IMMUNOCARD STAT CAMPY, MODEL 751530
Device Facts
| Record ID | K090700 |
|---|---|
| Device Name | IMMUNOCARD STAT CAMPY, MODEL 751530 |
| Applicant | Meridian Bioscience, Inc. |
| Product Code | LQP · Microbiology |
| Decision Date | May 28, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3110 |
| Device Class | Class 1 |
| Attributes | Pediatric |
Indications for Use
ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures. ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
Device Story
Lateral flow-based immunoassay for direct detection of Campylobacter jejuni and C. coli antigens in human stool. Stool sample diluted in buffer; added to device sample port. Antigen binds to monoclonal antibody-colloidal gold conjugate; complex migrates to capture zone. Capture monoclonal antibody on membrane binds complex, forming visible pink-red line. Control line (goat anti-mouse antibody) confirms adequate flow. Used in clinical, hospital, or reference laboratories by trained personnel. Visual interpretation of lines; positive result indicated by pink-red test line. Results used alongside clinical evaluation to aid diagnosis of Campylobacter infection.
Clinical Evidence
Clinical trial conducted at three U.S. sites with 421 patient samples (189 retrospective frozen, 232 fresh). Compared against bacterial culture. Combined sensitivity: 98.1% (95% CI: 90.1-99.7%); combined specificity: 95.9% (95% CI: 93.4-97.5%). Performance was consistent across age groups and sample types (preserved vs. unpreserved).
Technological Characteristics
Lateral flow immunochromatographic assay. Components: plastic cassette, test strip with immobilized monoclonal capture antibody (Test line) and goat anti-mouse antibody (Control line), gold-conjugated mouse monoclonal detection antibody. No calibrators. Qualitative visual readout. Standalone device; no instrumentation required. Preservatives: sodium azide and gentamycin in diluent/controls.
Indications for Use
Indicated for the qualitative detection of Campylobacter jejuni and Campylobacter coli antigens in human stool specimens from patients of all ages (1 month to 95 years) presenting with symptoms of gastroenteritis.
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
Related Devices
- K083464 — PREMIER CAMPY, MODEL 618096 · Meridian Bioscience, Inc. · Jan 30, 2009
- K210976 — Curian Campy · Meridian Bioscience, Inc. · Dec 23, 2021
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
K090700
B. Purpose for Submission:
To determine substantial equivalence for the ImmunoCard STAT! CAMPY, Model 7 used to detect Campylobacter (C. jejuni and C. coli) antigens in stool samples
C. Measurand:
Campylobacter jejuni and Campylobacter coli antigens
D. Type of Test:
Immunochromatographic rapid test based on the lateral flow principle
E. Applicant:
Meridian Bioscience, Inc.
F. Proprietary and Established Names:
ImmunoCard STAT! CAMPY, Model 7
G. Regulatory Information:
1. Regulation section: 21 CFR § 866.3110, Campylobacter spp.
2. Classification: Class I
3. Product code: LQP - Campylobacter spp.
4. Panel: Microbiology (83)
H. Intended Use:
1. Intended use:
ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool.
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ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.
ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in clinical hospital, reference, regional, private or state laboratory settings.
2. Indications for use:
Same as Intended Use
3. Special conditions for use statement(s):
For Prescription Use Only
4. Special instrument requirements:
None
I. Device Description:
ImmunoCard STAT! Campy is a lateral flow-based immunoassay for the direct detection of Campylobacter antigen in stool. The assay uses monoclonal antibodies specific for an antigen common to Campylobacter jejuni and Campylobacter coli. Stool specimen is added to Sample Diluent buffer and the diluted sample is added to the sample port of the device. Campylobacter antigen in the diluted sample binds to the monoclonal antibody-colloidal gold conjugate as the sample moves through the device. The Campylobacter capture antibody bound to the assay membrane at the Test position of the device binds the antigen-Campylobacter specific antibody-colloidal gold complex and yields a visible pink-red line. The control line functions as the internal assay control by showing adequate flow of diluted sample through the test device; improper assay execution and/or deterioration of test reagents. The control line is a goat antimouse antibody bound at the Control position of the device. A visible pink-red line at the Control position should be present each time a sample or control is tested. If no pink-red control line is seen, the test is considered invalid.
Reagents and Test Components:
- ImmunoCard STAT! Campy Test Device: Plastic cassette containing a test strip with an immobilized monoclonal antibody specific to Campylobacter jejuni and Campylobacter coli in the Test Line and a goat anti-mouse antibody in the Control Line. The strip contains a gold-conjugated mouse monoclonal antibody specific to C. jejuni and C. coli, which serves as the detection antibody. The test device is provided in a sealed foil pouch with desiccant.
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- ImmunoCard STAT! Campy Sample Diluent/Negative Control: A buffered protein solution containing sodium azide and gentamycin as preservatives
- ImmunoCard STAT! Campy Positive Control: Inactivated Campylobacter jejuni in a buffered protein solution containing sodium azide and gentamycin as preservatives
No calibrators are used with this device.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
ProSpecT Campylobacter EIA and Premier™ CAMPY EIA
2. Predicate 510(k) number(s):
K982315 and K083464, respectively
3. Comparison with predicates:
Differences between the proposed device and the predicates are highlighted in bold font.
| Item | ImmunoCard STAT!CAMPY | Predicate device ProSpecT Campylobacter | Predicate Device Premier CAMPY |
| --- | --- | --- | --- |
| Manufacturer | Meridian Bioscience | Remel | Meridian Bioscience |
| Assay type | Lateral flow | EIA | EIA |
| Intended use | | | |
| Qualitative/Quantitative | Qualitative | Qualitative | Qualitative |
| Screening, diagnostic or identification test | Diagnostic | Diagnostic | Diagnostic |
| Calibrator | No | No | No |
| Monitoring therapy | No | No | No |
| Reagents/components | | | |
| Microwells | No | YES | YES |
| Sample Diluent | Yes | Yes | Yes |
| Enzyme Conjugate | No | YES | YES |
| Wash Buffer | No | YES | YES |
| Substrate | No | YES | YES |
| Stop Solution | No | YES | YES |
| Positive Control | Yes | Yes | Yes |
| Negative Control | Yes | Yes | Yes |
| Test Device | Yes | NO | NO |
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| Species detected | | | | |
| --- | --- | --- | --- | --- |
| C. coli | | Yes | UNK | Yes |
| C. lari | No | No | No | |
| C. fetus | No | No | No | |
| Reading method | | | | |
| Visual | Yes | Yes | Yes | |
| Spectrophotometric | No | YES | YES | |
| End point | Pos = visible pink-red line Neg = no line | POS = YELLOW COLOR NEGATIVE = COLORLESS | POS = DEFINITE YELLOW COLOR NEG = COLORLESS VERY FAINT YELLOW | |
| Calibrator | No | No | No | |
| Equipment | Not needed | General laboratory semiautomated washer (optional) General laboratory spectrophotometer (optional) | General laboratory semiautomated washer (optional) General laboratory spectrophotometer (optional) StatFax microplate incubator/shaker (optional) | |
| Antibody sources | | | | |
| Capture | Mouse monoclonal | Rabbit polyclonal | Mouse monoclonal | |
| Detector | Mouse monoclonal | Rabbit polyclonal | Mouse monoclonal | |
| Sample Types | | | | |
| Human stool (direct) | Yes | Yes | Yes | |
| Broth culture | No | Yes | No | |
| Endpoint determinations | | | | |
| Visible? | Yes – pink-red line | Yes – yellow color | Yes – yellow color | |
| Positive (dual wavelength) | N/A | Yes ≥ 0.140 | Yes ≥ 0.100 | |
| Negative (dual wavelength) | N/A | Yes < 0.100 | Yes < 0.100 | |
| Indeterminant (dual wavelength) | N/A | Yes 0.100 to 0.139 | None | |
UNK = Unknown
## K. Standard/Guidance Document Referenced:
The sponsor provided Form FDA 3645 referencing the standard User Protocol for Evaluation of Qualitative Test Performance (FDA Recognition Number 020).
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L. Test Principle:
ImmunoCard STAT! Campy is a lateral flow-based immunoassay for the direct detection of Campylobacter antigen in stool. ImmunoCard STAT! Campy assay uses monoclonal antibodies specific for an antigen common to Campylobacter jejuni and Campylobacter coli. Stool sample is added to Sample Diluent buffer using the transfer pipette provided with the kit. The diluted sample is added to the sample port of the device.
Campylobacter antigen in the diluted sample binds to the monoclonal antibody-colloidal gold conjugate as the sample moves through the device. The Campylobacter capture monoclonal antibody bound to the assay membrane at the Test position of the device central window binds antigen-Campylobacter-antibody-colloidal gold complex and yields a visible pink-red line. When no antigen is present, no complex is formed and no pink-red line will appear at the Test position of the device central window. The control line serves as the assay control by showing adequate flow of diluted sample through the test device, improper assay execution, and or deterioration of test reagents. The control line is a goat anti-mouse antibody bound at the Control position of the reading window. A visible pink-red line at the Control position of the device central window should be present each time a sample or control is tested. If no pink-red control line is seen, adequate sample flow has not occurred and the test is considered invalid.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Intra-assay variability and inter-assay variability were assessed with a reference panel prepared from moderate positive (n = 2), negative (n = 2), high negative (n = 3) and low positive (n = 3) samples. High negative, low positive and moderate positive samples were prepared by inoculating negative stool matrix with known quantities of C. jejuni. In the case of low positive and high negative samples, the inoculum was added at concentrations that were at, or just below, the assay Limit of Detection (LoD). Aliquots of each panel were tested for five days, twice each day at three different test sites (Sites A, B and C). At least two technologists performed testing at each site.
Results for each site are tabulated below:
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| | Sample Qual. Result | Site 1 data generated with kit lot 751530.001 | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample ID | | Day 1 Run 1 DH | Day 1 Run 2 AML | Day 2 Run 1 DH | Day 2 Run 2 AML | Day 3 Run 1 DH | Day 3 Run 2 AML | Day 4 Run 1 DH | Day 4 Run 2 AML | Day 5 Run 1 DH | Day 5 Run 2 AML |
| Positive Control | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Negative Control | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Moderate Positive 2 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 2 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 2 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 2 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Percent Correlation | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| Correlation of cut off Specimens | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
Legend: DH etc = initials of person performing the test, Pos = positive, Neg = negative
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| | Sample Qual. Result | Site 2 data generated with lot 751530.001 | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample ID | | Day 1 Run 1 DM | Day 1 Run 2 JM | Day 2 Run 1 DM | Day 2 Run 2 JM | Day 3 Run 1 DM | Day 3 Run 2 JM | Day 4 Run 1 DM | Day 4 Run 2 JM | Day 5 Run 1 DM | Day 5 Run 2 JM |
| Positive Control | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Negative Control | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Moderate Positive 2 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 2 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | | Pos | Pos | Pos | Neg | Pos | Pos | Pos | Pos | Pos | Pos |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 2 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 2 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Percent Correlation | | 100.0% | 100.0% | 100.0% | 90.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| Correlation of cut off Specimens | | 100.0% | 100.0% | 100.0% | 83.3% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
Legend: DH etc = initials of person performing the test, Pos = positive, Neg = negative
| | Sample Qual. Result | Site 3 data generated with lot 751530.001 | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample ID | | Day 1 Run 1 KC | Day 1 Run 2 KMA | Day 2 Run 1 KC | Day 2 Run 2 KMA | Day 3 Run 1 KC | Day 3 Run 2 KMA | Day 4 Run 1 KC | Day 4 Run 2 KMA | Day 5 Run 1 KC | Day 5 Run 2 KMA |
| Positive Control | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Negative Control | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Moderate Positive 2 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 2 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 2 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 2 | | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Percent Correlation | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| Correlation of cut off Specimens | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
Legend: DH etc = initials of person performing the test, Pos = positive, Neg = negative
These results suggest that the ImmunoCard STAT! Campy assay is reproducible when used by different personnel within or between labs.
b. Linearity/assay reportable range:
Not applicable – this is a qualitative test with no numerical output
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Stability
A stability study was performed using a bracketed matrix representing the extreme conditions of storage. Studies were performed with preserved samples collected in Cary-Blair medium. The table below summarizes the study conditions:
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| No. | Sample Type | Sample Age | Storage Temp. | Storage Time | Case |
| --- | --- | --- | --- | --- | --- |
| 1 | Unpreserved | Fresh sample (0-48 hours old)
Frozen sample (0-24 hours from thaw) | Refrigerated (2-8 C) for no more than 8 hours after collection
If banked sample, test result immediately on thawing. | 0-2 hours after preparation of preserved aliquot for test below | Baseline sample type.
Baseline sample age.
Baseline storage temperature.
Baseline storage time. |
| 2 | Same as above | Same as above | Refrigerated (2-8 C) | Maximum 2-8 C storage time plus 24 hours
96 hours plus 24 hours (120 hours or 5 days) | Worst-case sample storage time for the baseline sample at the baseline temperature. |
| 3 | Same as above | Same as above | Upper limit of room temperature range + 2 C NT | Maximum room temperature storage time plus 24 hours NT | Worst-case sample storage time for the baseline sample at the worst-case limit of room temperature.
Bracket not used in this study.
No room temperature storage allowed. |
| 4 | Same as above | Same as above | Conventional freezer temperature (-16 to -28 C)
Track temperature during use. | Conventional freezer storage time plus 24 hours
2 months plus 24 hours, verify 1 year (interim time point after 2 weeks plus 24 hours) | Worst-case frozen storage time for the baseline sample under conditions of conventional freezer storage. |
| 5 | Same as above | Same as above | Ultra low freezer temperature (-66 to -84 C)
Track temperature during use. | Ultra low freezer storage time plus 24 hours
2 months plus 24 hours, verify 1 year (interim time point after 2 weeks plus 24 hours) | Best-case sample storage time for the baseline sample at the worst-case limit of ultra low freezer temperature. |
The results showed no line for negative samples and a definite or weak line with positive samples. Positive samples, including low positive sample, remained positive in all cases. Negative samples, including high negative, remain negative in all cases. Sample suitability was maintained when diluted samples were stored for up to 24 hours at $20 - 25^{\circ}\mathrm{C}$ or $2 - 8^{\circ}\mathrm{C}$. To ensure best practices, the sponsor recommends storage of diluted samples at $2 - 8^{\circ}\mathrm{C}$ only.
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d. Detection limit:
Samples were prepared from negative, archival, unpreserved, semi-solid stool specimens. The negative status of the samples was confirmed by the predicate method. Samples were spiked with decreasing amounts C. coli or C. jejuni obtained from stocks prepared to MacFarland Standard 4. Inoculated samples were tested immediately. The concentration of organisms in each sample was as follows:
| Organism C. jejuni
Sample ID | | Final organism concentration |
| --- | --- | --- |
| Sample 1 - | 2 dilutions below LoB | 1.5x10^{8} |
| Sample 2 -1 dilution below LoB | | 3.0x10^{8} |
| Sample 3 -Target LoB | | 6.0 x 10^{8} |
| Sample 4 -1 dilution above LoB | | 1.2 x 10 |
| Sample 5 -2 dilutions above LoB | | 2.4 x 10^{8} |
| Organism C. coli
Sample ID | | Final organism concentration |
| Sample 1 - | 2 dilutions below LoB | 3.75 x 10^{8} |
| Sample 2 - | 1 dilution below LoB | 7.50 x 10^{8} |
| Sample 3 -Target LoB | | 1.50 x 10 |
| Sample 4 -1 dilution above LoB | | 3.00 x 10 |
| Sample 5 -2 dilutions above LoB | | 6.00 x 10 |
The assay LoB and LoD determined samples spiked with known levels of C. coli and C. jejuni. Values were the same for semi-solid, liquid/watery or solid stool samples as these samples are diluted prior to testing to deliver a uniform matrix to the test.
e. Analytical specificity:
Interference Testing
In this study, the sponsor added selected drugs, and other non-microbial substances that might be present in stool samples from healthy persons or patients with signs and symptoms of gastroenteritis, to three positive and three negative samples. They then inoculated the samples with C. jejuni near the limit of detection (LoD) of the assay. The sponsor affirms that the following substances at the specified saturated solvent/diluent concentrations do not interfere with test results in the final concentrations listed: Barium sulfate (5 mg/mL); fecal fat (equivalent to 2.65 mg stearic plus 1.3 mg palmitic acids per mL), hemoglobin (as methemoglobin) (3.2 mg/mL), Imodium AD® (0.00667 mg/mL), Kaopectate® (0.87 mg/mL), mucin (3.33 mg/mL), Mylanta® (4.2 mg/mL), Pepto-
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Bismol® (0.87 mg/mL), Prilosec® (0.5 mg/mL), Tagamet® (0.5 mg/mL), TUMS® (0.5 mg/mL), urine (5% v/v), whole blood (5% v/v).
## Cross-reactivity Study
Crossreactivity studies were performed with positive and negative stool specimens inoculated with bacterial and fungal organisms to a final concentration of 1.1 x 10⁸ CFU/mL and virus ranging from 1.3 x 10⁴ to 3.1 x 10⁶ TCID50/mL. None of the following organisms in stool reacted with ImmunoCard STAT! CAMPY:
Aeromonas hydrophila, Bacteroides fragilis, Campylobacter fetus, Candida albicans, Citrobacter freundii, Clostridium difficile, Clostridium perfringens, Enterobacter cloacae, Enterococcus faecalis, Escherichia coli, Escherichia coli O157:H7, Escherichia fergusonii, Escherichia hermannii, Helicobacter pylori, Klebsiella pneumoniae, Lactococcus lactis, Listeria monocytogenes, Peptostreptococcus anaerobius, Plesiomonas shigelloides, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonas fluorescens, Salmonella Groups B-E, Serratia marcescens, Shigella boydii, Shigella flexneri, Shigella sonnei, Staphylococcus aureus, Staphylococcus epidermidis, Vibrio parahaemolyticus, Yersinia enterocolitica, Adenovirus Types 40 and 41, Coxsackievirus, Echovirus, and Rotavirus
## Strain Reactivity Study
The sponsor tested the reactivity using various strains of C. jejuni and C. coli (as shown in the table below). Each strain was spiked into a negative stool matrix. The negative sample matrix was confirmed nonreactive with the predicate device. Strains were diluted in phosphate-buffered saline to a MacFarland Standard #4. Ten μL of each organism was spiked into 100 μL of stool matrix. The negative dilution control was prepared by spiking the matrix with buffer instead of organism. The negative dilution control was nonreactive when tested. Results showed that all strains were reactive.
Summary of Reactivity Study
| Microorganism and ID # | Final conc. of microorganism in undiluted sample | Reactive? Y/N (at dilution) |
| --- | --- | --- |
| C. jejuni | | |
| 12081 | 1.1x10⁷ CFU/mL | Y |
| 10940 | 1.1x10⁷ CFU/mL | Y |
| 38106 | 1.1x10⁷ CFU/mL | Y |
| 6951 | 1.1x10⁷ CFU/mL | Y |
| 29411 | 1.1x10⁷ CFU/mL | Y |
| C. coli | | |
| 53138 | 1.1 x10⁸ CFU/mL | Y |
| 36994 | 1.1 x10⁸ CFU/mL | Y |
| 17755 | 1.1 x10⁸ CFU/mL | Y |
| 10956 | 1.1 x10⁸ CFU/mL | Y |
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f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method Comparison with Predicate:
See Clinical Studies Section
b. Matrix comparison:
Specimen matrix interference has not been observed in this assay as samples are significantly diluted before testing in Sample Diluent. For this reason, the Positive and Negative Controls supplied as part of this assay are prepared in matrices similar to the Sample Diluent. If control materials that are identical in composition to test samples are preferred, the user can prepare these by diluting known positive and negative specimens in Sample Diluent according to the SPECIMEN PREPARATION section of the package insert.
1. Clinical Studies:
a. Clinical Sensitivity
ImmunoCard STAT! CAMPY was evaluated by three independent laboratories located in different geographical regions of the United States. Four hundred and twenty one qualified samples were tested. Of these samples 189 (45%) were retrospective frozen samples. Fifty one percent of the samples (216/421) were collected without a preservative. The remaining samples (205/421) were collected in a Cary-Blair medium. Samples were collected from males (44%) and females (52%). In the case of 4% of the patients, gender was not recorded. The age groups of the patients from whom samples were collected ranged from one month of age to 95 years. The sponsor compared the performance of their device to bacterial culture. No differences in test performance were observed based on patient age or gender.
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Table 1. Performance characteristics by clinical site
| | Positive Samples | | | Negative Samples | | |
| --- | --- | --- | --- | --- | --- | --- |
| Site | ICS/ Culture | Sensitivity % | 95% CI | ICS/ Culture | Specificity % | 95% CI |
| Site 1 | 17/17 | 100% | 81.6-100% | 92/95 | 96.8% | 91.1-98.9% |
| Site 2 | 18/19 | 94.7% | 75.4-99.1% | 130/135 | 96.3% | 91.6-98.4% |
| Site 3 | 17/17 | 100% | 81.6-100% | 131/138 | 94.9% | 89.9-97.5% |
| Combined Sites | 52/53 | 98.1% | 90.1-99.7% | 353/368 | 95.9% | 93.4-97.5% |
Table 2 – Performance characteristics by patient age
| | Positive Samples | | | Negative Samples | | |
| --- | --- | --- | --- | --- | --- | --- |
| Patient Age | ICS/ Culture | Sensitivity % | 95% CI | ICS/ Culture | Specificity % | 95% CI |
| Birth to 1 month | 0/0 | N/A | N/A | 1/1 | 100% | 20.7-100% |
| >1 month to 2 years | 2/2 | 100% | 34.2-100% | 66/68 | 97.1% | 89.9-99.2% |
| >2 years to 12 years | 5/5 | 100% | 56.6-100% | 88/93 | 94.6% | 88.0-97.7% |
| >12 years to 21 years | 1/1 | 100% | 20.7-100% | 40/42 | 95.2% | 84.2-98.7% |
| >21 years | 27/28 | 96.4% | 82.3-99.4% | 158/164 | 96.3% | 92.2-98.3% |
| Not Defined | 17/17 | 100% | 81.6-100% | 0/0 | N/A | N/A |
Table 3 – Performance characteristics by sample type (preserved vs unpreserved)
| | Positive Samples | | | Negative Samples | | |
| --- | --- | --- | --- | --- | --- | --- |
| Specimen Type Preserved | ICS/ Culture | Sensitivity % | 95% CI | ICS/ Culture | Specificity % | 95% CI |
| Site 1 | 12/12 | 100% | 75.8-100% | 92/95 | 96.8% | 91.1-98.9% |
| Site 2 | 13/14 | 92.9% | 68.5-98.7% | 61/66 | 92.4% | 83.5-96.7% |
| Site 3 | 17/17 | 100% | 81.6-100% | 1/1 | 100% | 20.7-100% |
| | | | | | | |
| Specimen Type Unpreserved | ICS/ Culture | Sensitivity % | 95% CI | ICS/ Culture | Specificity % | 95% CI |
| Site 1 | 5/5 | 100% | 56.6-100% | 0/0 | N/A | N/A |
| Site 2 | 5/5 | 100% | 56.6-100% | 69/69 | 100% | 94.7-100% |
| Site 3 | 0/0 | N/A | N/A | 130/137 | 94.9% | 89.8-97.5% |
Table 4 – Performance characteristics of fresh and frozen samples
| | Positive Samples | | | Negative Samples | | |
| --- | --- | --- | --- | --- | --- | --- |
| Specimen Type Fresh | ICS/ Culture | Sensitivity % | 95% CI | ICS/ Culture | Specificity % | 95% CI |
| Site 1 | 0/0 | N/A | N/A | 91/94 | 96.8% | 91.0-98.9% |
| Site 2 | 2/3 | 66.7% | 20.8-93.9% | 130/135 | 96.3% | 91.6-98.4% |
| Site 3 | 0/0 | N/A | N/A | 0/0 | N/A | N/A |
| Total Fresh | 2/3 | 66.7% | 20.8-93.9% | 221/229 | 96.5% | 93.3-98.2% |
| | | | | | | |
| Specimen Type Frozen | ICS/ Culture | Sensitivity % | 95% CI | ICS/ Culture | Specificity % | 95% CI |
| Site 1 | 17/17 | 100% | 81.6-100% | 1/1 | 100% | 20.7-100% |
| Site 2 | 16/16 | 100% | 80.6-100% | 0/0 | N/A | N/A |
| Site 3 | 17/17 | 100% | 81.6-100% | 131/138 | 94.9% | 89.9-97.5% |
| Total Frozen | 50/50 | 100% | 92.9-100% | 132/139 | 95.0% | 90.0-97.5% |
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Site 1 – Prospective versus Retrospective Samples
| Prospective samples (fresh) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Negative | 3 | 91 | 94* | 0 | 95 | 0 | 95 |
| Total | 3 | 91 | 94 | 0 | 95 | 0 | 95 |
| | | | | | | | |
| Sensitivity | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Specificity | 91/94 | 96.8% | 91.0 – 98.9% | 95/95 | 100% | 96.1 – 100% | |
| Correlation | 91/94 | 96.8% | 91.0 – 98.9% | 95/95 | 100% | 96.1 – 100% | |
| | | | | | | | |
| Retrospective samples (frozen) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 17 | 0 | 17 | 17 | 0 | 0 | 17 |
| Negative | 0 | 1 | 1 | 0 | 1 | 0 | 1 |
| Total | 17 | 1 | 18 | 17 | 1 | 0 | 18 |
| | | | | | | | |
| Sensitivity | 17/17 | 100% | 81.6 – 100% | 17/17 | 100% | 81.6 – 100% | |
| Specificity | 1/1 | 100% | 20.7 – 100% | 1/1 | 100% | 20.7 – 100% | |
| Correlation | 18/18 | 100% | 82.4 – 100% | 18/18 | 100% | 82.4 – 100% | |
Site 2 – Prospective versus Retrospective Samples
| Prospective samples (fresh) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 2 | 1 | 3 | 2 | 1 | 0 | 3 |
| Negative | 5 | 130 | 135 | 0 | 125 | 0 | 125* |
| Total | 7 | 131 | 138 | 2 | 126 | 0 | 128 |
| | | | | | | | |
| Sensitivity | 2/3 | 66.7% | 20.8 – 93.9% | 2/3 | 66.7% | 20.8 – 93.9% | |
| Specificity | 130/135 | 96.3% | 91.6 – 98.4% | 125/125 | 100% | 97.0 – 100% | |
| Correlation | 132/138 | 95.7% | 90.8 – 98.0% | 127/128 | 99.2% | 95.7 – 99.9% | |
| | | | | | | | |
| Retrospective samples (frozen) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 16 | 0 | 16 | 16 | 0 | 0 | 16 |
| Negative | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | 16 | 0 | 16 | 16 | 0 | 0 | 16 |
| | | | | | | | |
| Sensitivity | 16/16 | 100% | 80.6 – 100% | 16/16 | 100% | 80.6 – 100% | |
| Specificity | N/A | N/A | N/A | N/A | N/A | N/A | |
| Correlation | 16/16 | 100% | 80.6 – 100% | 16/16 | 100% | 80.6 – 100% | |
Site 3 – Prospective versus Retrospective Samples
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14
| Prospective samples (fresh) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Negative | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | | | | | | | |
| Sensitivity | N/A | N/A | N/A | N/A | N/A | N/A | |
| Specificity | N/A | N/A | N/A | N/A | N/A | N/A | |
| Correlation | N/A | N/A | N/A | N/A | N/A | N/A | |
| | | | | | | | |
| Retrospective samples (frozen) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 17 | 0 | 17 | 17 | 0 | 0 | 17 |
| Negative | 7 | 131 | 138 | 1 | 137 | 0 | 138 |
| Total | 24 | 131 | 155 | 18 | 137 | 0 | 155 |
| | | | | | | | |
| Sensitivity | 17/17 | 100% | 81.6 - 100% | 17/17 | 100% | 81.6 - 100% | |
| Specificity | 131/138 | 94.9% | 89.9 - 97.5% | 137/138 | 99.3% | 96.0 - 99.9% | |
| Correlation | 148/155 | 95.5% | 91.0 - 97.8% | 154/155 | 99.4% | 96.4 - 99.9% | |
## Combined Site Data- Prospective versus Retrospective Samples
| Prospective samples (fresh) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 2 | 1 | 3 | 2 | 1 | 0 | 3 |
| Negative | 8 | 221 | 229* | 0 | 220 | 0 | 220** |
| Total | 10 | 222 | 232 | 2 | 221 | 0 | 223 |
| | | | | | | | |
| Sensitivity | 2/3 | 66.7% | 20.8 - 93.9% | 2/3 | 66.7% | 20.8 - 93.9% | |
| Specificity | 221/229 | 96.5% | 93.3 - 98.2% | 220/220 | 100% | 98.3 - 100% | |
| Correlation | 223/232 | 96.1% | 92.8 - 97.9% | 222/223 | 99.6% | 97.5 - 100% | |
| | | | | | | | |
| Retrospective samples (frozen) | ICS CAMPY | | | ProSpecT Campylobacter (predicate) | | | |
| Stool Culture | Positive | Negative | Total | Positive | Negative | Indeterm. | Total |
| Positive | 50 | 0 | 50 | 50 | 0 | 0 | 50 |
| Negative | 7 | 132 | 139 | 1 | 138 | 0 | 139 |
| Total | 57 | 132 | 189 | 51 | 138 | 0 | 189 |
| | | | | | | | |
| Sensitivity | 50/50 | 100% | 92.9 - 100% | 50/50 | 100% | 92.9 - 100% | |
| Specificity | 132/139 | 95.0% | 90.0 - 97.5%* | 138/139 | 99.3% | 96.0 - 99.9% | |
| Correlation | 182/189 | 96.3% | 92.6 - 98.2% | 188/189 | 99.5% | 97.1 - 99.9% | |
* One sample was QNS for testing by ICS CAMPY.
** Ten samples were excluded from the calculations due to a ProSpecT run control failure.
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b. Clinical Specificity
See 3a above
c. Other Clinical Supportive data
N/A
4. Clinical cut-off:
N/A
5. Expected Values/Reference Range:
The performance of ImmunoCard STAT! CAMPY was evaluated during 2009 using retrospective positive and negative samples collected during 2008 and prospective positive and negative samples, which were collected in 2009. The samples were collected from different geographic regions in the United States. The incidence of positive samples was approximately 1.5% during the 2008 and approximately 1.2% during the 2009 sample collection seasons. The incidence for an individual laboratory may differ from this number since it is dependent on factors such as locale, the time of year and occurrence of an outbreak (if applicable).
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
