Campylobacter Chek

K191442 · Techlab, Inc. · LQP · Jun 20, 2019 · Microbiology

Device Facts

• Record ID: K191442
• Device Name: Campylobacter Chek
• Applicant: Techlab, Inc.
• Product Code: LQP · Microbiology
• Decision Date: Jun 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

The CAMPYLOBACTER CHEK test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK test is designed to detect C. jejuni, C. coli, C. lari, and C. upsaliensis from patients with symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

Device Story

CAMPYLOBACTER CHEK is an in vitro diagnostic device used for the detection of Campylobacter species. It functions as a serological reagent. The device is intended for professional use in clinical laboratory settings to aid in the diagnosis of Campylobacter-related infections. It operates via immunological detection methods to identify specific antigens or antibodies associated with the pathogen. Results are interpreted by laboratory personnel to assist clinicians in patient management and treatment decisions.

Clinical Evidence

Bench testing only. Analytical validation performed using clinical isolates spiked into negative fecal matrix. Study evaluated 5 C. lari and 5 C. upsaliensis isolates across unpreserved and preserved media (Cary Blair, C&S) over 3 days by multiple technicians (n=135 data points). Results: PPA for C. lari was 100% (95% CI: 97.2%, 100%); PPA for C. upsaliensis was 97.0% (95% CI: 92.6%, 98.8%). Additional studies included LoD determination, inclusivity, interfering substances, and prozone effect.

Technological Characteristics

Serological reagent for the detection of Campylobacter species; classified under 21 CFR 866.3110; Product Code LQP.

Indications for Use

Indicated for qualitative detection of Campylobacter-specific antigen in human fecal specimens (preserved or unpreserved) from patients with gastroenteritis symptoms to detect C. jejuni, C. coli, C. lari, and C. upsaliensis.

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.

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K191442

B Applicant
Techlab, Inc.

C Proprietary and Established Names
CAMPYLOBACTER CHEK

D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LQP | Class I | 21 CFR 866.3110 - Campylobacter fetus Serological Reagents | MI – Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS I device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device:
CAMPYLOBACTER CHEK
510(k) number: K173219

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

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3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for an update to the Indications for Use to include detection of additional Campylobacter species.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

| Device & Predicate Device(s): | CAMPYLOBACTER CHEK K191442 (Device) | CAMPYLOBACTER CHEK K173219 (Predicate) |
| --- | --- | --- |
| Similarities | | |
| Intended Use/Indications for Use | The CAMPYLOBACTER CHEK test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK test is designed to detect C. jejuni, C. coli, C. lari, and C. upsaliensis from patients with symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. | The CAMPYLOBACTER CHEK test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK test is designed to detect C. jejuni and C. coli from patients with symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. |
| Measured Analyte | Campylobacter-specific antigen | Same |
| Target Population | Persons suspected of having Campylobacter infection | Same |
| Type of Test | Qualitative | Same |
| Sample Matrix | Human Fecal Specimen | Same |
| Controls | Positive and negative control included in the kit. Internal Control line | Same |
| Storage | Refrigerated (2-8°C) | Same |
| Format | Microwell (96 tests) | Same |
| Technology | Enzyme Linked Immunoassay (ELISA) | Same |
| Interpretation | Spectrophotometrically and visually | Same |
| Specimen Type | Fecal specimens in Cary-Blair and C&S Transport Media | Same |
| Antibody Format | Monoclonal/Polyclonal | Same |

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| Time to Result | Approximately 1 hour | Same |
| --- | --- | --- |
| Differences | | |
| Species Detected | C. jejuni, C. coli, C. lari, and C. upsaliensis | C. jejuni and C. coli |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

A formal risk assessment was conducted for the CAMPYLOBACTER CHEK assay. This assessment included Failure Mode Effects and Analysis (FMEA) for the assay design. This analysis identified false negative and false positive results i.e., true Campylobacter infection not identified or false Campylobacter infection identified, as the worst-case risks to the patient. It was concluded based on FMEA and verification testing that the risks associated with detection of C. lari and C. upsaliensis are mitigated and therefore CAMPYLOBACTER CHEK is safe and effective for its intended use.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The following studies were performed to demonstrate risk mitigation:

## Limit of Detection

The limit of detection (LoD) for the modified CAMPYLOBACTER CHEK test was determined by spectrophotometry at both single (450 nm) and dual wavelength (450/620 nm) using whole organisms of both C. lari and C. upsaliensis spiked into unpreserved and preserved media, i.e., raw stool fecal matrix and Cary Blair and C&S media, respectively. Concentrations were calculated in colony forming units per milliliter (CFU/mL) and their equivalent in CFU/test by factoring in the dilutions and the final volume used in the assay. The LoD is the concentrations of organisms that yields a positive result 95% of the time and a negative result 5% of the time. The LoDs that were determined using single wavelength readings for both species were equivalent to those obtained using dual wavelength readings. Table 1 lists the LoD determined at dual wavelength.

Table 1. LoD for C. lari and C. upsaliensis Read at Dual Wavelength

| C. lari | | C. upsaliensis | |
| --- | --- | --- | --- |
| CFU/mL | CFU/test | CFU/mL | CFU/test |
| Fecal Matrix | | | |
| 4.60 X 10^{5} | 9,200 | 4.65 X 10^{5} | 9,300 |
| Cary Blair | | | |
| 1.09 X 10^{6} | 13,625 | 1.02 X 10^{6} | 12,750 |
| C&S | | | |
| 1.18 X 10^{6} | 14,750 | 1.02 X 10^{6} | 12,750 |

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# Inclusivity Study

The sponsor tested the reactivity of Campylobacter isolates from Centre National de Reference des Campylobacters et Helicobacters - Centre Hospitalier Universitaire de Bordeaux by spiking each isolate listed in Table 2 into negative fecal matrix at $2-3\mathrm{x}$ LoD and testing with the CAMPYLOBACTER CHEK. All results were read at dual-wavelength and were positive, with the exception of C. upsaliensis strains 2016/1931 and 2017/0506H. C. upsaliensis strain 2016/1931 was positive at $4\mathrm{x}$ LoD for all replicates and C. upsaliensis strain 2017/0506H was positive for a single replicate at $4\mathrm{x}$ LoD and all replicates at $5\mathrm{x}$ LoD.

Table 2. Strains Evaluated for Reactivity with Modified CAMPYLOBACTER CHEK

| C. lari | C. upsaliensis |
| --- | --- |
| 2013/0823H | 2016/0385 |
| 2014/2772 | 2016/1931 |
| 2015/0519 | 2016/1950 |
| 2015/0814 | 2016/2697 |
| 2015/1582 | 2016/2826 |
| 2015/1657 | 2017/0349 |
| 2015/2189 | 2017/0506H |
| 2015/2983 | 2017/2584 |
| 2016/0235 | 2018/0319H |
| 2016/1130H | 2018/1669 |

# Interfering Substances Study

The modified CAMPYLOBACTER CHEK test was evaluated for interfering substances with the substances and concentrations listed in Table 3. None of the substances where shown to interfere with the performance of the modified CAMPYLOBACTER CHEK test, except for vancomycin. One C. upsaliensis positive sample spiked with vancomycin unexpectedly yielded a negative result. However, upon repeat testing of the same aliquot, the sample tested positive in triplicate. This is acceptable.

Table 3. Interfering Substances

| Barium sulfate (5% w/v) | Benzalkonium Chloride (1% w/v) |
| --- | --- |
| Ciprofloxacin (0.25% w/v) | Ethanol (1% w/v) |
| Hog gastric mucin (3.5% w/v) | Human blood (40% v/v) |
| Hydrocortisone (1% w/v) | Imodium (5% v/v) |
| Kaopectate (5% v/v) | Leukocytes (0.05% w/v) |
| Maalox Advanced (5% v/v) | Mesalazine (10% w/v) |
| Metronidazole (0.25% w/v) | Mineral Oil (10% w/v) |
| Mylanta (4.2 mg/mL) | Naproxen Sodium (5% w/v) |
| Nonoxynol-9 (1% w/v) | Nystatin (1% w/v) |
| Palmitic Acid/Fecal Fat (40% w/v) | Pepto-Bismol (5% v/v) |
| Phenylephrine (1% w/v) | Polyethylene glycol 3350 (10% w/v) |
| Prilosec OTC (5 μg/mL) | Sennosides (1% w/v) |
| Simethicone (10% w/v) | Stearic Acid/Fecal Fat (40% w/v) |
| Tagamet (5 μg/mL) | TUMS (50 μg/mL) |

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Human Urine (5% v/v)
Vancomycin (0.25% w/v)

# Prozone Effect Study

The purpose of this study was to demonstrate that a high concentration of Campylobacter (antigen) does not interfere with a positive reaction in the modified CAMPYLOBACTER CHEK test. High samples were prepared by spiking a negative fecal pool with 1.6x10⁸ whole organisms of C. lari and 1.28x10⁸ whole organisms of C. upsaliensis. A total of five different dilutions of C. lari and C. upsaliensis were prepared and tested. Testing was performed in triplicate according to the Package Insert instructions. The results demonstrated that there was no overall hook affect, and that elevated levels of whole organism did not affect the detection of Campylobacter.

# Analytical Validation Study

The performance of the modified CAMPYLOBACTER CHEK test was determined by testing a panel of five C. lari and five C. upsaliensis clinical isolates. All samples were prepared by spiking negative, pooled fecal matrix with whole organism at 2x LoD. Both unpreserved stool and preserved stool (Cary Blair and C&S transport media) were evaluated during the study. Due to availability of limited number of representative isolates, each isolate was tested once a day over a three-day period by multiple technicians at a single internal site for a total of 135 data points. The results of this study demonstrated positive percent agreement (PPA) with expected results of 100% for C. lari and 97.0% for C. upsaliensis. The results are illustrated in Table 4.

Table 4. Analytical Validation Study - Performance of the Modified CAMPYLOBACTER CHEK

| Species | Percent Agreement | 95% CI |
| --- | --- | --- |
| C. lari | 100% (135/135) | 97.2%, 100% |
| C. upsaliensis | 97.0% (131/135) | 92.6%, 98.8% |

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the specific modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared predicate device.

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