LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II

K131441 · DiaSorin, Inc. · LGD · Aug 9, 2013 · Microbiology

Device Facts

• Record ID: K131441
• Device Name: LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
• Applicant: DiaSorin, Inc.
• Product Code: LGD · Microbiology
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

The LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples. It is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. The LIAISON® Control Toxo IgM II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON Toxo IgM II assay on the LIAISON® XL Analyzer.

Device Story

LIAISON® Toxo IgM II is an automated antibody capture chemiluminescence immunoassay (CLIA) for qualitative detection of Toxoplasma gondii IgM antibodies in human serum. Performed on LIAISON® XL Analyzer; system handles all incubation and wash steps. Input: human serum sample. Process: IgM antibodies bind to magnetic particles coated with mouse monoclonal anti-human IgM; mouse monoclonal anti-Toxoplasma gondii antibody conjugated to isoluminol derivative binds to captured antigen. Flash chemiluminescence induced by starter reagents; light signal (RLU) measured by photomultiplier. Output: qualitative result (AU/mL) indicating presence of IgM. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing acute/recent infection when used alongside IgG testing. Benefits: automated processing reduces manual labor and assay time compared to traditional EIA methods.

Clinical Evidence

Clinical performance evaluated via prospective study (804 samples, including 201 pregnant women) and retrospective study (33 positive samples). Comparison against predicate showed high agreement. CDC panel study (100 samples) demonstrated 100% agreement with true positive/negative status. Analytical specificity confirmed via cross-reactivity testing (115 samples) and DTT treatment. No interference observed for common endogenous substances.

Technological Characteristics

Chemiluminescent immunoassay (CLIA). Components: magnetic particles coated with mouse monoclonal anti-human IgM; isoluminol-antibody conjugate. Analyte: T. gondii IgM. Measurement: photomultiplier (flash chemiluminescence). Form factor: automated kit for LIAISON® XL Analyzer. Storage: 2-8°C. Connectivity: integrated with LIAISON® XL system. Software: automated assay control and data processing.

Indications for Use

Indicated for qualitative determination of IgM antibodies to Toxoplasma gondii in human serum as an aid in presumptive diagnosis of acute or recent infection, including in pregnant women. 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

• Diamedix Is-Toxoplasma IgM Capture Test System (K001707)

Submission Summary (Full Text)

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K131441

# 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

## SUBMITTED BY:

Sandra Zimniewicz Regulatory/Clinical Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone [phone] Fax [phone] Email: [e-mail]

AUG 09 2013

NAME OF DEVICE:

Trade Name:

| | LIAISON® Control Toxo IgM II |
|----------------------------|--------------------------------------------------------------------------------------|
| Common Names/Descriptions: | Toxoplasma IgM Assay and Toxo IgM Controls |
| Classification Names: | Toxoplasma gondii Serological Reagent: Class II , 21 CFR 866.3780; Microbiology (83) |
| Product Code: | LGD |
| PREDICATE DEVICE: | Diamedix Is-Toxoplasma IgM Capture Test System (K001707) |

LIAISON® Toxo IgM II

# DEVICE DESCRIPTION:

# INTENDED USE:

The LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples. It is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening.

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

### KIT DESCRIPTION:

The method for qualitative determination of specific IgM to Toxoplasma gondii is an antibody capture chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with IgG (mouse, monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgM, Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody coniugate).

During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen and the immune complex thus formed reacts with IgM already bound to the solid phase. After the incubations, 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 Toxoplasma gondii IgM concentration present in calibrators, samples or controls.

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

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# COMPARISON TO PREDICATE DEVICE:

| Table 1: Table of Similarities | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | New Device<br>DiaSorin LIAISON® Toxo IgM II | Predicate Device<br>Diamedix Is-Toxoplasma IgM<br>Capture Test Kit (K001707) |
| Intended Use | The LIAISON® Toxo IgM II assay<br>uses chemiluminescent<br>immunoassay (CLIA) technology<br>on the LIAISON® Analyzer for the<br>qualitative determination of IgM<br>antibodies to Toxoplasma gondii in<br>human serum specimens. It is<br>intended for use as an aid in the<br>presumptive diagnosis of acute or<br>recent Toxoplasma gondii infection,<br>including pregnant women. It is<br>recommended that the LIAISON®<br>Toxo IgM II assay be performed in<br>conjunction with a Toxoplasma<br>gondii IgG assay.<br>This product has not been<br>cleared/approved by the FDA for<br>blood/plasma donor screening. | The Diamedix Is-Toxoplasma IgM<br>Capture Test Kit is a capture<br>enzyme immunoassay (EIA) for the<br>presumptive qualitative detection of<br>IgM antibodies to Toxoplasma<br>gondii in human serum by capture<br>enzyme immunoassay. When<br>performed in conjunction with an<br>anti-Toxoplasma gondii IgG assay,<br>the Is-Toxoplasma IgM Capture<br>assay can be used as an aid in the<br>presumptive diagnosis of acute,<br>recent or reactivated Toxoplasma<br>gondii infection. Performance has<br>not been established in newborns.<br>This product has not been<br>cleared/approved by the FDA for<br>blood/plasma donor screening. |
| Measured Analyte | IgM antibodies to Toxoplasma<br>gondii | IgM antibodies to Toxoplasma<br>gondii |
| Reagent Storage | On-board or in refrigerator @ 2-8°C | In refrigerator @ 2-8°C |
| Calibrators | Included with kit | Included with kit |
| Controls | 2 levels (negative and positive) | 2 levels (negative and positive) |
| Sample matrix | Human Serum | Human Serum |
| Antigen | Toxoplasma gondii, RH strain | Toxoplasma gondii, RH strain |
| Capture Antibody | Mouse monoclonal anti-human IgM | Mouse monoclonal anti-human<br>IgM |
| Table 2 : Table of Differences | | |
| Characteristic | New Device<br>DiaSorin LIAISON® Toxo IgM II | Predicate Device<br>Diamedix Is-Toxoplasma IgM<br>Capture Test Kit (K001707) |
| Assay Type | Chemiluminescent Immunoassay | Enzyme Immunoassay |
| Calibration | Two point verification of stored<br>master curve | Single point Cut-Off Calibrator |
| Unit of Measure | AU/mL | Index Value |
| Cut-Off | 10.0 AU/mL | 1.10 Index Value |
| Equivocal Zone | 8.0 - 9.9 AU/mL | 0.90 - 1.09 Index Value |
| Sample size | 20 μL | 2 μL |
| Sample Handling/<br>Processing | Automated | Manual or Automated |
| Assay Time | 40 minutes | 140 minutes |
| Controls | Provided Separately | Included with kit |
| Capture Reagent | Magnetic particles coated with IgG<br>to human IgM (mouse<br>monoclonal) | Microwells coated with mouse<br>monoclonal anti-human IgM (heavy<br>chain) |
| Conjugate | Mouse monoclonal antibodies to<br>Toxoplasma gondii conjugated to<br>an isoluminol derivative | Mouse monoclonal anti-Toxoplasma<br>gondii conjugated to horseradish<br>peroxidase |
| Measurement<br>System | Photomultiplier (flash<br>chemiluminescence reader) | Spectrophotometer (EIA microtiter<br>plate reader) |

.

1999 - 1999 - 1999

.

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### PERFORMANCE DATA:

### COMPARATIVE CLINICAL STUDIES:

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

### A. Prospective:

The prospective populations consist of non-selected subjects sent to the laboratory for Toxoplasma gondii IgM 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 vears. 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.

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The prospective population of pregnant women consists of 201 females with ages ranging from 14 years to 44 years. There were 70 samples from subjects in the 1st trimester, 50 samples form subjects in the second trimester and 81 samples from subjects in the 3rd trimester of pregnancy.

#### Prospective US Population Comparison

| | | Percent Agreement | Exact 95% Confidence Interval |
|----------|---------|-------------------|-------------------------------|
| Negative | 203/203 | 100.0% | 98.2 - 100.0% |
| Positive | 0/1 | NA | 1.3 - 84.2% |

#### Prospective European Population Comparison

| | | Percent Agreement | Exact 95% Confidence Interval |
|----------|---------|-------------------|-------------------------------|
| Negative | 499/506 | 98.9 % | 97.1 - 99.4% |
| Positive | 93/94 | 98.9 % | 94.3 - 99.7% |

#### Pregnant Women Population Comparison

| | | Percent Agreement | Exact 95% Confidence Interval |
|----------|---------|-------------------|-------------------------------|
| Negative | 194/197 | 98.5 % | 94.1 - 99.1% |
| Positive | 1/4 | 25.0 % | 4.6 - 70.0% |

# B. Retrospective/PreSelected Population:

The retrospective population was defined as pre-selected samples from individuals who had a positive Toxoplasma gondii IgM result by the comparator assay. Thirty three (33) samples were included in this study. The 33 individuals from the retrospective population were 93.9% Females (n=31) and 6.1% Males (n=2) ranging in age from 15 to 47 vears.

#### Retrospective Population Comparison

| | | Percent Agreement | Exact 95% Confidence Interval |
|----------|-------|-------------------|-------------------------------|
| Positive | 33/33 | 100.0 % | 89.7 - 99.9% |

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

# C. CDC Panel Study:

The CDC Toxoplasma 1998 Human Serum Panel is comprised of 100 frozen blind specimens (32 Toxoplasma IgM true positive samples and 65 Toxoplasma IgM true negative samples and 3 dilutions of 3 true Toxoplasma IgM positive samples). The panel was tested by LIAISON® Toxo IqM II assay at site #3.

The results were submitted to the CDC (Reference Immunodiagnostic Lab, Biology and Diagnostic Branch Division of Parasitic Diseases) for data analysis. As communicated

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by the CDC, the LIAISON® Toxo IgM II assay correctly detected the 32 Toxoplasma IgM true positive samples (100% agreement) and the 65 Toxoplasma IgM true negative samples (100% agreement).

#### D. Prevalence:

The observed prevalence of the LIAISON® Toxo IgM II assay was calculated for the prospective populations consisting of the 804 samples from patients sent to the lab for Toxoplasma gondii testing and 201 pregnant women.

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 IgM II assay for the US population is 0%, the European population had a prevalence of 16.7% and pregnant women a prevalence of 1.5%.

#### PRECISION:

Precision was assessed by measuring repeatability at one site using two kit controls and seven serum samples prepared to span the measuring range of the assay. Mean, standard deviation, and coefficient of variation (%CV) were calculated using multiple sources of variability that include within-run, within-day, between-day, and total variability. The following results were obtained from one site with one kit lot assayed in duplicate in two assays per day over 20 operating days.

| | Sample | Mean | Within-Run | | Within-Day | | Between-Day | | Total | |
|-------------------|--------|-------|------------|-------|------------|-------|-------------|--------|--------|--------|
| Sample ID | N | AU/mL | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Negative Control* | 80 | <3.0* | 23.92* | 3.7%* | 9.78* | 1.5%* | 17.06* | 2.6%* | 30.96* | 4.8%* |
| Positive Control | 80 | 18.4 | 0.46 | 2.50% | 0.46 | 2.50% | 1.4 | 7.60% | 1.54 | 8.40% |
| Toxo IgM-A* | 80 | <3.0* | 28.18* | 3.2%* | 15.26* | 1.7%* | 36.26* | 4.1%* | 48.39* | 5.5%* |
| Toxo IgM-B | 80 | 4.9 | 0.1 | 2.10% | 0.1 | 2.00% | 0.21 | 4.30% | 0.25 | 5.20% |
| Toxo IgM-C | 80 | 15.9 | 0.53 | 3.30% | 0.4 | 2.50% | 1.07 | 6.80% | 1.26 | 8.00% |
| Toxo IgM-D | 80 | 36.1 | 1.13 | 3.10% | 1.03 | 2.80% | 3.66 | 10.10% | 3.97 | 11.00% |
| Toxo IgM-E | 80 | 54.6 | 1.48 | 2.70% | 1.27 | 2.30% | 5.53 | 10.10% | 5.86 | 10.70% |
| Toxo IgM-F | 80 | 86.8 | 2.16 | 2.50% | 2.16 | 2.50% | 8.21 | 9.40% | 8.75 | 10.10% |
| Toxo IgM-G | 80 | 121 | 4.27 | 3.50% | 2.38 | 2.00% | 11.55 | 9.50% | 12.54 | 10.40% |

*Dose and corresponding AUs were below the reading range of the assay.

#### REPRODUCIBILITY

Reproducibility was assessed across all three testing sites using two kit controls and 7 serum samples prepared to span the measuring range of the assay. Mean, standard deviation, and coefficient of variation (%CV) were calculated using multiple sources of variability that include within-run, within-day, site to site to site and total variability. The following results were obtained from three sites with two kit lots assayed in duplicate in two assays per day over 20 operating days.

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| | Sample | Mean | Within-Run | | Within-Day | | Between-Day | | Site to Site | | Total | |
|----------------------|--------|-------|------------|-------|------------|-------|-------------|--------|--------------|-------|---------|--------|
| Sample ID | N | AU/mL | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Negative<br>Control* | 480 | <3.0* | 55.66* | 8.1%* | 34.30* | 5.0%* | 48.37* | 7.1%* | 33.92* | 5.0%* | 93.67* | 13.7% |
| Positive<br>Control | 480 | 18.1 | 0.76 | 4.20% | 0.34 | 1.90% | 1.62 | 9.00% | 0.61 | 3.40% | 1.89 | 10.50% |
| Toxo IgM-A* | 480 | <3.0* | 38.12* | 4.0%* | 27.82* | 2.9%* | 58.87* | 6.2%* | 50.16* | 5.3%* | 105.01* | 11.0% |
| Toxo IgM-B | 480 | 4.7 | 0.14 | 3.00% | 0.1 | 2.10% | 0.36 | 7.50% | 0.14 | 2.90% | 0.42 | 9.00% |
| Toxo IgM-C | 480 | 15.6 | 0.52 | 3.40% | 0.35 | 2.30% | 1.31 | 8.40% | 0.55 | 3.60% | 1.53 | 9.90% |
| Toxo IgM-D | 480 | 34.2 | 1.39 | 4.10% | 0.89 | 2.60% | 3.43 | 10.00% | 2.33 | 6.80% | 4.41 | 12.90% |
| Toxo IgM-E | 480 | 52.5 | 2.22 | 4.20% | 1.73 | 3.30% | 5.65 | 10.80% | 3.46 | 6.60% | 7.08 | 13.50% |
| Toxo IgM-F | 480 | 84.6 | 3.51 | 4.10% | 2.28 | 2.70% | 8.05 | 9.50% | 4.52 | 5.30% | 10.04 | 11.90% |
| Toxo IgM-G | 480 | 114.9 | 4.74 | 4.10% | 3.64 | 3.20% | 12.41 | 10.80% | 6.47 | 5.60% | 15.13 | 13.20% |

*Dose and corresponding AUs were below the reading range of the assay.

# CONCLUSION

The results from the nonclinical and clinical studies submitted in this premarket notification demonstrate that the LIAISON® Toxo IgM II is substantially equivalent to the predicate device.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DiaSorin Inc. C/O Sandra Zimniewicz 1951 Northwestern Avenue Stillwater, MN 55082

August 9, 2013

Re: K131441

Trade/Device Name: LIAISON® Toxo IgM II, LIAISON® Control Toxo IgM II Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii, Serological Reagent Regulatory Class: Class II Product Code: LGD Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Zimniewicz:

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 practice 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/Saletv/ReportalProblem/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.

# Stephen J. Lovell -S for

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

Enclosure

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# Indications for Use

510(k) Number (if known): K131441

LIAISON® Toxo IgM II Device Name: LIAISON® Control Toxo IgM II

DiaSorin LIAISON Toxo IgM II assay uses Indications for Use: The chemiluminescent immunoassay (CLIA) technology on the LIAISON XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON Toxo IgM II is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma qondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening.

> The DiaSorin LIAISON® Control Toxo IgM II is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® Toxo IgM II assay on the LIAISON® XL Analyzer.

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ribhi Shawar -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_K131441