LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II

K132234 · DiaSorin, Inc. · LGD · Aug 28, 2013 · Microbiology

Device Facts

• Record ID: K132234
• Device Name: LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
• Applicant: DiaSorin, Inc.
• Product Code: LGD · Microbiology
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for 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 FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.

Device Story

The LIAISON® Toxo IgG II is an indirect chemiluminescent immunoassay (CLIA) performed on the LIAISON® XL Analyzer. It uses magnetic particles coated with Toxoplasma gondii antigen and a mouse monoclonal anti-human IgG conjugate linked to an isoluminol derivative. The analyzer performs all incubation and wash steps. During the first incubation, patient IgG antibodies bind to the solid phase; during the second, the conjugate binds to the captured IgG. Starter reagents induce a flash chemiluminescence reaction, measured as relative light units (RLU) by a photomultiplier. The system provides qualitative results (IU/mL) to aid clinicians in assessing Toxoplasma gondii infection and immune status. Used in clinical laboratories by trained personnel. Benefits include automated processing and rapid turnaround compared to manual ELISA methods.

Clinical Evidence

Clinical performance evaluated via prospective study (804 samples: 204 US, 600 European) and 202 pregnant women, plus retrospective study (42 positive samples). CDC serum panel (100 samples) showed 100% sensitivity and 100% specificity. Prospective US population agreement: 100% negative, 100% positive. European population: 94.3% negative, 98.8% positive. Pregnant population: 100% negative, 85.7% positive.

Technological Characteristics

Indirect CLIA; magnetic particles coated with inactivated T. gondii (RH strain); mouse monoclonal anti-human IgG-isoluminol conjugate. Automated on LIAISON® XL Analyzer. Flash chemiluminescence detection via photomultiplier. Standardized to WHO 2nd International Standard (1980) via E6 National Standard Serum. Reagents include BSA, phosphate buffer, ProClin® 300. Connectivity via RFID tag for master curve storage.

Indications for Use

Indicated for qualitative determination of Toxoplasma gondii IgG antibodies in human serum to assess serological status and immune status, including in pregnant women. Not for blood/plasma donor screening. Not established for immunocompromised/immunosuppressed patients, cord blood, neonates, or infants.

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

• Diamedix Is-Toxoplasma IgG ELISA (K981498)

Submission Summary (Full Text)

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K132234

#### 510(k) SUMMARY

| SUBMITTED BY: | Kelly R. Sauer<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>Email: [e-mail] |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AUG 2 8 2013 | |
| DATE PREPARED: | July 17, 2013 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® Toxo IgG II<br>LIAISON® Control Toxo IgG II |
| Common Names/Descriptions: | Toxoplasma gondii IgG assay and<br>Toxoplasma gondii IgG controls |
| Classification Names: | Toxoplasma gondii serological reagents:<br>Class II, 21 CFR: 866.3780; Microbiology (83) |
| | Single (Specified) analyte controls (assayed<br>and unassayed): Class I, reserved<br>21 CFR 862.1660; Clinical Chemistry (75) |
| Product Code: | LGD<br>JJX |
| PREDICATE DEVICES : | Diamedix Is-Toxoplasma IgG ELISA<br>Reference K981498 (assay)<br>DiaSorin LIAISON® Control Rubella IgM<br>(K122397) |

#### DEVICE DESCRIPTION:

#### INTENDED USE:

The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for 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

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This assay has not been cleared/approved by the FDA for blood/plasma donor screening.

U.S. Federal Law restricts this device to sale by or on the order of a physician.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.

The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.

#### KIT DESCRIPTION:

The method for qualitative determination of IgG antibodies to Toxoplasma gondii (anti-Toxo IgG) is an indirect chemiluminescence immunoassay (CLIA). 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 conjuqate 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 IqG in calibrators, samples or controls.

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

# COMPARISON TO PREDICATE DEVICE:

The DiaSorin LIAISON® Toxo IgG II assay is substantially equivalent in principle and performance to the Diamedix Is-Toxoplasma IgG ELISA (K981498) which was FDA cleared August 21, 1998. The DiaSorin LIAISON Control Toxo II is substantially equivalent in principle to the DiaSorin LIAISON Control Rubella IgM (K122397) which was FDA cleared September 6, 2012.

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| Characteristic | New Device<br>DiaSorin LIAISON® Toxo IgG II | Predicate Device<br>Diamedix Is-Toxoplasma IgG<br>ELISA (K981498) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LIAISON® Toxo IgG II assay<br>uses chemiluminescent<br>immunoassay (CLIA) technology on<br>the LIAISON® XL Analyzer for the<br>qualitative determination of specific<br>IgG antibodies to Toxoplasma<br>gondii in human serum. The results<br>of this assay can be used as an aid<br>in the assessment of the patient's<br>serological status to infection with<br>Toxoplasma gondii and in the<br>determination of immune status of<br>individuals including pregnant<br>women.<br>This assay has not been<br>cleared/approved by the FDA for<br>blood/plasma donor screening. U.S.<br>Federal Law restricts this device to<br>sale by or on the order of a licensed<br>practitioner. Assay performance<br>characteristics have not been<br>established for<br>immunocompromised or<br>immunosuppressed patients, cord<br>blood, neonatal specimens, or<br>infants. | The Diamedix Is-Toxoplasma IgG<br>Test Kit is an enzyme-linked<br>immunoassay (ELISA) for the<br>qualitative and quantitative<br>detection of IgG to Toxoplasma<br>gondii in human serum. The<br>results of the assay can be used as<br>an aid in the assessment of the<br>patient's immunological response<br>to infection with T. gondii and in the<br>determination of immune status of<br>individuals, including females of<br>child-bearing age. The evaluation<br>of paired sera can aid in the<br>diagnosis of primary or reactivated<br>infection. This product is not FDA<br>cleared for use in screening blood<br>and plasma donors. |
| Measured<br>Analyte | IgG antibodies to Toxoplasma gondii | Same |
| Reagent Storage | On-board or in refrigerator @ 2-8°C | In refrigerator @ 2-8°C |
| Calibrators | Included with kit | Same |
| Controls | 2 levels (negative and positive) | Same |
| Sample matrix | Human Serum | Same |
| Table 2 : Table of Differences | | |
| Characteristic | New Device<br>DiaSorin LIAISON® Toxo IgG II | Predicate Device<br>Diamedix Is-Toxoplasma IgG<br>ELISA (K981498) |
| Assay Type | Chemiluminescent Immunoassay | Enzyme Immunoassay |
| Calibration<br>Standarization | E6 (National Health Laboratory,<br>France, 1987) standardized against<br>WHO 2nd International Standard | WHO 3rd International Standard |
| Calculation of<br>Results | Qualitative assay | Qualitative or Quantitative |
| Calibration | Two point verification of stored master<br>curve | Single point Cut-Off Calibrator<br>(Qualitative)<br>Three point - 3 Standards |
| Unit of Measure | IU/mL | Index Value (Qualitative)<br>IU/mL (Quantitative) |
| Cut-Off | ≥ 8.8 IU/mL | 1.10 Index Value (Qualitative)<br>50.0 IU/mL (Quantitative) |
| Equivocal Zone | ≥ 7.2 - < 8.8 IU/mL | 0.90 - 1.09 Index Value |
| Sample size | 20 µL | Minimum of 2 µL |
| Sample Handling/<br>Processing | Automated | Manual or Automated |
| Assay Time | 35 minutes | 140 minutes |
| Controls | Provided Separately | Included with kit |
| Conjugate | Mouse monoclonal to human IgG<br>linked to isoluminol derivative | Goat anti-human IgG labeled<br>with horseradish peroxidase |
| Measurement<br>System | Photomultiplier (flash<br>chemiluminescence reader) | Spectrophotometer (EIA<br>microtiter plate reader) |

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| Table 3: Summary of Similarities and Differences LIAISON<br>Control Toxo IgG II | | | | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Characteristic | New Device<br>DiaSorin LIAISON® Control<br>Toxo IgG II | Predicate Device<br>DiaSorin LIAISON® Control<br>Rubella IgM (K122397) | | |
| Intended Use | The LIAISON® Control Toxo IgG II<br>is intended for use as assayed<br>quality control samples to monitor<br>the performance of the LIAISON®<br>Toxo IgG II assay. | The LIAISON® Control Rubella IgM<br>is intended for use as assayed<br>quality control samples to monitor<br>the performance of the LIAISON®<br>Rubella IgM assay. | | |
| Storage | Store at 2-8º C until ready to use | Same | | |
| Levels | 2 levels: negative and positive | Same | | |
| Open Use | 8 weeks stored at 2-8º C | Same | | |
| Matrix | Liquid human serum or<br>defibrinated plasma provided in<br>vials<br>0.2% ProClin® 300 | Same | | |

#### PERFORMANCE DATA:

#### COMPARATIVE CLINICAL STUDIES:

Prospective and retrospective studies were performed to evaluate the performance of the LIAISON® Toxo IgG II assay among individuals who were sent to the lab for Toxoplasma gondii testing, pregnant women (prospective) and on frozen or repository samples from individuals with a positive Toxoplasma gondii IgG result by the comparator assay (retrospective).

# A. Prospective:

The prospective populations consist of non-selected subjects sent to the laboratory for Toxoplasma gondii IgG testing (US and European subjects) and pregnant women.

The prospective US population consisting of 204 individuals were 96.1% Female (n=196) and 3.9% Male (n=8) ranging in age from 18 years to 42 years. There were 147 samples from patients where the age was unknown.

The prospective European population consisted of 600 individuals. Age and gender for these samples are unknown.

The prospective population of pregnant women consists of 202 females with ages ranging from 14 years to 44 years. There were 71 samples from subjects in the 18 trimester, 50 samples form subjects in the second trimester and 81 samples from subjects in the 3rd trimester of pregnancy.

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| | | Percent Agreement | Exact 95% Confidence Interval |
|-----------------------------------------------------------|---------|-------------------|-------------------------------|
| Negative | 183/183 | 100.0% | 98.0 - 100.0% |
| Positive | 21/21 | 100.0% | 84.5 - 100.0% |
| Toxoplasma IgG Prospective European Population Comparison | | | |
| | | Percent Agreement | Exact 95% Confidence Interval |
| Negative | 252/267 | 94.3% | 90.9 - 96.6% |

Toxoplasma IgG Preqnant Population Comparison

| | | Percent Agreement | Exact 95% Confidence Interval |
|----------|---------|-------------------|-------------------------------|
| Negative | 188/188 | 100.0 % | 98.0 - 100.0% |
| Positive | 12/14 | 85.7 % | 60.1 - 96.0% |

98.8 %

#### B. Retrospective/PreSelected Population:

329/333

The retrospective population was defined as pre-selected samples from individuals who had a positive Toxoplasma gondii IgG result by the comparator assay. Forty two (42) samples were included in this study. The 42 individuals from the retrospective population were 95.2% females (n=40) and 4.8% males (n=2) ranqinq in age from 0 to 47 years.

96.6 - 99.5%

Toxoplasma IgG Retrospective Population

| | | Percent Agreement | Exact 95% Confidence Interval |
|----------|-------|-------------------|-------------------------------|
| Positive | 42/42 | 100.0 % | 91.8 - 100.0% |

The results demonstrate that the LIAISON® Toxo IgG II assay can be used with the LIAISON® XL Analyzer for the qualitative detection of IgG antibodies to Toxoplasma aondii.

# C. CDC Panel Study:

Positive

The CDC Toxoplasma 1998 Human Serum Panel is comprised of 100 frozen blind specimens (70 Toxoplasma IgG true positive samples and 30 Toxoplasma IgG true negative samples .The panel was tested by LIAISON® Toxo IgG II assay at.

The results were submitted to the CDC (Reference Immunodiagnostic Lab, Biology and Diagnostic Branch Division of Parasitic Diseases) for data analysis. As communicated by the CDC, the LIAISON® Toxo IgG II assay correctly detected the 70 Toxoplasma IgG true positive samples (100% Sensitivity) and the 30 Toxoplasma IgG true negative samples (100% Specificity).

# D. Prevalence:

The observed prevalence of the LIAISON® Toxo IgG II assay was calculated for the prospective populations consisting of the 804 samples from patients sent to the lab for Toxoplasma gondii testing and 202 pregnant women.

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The prevalence may vary depending upon geographical location, age, gender, type of test employed, specimen collection and handling procedures as well as clinical history of the patient.

The observed prevalence of LIAISON® Toxo IgG II assay for the US population is 10.3%, the European population had a prevalence of 57.0% and pregnant women a prevalence of 5.9%.

#### PRECISION/REPRODUCIBILITY:

#### 20 Day Study

Assay precision was evaluated according to CLSI EP5-A2. Six serum samples containing concentrations of analyte prepared to span the range of the assay and the LIAISON® Control Toxo IgG II (positive and negative) were assaved in duplicate in two runs per day over 20 operating days.

The following repeatability results were obtained from the samples tested internally at DiaSorin Inc. in one kit lot.

| Sample<br>ID | N | Mean<br>IU/mL | Within-Run | | Within-Day | | Between-Day | | Total | |
|-----------------------------------|----|---------------|------------|-------|------------|-------|-------------|--------|--------|--------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg<br>Control*<br>Pos<br>Control | 80 | <3.0 | 90.36* | 5.6%* | 89.13* | 5.5%* | 155.58* | 9.6%* | 200.8* | 12.4%* |
| Pos<br>Control | 80 | 22.8 | 1.19 | 5.2% | 0.68 | 3.0% | 0.48 | 2.1% | 1.45 | 6.4% |
| Sample<br>#1* | 80 | <3.0 | 151.7* | 6.3%* | 48.72* | 2.0%* | 262.18* | 10.9%* | 306.8* | 12.8%* |
| Sample<br>#2 | 80 | 7.5 | 0.53 | 7.2% | 0.54 | 7.2% | 0.00 | 0.0% | 0.75 | 10.0% |
| Sample<br>#3 | 80 | 15.8 | 0.85 | 5.4% | 0.58 | 3.7% | 0.41 | 2.6% | 1.11 | 7.0% |
| Sample<br>#4 | 80 | 13.2 | 0.76 | 5.8% | 0.82 | 6.2% | 0.14 | 1.1% | 1.13 | 8.5% |
| Sample<br>#5 | 80 | 27.0 | 1.13 | 4.2% | 1.21 | 4.5% | 0.70 | 2.6% | 1.80 | 6.6% |
| Sample<br>#6 | 80 | 76.9 | 4.35 | 5.7% | 2.94 | 3.8% | 3.16 | 4.1% | 6.12 | 8.0% |

#### Repeatability

* Dose and corresponding RLU's were below the reading range of the assay. Precision calculations are based on signal (RLU) for the two samples.

The following reproducibility results were obtained from the same six samples and the LIAISON® Control Toxo IgG II (positive and negative) tested at two external sites and at DiaSorin Inc. in two kit lots assayed in duplicate in two runs per day over 20 operating days.

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| Reproducibility | | | | | | | | | | | | |
|-----------------|--------|-------|------------|-------|------------|-------|-------------|-------|--------------|--------|---------|--------|
| | Sample | Mean | Within-Run | | Within-Day | | Between-Day | | Between Site | | Total | |
| Sample<br>ID | N | IU/mL | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg<br>Control* | 480 | <3.00 | 100.82* | 6.4%* | 87.89* | 5.5%* | 147.49 | 9.3%* | 208.12* | 13.1%* | 320.20* | 20.2%* |
| Pos<br>Control | 480 | 22.8 | 1.4 | 6.1% | 0.74 | 3.3% | 1.6 | 7.0% | 0.7 | 3.1% | 2.69 | 11.8% |
| Sample<br>#1* | 480 | <3.00 | 136.38* | 5.5%* | 94.22* | 3.8%* | 215.71* | 8.7%* | 375.14* | 15.2%* | 603.16* | 24.4%* |
| Sample<br>#2 | 480 | 7.4 | 0.48 | 6.5% | 0.33 | 4.5% | 0.42 | 5.8% | 0.21 | 2.8% | 0.88 | 12.0% |
| Sample<br>#3 | 480 | 15.3 | 0.79 | 5.2% | 0.61 | 4.0% | 0.8 | 5.2% | 0.38 | 2.5% | 1.72 | 11.2% |
| Sample<br>#4 | 480 | 13.6 | 0.68 | 5.0% | 0.6 | 4.4% | 0.89 | 6.6% | 0.44 | 3.2% | 1.43 | 10.5% |
| Sample<br>#5 | 480 | 26.9 | 1.23 | 4.6% | 1.12 | 4.2% | 1.43 | 5.3% | 0.92 | 3.4% | 2.81 | 10.5% |
| Sample<br>#6 | 480 | 77.3 | 3.92 | 5.1% | 4.42 | 5.7% | 5.95 | 7.7% | 2.77 | 3.6% | 9.44 | 12.2% |

* Dose and corresponding RLUs were below the reading range of the assay. Precision calculations are based on signal (RLU) for the two samples.

#### CONCLUSION:

The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labeling is sufficient and it satisfies the requirements of 21CFR 809.10.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Pablic Health Service

August 28, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DiaSorin Inc. C/O Kelly Sauer, Regulatory Affairs Specialist 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285

Re: K132234

Trade/Device Name: LIAISON Toxo IgG II, LIAISON Control Toxo IgG II Regulation Number: 21 CFR 866.3780 Regulation Name: Toxophasma gondii, Scrological Reagent Regulatory Class: Class II Product Code: LGD Dated: July 11, 2013 Received: July 18, 2013

Dear Ms. Sauer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set

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Page 2 - Sandra Zimniewicz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Uwe Scherf -S ""

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Fitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

LIAISON® Control Toxo IgG II

LIAISON® Toxo IgG II

510(k) Number:

K132234

Device Name:

Indications For Use:

The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for 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 FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.

The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.

Prescription Use __x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Ribhi Shawar -S

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