.35 | 8.67 | 7.17 | 27.65 | 6.91 | 26.67 |
| TM5 | 90 | 14.0 | 0.97 | 6.83 | 3.57 | 8.73 | 2.44 | 17.46 | 2.64 | 18.84 |
| TM6 | 90 | 18.8 | 0.88 | 4.52 | 6.00 | 8.62 | 5.16 | 27.41 | 4.95 | 26.31 |

*TMS3 dose was below the reading range of the assay. Precision calculations are based on signal (RLU) for this sample.

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#### CROSS-REACTIONS:

Cross-reactivity studies for the LIAISON® Toxo IgM assay were designed to evaluate potential interference from IgM immunoglobulins directed against closely-related members of the herpes virus fincherchoo from 18m inntantal that may cause symptoms similar to Toxoplasmosis family (10 v 1, 10 v 1, 10 v 1, 10 virus, hepatitis B virus) and conditions that may result from atypical immune system activity (rheumatoid factor (RF), anti-nuclear antibodies (ANA)). Samples for these studies were selected using commercially available devices.

| Organism/condition | Number of Expected<br>Negative Samples | LIAISON®<br>Positive Result |
|--------------------|----------------------------------------|-----------------------------|
| HAV Total | 9 | (0/9) |
| HBc Total | 21 | (0/21) |
| VZV IgM | 8 | (0/8) |
| Rubella IgM | 7 | (0/7) |
| CMV IgM | 13 | (0/13) |
| VCA IgM | 14 | (0/14) |
| HSV1-2 IgM | 10 | (0/10) |
| ANA | 10 | (0/10) |
| RF | 10 | (0/10) |
| HAMA | 10 | (0/10) |
| Total | 112 | (0/112) |

No positive result was found for the samples when tested by LIAISON® Toxo IgM.

WARNING: Assay interference due to circulating antibodies against HIV and Hepatitis C virus has not been evaluated. The user is responsible for establishing cross-reactivity performance with these infectious agents.

#### INTERFERING SUBSTANCES:

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).

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| SUBMITTED BY: | Mari A. Meyer<br>Regulatory Affairs Specialist<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® TOXO IgG |
| Common Names/Descriptions: | Immunoassay for the detection of IgG antibodies to<br>Toxoplasma gondii |
| Classification Names: | Enzyme Linked Immunosorbent Assay, Toxoplasma |
| Product Code: | LGD |
| PREDICATE DEVICES: | Diamedix Is-Toxoplasma IgG ELISA Kit (K981498) |
| DEVICE DESCRIPTION: | |

#### 6.0 510 (k) SUMMARY

#### INTENDED USE:

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.

This assay has not been cleared/approved by the F.D.A for blood/plasma donor 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 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.

{5}------------------------------------------------

#### PERFORMANCE DATA:

#### COMPARATIVE CLINICAL TRIALS:

A total of 887 prospectively collected samples were tested – 613 collected from the U.S. and 274 collected in A lotal of oor prospouroly oollooted camples from pregnant women. In addition, 200 archived iron Larope: The G.O. onliedion modaod 200 can processed. The testing was performed at four sites. All samples were tested with the LIAISON® Toxo IgG Assay and an enzyme immunoassay ELISA or Sabin Feldman Dye test.

reluivocal results were not repeat tested per the manufacturers' recommendations; these results were not included in the calculations of overall agreement.

#### U.S. Prospective samples:

| LIAISON® Toxo IgG<br>Results | ELISA Results | | | | | Percent Agreement | | Exact 95% confidence<br>interval |
|------------------------------|---------------|-----------|----------|-------|----------|-------------------|-----------|----------------------------------|
| | Positive | Equivocal | Negative | Total | Positive | 91.8% | (78/85) | 83.8 – 96.6% |
| Positive | 78 | 1 | 8 | 87 | Negative | 95.3% | (304/319) | 92.4 - 97.3% |
| Equivocal | 3 | 4 | 7 | 13 | Overall | 93.5% | (386/413) | 90.6 - 95.6% |
| Negative | 4 | 4 | 304 | 313 | | | | |
| Total | 85 | 9 | 319 | 413 | | | | |

#### European Prospective samples:

| LIAISON® Toxo IgG<br>Results | ELISA Results | | | |
|------------------------------|---------------|-----------|----------|-------|
| Results | Positive | Equivocal | Negative | Total |
| Positive | 139 | 3 | 7 | 149 |
| Equivocal | 2 | 0 | 4 | 6 |
| Negative | 0 | 3 | 116 | 119 |
| Total | 141 | 6 | 127 | 274 |

| | Percent Agreement | | Exact 95% confidence<br>interval |
|----------|-------------------|-----------|----------------------------------|
| Positive | 98.6% | (139/141) | 94.9 - 99.8% |
| Negative | 91.3% | (116/127) | 85.0 - 95.6% |
| Overall | 94.5% | (255/268) | 91.9 - 97.4% |

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Prospective samples: Pregnant Women

| LIAISON® Toxo IgG<br>Results | ELISA Results<br>Positive | Equivocal | Negative | Total |
|------------------------------|---------------------------|-----------|----------------------------------|-------|
| Positive | 48 | 2 | 3 | 53 |
| Equivocal | 1 | 0 | 1 | 2 |
| Negative | 1 | 1 | 143 | 145 |
| Total | 50 | 3 | 147 | 200 |
| | Percent Agreement | | Exact 95% confidence<br>interval | |
| Positive: | 96.0% | (48/50) | 86.3 – 99.5% | |
| Negative: | 97.3% | (143/147) | 91.2 - 99.2% | |
| Overall: | 96.5% | (190/197) | 92.8 - 98.6% | |

#### Retrospective Samples:

| LIAISON® Toxo<br>IgG Results | Sabin Feldman Dye test Results | Positive | Equivocal | Negative | Total |
|------------------------------|--------------------------------|-------------------------------|--------------------|--------------|-------|
| Positive | | 149 | 0 | 0 | 149 |
| Equivocal | | 1 | 0 | 0 | 1 |
| Negative | | 0 | 0 | 50 | 50 |
| Total | | 150 | 0 | 50 | 200 |
| | | Percent Agreement | | | |
| | | Positive | 99.3%<br>(149/150) | 96.3 - 99.9% | |
| | | Negative | 100.0%<br>(0/0) | 92.0 - 100.0 | |
| | | Overall | 99.5%<br>(49/50) | 97.2 - 99.9% | |
| | | Exact 95% confidence interval | | | |

### CDC PANEL STUDY:

The CDC (Centers for Disease Control and Prevention) Toxoplasma 1998 Human Serum Panel was tested by LIAISON® Toxo IgG assay. The panel is comprised of 100 frozen blinded specimens, 70 Toxoplasma positive samples and 30 toxoplasma negative samples. The data obtained were submitted to the CDC for analysis. The LIAISON® Toxo IgG Assay correctly detected the 70 positive and the 30 negative specimens. Note: These results are presented as a means to convey further information on the negative ope of this assay with a masked, characterized serum panel. This does not imply endorsement of the assay by the CDC.

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#### REPRODUCIBILITY:

REEKODUCIDIDIDIDIDIDIDIDIDIDIDIA
An assay reproducibility study was conducted at two external US laboratories and at pitch site An assay reproducibility Study Was ochaded at was prepared by DiaSorin and provided to each site for parier comprised of o Trezon ropotition of the panel contained samples prepared to represent low to mid positive analyte levels. All panel members were divided into aliquots and stored frozen prior to testing. positive analyte levels. All panel mombers works in three replicates per run for ten runs. The results are summarized below.

| ID# | N | mean<br>(IU/mL) | within<br>run<br>S.D. | within<br>run<br>%CV | between<br>run<br>S.D. | between<br>run<br>%CV | between<br>site<br>S.D. | between<br>site<br>%CV | overall<br>sd. | overall<br>%CV |
|------|----|-----------------|-----------------------|----------------------|------------------------|-----------------------|-------------------------|------------------------|----------------|----------------|
| TGS1 | 90 | 16.4 | 0.38 | 2.31 | 3.23 | 7.02 | 0.59 | 3.62 | 1.35 | 8.26 |
| TGS2 | 89 | 33.4 | 0.18 | 2.88 | 1.46 | 5.07 | 0.81 | 2.42 | 0.46 | 5.94 |
| TGS3 | 90 | 12.9 | 0.16 | 1.57 | 1.33 | 4.95 | 0.82 | 6.38 | 0.36 | 7.22 |
| TG1 | 90 | 7.6 | 0.96 | 2.38 | 6.37 | 4.96 | 0.28 | 3.68 | 1.99 | 6.05 |
| TG2 | 90 | 8.1 | 0.18 | 2.18 | 1.54 | 4.25 | 0.30 | 3.69 | 0.45 | 5.58 |
| TG3 | 90 | 11.1 | 0.19 | 1.92 | 1.72 | 5.27 | 0.29 | 2.61 | 0.47 | 6.22 |
| TG4 | 90 | 7.1 | 0.20 | 2.22 | 2.50 | 4.08 | 0.20 | 2.89 | 0.93 | 5.07 |
| TG5 | 90 | 9.1 | 0.21 | 2.07 | 2.13 | 3.50 | 0.32 | 3.45 | 0.69 | 5.17 |
| TG6 | 90 | 10.4 | 0.21 | 2.02 | 1.99 | 4.78 | 0.35 | 3.34 | 0.60 | 5.79 |

#### CROSS-REACTIONS:

Cross-reactivity studies for the LIAISON® Toxo IgG assay were designed to evaluate potential interference from IgG immunoglobulins directed against closely-related members of the herpes virus finans/USV-1, HSV-2, VZV, CMV), other organisms that may cause symptoms similar to Toxoplasmosis (i.e., EBV, rubella virus, hepatitis A virus, hepatitis B virus) and conditions that may result from atypical immune system activity [rheumatoid factor (RF), anti-nuclear antibodies (ANA)]. Samples for these studies were selected using commercially available devices.

| Organism/condition | Number of Expected<br>Negative Samples | LIAISON®<br>Positive Result |
|--------------------|----------------------------------------|-----------------------------|
| HAV Total | 12 | (0/12) |
| HBc Total | 17 | (0/17) |
| VZV IgG | 8 | (0/8) |
| Rubella IgG | 5 | (0/5) |
| CMV IgG | 10 | (0/10) |
| VCA IgG | 12 | (0/12) |
| HSV1-2 IgG | 2 | (0/2) |
| ANA | 7 | (0/7) |
| RF | 8 | (0/8) |
| HAMA | 7 | (0/7) |
| Total | 88 | (0/88) |

No positive result was found for the samples when tested by LIAISON® Toxoplasma IgG.

{8}------------------------------------------------

## WARNING: Assay interference due to circulating antibodies against HIV and Hepatitis C virus has withing. The user is responsible for establishing cross-reactivity performance with these infectious agents.

#### INTERFERING SUBSTANCES:

Controlled studies of potentially interfering substances showed that the assay performance was not ഗ്ഗന്തം അവലംബം mg/dL bilirubin).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/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 stripes forming its wing and body. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2006 FEB 8

Ms. Mari Meyer Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285

k052499 Re:

Trade/Device Name: LIAISON® Toxo IgG LIAISON® Toxo IgM Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: January 5, 2006 Received: January 6, 2006

Dear Ms. Meyer:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > 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).

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

## Page 2 -

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 [phone]. 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 [phone] or [phone] 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
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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K052499

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# 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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