PLATELIA ASPERGILLUS EIA MODEL 62793

K093678 · Bio-Rad · NOM · Jan 13, 2011 · Microbiology

Device Facts

• Record ID: K093678
• Device Name: PLATELIA ASPERGILLUS EIA MODEL 62793
• Applicant: Bio-Rad
• Product Code: NOM · Microbiology
• Decision Date: Jan 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3040
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The Platelia™ Aspergillus ElA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar Lavage (BAL) fluid samples. The Platelia™ Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

Device Story

Platelia™ Aspergillus EIA is a one-stage immunoenzymatic sandwich microplate assay; detects galactomannan antigen in human serum and BAL fluid. Samples undergo heat treatment with EDTA to dissociate immune complexes and precipitate interfering proteins. Assay utilizes rat EBA-2 monoclonal antibodies; one set coats microplate wells to bind antigen; second set is peroxidase-linked for detection. Following incubation, unbound material is washed away; substrate solution added to form blue color; reaction stopped with acid, turning color yellow. Absorbance measured via spectrophotometer at 450 and 620/630 nm. Used in clinical laboratories by trained personnel. Output is optical density/index value; aids clinicians in diagnosing Invasive Aspergillosis when combined with other diagnostic evidence. Benefits include improved diagnostic capability for invasive fungal infection in high-risk patients.

Clinical Evidence

Clinical studies evaluated sensitivity and specificity in pediatric and adult populations. Serum: 1954 pediatric samples (17 proven/probable IA) and 1724 adult samples (29 proven/probable IA). BAL fluid: 449 samples from SOT/lung transplant recipients and 99 samples from high-risk hematology patients. Sensitivity for serum: 52.9% (pediatric), 79.3% (adult). Sensitivity for BAL: 100% (SOT), 66.7% (lung transplant), 98.3% (hematology). Specificity for serum: 98.5% (pediatric), 98.5% (adult). Specificity for BAL: 94.3% (SOT/lung), 80.5% (hematology). Reproducibility studies performed per CLSI guidelines.

Technological Characteristics

Immunoenzymatic sandwich microplate assay. Components: 96-well antibody-coated microplate, rat EBA-2 monoclonal antibodies, peroxidase-linked conjugate, TMB chromogen, stop solution. Sensing principle: spectrophotometric absorbance at 450/620-630 nm. Incubation: 37°C for 90 minutes. Sample preparation: heat treatment with EDTA. Connectivity: standalone. Software: none (manual/instrument-based optical density calculation).

Indications for Use

Indicated for detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar Lavage (BAL) fluid samples as an aid in the diagnosis of Invasive Aspergillosis, used in conjunction with other diagnostic procedures (culture, histology, radiography).

Regulatory Classification

Identification

Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies to Aspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the genus Aspergillus. Aspergillosis is a disease marked by inflammatory granulomatous (tumor-like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.

Predicate Devices

• Platelia™ Aspergillus EIA (K060641)

Submission Summary (Full Text)

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510k Summary K093678

# SECTION 2

# 510(k) SUMMARY

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510k Summary K093678

#### 510(k) SUMMARY:

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

| The assigned 510(k) number is: | |
|--------------------------------|---------------------|
| DATE: | November 20th, 2009 |

| APPLICANT: | Bio-Rad<br>3, Boulevard Raymond Poincar<br>92430 Marnes-la-Coquette, France |
|-------------------------|-----------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT: | Dr. Sylvie Confida |

| TELEPHONE: | 33-1-47-95-6138 |
|----------------------|------------------------------------------------|
| FAX: | 33-1-47-95-6242 |
| PRODUCT TRADE NAME: | Bio-Rad Laboratories Platelia™ Aspergillus EIA |
| COMMON NAME: | Aspergillus Antigen EIA |
| CLASSIFICATION NAME: | Antigen, Galactomannan, Aspergillus spp. |
| PREDICATE DEVICE: | Platelia™ Aspergillus EIA |

#### DEVICE DESCRIPTION

The Platelia™ Aspergillus EIA is a one-stage immunoenzymatic sandwich microplate assay which detects galactomannan in human serum and BAL fluid samples. The assay uses rat EBA-2 monoclonal antibodies, which are directed against Aspergillus galactomannan, and have been characterized in previous studies. The monoclonal antibodies are used, (1) to coat the wells of the microplate and bind the antigen, and (2) to detect the antigen bound to the sensitized microplate reagent: peroxidaselinked monoclonal antibodies).

Serum or BAL fluid samples are heat-treated in the presence of EDTA in order to dissociate immune complexes and to precipitate proteins that could possibly interfere with the test. The treated samples and conjugate are added to the wells coated with monoclonal antibodies, and incubated. A monoclonal antibody - galactomannan monoclonal antibody / peroxidase complex is formed in the presence of galactomannan antigen.

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The strips are washed to remove any unbound material. Next, the substrate solution is added, which will react with the complexes bound to the well to form a blue color reaction. The enzyme reaction is stopped by the addition of acid, which changes the blue color to yellow. The absorbance (optical density) of specimens and controls is determined with a spectrophotometer set at 450 and 620/630 nm wavelength.

## INTENDED USE

The Platelia™ Aspergillus ElA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar Lavage (BAL) fluid samples.

The Platelia™ Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

## INDICATIONS FOR USE

The Platelia™ Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar Lavage (BAL) fluid samples.

The Platelia™ Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

# TECHNOLOGICAL CHARACTERISTICS

The following tables summarize similarities and differences between the Platelia™ Aspergillus EIA (62793) and the current Platelia™ Aspergillus EIA (k060641):

## Table 1(a) Similarities between intended use

| Similarities in<br>Function and Use | Platelia™ Aspergillus EIA,<br>Catalog 62793 | Platelia™ Aspergillus EIA<br>current (k060641) |
|-------------------------------------|---------------------------------------------|------------------------------------------------|
| Intended Use | Galactomannan antigen<br>detection. | Galactomannan antigen<br>detection. |

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| Differences in<br>Function and Use | Platelia™ Aspergillus EIA,<br>Catalog 62793 | Platelia™ Aspergillus EIA<br>(k060641) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use | Detection of Aspergillus<br>galactomannan antigen in<br>adult and pediatric serum and<br>Bronchoalveolar Lavage<br>(BAL) Fluid samples. | Detection of Aspergillus<br>galactomannan antigen in adult<br>and pediatric serum samples. |
| Matrix | Serum and Bronchoalveolar<br>Lavage (BAL) Fluid samples | Serum |
| Intended Use<br>/Indications for Use | Both the Intended Use and<br>Indications for Use are same. | The Intended Use and<br>Indications for Use are<br>different. |

# Table 1(b) Differences between intended use

## Table 2 Similarities between reagents and materials

| Similarities in<br>Components /<br>Materials | Platelia™ Aspergillus EIA,<br>Catalog 62793 | Platelia™ Aspergillus EIA<br>(k060641) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Microplate | 96 well microplate -<br>antibody coated microwells | 96 well microplate - antibody<br>coated microwells |
| Reagents | Conjugate, Wash Buffer,<br>Substrate, TMB Chromogen,<br>Sample Diluent, Positive<br>Control, Stop Solution. | Conjugate, Wash Buffer,<br>Substrate, TMB Chromogen,<br>Sample Diluent, Positive<br>Control, Stop Solution. |

# Table 3 Similarities between assay procedures.

| Similarities in<br>Assay Procedures | Platelia™ Aspergillus EIA<br>Catalog 62793 | Platelia™ Aspergillus EIA<br>(k060641) |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------|
| Incubation<br>temperature of the<br>microplate after<br>addition of the<br>conjugate and the<br>treated sera. | Incubation temperature: 37°C | Incubation temperature: 37°C |
| Incubation time of<br>the microplate after<br>addition of the<br>conjugate and the<br>treated sera. | Incubation time: 90 ± 5<br>minutes | Incubation time: 90 ± 5<br>minutes |

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| Differences in<br>Limitations of the<br>Procedure (Section<br>13) | Platelia™ Aspergillus EIA,<br>Catalog 62793 | Platelia™ Aspergillus EIA<br>(k060641) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Limitation: Point 11 | Addition of Histoplasma and<br>Geotrichum to the list of<br>fungi causing cross-reactivity | |
| Limitation: Point 12 | Addition of a limitation that<br>cross-reactivity of BAL fluid<br>with Mycoplasma and<br>anaesthetic drugs used to<br>numb the neck/throat area<br>has not been evaluated. | |
| Limitation: Point 13 | Addition of limitation<br>regarding positive reactions<br>observed in patients<br>receiving products<br>containing sodium gluconate,<br>galactofuranose or<br>galactomannan. | |
| Limitation: Point 14 | Addition of limitation<br>regarding positive reactions<br>observed in patients<br>receiving PLASMA-<br>LYTE™ solution. | |
| Limitation: Point 15 | Addition of limitation about<br>assay results in BAL fluid<br>samples from<br>immunocompromised<br>patients to be interpreted<br>with caution. | |

# Table 4 Differences between Limitations of the Procedure

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| Limitation: Point 16 | Results of the Platelia™ | |
|----------------------|-------------------------------|--|
| | Aspergillus EIA in | |
| | Bronchoalveolar Lavage | |
| | (BAL) fluid samples between | |
| | 0.5-1.0 index have a lower | |
| | predictive value than BAL | |
| | sample results > 1.0 index | |
| | values, therefore the results | |
| | between 0.5-1.0 index values | |
| | should be reviewed and | |
| | supported by other clinical, | |
| | radiological or laboratory | |
| | evidence of invasive | |
| | aspergillosis8, 17 | |

## PERFORMANCE EVALUATION SUMMARY

## A. EXPECTED VALUES

## I. SERUM

The expected prevalence of Invasive Aspergillosis varies with the patient population: rates from 5-20% have been reported.

The following results have been obtained from clinical studies conducted on pediatric (age < 21 years) patients in the United States and on adult patients in North America.

## A.-Pediatrics

A clinical study was conducted on a total of 1954 serum samples from 129 immunocompromised pediatric (Age ≤ 21 years) patients, at high risk for Invasive Aspergillosis (IA) and patients diagnosed with Proven and Probable Invasive Aspergillosis, at three testing centers in the United States to determine the performance characteristics of the Platelia™ Aspergillus EIA. The distribution of index for these populations is shown in the following charts:

## Pediatric Patients diagnosed without Invasive Aspergillosis (control population)

A total of 1625* pediatric serum samples obtained from 108 immunocompromised pediatric patients at three testing centers in the United States were tested to determine the performance characteristics of the Platelia™ Aspergillus EIA. The distribution of index values for samples is shown in the following chart:

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Image /page/6/Figure/2 description: The image shows the words "Figure I" in a bold, serif font. The word "Figure" is capitalized, and the Roman numeral "I" is also capitalized. The text is black against a white background. The image appears to be a label or title for a figure or diagram.

Image /page/6/Figure/3 description: The image is a bar graph titled "Distribution of the Serum Index Value from the Pediatric Control Population (N=1625)". The x-axis is labeled "Index" and shows values from 0-0.1 to >1.5. The y-axis is labeled "Number of Sera" and ranges from 0 to 900. The bar graph shows that the highest number of sera is in the 0.2-0.3 range, with a value of 805.

*Note: 80 samples, from 4 control patients with positive galactomannan antigen results coinciding with piperacillin/tazobactam (Zosyn®) therapy were excluded.

## Pediatric Patients diagnosed with Invasive Aspergillosis

The scatter plot depicts galactomannan assay results for the 249 serum samples from 17 patients in this study diagnosed with proven or probable Invasive Aspergillosis as defined by EORTC/NIAID definitions. Not every serum sample from each patient is expected to be positive. The expected prevalence of Invasive Aspergillosis varies with the patient population; rates from 5-20% have been reported 10.23. The prevalence rate of this study was 13.6%.

## Figure 2

Image /page/6/Figure/8 description: The image is a scatter plot titled "Pediatric Proven/ Probable Aspergillosis: Distribution of Index/ Pediatric Patient (N=17)". The x-axis is labeled "Patient Number" and ranges from 0 to 18. The y-axis is labeled "Index" and ranges from 0.0 to >2.0. The scatter plot shows the distribution of index values for each patient, with a horizontal line at 0.5.

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#### B. Adults

A clinical study was conducted on a total of 1724 serum samples from 172 bone marrow transplant (BMT) and leukemic patients diagnosed with and without Invasive Aspergillosis, at three testing centers in North America to determine the performance characteristics of the Platelia™ Aspergillus EIA. The distribution of index values for these populations is represented in the following charts.

#### Adult Patients diagnosed without Invasive Aspergillosis (control population)

A total of 1262 serum samples obtained from 143 bone marrow transplant (BMT) and leukemic patients at three testing centers in North America were tested with the Platelia™ Aspergillus EIA test. The distribution of index values is shown in the following chart:

Image /page/7/Figure/6 description: The image shows the text "Figure 3" in a bold, serif font. The text is black against a white background. The number 3 is slightly smaller than the word "Figure".

Image /page/7/Figure/7 description: The image is a bar graph titled "Distribution of the Serum Index Value from the Adult Control Population (N=1262)". The x-axis is labeled "Index" and shows index ranges from 0-0.1 to >1.5. The y-axis is labeled "Number of Sera" and ranges from 0 to 800. The bar graph shows the number of sera for each index range, with the highest number of sera in the 0.2-0.3 range (662).

## Adult Patients diagnosed with Invasive Aspergillosis

This scatter plot depicts galactomannan assay results for the 462 serum samples from 29 patients in this study diagnosed with proven or probable Invasive Aspergillosis as defined by EORTC/NIAID definitions. Not every serum sample from each patient is expected to be positive. The expected prevalence of Invasive Aspergillosis varies with the patient population; rates from 5-20% have been reported 10,23. The prevalence rate for this study was 16.9%.

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Image /page/8/Figure/2 description: The image shows the words "Figure 4" in a serif font. The words are in bold and are black. There is a period after the number 4.

Image /page/8/Figure/3 description: The image is a scatter plot titled "Adult Proven/Probable Aspergillosis: Distribution of Index/Adult Patient (N=29)". The x-axis is labeled "Patient Number" and ranges from 0 to 30. The y-axis is labeled "Index" and ranges from 0.0 to greater than or equal to 2.0. The scatter plot shows the distribution of index values for each patient, with a horizontal line at 0.5.

The following graphs represent examples of a patient without clinical signs or symptoms óf Invasive Aspergillosis (negative for Aspergillus) and a patient with proven or probable Invasive Aspergillosis (positive for Aspergillus) respectively.

Image /page/8/Figure/5 description: This image contains the text "Figure 5 Negative patient". The text is in bold font. The figure number is at the top, and the description of the figure is below it.

Image /page/8/Figure/6 description: The image is a graph titled "CONTROL PATIENT". The x-axis is labeled "Days" and ranges from 0 to 60. The y-axis is labeled "Index" and ranges from 0 to 1.6. The graph shows a line with diamond markers that fluctuates between 0 and 0.3, with a few peaks around 0.2, and a horizontal line at 0.5.

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## Figure 6 Positive patient

Image /page/9/Figure/3 description: This image is a line graph titled "PROVEN INVASIVE ASPERGILLOSIS PATIENT". The x-axis is labeled "Days" and ranges from 0 to 60. The y-axis is labeled "Index" and ranges from 0 to 1.6. The line on the graph starts at approximately 0.2, rises sharply around day 25, peaks around day 30 at approximately 1.5, and then gradually declines to around 0.4 by day 55.

## II. BAL FLUID

Two studies were conducted on a total of 449 BAL samples from 178 Solid Organ transplant (SOT) and lung transplant recipients with and without invasive aspergillosis in the United States to determine the performance characteristics of the Platelia™ Aspergillus EIA kit with Bronchoalveolar Lavage Fluid samples.

Of these, there were 403 BAL samples from 167 solid organ and lung transplant recipients without invasive aspergillosis.

In addition, a retrospective analysis was performed on BAL samples from 99 evaluable high risk haematology patients in a study outside the United States which included 58 patients with proven or probable invasive aspergillosis.

Expected values in BAL samples from the combined SOT and lung transplant recipients without Invasive Aspergillosis are presented in the table below. Results are presented by samples from transplant recipients with and without mold colonization.

#### Table 1

Expected Values by Sample Combined SOT and Lung Transplant Recipients without Invasive Aspergillosis N =403 BAL Fluids

| Diagnosis | N | Positive (%) | Negative (%) |
|----------------------------------|-----|------------------|----------------|
| Controls without<br>colonization | 341 | 11/341(3.2%) | 330/341(96.8%) |
| Controls with colonization | 62 | 12/62<br>(19.4%) | 50/62 (80.6%) |
| Control Total | 403 | 23/403(5.7%) | 380/403(94.3%) |

Expected values in BAL samples from the combined SOT and lung transplant recipients without Invasive Aspergillosis are presented by transplant type in the table below.

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#### Table 2

#### Expected Values by Sample Combined SOT and Lung Transplant Recipients without Invasive Aspergillosis By Transplant Type N =403 RAL Fluids

| N - 403 BAL Fluids | | | |
|--------------------|-----|------------------|--------------------|
| Transplant Type | N | Positive (%) | Negative (%) |
| Heart | 28 | 3/28 (10.7%) | 25/28 (89.3%) |
| Kidney | 25 | 3/25 (12.0%) | 22/25 (88.0%) |
| Liver | 23 | 1/23 (4.3%) | 22/23 (95.7%) |
| Lung | 327 | 16/327 (4.9%) | 311/327<br>(95.1%) |
| Control Total | 403 | 23/403<br>(5.7%) | 380/403<br>(94.3%) |

Expected values were also evaluated in a total of 41 BAL fluid samples from 41 hematological disease patients without Invasive Aspergillosis and are presented in the Table below

#### Table 3

## Expected Values by Sample Hematologic disease patients without Invasive Aspergillosis N =41 BAL Fluids

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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Controls | | 8/41 (19.5%) | 33/41 (80.5%) |

#### B. REPRODUCIBILITY STUDIES

#### a) Reproducibility Studies In Serum

Inter-assay and Intra-assay variability for the Platelia™ Aspergillus EIA were determined in a study using a panel of 6 pooled patient serum samples (one negative, one low positive, two positive, and two high positive) obtained at three clinical trial sites in North America. Each of the 6 panel members were tested in triplicate (x3) on 3 different days, on one lot, at two sites (total number of replicates at each site = 9). Each of the 6 panel members was tested in duplicate (x2) on 3 different days, on 1 lot, at a third site (total number of replicates at the third site = 6). One (1) operator performed all precision testing at each site. The data were analyzed according to the Clinical Laboratory Standards Institute (CLSI) (formerly National Committee for Clinical Laboratory Standards (NCCLS)). The mean optical density (OD) and mean index value, standard deviation (SD), percent coefficient of variation (%CV), within run precision (intraassay) and within site (inter-assay) precision for each panel member at each site are illustrated below in the following tables.

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#### Table 4

| C: | |
|----|--|
| 1 | |

| Site 1 | Panel Member | Neg | | Low Pos | | Pos #1 | | Pos #2 | | High Pos#1 | | High Pos #2 | | Neg Control | | CO Control | | Pos Control | |
|--------|---------------------------------|-------|-------|---------|-------|--------|-------|--------|-------|------------|-------|-------------|-------|-------------|-------|------------|-------|-------------|-------|
| | | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index |
| | N | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 3 | 3 | 6 | 6 | 3 | 3 |
| | Mean | 0.052 | 0.09 | 0.445 | 0.74 | 0.702 | 1.17 | 0.931 | 1.563 | 1.227 | 2.06 | 2.887 | 4.83 | 0.046 | 0.08 | 0.606 | 1.00 | 2.216 | 3.67 |
| | Within Run<br>(intra-assay)1 SD | 0.002 | 0.00 | 0.022 | 0.03 | 0.059 | 0.09 | 0.044 | 0.08 | 0.051 | 0.09 | 0.089 | 0.17 | N/A | N/A | 0.02 | 0.03 | N/A | N/A |
| | %CV | N/A | N/A | 4.8% | 4.4% | 8.4% | 7.6% | 4.7% | 5.1% | 4.2% | 4.4% | 3.1% | 3.6% | N/A | N/A | 3.7% | 3.4% | N/A | N/A |
| | Total<br>(inter-assay)2 SD | 0.036 | 0.04 | 0.051 | 0.08 | 0.070 | 0.14 | 0.044 | 0.25 | 0.058 | 0.29 | 0.169 | 0.58 | N/A | N/A | 0.102 | 0.03 | 0.317 | 0.12 |
| | %CV | N/A | N/A | 11.5% | 10.4% | 10.0% | 11.6% | 4.7% | 15.7% | 4.7% | 14.3% | 5.9% | 11.9% | N/A | N/A | 16.9% | 2.8% | 14.3% | 3.3% |
| Site 2 | Panel Member | Neg | | Low Pos | | Pos #1 | | Pos #2 | | High Pos#1 | | High Pos #2 | | Neg Control | | CO Control | | Pos Control | |
| | | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index |
| | N | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 3 | 3 | 6 | 6 | 3 | 3 |
| | Mean | 0.040 | 0.10 | 0.280 | 0.70 | 0.364 | 0.89 | 0.602 | 1.49 | 0.801 | 2.01 | 1.381 | 3.43 | 0.074 | 0.18 | 0.415 | 1.00 | 1.197 | 2.97 |
| | Within Run<br>(intra-assay)1 SD | 0.006 | 0.01 | 0.041 | 0.09 | 0.023 | 0.07 | 0.045 | 0.11 | 0.046 | 0.10 | 0.047 | 0.11 | N/A | N/A | 0.00 | 0.01 | N/A | N/A |
| | %CV | N/A | N/A | 14.5% | 13.0% | 6.4% | 7.6% | 7.5% | 7.1% | 5.7% | 4.8% | 3.5% | 3.2% | N/A | N/A | 1.1% | 1.1% | N/A | N/A |
| | Total<br>(inter-assay)2 SD | 0.006 | 0.03 | 0.058 | 0.19 | 0.083 | 0.18 | 0.057 | 0.28 | 0.042 | 0.53 | 0.079 | 1.00 | N/A | N/A | 0.094 | 0.01 | 0.068 | 0.54 |
| | %CV | N/A | N/A | 20.8% | 27.0% | 22.7% | 19.8% | 9.5% | 18.7% | 5.3% | 26.5% | 5.8% | 29.2% | N/A | N/A | 22.7% | 0.9% | 5.7% | 18.2% |
| Site 3 | Panel Member | Neg | | Low Pos | | Pos #1 | | Pos #2 | | High Pos#1 | | High Pos #2 | | Neg Control | | CO Control | | Pos Control | |
| | | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index |
| | N | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 3 | 3 | 6 | 6 | 3 | 3 |
| | Mean | 0.049 | 0.10 | 0.388 | 0.81 | 0.652 | 1.36 | 0.830 | 1.73 | 1.158 | 2.41 | 2.378 | 4.96 | 0.059 | 0.12 | 0.480 | 1.00 | 1.652 | 3.45 |
| | Within Run<br>(intra-assay)1 SD | 0.003 | 0.01 | 0.009 | 0.02 | 0.082 | 0.17 | 0.068 | 0.14 | 0.094 | 0.20 | 0.126 | 0.25 | N/A | N/A | 0.028 | 0.06 | N/A | N/A |
| | %CV | N/A | N/A | 2.4% | 2.4% | 12.5% | 12.2% | 8.2% | 8.2% | 8.1% | 8.2% | 5.3% | 5.1% | N/A | N/A | 5.8% | 5.8% | N/A | N/A |
| | Total<br>(inter-assay)2 SD | 0.012 | 0.03 | 0.078 | 0.13 | 0.068 | 0.15 | 0.104 | 0.25 | 0.082 | 0.15 | 0.111 | 0.34 | N/A | N/A | 0.028 | 0.04 | 0.056 | 0.23 |
| | %CV | N/A | N/A | 20.0% | 15.8% | 10.5% | 11.1% | 12.5% | 14.3% | 7.1% | 6.2% | 4.7% | 6.8% | N/A | N/A | 5.8% | 4.1% | 3.4% | 6.6% |

N/A = not applicable

'NCCLS EP5-A, Vol. 19, No. 2, Page 24, Equation (C2) 2 NCCLS EP5-A, Vol. 19, No. 2, Page 25, Equation (C3) and Equation (C4)

## b) Reproducibillity Studies in BAL

Inter-assay and Intra-assay variability for the Platelia™ Aspergillus EIA were determined in a study using a panel of 4 pooled patient BAL samples spiked with purified galactomannan (one negative, one high negative, one low positive and one medium positive) at 3 testing sites (Two US clinical testing sites and one internal site). Each of the 4 panel members and the controls were tested in duplicate (x2) in 2 runs per day on 5 different days on one lot (Total number of replicates at each site = 120). Two (2) operators performed all precision testing at each site. The data was analyzed according to the Clinical Laboratory Standards Institute (CLSI) (formerly National Committee for Clinical Laboratory Standards (NCCLS)). The mean optical density (OD) and mean index value, standard deviation (SD), percent coefficient of variation (%CV), within run precision (intra-assay) and between site, between day, between operator and between run (inter-assay) precision for each panel member are illustrated below in the following table:

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#### Table 5

## Combined Sites Summary

| Summary | | Negative<br>N= 60 | | High Negative<br>N=60 | | Low<br>Positive<br>N=60 | | Medium<br>Positive<br>N=60 | | Positive<br>Control<br>N=60 | | Negative<br>Control<br>N=60 | |
|------------------|-----|-------------------|-------|-----------------------|-------|-------------------------|-------|----------------------------|-------|-----------------------------|-------|-----------------------------|-------|
| | | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index | OD | Index |
| Mean | | 0.121 | 0.29 | 0.214 | 0.50 | 0.375 | 0.88 | 0.575 | 1.35 | 1.580 | 3.72 | 0.047 | 0.11 |
| Within<br>Run | SD | N/A | N/A | 0.037 | 0.103 | 0.035 | 0.078 | 0.029 | 0.067 | 0.111 | 0.265 | N/A | N/A |
| (Intra<br>Assay) | %CV | N/A | N/A | 17.4% | 20.5% | 9.3% | 8.9% | 5.0% | 5.0% | 7.0% | 7.1% | N/A | N/A |
| Total | SD | N/A | N/A | 0.042 | 0.095 | 0.061 | 0.122 | 0.070 | 0.138 | 0.190 | 0.438 | N/A | N/A |
| (Inter<br>Assay) | %CV | N /A | N/A | 19.6% | 18.9% | 16.2% | 13.9% | 12.2% | 10.2% | 12.0% | 11.8% | N/A | N/A |

## C. PERFORMANCE EVALUATION STUDIES

## I. SERUM SAMPLES

Clinical testing to evaluate the sensitivity, specificity, and predictive value of the Platelia™ Aspergillus EIA was conducted on pediatric (age ≤ 21 years) patients at three sites located in the United States and on adult patients at three sites located in North America. The studies were conducted using a total of 1954 serum samples collected from 129 pediatric patients and a total of 1724 serum samples collected from 172 adult patients from the following populations*:

· patients without signs of Invasive Aspergillosis (control patients)

· patients with Probable Invasive Aspergillosis

· patients with Proven Invasive Aspergillosis

* The Invasive Fungal Infection Cooperative Group (IFICG) of the European Organization for Research and Treatment of Cancer (EORTC) and the Mycosis Study Group (MSG) of the National Institute of Allergy and Infectious Diseases (NIAID) in 2002 have defined criteria for diagnosis of Invasive Aspergillosis (IA) in patients with hematologic malignancy or hematopoetic stem cell transplant. 4

#### SENSITIVITY

#### A. Pediatrics

Results from this study have been analyzed in terms of patient sensitivity. Sensitivity testing was conducted using the Platelia™ Aspergillus EIA at three sites on a combined total of 17 immunocompromised pediatric patients diagnosed with Proven or Probable Invasive Aspergillosis.

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## Table 6

| Diagnosis | Number of<br>patients | Sensitivity | 95% Confidence<br>Interval |
|-----------------------------------------------|-----------------------|--------------|----------------------------|
| Proven Aspergillosis | 9 | 44.4% (4/9) | 18.9-73.3% |
| Probable Aspergillosis | 8 | 62.5% (5/8) | 30.6-86.3% |
| Combined Proven and<br>Probable Aspergillosis | 17* | 52.9% (9/17) | 31.0-73.8% |

*Note: 8 of the 17 patients gave negative Aspergillus galactomannan antigen results. All of the 8 patients with negative Aspergillus galactomannan antigen results received therapy with multiple antifungal agents. The concomitant use of mold-active anti-fungal therapy in some patients with Invasive Aspergillosis may result in reduced sensitivity 1.

## B. Adults

Sensitivity testing was conducted using the Platelia™ Aspergillus ElA at three sites on a combined total of 29 Bone Marrow Transplant (BMT) and Leukemia adult patients diagnosed with Proven or Probable Invasive Aspergillosis.

#### Table 7

| Diagnosis | Number of<br>patients | Sensitivity | 95% Confidence<br>Interval |
|-----------------------------------------------|-----------------------|---------------|----------------------------|
| Proven Aspergillosis | 11 | 81.8% (9/11) | 52.3-94.9% |
| Probable Aspergillosis | 18 | 77.8% (14/18) | 54.8-91.0% |
| Combined Proven and<br>Probable Aspergillosis | 29 | 79.3% (23/29) | 61.6-90.2% |

## SPECIFICITY

#### A. Pediatrics

Specificity by pediatric patients

Specificity testing was conducted using the Platelia™ Aspergillus EIA at three sites on a combined total of 108* immunocrompomised pediatric patients without signs of Invasive Aspergillosis (control patients).

#### Table 8

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| Site | Number of patients | Specificity | 95% Confidence<br>Interval |
|----------------|--------------------|----------------|----------------------------|
| 1 | 44 | 86.4 % (38/44) | 73.3-93.6% |
| 2 | 59 | 86.4 % (51/59) | 75.5-93.0% |
| 3 | 5 | 100% (5/5) | 56.6-100% |
| Combined Sites | 108 | 87.0% (94/108) | 79.4-92.1% |

*Note: 4 patients with positive galactomannan antigen results coinciding with piperacillin / tazobactam therapy were excluded.

#### Specificity by pediatric samples

Specificity testing was conducted using the Platelia™ Aspergillus EIA at three sites on a combined total of 1625* samples obtained from 108 immunocrompomised pediatric patients without signs of Invasive Aspergillosis (control patients).

| Site | Number of samples | Specificity | 95% Confidence<br>Interval |
|----------------|-------------------|-------------------|----------------------------|
| 1 | 794 | 98.9% (785/794) | 97.9-99.4% |
| 2 | 731 | 97.8% (715/731) | 96.5-98.6% |
| 3 | 100 | 100% (100/100) | 96.3-100% |
| Combined Sites | 1625 | 98.5% (1600/1625) | 97.7-99.0% |

## Table 9

*Note: 80 samples from 4 patients with positive galactomannan antigen results coinciding with piperacillin / tazobactam therapy were excluded.

#### B. Adults

Specificity by adult patients

Specificity testing was conducted using the Platelia™ Aspergillus EIA at three sites on a combined total of 143 Bone Marrow Transplant (BMT) and Leukemia adult patients without signs of Invasive Aspergillosis (control patients).

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| Site | Number of patients | Specificity | 95% Confidence<br>Interval |
|----------------|--------------------|-----------------|----------------------------|
| 1 | 28 | 78.6% (22/28) | 60.5-89.8% |
| 2 | 77 | 93.4% (71/77) | 84.0-96.4% |
| 3 | 38 | 89.5% (34/38) | 75.9-95.8% |
| Combined Sites | 143 | 88.8% (127/143) | 82.6-93.0% |

## Specificity by adult samples

Specificity testing was conducted using the Platelia™ Aspergillus EIA at three sites on a combined total of 1262 samples obtained from 143 Bone Marrow Transplant (BMT) and Leukemia adult patients without signs of Invasive Aspergillosis (control patients).

| 'able<br>1<br>I<br>T |
|----------------------|
|----------------------|

| Site | Number of samples | Specificity | 95% Confidence<br>Interval |
|----------------|-------------------|-------------------|----------------------------|
| 1 | 349 | 98.0% (342/349) | 95.9-99.0% |
| 2 | 560 | 98.6% (552/560) | 97.2-99.3% |
| 3 | 353 | 98.9% (349/353) | 97.1-99.6% |
| Combined Sites | 1262 | 98.5% (1243/1262) | 97.7-99.0% |

## PREDICTIVE VALUE

Positive and negative predictive values have been analyzed for the patient population in this study. Based on the actual average of 13.6% prevalence rate in pediatrics and 16.9% prevalence rate in adults observed in this study, positive and negative predictive values have been calculated as below:

## A. Pediatrics

| Study Prevalence 13.6% | |
|------------------------|--------------------------------------|
| PPV: 39.1% | 95% Confidence Interval : 22.2-59.2% |
| NPV: 92.2% | 95% Confidence Interval : 85.3-96.0% |

## B. Adults

| Study Prevalence 16.9% | |
|------------------------|-------------------------------------|
| PPV: 59.0% | 95% Confidence Interval:43.4-72.9% |
| NPV: 95.5% | 95% Confidence Interval: 90.5-97.9% |

The expected prevalence of Invasive Aspergillosis varies with the patient population; rates from 5-20% have been reported 19,23. For patient populations on the lower end of the

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510k Summary K093678

published prevalence, the positive and negative predictive values have been re-calculated using a 5% prevalence rate.

#### A. Pediatrics

| Calculated Prevalence 5% | |
|--------------------------|--------------------------------------|
| PPV : 17.6% | 95% Confidence Interval : 6.5-39.8% |
| NPV : 97.2% | 95% Confidence Interval : 92.1-99.1% |

# B. Adults

| Calculated Prevalence 5% | |
|--------------------------|-------------------------------------|
| PPV: 27.2% | 95% Confidence interval: 13.7-46.7% |
| NPV: 98.8% | 95% Confidence Interval: 95.4-99.7% |

## CROSS REACTIVITY

#### a) Cross Reactivity - Serum

A study to evaluate the effect of potentially interfering medical conditions unrelated to Invasive Aspergillosis was performed with one lot of the Platelia™ Aspergillus EIA kit. The following serum samples were tested for cross-reactivity with the PlateliaTM Aspergillus EIA. A total of 151 sera were tested.

#### Table 12

. . . . . .

| Pathology | # Samples Tested | # Positives |
|-------------------------------------------------------------------------|------------------|-------------|
| Rheumatoid Factor | 10 | 0 |
| ANA Positive | 10 | 0 |
| IgG Hypergammaglobulinemia | 10 | 0 |
| IgM Hypergammaglobulinemia | 10 | 0 |
| Cancer* | 11 | 0 |
| Non-Viral Cirrhosis (primary biliary;<br>alcohol induced; drug induced) | 10 | 0 |
| Multiple Transfusions | 10 | 0 |
| Multiparous Females | 10 | 0 |
| HAV | 10 | 0 |
| HCV | 10 | 0 |
| Rubella | 10 | 0 |
| CMV | 10 | 0 |
| Syphilis (RPR+) | 10 | 0 |
| Toxoplasmosis | 10 | 0 |
| Mycoplasma | 10 | 0 |

* One each of bladder, breast(2), colon, endometrial, lung, prostate, renal, and squamous(3).

II. BAL FLUID SAMPLES- Performance Characteristics

Sensitivity and specificity of the Platelia™ Aspergillus EIA with BAL fluid samples were evaluated in two studies in the United States on 116 samples from 62 solid organ transplant recipients and 333 samples from 116 lung transplant recipients and one study

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outside the United States on 99 samples from 99 high risk hematology patients with and without invasive aspergillosis.

# A. SENSITIVITY

Sensitivity was evaluated in Solid Organ Transplant and Lung Transplant recipients diagnosed with invasive aspergillosis as well as hematologic disease patients diagnosed with invasive aspergillosis according to the EORTC/MSG criteria.

I. Solid Organ Transplant recipients with Invasive Aspergillosis

Of the total of 116 samples from 62 Solid Organ Transplant recipients in one study, sensitivity was evaluated in 5 recipients diagnosed with invasive aspergillosis as shown in the table below.

#### Table 13

#### Proven or Probable Invasive Aspergillosis in Solid Organ Transplant Recipients

| Diagnosis | N | Index ≥ 0.5 | Sensitivity | 95% Confidence<br>Interval |
|--------------------------------------------------|---|-------------|-------------|----------------------------|
| Proven Aspergillosis | 2 | 2 | 2/2 (100%) | 34.2 - 100% |
| Probable<br>Aspergillosis | 3 | 3 | 3/3 (100%) | 43.8 - 100% |
| Combined Proven<br>and Probable<br>Aspergillosis | 5 | 5 | 5/5 (100%) | 56.5 - 100% |

## By Patient

#### Table 14

# Proven or Probable Invasive Aspergillosis in Solid Organ Transplant Recipients By Transplant Type

| Transplant<br>Type | N | Index ≥<br>0.5 | Sensitivity | 95%<br>Confidence<br>Interval |
|--------------------|---|----------------|-------------|-------------------------------|
| Heart | 1 | 1 | 1/1 (100%) | 20.6 - 100% |
| Kidney | 3 | 3 | 3/3 (100%) | 43.8 - 100% |
| Liver | 1 | 1 | 1/1 (100%) | 20.6 - 100% |
| Total | 5 | 5 | 5/5 (100%) | 56.5 - 100% |

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II. Lung Transplant recipients with invasive aspergillosis

Of the total of 333 samples from 116 Lung Transplant recipients in another study, sensitivity was evaluated in 6 recipients diagnosed with invasive aspergillosis as shown in the table below.

## Table 15

# Proven or Probable Invasive Aspergillosis in Lung Transplant Recipients By patient

| Diagnosis | N | Index ≥ 0.5 | Sensitivity | 95%<br>Confidence<br>Interval |
|-----------------------------------------------|---|-------------|-------------|-------------------------------|
| Proven Aspergillosis | 2 | 1 | 1/2 (50.0%) | 9.4 - 90.6% |
| Probable Aspergillosis | 4 | 3 | 3/4 (75.0%) | 30.0 - 95.4% |
| Combined Proven and<br>Probable Aspergillosis | 6 | 4 | 4/6 (66.7%) | 30.0 - 90.3% |

III. Hematologic disease patients with invasive aspergillosis

Sensitivity was also evaluated in a third study in 58 samples from 58 hematologic disease patients diagnosed with invasive aspergillosis as shown in the table below. In the study a retrospective analysis was performed on BAL samples from high risk hematology patients using the Platelia™ Aspergillus EIA. The data from this published study below was evaluated to establish the performance characteristics of the Platelia™ Aspergillus EIA on BAL fluid.

Maertens et al. 2009 Bronchoalveolar Lavage Fluid Galactomannan for the Diagnosis of Invasive Pulmonary Aspergillosis in Patients with Hematologic Diseases. Clin. Infec. Diseas.49:1688-93

#### Table 16

| Diagnosis | N | Index ≥ 0.5 | Sensitivity | 95%<br>Confidence<br>Interval |
|-----------------------------------------------|----|-------------|------------------|-------------------------------|
| Proven Aspergillosis | 31 | 31 | 31/31 (100%) | 89.0 - 100% |
| Probable Aspergillosis | 27 | 26 | 26/27 (96.3%) | 81.7 - 99.3% |
| Combined Proven and<br>Probable Aspergillosis | 58 | 57 | 57/58<br>(98.3%) | 90.8 - 99.7% |

#### Proven or Probable Invasive Aspergillosis in Hematologic Disease Patients

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#### B. SPECIFICITY

Specificity was evaluated in a total of 98 BAL samples from 57 SOT recipients and 305 BAL samples from 110 Lung Transplant recipients without invasive aspergillosis and is shown in the table below. Results are presented by samples from transplant recipients with and without mold colonization.

#### Table 17

## Specificity by Sample Combined SOT and Lung Transplant Recipients without Invasive Aspergillosis N = 403 BAL Fluids

| Diagnosis | N | Index < 0.5 | Negative (%) | 95%<br>Confidence<br>Interval |
|-------------------------------|-----|-------------|----------------|-------------------------------|
| Controls without colonization | 341 | 330 | 330/341(96.8%) | 94.3 - 98.2% |
| Controls with colonization | 62 | 50 | 50/62 (80.6%) | 69.1 - 88.6% |
| Control Total | 403 | 380 | 380/403(94.3%) | 91.6 - 96.2% |

Specificity in BAL samples from the combined SOT and Lung Transplant recipients without invasive aspergillosis is presented by transplant type in the table 16 below.

Table 18

## Specificity by Sample Combined SOT and Lung Transplant Recipients without Invasive Aspergillosis By Transplant Type N = 403 BAL Fluids

| Transplant Type | N | Index<br>< 0.5 | Negative (%) | 95% Confidence<br>Interval |
|-----------------|-----|----------------|-----------------|----------------------------|
| Heart | | | 25/28 (89.3%) | 72.8 - 96.3% |
| Kidney | 25 | 22 | 22/25 (88.0%) | 70.0 - 95.8% |
| Liver | 23 | | 22/23 (95.7%) | 79.0 - 99.2% |
| Lung | 327 | 311 | 311/327 (95.1%) | 92.2 - 97.0% |
| Control Total | 403 | 380 | 380/403 (94.3%) | 91.6 - 96.2% |

Specificity was also evaluated in a total of 41 BAL samples from 41 hematologic disease patients without invasive aspergillosis and is shown in the table below.

Table 19

.

## Specificity by Sample Hemotalogic Disease Patients without Invasive Aspergillosis N= 41

| Diagnosis | N | Index <0.5 | Negative (%) | 95% Confidence Interval |
|------------------|----|------------|---------------|-------------------------|
| Control Patients | 41 | 33 | 33/41 (80.5%) | 66.0 - 89.8% |

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Image /page/20/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

BIO-RAD Laboratories c/o Priva Bondre Regulatory Affairs Representative 6565 185" Ave. NE Redmond. WA 98052

JAN 13 2011

k093678 Regulation Number: Regulation Name: Regulatory Class: Product Code: Dated: Received:

Trade/Device Name: Platelia "Aspergillus ElA 21CFR §866.3040 Aspergillus spp. Serological reagents. Class I NOM January 7, 2011 January 11, 2011

Dear Ms. Bondre:

Re:

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 class II (Special Controls), it may be subject to such 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section

{21}------------------------------------------------

Page 2 – Priya Bondre

510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

Vally Augusto

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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Bio-Rad Laboratories Platelia™ Aspergillus EIA-Bronchoalveolar Lavage Fluid

For and the same

Premarket 510(k) Notification

CONFIDENTIAL

# Indications for Use

K093678

JAN 1 3 2011

510(k) Number (if known): Not known at this time

Device Name: Platelia™ Aspergillus EIA

#### Indications For Use:

The Platelia™ Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric sevurosary Bronchoalveolar lavage (BAL) fluid samples.

The Platelia™ Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination aff biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of invasive aspergillosis.

Prescription Use X (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)

Ludolite Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093678