LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

K181464 · DiaSorin, Inc. · LYR · Aug 31, 2018 · Microbiology

Device Facts

• Record ID: K181464
• Device Name: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
• Applicant: DiaSorin, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Aug 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. The test must be performed on the LIAISON® XL Analyzer. The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay. The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.

Device Story

LIAISON Helicobacter Antigen is a chemiluminescent immunoassay (CLIA) for qualitative detection of H. pylori antigen in human stool. Input: stool samples extracted via LIAISON Stool Extraction Device. Operation: delayed one-step sandwich assay; stool extract incubated with paramagnetic particles coated with capture antibody; isoluminol-conjugated antibody added; unbound material washed; starter reagents added to initiate flash chemiluminescence. Output: relative light units (RLU) measured by photomultiplier on LIAISON XL Analyzer; proportional to antigen concentration. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing H. pylori infection and monitoring post-therapy eradication. Benefits: provides automated, objective diagnostic aid for H. pylori infection.

Clinical Evidence

Prospective clinical study of 285 specimens (277 pre-therapy, 8 post-therapy) compared LIAISON Helicobacter Antigen to a composite reference method (histology, culture, urease test). Pre-therapy population (n=277): clinical sensitivity 95.5% (95% CI: 87.5–99.1%), clinical specificity 98.6% (95% CI: 95.9–99.7%). Post-therapy population (n=8): clinical sensitivity 100% (95% CI: 63.1–100%). Precision/reproducibility studies (12-day and 5-day) demonstrated acceptable performance across sites and operators.

Technological Characteristics

Automated chemiluminescent immunoassay (CLIA) using paramagnetic particles coated with monoclonal capture antibody and isoluminol-conjugated detection antibody. Form factor: reagent integral for use on LIAISON XL Analyzer. Connectivity: integrated with LIAISON XL system. Software: automated processing of incubation, washing, and signal measurement. Sterilization: not specified.

Indications for Use

Indicated for adult patients (≥ 22 years) suspected of H. pylori infection or those requiring post-therapy response monitoring after at least 4 weeks of therapy discontinuation.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Predicate Devices

• Meridian Platinum Premier HpSA PLUS (K053335)

Reference Devices

• LIAISON® H. pylori IgG Control Set (K161139)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.

August 31, 2018

DiaSorin Inc. Sandra Zimniewicz Regulatory Affairs Specialist 1951 Northwestern Ave. Stillwater. Minnesota 55082-0285

Re: K181464

Trade/Device Name: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR, JJX, JJF Dated: June 5, 2018 Received: June 6, 2018

Dear Sandra 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

**Ribhi Shawar** -S
For

Uwe Scherf, 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) K181464

#### Device Name

LIAISON® Helicobacter Antigen LIAISON® Helicobacter Antigen Control Set

#### Indications for Use (Describe)

The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

The test must be performed on the LIAISON® XL Analyzer.

The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay.

The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY

| SUBMITTED BY: | Sandra Zimniewicz<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] |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | August 31, 2018 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® Helicobacter Antigen<br>LIAISON® Helicobacter Antigen Control Set |
| Common Names/Descriptions: | Helicobacter pylori Antigen assay and<br>Helicobacter pylori Antigen controls |
| Classification Names: | Campylobacter fetus serological reagents:<br>Class I, 21 CFR: 866.3110; Microbiology (83) |
| | Single (Specified) analyte controls (assayed<br>and unassayed): Class I,<br>21 CFR 862.1660; Clinical Chemistry (75) |
| Product Code: | LYR - Campylobacter fetus serological reagents<br>JJX - Single (Specified) analyte controls<br>(assayed and unassayed)<br>JJF – Analyzer, Chemistry, Micro,<br>For Clinical Use |
| PREDICATE DEVICES : | Meridian Platinum Premier HpSA PLUS<br>Reference_K053335 assay<br>LIAISON® H. pylori IgG Control Set (K161139) |

# DEVICE DESCRIPTION:

#### INTENDED USE:

The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other

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clinical and laboratory data to assist the clinician in making individual patient management decisions.

The test must be performed on the LIAISON® XL Analyzer.

The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay. The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.

#### KIT DESCRIPTION:

controls or samples.

The LIAISON® Helicobacter Antigen assay is a delayed one-step sandwich assay for detection of H. pylori stool antigen. H. pylori antigen is first extracted from human stool samples with sample diluent using the LIAISON® Stool Extraction Device.

The assay uses a monoclonal antibody for detection of H. pylori stool antigen. The assay uses 200 µL of sample consisting of a mixture of extraction buffer and stool extracted H. pylori stool antigen which is incubated with paramagnetic particles coated with a capture antibody for H. pylori stool antigen. Following incubation, an isoluminol conjugated antibody for H. pylori stool antigen is added to the reaction and incubated. After the second incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of H. pylori stool antigen present in the calibrators,

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

| Similarities | | |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device: LIAISON® Helicobacter<br>Antigen (K181464) | Predicate: Premier<br>Platinum HpSA PLUS<br>(K053335) |
| Product Code | LYR | Same |
| Intended Use | The LIAISON® Helicobacter Antigen<br>assay is a chemiluminescent<br>immunoassay (CLIA) intended for the<br>qualitative determination of<br>Helicobacter pylori (H. pylori) antigen<br>in human stool. The test is an aid in<br>the diagnosis of patients suspected of<br>H. pylori infection and to measure post<br>therapy response from patients who<br>have discontinued therapy for at least<br>4 weeks. Assay results should be used<br>in conjunction with other clinical and | The Premier Platinum<br>HpSA PLUS enzyme<br>immunoassay (EIA) is an in<br>vitro qualitative procedure<br>for the detection of<br>Helicobacter pylori<br>antigens in human stool.<br>Test results are intended to<br>aid in the diagnosis of H.<br>pylori infection and to<br>monitor response during<br>and post-therapy in |

## COMPARISON TO FDA CLEARED METHOD

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| Similarities | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device: LIAISON® Helicobacter<br>Antigen (K181464) | Predicate: Premier<br>Platinum HpSA PLUS<br>(K053335) |
| | laboratory data to assist the clinician in<br>making individual patient management<br>decisions.<br>The test must be performed on the<br>LIAISON® XL Analyzer.<br>The LIAISON® Helicobacter Antigen<br>Control Set is intended for use as<br>assayed quality control samples to<br>monitor the performance of the<br>LIAISON® Helicobacter Antigen assay.<br>The performance characteristics of the<br>LIAISON® Helicobacter Antigen<br>Control Set have not been established<br>for any other assay or instrument<br>platforms different from the LIAISON®<br>XL. | patients. Accepted medical<br>practice recommends that<br>testing by any current<br>method, to confirm<br>eradication, be done at<br>least four weeks following<br>completion of therapy. |
| Results | Qualitative | Same |
| Measurand | <i>H. pylori</i> antigen | Same |
| Specimen<br>Required | Stool | Same |

| Differences | | |
|-----------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Item | Device: LIAISON Helicobacter Antigen<br>(K181464) | Predicate: Premier<br>Platinum HpSA PLUS<br>(K053335) |
| Limit of<br>Detection | 4 ng/mL | $\ge$ 4.67 ng/mL in stool |
| Technology | Automated Chemiluminescent<br>Immunoassay (CLIA) | Manual/Semiautomated<br>Enzyme Immunoassay<br>(EIA) |
| Cutoff | 1.1 Index (for positive) | 0.100 at OD450/630 |
| Interpretation | Negative <0.90 Index<br>Equivocal ( $\ge$ 0.90 Index and < 1.10 Index)<br>Positive $\ge$ 1.10 Index | Negative <0.100 OD450/630<br>Positive $\ge$ 0.100 OD450/630 |

## PERFORMANCE DATA: COMPARATIVE CLINICAL STUDIES:

A prospective study was performed to compare the performance of the LIAISON®

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Helicobacter Antigen assay to at least two of the three methods which comprise the Composite Reference Method (CRM): Histological Evaluation, Culture of the Organism, and Urease Detection Test.

The prospective study consisted of 285 specimens collected from subjects undergoing evaluation for H. pylori infection to determine infection status both pre and post therapy. Prospective samples were collected at multiple sites, and regions, within the US and outside the US (OUS).

## Pre-Therapy population

The pre-therapy study population consisted of 277 male or female adult subjects (≥ 22 years), undergoing evaluation to determine H. pylori infection status prior to any therapeutic intervention.

The results are summarized as sensitivity and specificity with 95% confidence intervals.

| | Composite Reference Method Diagnosis | | |
|-------------------------------|--------------------------------------|--------------|-------|
| LIAISON® Helicobacter Antigen | Infected | Not Infected | Total |
| Positive | 64 | 3 | 67 |
| Equivocal | 0 | 0 | 0 |
| Negative | 3 | 207 | 210 |
| Total | 67 | 210 | 277 |

H. pylori Pre-Therapy Population Comparison

| | | | 95% Confidence Interval |
|----------------------|---------|-------|-------------------------|
| Clinical Specificity | 207/210 | 98.6% | 95.9 – 99.7% |
| Clinical Sensitivity | 64/67 | 95.5% | 87.5 – 99.1% |

## Post-Therapy population

The post-therapy study population consisted of 8 male or female adult subjects (≥ 22 years), undergoing evaluation to measure post therapy response for H. Pylori.

The results are summarized as sensitivity with 95% confidence intervals.

#### H. pylori Post-Therapy Population Comparison

| | Composite Reference Method Diagnosis | | |
|-------------------------------|--------------------------------------|--------------|-------|
| LIAISON® Helicobacter Antigen | Infected | Not Infected | Total |
| Positive | 8 | 0 | 8 |
| Equivocal | 0 | 0 | 0 |
| Negative | 0 | 0 | 0 |
| Total | 8 | 0 | 8 |

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| | | | 95% Confidence Interval |
|----------------------|-----|------|-------------------------|
| Clinical Sensitivity | 8/8 | 100% | 63.1 - 100% |

#### Prevalence:

The observed prevalence of the LIAISON® Helicobacter Antigen assay was calculated from the 277 specimens obtained from eligible subjects of the pre-therapy population who underwent EGD with signs and symptoms of a Helicobacter pylori infection. The specimens were from 86 males (31%) and 191 females (69%), collected from multiple U.S. and OUS geographical locations. Known ages ranged from 22 to 87 years old.

The observed prevalence of the LIAISON® Helicobacter Antigen assay is 24.2%. 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.

## PRECISION/REPRODUCIBILITY:

#### 12 Day Study

A within-laboratory precision study was performed consulting CLSI document EP5-A3 in the preparation of the testing protocol. Six contrived antigen samples containing high negative, low positive and moderate positive concentrations of H. pylori stool antigen and kit controls (negative and positive). All samples and controls were assayed in duplicate, two runs per day over twelve operating days with multiple technicians. The following within-laboratory precision results were obtained from samples tested internally at DiaSorin Inc. with one kit lot using one LIAISON® XL Analyzer.

| Sample ID | Mean | Within Run | | Within Day | | Between Day | | Total | |
|-----------|-------|------------|------|------------|------|-------------|------|-------|------|
| N=48 | Index | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg Ctrl | 0.06 | 0.00 | 7.8% | 0.00 | 0.0% | 0.00 | 4.6% | 0.00 | 7.8% |
| Neg Ctrl | 0.06 | 0.00 | 7.6% | 0.00 | 0.0% | 0.00 | 5.6% | 0.01 | 8.8% |
| Pos Ctrl | 2.72 | 0.05 | 1.9% | 0.04 | 1.5% | 0.03 | 1.2% | 0.07 | 2.6% |
| Pos Ctrl | 2.70 | 0.06 | 2.4% | 0.03 | 1.2% | 0.01 | 0.2% | 0.07 | 2.7% |
| Sample #1 | 0.80 | 0.02 | 2.6% | 0.02 | 2.3% | 0.03 | 3.1% | 0.04 | 4.7% |
| Sample #2 | 0.84 | 0.02 | 2.9% | 0.01 | 1.0% | 0.03 | 3.8% | 0.04 | 4.9% |
| Sample #3 | 1.84 | 0.06 | 3.1% | 0.02 | 1.2% | 0.04 | 2.4% | 0.08 | 4.1% |
| Sample #4 | 1.99 | 0.04 | 2.1% | 0.07 | 3.5% | 0.02 | 1.0% | 0.08 | 4.2% |
| Sample #5 | 3.03 | 0.08 | 2.7% | 0.00 | 0.0% | 0.07 | 2.2% | 0.10 | 3.3% |
| Sample #6 | 3.00 | 0.08 | 2.6% | 0.06 | 2.1% | 0.06 | 2.0% | 0.12 | 3.9% |

#### Within-Laboratory Precision

## 5 Day Study

A reproducibility/precision study was performed at two external sites and internally at DiaSorin Inc. consulting CLSI document EP15-A3 in the preparation of the testing protocol. Six contrived antigen samples containing high negative, low positive and

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moderate positive concentrations of H. pylori stool antigen and kit controls (negative and positive) as duplicate samples were assayed in replicates of three, in two runs per day over 5 operating days with two technicians at each site performing the test every day. The following reproducibility/precision results were obtained from samples tested at the three sites using one kit lot.

| Sample ID | Mean<br>Index | Within Run | | Run to Run<br>Within Day | | Day to Day<br>Within Site | | Site to Site | | Total | |
|-----------|---------------|------------|------|--------------------------|------|---------------------------|------|--------------|-------|-------|-------|
| | Value | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg Ctrl | 0.07 | 0.004 | 5.1% | 0.002 | 2.4% | 0.002 | 2.1% | 0.009 | 12.5% | 0.010 | 13.9% |
| Neg Ctrl | 0.07 | 0.003 | 4.0% | 0.003 | 4.0% | 0.001 | 1.4% | 0.007 | 10.0 | 0.009 | 11.5% |
| Pos Ctrl | 4.80 | 0.076 | 1.6% | 0.050 | 1.0% | 0.063 | 1.3% | 0.105 | 2.2% | 0.153 | 3.1% |
| Pos Ctrl | 4.78 | 0.070 | 1.5% | 0.050 | 1.0% | 0.068 | 1.4% | 0.113 | 2.4% | 0.157 | 3.3% |
| Sample #1 | 2.12 | 0.034 | 1.6% | 0.038 | 1.8% | 0.108 | 5.1% | 0.119 | 5.6% | 0.168 | 8.0% |
| Sample #2 | 2.37 | 0.049 | 2.1% | 0.046 | 1.9% | 0.156 | 6.6% | 0.226 | 9.5% | 0.283 | 11.9% |
| Sample #3 | 0.69 | 0.024 | 3.5% | 0.021 | 3.0% | 0.037 | 5.4% | 0.065 | 9.4% | 0.081 | 11.8% |
| Sample #4 | 0.69 | 0.023 | 3.3% | 0.026 | 3.8% | 0.019 | 2.7% | 0.065 | 9.4% | 0.077 | 11.0% |
| Sample #5 | 1.21 | 0.031 | 2.5% | 0.037 | 3.1% | 0.029 | 2.4% | 0.093 | 7.7% | 0.109 | 9.0% |
| Sample #6 | 1.20 | 0.021 | 1.7% | 0.030 | 2.5% | 0.056 | 4.7% | 0.120 | 10.1% | 0.138 | 11.5% |

## Reproducibility

## REAGENT STABILITY

| LIAISON® Helicobacter Antigen | |
|--------------------------------------------------------------------|-----------|
| Study | Stability |
| Calibration Curve | 4 weeks |
| Reagent Integral Open Use storage On-board Analyzer | 8 weeks |
| Reagent Integral Open Use storage at 2-8°C | 8 weeks |
| Calibrator Freeze/Thaw cycles | 3 cycles |
| Reconstituted Calibrator open use at room temperature<br>(18-25°C) | 8 hours |
| Reconstituted Calibrator open use at 2 - 8°C | 28 days |
| Reconstituted Calibrator open use at -20°C | 16 weeks |

| LIAISON® Helicobacter Antigen Control Set | |
|-----------------------------------------------------------------------|-----------|
| Study | Stability |
| Reconstituted Positive Control Open Use at -20°C | 16 weeks |
| Reconstituted Positive Control Freeze/Thaw cycles | 3 cycles |
| Negative and Reconstituted Positive Control Open Use storage at 2-8°C | 28 days |

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## SPECIMEN STABILITY

Studies were performed to determine the stability of sample at different storage conditions. The results are provided in the tables below.

| Stool Sample | |
|--------------------------------------------------------------|-----------|
| Study | Stability |
| Refrigerated at 2- 8°C | 72 hours |
| Store samples frozen at -20°C if not tested within 72 hours. | |

| Sample Extract | |
|------------------------------|-----------|
| Study | Stability |
| Room temperature (18 - 25°C) | 8 hours |
| Refrigerated at 2- 8°C | 72 hours |
| Frozen at -20°C | 12 weeks |
| Freeze/Thaw cycles | 3 cycles |

#### 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.