Copan FecalSwab Collection, Transport and Preservation System

K220052 · Copan Italia Spa · JSM · Dec 16, 2022 · Microbiology

Device Facts

• Record ID: K220052
• Device Name: Copan FecalSwab Collection, Transport and Preservation System
• Applicant: Copan Italia Spa
• Product Code: JSM · Microbiology
• Decision Date: Dec 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

The Copan FecalSwab Collection, Transport and Preservation System is intended for collection of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel.

Device Story

Device is a collection kit comprising a flocked nylon swab and a plastic tube containing 2 mL of transport medium (chloride salts, sodium salts, phosphate buffer, L-cysteine, agar). Used by clinicians to collect rectal or stool specimens. Medium maintains bacterial viability during transport to laboratory. In lab, specimens are processed for culture or molecular testing via BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Enteric Bacterial Panel (xEBP). Device enables transition from raw stool to standardized transport medium for downstream molecular analysis. Benefits include preserved sample integrity and compatibility with automated molecular diagnostic platforms.

Clinical Evidence

No clinical data. Bench testing only. Studies included Limit of Detection (LoD) verification for BD MAX EBP/xEBP targets, bacterial viability recovery (roll plate and swab elution methods), specimen storage stability (nested testing up to 10 days), and PCR interference/inhibition studies using the Sample Processing Control (SPC). All targets met acceptance criteria of ≥95% detection.

Technological Characteristics

Kit includes polypropylene conical bottom vial with 2 ml medium (chloride salts, sodium salts, phosphate buffer, L-Cysteine, agar, water) and flocked nylon swab. Sterilized via radiation (ISO 11137-2). Shelf life 15 months. Standalone collection device; no electronic components or software.

Indications for Use

Indicated for collection and preservation of viable enteric pathogenic bacteria from rectal swabs and stool specimens for transport to a laboratory for culture or molecular testing using the BD MAX Enteric Bacterial Panel and BD MAX Extended Enteric Bacterial Panel. Prescription use only.

Regulatory Classification

Identification

A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Predicate Devices

• Copan Fecalswab Collection, Transport And Preservation System (K142094)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K220052

B Applicant

Copan Italia

C Proprietary and Established Names

Copan FecalSwab Collection, Transport and Preservation System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JSM | Class I, reserved | 21 CFR 866.2390 - Transport Culture Medium | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

In collaboration with Becton, Dickinson and Company (BD), Copan Italia is seeking substantial equivalence determination for the Copan FecalSwab Collection Transport and Preservation System for use with BD MAX Enteric Bacterial panel and BD MAX Extended Enteric Bacterial panel.

B Measurand:

Not Applicable

C Type of Test:

Copan FecalSwab Collection, Transport and Preservation System

## III Intended Use/Indications for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The Copan FecalSwab Collection, Transport and Preservation System is intended for collection and preservation of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

D Special Instrument Requirements:

The specimens collected will be tested using the BD MAX Enteric Bacterial Panel and BD MAX Extended Enteric Bacterial Panel on the BD MAX System.

IV Device/System Characteristics:

A Device Description:

The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab) is supplied in a collection kit format. Each collection kit consists of a package containing a plastic tube filled with 2 ml of FecalSwab transport and preservation medium and a specimen collection flocked swab intended both for rectal and stool specimen collection. In the laboratory, rectal and stool specimen are processed using standard clinical laboratory operating procedures for culture.

The Copan FecalSwab Collection, Transport and Preservation System was previously cleared (K142094) for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimen are intended be processed using standard clinical laboratory operating procedures for culture but is not cleared for use with downstream molecular assays. The FecalSwab has been demonstrated to be suitable for testing samples with the BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Bacterial Panel (xEBP).

B Principle of Operation:

The Copan FecalSwab Collection, Transport and Preservation System (FecalSwab) is supplied in a collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2 ml of transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber.

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The FecalSwab transport and preservation medium is a maintenance medium designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory. The FecalSwab Transport and Preservation Medium is comprised of the following:

- Chloride salts
- Sodium salts
- Phosphate buffer
- L-Cysteine
- Agar
- Water

The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System has a solid plastic shaft with a molded breakpoint site and are sterile.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Copan Fecalswab Collection, Transport And Preservation System

B Predicate 510(k) Number(s):

K142094

C Comparison with Predicate(s):

| Device & Predicate Device(s): | Device: K220052 | Predicate: K142094 |
| --- | --- | --- |
| Device Trade Name | Copan FecalSwab Collection, Transport and Preservation System | Copan FecalSwab Collection, Transport and Preservation System |
| General Device Characteristic | Copan FecalSwab is a Collection, Transport and Preservation System supplied in a collection kit format. | Copan FecalSwab is a Collection, Transport and Preservation System supplied in a collection kit format. |
| General Device Characteristic Similarities | | |
| Intended Use; Collection Device | The Copan FecalSwab Collection, Transport and Preservation System is intended for collection and preservation of viable enteric pathogenic bacteria from | The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to |

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| | rectal swabs and stool specimens during transport from the collection site to the testing laboratory for standard culture procedures. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Bacterial Panel. | preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. |
| --- | --- | --- |
| **Specimen Type** | Stool specimen, rectal specimen

**Note:** The scope of this clearance does not intend to seek claims for use of rectal specimens with the BD MAX EBP and xEBP Assays. | Same |
| **Microorganisms supported** | Enteric pathogenic bacteria | Same |
| **Single Use Device** | Yes | Same |
| **Container** | Polypropylene conical bottom vial | Same |
| **Product Configuration** | Medium in vial & cap System including Medium and swab in peel pouch option. | Same |
| **pH of Medium** | 6.90 – 7.50 | Same |
| **Storage Temperature** | 5-25°C | Same |
| **Medium Volume** | 2 mL | Same |
| **Swab Shaft** | Plastic | Same |
| **Swab Tip** | Flocked nylon | Same |
| **Shelf Life** | 15 months | Same |
| **Medium Formulation** | Chloride salts Sodium salts Phosphate buffer L-Cysteine Agar Distilled water | Same |
| **Product code** | JSM, LIO | Same |
| **General Device Characteristic Differences** | | |

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| | | |
| --- | --- | --- |
| Claimed instrument platforms | The BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel. | None |
| List of claimed organisms | Escherichia coli
Escherichia coli O157:H7
Salmonella typhimurium
Shigella sonnei
Campylobacter jejuni
Yersinia enterocolitica
Vibrio parahaemolyticus
Enterococcus faecalis
Vancomycin resistant (VRE)
Clostridium difficile
Plesiomonas shigelloides | Escherichia coli
Escherichia coli O157:H7
Salmonella typhimurium
Shigella sonnei
Campylobacter jejuni
Yersinia enterocolitica
Vibrio parahaemolyticus
Enterococcus faecalis
Vancomycin resistant (VRE)
Clostridium difficile |

VI Standards/Guidance Documents Referenced:

CLSI M40-A2:2014 Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition

ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the radiation dose

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
Not Applicable

2. Linearity:
Not Applicable

3. Analytical Specificity/Interference:
PCR Interfering Substances
Exogenous interfering substance studies were conducted in the original BD MAX EBP and BD MAX xEBP clearance. An additional interference study was conducted to assess the contents of the Copan Fecal Swab Collection, Transport and Preservation System using the sample processing control (SPC) that is included with BD MAX EBP and BD MAX xEBP assays. The SPC target is intended to monitor the presence of potential inhibitory substances in each reaction. The study was designed to leave the swabs inside the transport device tubes

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for the duration of the incubation period and amplification of the sample processing control (SPC) target was successful at every stability time point tested. The results indicate that there was no interference or inhibition in any of the components of the FecalSwab collection, transport, and preservation system. The SPC monitors DNA extraction, thermal cycling, reagent integrity and the presence of inhibitory substances. Results of tests are shown in table 1 below.

Table 1: PCR Interfering Substance SPC Results from FecalSwab Specimen Storage Stability Studies.

| Specimen storage condition in FecalSwab | Specimen storage condition in Sample Buffer Tube (SBT) | Total Days | Number of replicates tested | Number of replicates providing amplification for SPC target |
| --- | --- | --- | --- | --- |
| NA | NA | 0 | 48 | 48/48 |
| 1 Day at 25±2°C | NA | 1 | 24 | 24/24 |
| 2 Days at 25±2°C | NA | 2 | 24 | 24/24 |
| 1 Day at 25±2°C | 2 Days at 25±2°C | 3 | 24 | 24/24 |
| 1 Day at 25±2°C | 3 Days at 25±2°C | 4 | 24 | 24/24 |
| 1 Day at 25±2°C | 5 Days at 2-8°C | 6 | 24 | 24/24 |
| 1 Day at 25±2°C | 6 Days at 2-8°C | 7 | 24 | 24/24 |
| 5 Days at 2-8°C | NA | 5 | 24 | 24/24 |
| 6 Days at 2-8°C | NA | 6 | 24 | 24/24 |
| 5 Days at 2-8°C | 2 Days at 25±2°C | 7 | 24 | 24/24 |
| 5 Days at 2-8°C | 3 Days at 25±2°C | 8 | 24 | 24/24 |
| 5 Days at 2-8°C | 5 Days at 2-8°C | 10 | 24 | 24/24 |
| 5 Days at 2-8°C | 6 Days at 2-8°C | 11 | 24 | 24/24 |

## Microbial Interfering Substances

Microbial interference studies were conducted in the original BD MAX EBP and BD MAX xEBP clearance. No modifications were made to the BD MAX EBP and BD MAX xEBP assay design, reagents, workflow, algorithm, or interpretation of results. When the Copan FecalSwab device is used in combination with BD MAX EBP and BD MAX xEBP the media does not have any effect on BD instruments or any effect on signal overlap.

4. Assay Reportable Range:

Not Applicable

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Sterilization

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No changes to the sterile barrier (film-film peel-pouch), sterilization method, sterilization dose and SAL have been made to the device since the original clearance of the Copan FecalSwab Collection, Transport and Preservation System (K142094).

## Shelf Life

The FecalSwab has a claimed shelf life of 15 months. The FecalSwab was verified to meet performance requirements for enteric bacteria viability through 15 months in the studies submitted with the original FecalSwab premarket notification (K142094).

## Bacterial Recovery (Viability)

Bacterial Recovery (Viability) Studies in the original clearance for the Copan fecal swab (K142094) did not include *Plesiomonas shigelloides* (*P. shigelloides*) (ATCC 14029) as a claimed organism. *P. shigelloides* is a claimed organism on the BD MAX EBP and xEBP panel and as a result *P. shigelloides* is added to the claimed organisms for the subject device. All other organisms claimed on the BD MAX EBP and xEBP panel have been previously validated with viability studies using the subject device (K142094). Recovery studies were conducted to evaluate the ability of the FecalSwab to maintain viability of *P. shigelloides*. The organism was spiked into negative clinical fecal matrix then stored at 20 - 25°C for 48 hrs. and at 2 - 8°C for 72 hrs. The stability study was conducted using three production lots. Viability studies used the roll plate method and the swab elution method. Different dilutions of *P. shigelloides* were contrived using clinical negative fecal matrix followed by immediately adding the stool and organisms into the subject transport device. The negative clinical fecal matrix was prepared using formed stools from more than 4 healthy asymptomatic subjects. The pooled stool was then homogenized in Phosphate Buffer Saline (PBS) (30% stool in 70% PBS). The media was confirmed to be negative by plating a portion of each pool on an appropriate agar plate.

To distinguish and count the target colonies in the case of *P. shigelloides*, in the presence of resistant flora, a differential and selective agar were used to grow the target organism (Inositol Brilliant Green Bile Agar). For the swab elution method, the inoculum suspension was prepared by making a direct suspension in 0.85% physiological saline (pH 6.8-7.2) of isolated colonies from approximately 1.5 x 10⁸ CFU/ml, (0.5 McFarland standard). This inoculum was diluted 10 folds in fecal matrix to provide suspensions with concentrations of 1.5 x 10⁴ CFU/ml, 1.5 x 10³ CFU/ml, and 1.5 x 10² CFU/mL. 100 μL of an inoculum was pipetted onto swabs and placed into tubes and stored (T = 0, 6, 24, 48, and 72 hours) (3 lots used) for each holding temperature or time combination. The zero-time controls were plated in triplicates for each inoculum concentrations prepared. All other spiked swabs and media were held at specified temperatures for specific times (at 20-25°C for 6, 24, 48 hrs. and at 2-8°C for 6, 24, 48, and 72 hrs.). After each specific time point and storage condition, all tubes were vortexed for a minimum of 5 seconds and the medium was then plated by pipetting 100 μL from each tube onto the appropriate culture medium in triplicates (Inositol Brilliant Green Bile Agar) and incubated at 35 ± 2°C in an aerobic atmosphere for 24 hrs. The colonies were then counted (only pink colored colonies were appropriate for counting). The average CFU was determined for each concentration for each time point and storage condition.

The inoculum for the roll plate method was prepared the same way as the swab elution method above, with 100 μL aliquots of the prepared inoculum diluted to 1.5 x 10⁴, 1.5 x 10³ and 1.5 x 10² CFU/ml. The dilutions were transferred into 24-wells at time 0, 6, 24, 48, and 72 hrs. for plating onto the appropriate culture medium and stored at 2-8°C and 20-25°C. The

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swab was used to transfer the inoculum into the subject device according to the instructions for use. Each time point and storage condition were made in triplicate. At each time point tested, the swabs were removed from the subject device and the media was inoculated on the surface of Inositol Brilliant Green Bile Agar culture medium plates by rolling the swab across the surface of the culture media. Plates were incubated at 35-37°C for 24 hrs. with only pink colonies being counted and the average CFU calculated from 3 plates from each holding temperature and each concentration.

The acceptance criteria for both bacterial recovery methods were as follows: Cultures from transport medium tubes held at both 2 - 8°C and 20 - 25°C for 6hrs., 24 hrs., 48 hrs., and 72hrs. for each temperature must remain within 2 log₁₀ of the initial microorganism concentration (time point 0). All data demonstrated the ability of the FecalSwab to maintain viability of bacteria under the claimed conditions of use (table 2 and 3).

Table 2: Summary of Plesiomonas shigelloides Recovery Study ((Swab Elution Method)

| | Average CFU recovered from three lots | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Holding Temperature | T=0 | T=6h | T=24h | T=48h | T=72h | T=48/72 hrs. Log reduction (-) or Log increase (+) |
| 2-8°C | 1.19E+03 | 1.17E+03 | 1.02E+03 | 9.26E+02 | 8.01E+02 | -0.17 |
| 20-25°C | 1.19E+03 | 1.09E+03 | 2.23E+03 | 4.95E+03 | | 0.61 |

Table 3: Summary of Plesiomonas shigelloides Recovery Study (Roll Plate Method)

| | Average CFU recovered from three lots | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Holding Temperature | T=0 | T=6h | T=24h | T=48h | T=72h | T=48/72 hrs. Log reduction (-) or Log increase (+) |
| 2-8°C | 1.31E+02 | 1.11E+02 | 1.12E+02 | 1.17E+02 | 1.35E+02 | 0.01 |
| 20-25°C | 1.31E+02 | 1.21E+02 | 1.83E+02 | 1.09E+03 | | 0.92 |

## Specimen Storage Stability

Nucleic acid storage and stability was evaluated for specimens stored in the FecalSwab collection device under the same storage conditions claimed in BD MAX EBP and BD MAX xEBP clearance when using preserved stool specimens. Acceptable storage conditions for preserved stool specimens in the original clearance for BD MAX EBP and BD MAX xEBP

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were either $25 \pm 2^{\circ}\mathrm{C}$ for 24 hrs. or $2 - 8^{\circ}\mathrm{C}$ for 5 days prior to testing. A study was conducted to test the previously cleared stability claims of $25 \pm 2^{\circ}\mathrm{C}$ for 24 hrs. or $2 - 8^{\circ}\mathrm{C}$ for 5 days, using the subject transport device.

Studies included a nested stability testing to show that specimens stored in FecalSwab medium at the described conditions (i.e., Day 1: 24 hours in FecalSwab at $25 \pm 2^{\circ} \mathrm{C}$ , Day 3: 24 hours in FecalSwab at $25 \pm 2^{\circ} \mathrm{C} + 48$ hours at $25 \pm 2^{\circ} \mathrm{C}$ in SBT, Day 6: 24 hours in FecalSwab at $25 \pm 2^{\circ} \mathrm{C} + 5$ days at $2 - 8^{\circ} \mathrm{C}$ in SBT, Day 5: 5 days in FecalSwab at $2 - 8^{\circ} \mathrm{C}$ , Day 7: 5 days in FecalSwab at $2 - 8^{\circ} \mathrm{C} + 48$ hours at $25 \pm 2^{\circ} \mathrm{C}$ in SBT, and Day 10: 5 days in FecalSwab at $2 - 8^{\circ} \mathrm{C} + 5$ days at $2 - 8^{\circ} \mathrm{C}$ in SBT) continued to be stable at $2 - 8^{\circ} \mathrm{C}$ for up to 120 hours (5 days) or at $25 \pm 2^{\circ} \mathrm{C}$ for up to 48 hours. The study included four panels consisting of two different organisms mixed into each panel. Each panel used clinical matrix and was contrived at a concentration of $2 \times \mathrm{LoD}$ (Table 4). The acceptance criteria for the Fecalswab were a minimum of $95\%$ detection for all targets at $2 - 8^{\circ} \mathrm{C}$ for up to 120 hours (5 days) or at $25 \pm 2^{\circ} \mathrm{C}$ for up to 48 hours when SBT was used as described above in parentheses and results showed that each organism tested for both BD MAX EBP and xEBP had $\geq 95\%$ detection at all the target storage stability time points claimed in the package insert (as shown in Table 5).

Table 4: Specimen Stability Multiplex Organism Mix Compositions and Organisms Concentration in SBT during the test Expressed in Colony Forming Units (CFU/ml).

| PANEL | ORGANISMS | CFUs/mL in SBT (LoD) from the PI | CFUs/mL in SBT (2XLoD) from the PI | Actual 2XLoD concentration of each strain in CFUs/mL SBT |
| --- | --- | --- | --- | --- |
| BD MAX EBP multiplex mix #1 | Campylobacter jejuni | 10 | 20 | 56 |
| | Shigella sonnei | 124 | 248 | 144 |
| BD MAX EBP multiplex mix #2 | Escherichia coli STX1 | 223 | 446 | 361 |
| | Salmonella typhimurium | 193 | 386 | 373 |
| BD MAX xEBP multiplex mix #1 | Yersinia enterocolitica | 227 | 454 | 576 |
| | Escherichia coli ETEC | 137 | 274 | 361 |
| BD MAX xEBP multiplex mix #2 | Vibrio parahaemolyticus | 124 | 248 | 396 |
| | Plesiomonas shigelloides | 257 | 514 | 329 |

Table 5: Summary of FecalSwab specimen storage stability results with BD MAX EBP and BD MAX xEBP.

| | FecalSwab 25±2°C nested to SBT at 2-8°C and 25±2°C | | | FecalSwab 2-8°C nested to SBT at 2-8°C and 25±2°C | | |
| --- | --- | --- | --- | --- | --- | --- |
| Organism | Day | N° positive replicates | % Pos | Day | N° positive replicates | % Pos |
| Plesiomonas shigelloides ATCC 14029 | 1 | 23/24 | 96 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| | 1 | 24/24 | 100 | 5 | 24/24 | 100 |

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| Vibrio parahaemolyticus ATCC 17802 | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| --- | --- | --- | --- | --- | --- | --- |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| Yersinia enterocolitica ATCC 9610 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| Escherichia coli ETEC ATCC 35401 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| Campylobacter jejuni ATCC 43429 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 23/24 | 96 | 10 | 24/24 | 100 |
| Shigella sonnei ATCC 9290 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| Escherichia coli STX1 ATCC 43890 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| Salmonella typhimurium ATCC 14028 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| | 6 | 24/24 | 100 | 10 | 24/24 | 100 |

6. Detection Limit (LoD):

LoD studies were performed to determine the analytical sensitivity with the BD MAX EBP and BD MAX xEBP System when used with the FecalSwab specimen collection device has similar analytical performance compared to raw stool when used with these systems. The pooled negative clinical stool matrix was pre-tested with an FDA cleared assay for each target organism and determined to be negative prior to use. The stool matrix was used as a negative sample or was spiked to generate positive samples with the following organisms: Salmonella typhimurium, ATCC 14028; Escherichia coli STX1, ATCC 43890; Campylobacter jejuni, ATCC 43429 and Shigella sonnei, ATCC 9290. A 0.5 McFarland standard was made for each organism and further diluted. The 0.5 McFarland was confirmed with culture to determine the CFU/mL concentration, each organism was then serially diluted down to the LoD. The LoD is reported in CFU/mL.

$150~\mu \mathrm{L}$ each of the inoculated stool samples was used to spike 12 tubes of the FecalSwab transport medium according to the IFU. After inoculation, $50~\mu \mathrm{L}$ of each inoculated FecalSwab tube specimens were transferred into a total of 24 BD MAX sample buffer tubes (SBTs) in parallel according to the manufacturer's instructions for BD MAX assays. This procedure was repeated for each dilution and mix. The external controls were processed and tested as described in the BD MAX EBP and BD MAX xEBP IFUs. The LoD is the concentration at which $>95\%$ of the sample tested positive. Table 6 and 7 include the LoD concentrations of organisms in CFU/mL when FecalSwab specimens were tested with the BD MAX EBP and BD MAX xEBP.

Table 6: Limit of Detection Concentrations (CFU/mL) for FecalSwab specimens tested with BD MAX Enteric Bacterial Panel

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| Specimen type | Salmonella typhimurium ATCC 14028 | Escherichia coli STX1 ATCC 43890 | Campylobacter jejuni ATCC 43429 | Shigella sonnei ATCC 9290 |
| --- | --- | --- | --- | --- |
| FecalSwab | 7.16E+05 | 1.30E+05 | 1.17E+04 | 1.74E+05 |

Table 7: Limit of Detection Concentrations (CFU/mL) for FecalSwab specimens tested with BD MAX Extended Enteric Bacterial Panel

| Specimen type | Plesiomonas shigelloides ATCC 14029 | Yersinia enterocolitica ATCC 9610 | Vibrio parahaemolyticus ATCC 17802 | Escherichia coli ETEC ATCC 35401 |
| --- | --- | --- | --- | --- |
| FecalSwab | 7.94E+04 | 1.23E+05 | 7.12E+04 | 1.23E+05 |

For each organism tested across both the BD MAX enteric bacterial panel and extended bacterial panel, an LoD was identified. These results support that the FecalSwab has equivalent analytical performance to raw stool when used with BD MAX EBP and BD MAX xEBP cleared devices.

## Analytical Specificity-False positivity

The analytical specificity of the BD MAX System when used with the FecalSwab specimens was evaluated using data generated from the storage stability studies. This study was designed to demonstrate that the FecalSwab medium does not interfere with BD MAX EBP and BD MAX xEBP SBTs resulting in false positive results. Three lots of negative pooled stool matrix were prepared from 4 healthy, asymptomatic volunteers and homogenized in PBS to serve as negative fecal matrix (30% stool and 70% PBS). All of the FecalSwab tubes with the negative fecal matrix were processed according to the package insert. These samples were then tested on the BD MAX systems after generating two SBTs from each individual collection tube initially inoculated (3 Copan FecalSwab lots were used). Data from the FecalSwab media and negative fecal matrix is presented in table 8. Testing resulted in no false positive results.

Table 8: Analytical Specificity: False Positive Study results from FecalSwab Specimen Storage Stability Study

| Number of FecalSwab prepared | Number of SBT tubes generated and tested | Number of replicates providing false positive result due to FecalSwab interference |
| --- | --- | --- |
| 168 | 336 (2 for each tube of FS-) | 0/334* |

*2 SBTs have been excluded from the final calculation since an environmental contamination occurred during test.

Cross-Reactivity of FecalSwab Specimens with BD MAX EBP and BD MAX xEBP Cross-Reactivity studies were conducted and validated in the original clearance of the BD MAX EBP and BD MAX xEBP using unpreserved stool. In the previous clearance unpreserved stool was determined to be the most challenging specimen type. The FecalSwab collection device has no impact on the genetic sequences of potentially cross-reacting

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organisms and no changes were made to the BD MAX EBP or BD MAX xEBP assay primers or probes to accommodate FecalSwab preserved stool specimens. It was concluded that no additional cross-reactivity studies were necessary.

7. Assay Cut-Off:
Not Applicable

## B Comparison Studies:

1. Method Comparison with Predicate Device:
Not Applicable

2. Matrix Comparison:
Not Applicable

## C Clinical Studies:

1. Clinical Sensitivity:
Not Applicable

2. Clinical Specificity:
Not Applicable

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not Applicable

## D Clinical Cut-Off:
Not Applicable

## E Expected Values/Reference Range:
Not Applicable

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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