(72 days)
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.
ImmunoCard STAT! CAMPY is an immunochromatographic, rapid test for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of Campylobacteriosis. The assay is intended to be used by hospital and reference laboratories to test for bacterial colonization. It is used in conjunction with information obtained from the patient's clinical symptoms and with other tests to diagnose Campylobacter infection. The assay consists of ImmunoCard STAT! Test Devices (containing specific capture antibodies and colloidal gold-antibody conjugate detector antibodies), ImmunoCard STAT! CAMPY Sample Diluent/Negative Control and ImmunoCard STAT! CAMPY Positive Control.
No calibrators are used with this device.
The ImmunoCard STAT! CAMPY device is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens (specifically C. jejuni and C. coli) in human stool samples. Test results are intended to be used in conjunction with a patient's clinical evaluation and other diagnostic procedures within hospital, reference, regional, private, or state laboratory settings, not for point-of-care use.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list predefined "acceptance criteria" for sensitivity and specificity. However, based on the clinical study results, the collective performance demonstrates acceptable diagnostic accuracy for the intended use. The table below presents the overall combined site performance:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Combined Sites) |
|---|---|---|
| Sensitivity | High sensitivity for detecting Campylobacter infection | 98.1% (95% CI: 90.1-99.7%) |
| Specificity | High specificity to minimize false positives | 95.9% (95% CI: 93.4-97.5%) |
| Analytical Sensitivity (C. jejuni) | Detect C. jejuni at low concentrations | 1.2 x 10^5 cells/mL |
| Analytical Sensitivity (C. coli) | Detect C. coli at low concentrations | 3.0 x 10^5 cells/mL |
| Reproducibility | Consistent results across sites, operators, and days | 99.7% correlation for expected results |
| Cross-reactivity | No significant cross-reactivity with common enteric pathogens or normal flora | None of the tested organisms reacted with the device |
| Interference | No significant interference from common stool substances or medications | None of the tested substances met criteria for an interferent |
2. Sample size used for the test set and the data provenance:
- Sample Size: A total of 421 qualified patient samples were used in the clinical trials.
- Data Provenance: The data was collected from three independent test sites located in the Midwestern and Southeastern regions of the United States. 189 of these samples were retrospective frozen samples, while the remaining were likely prospective as they were tested in an unpreserved state. Forty-nine percent of samples were collected in Cary-Blair-based transport and preservative media, and the rest were unpreserved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth for the clinical test set was established using bacterial culture as the reference comparator method. The document does not specify the number of experts or their qualifications for performing and interpreting these bacterial cultures. However, bacterial culture is a standard microbiological reference method.
4. Adjudication method for the test set:
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical test set results. The comparison was primarily made between the ImmunoCard STAT! CAMPY result and the bacterial culture result.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an in vitro diagnostic test (a lateral flow immunoassay) and not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader performance improvement with or without AI assistance is not applicable to this device. The reading method is visual, indicating a positive result by a visible pink-red line and a negative result by no line.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The ImmunoCard STAT! CAMPY is a standalone in vitro diagnostic test that provides a visual reading (presence or absence of a line). Its performance is inherently "standalone" in the sense that the test device itself produces the result, which is then interpreted visually by a human operator. There is no algorithm involved in the interpretation process described.
7. The type of ground truth used:
The ground truth used for the clinical performance evaluation was bacterial culture.
8. The sample size for the training set:
The document does not explicitly specify a "training set" in the context of machine learning or algorithm development. For this type of in vitro diagnostic device, the development typically involves analytical studies (like analytical sensitivity, specificity, interference, cross-reactivity) and then clinical validation. The samples used for design and development (which could be considered analogous to a training set in some contexts) are not quantified here.
9. How the ground truth for the training set was established:
As there is no explicitly defined "training set" in the context of an algorithm, the method for establishing its ground truth is not detailed. However, for the analytical studies (e.g., analytical sensitivity), known quantities of C. jejuni or C. coli were used to spike samples, establishing a controlled and known "ground truth" for those specific tests. For cross-reactivity and interference studies, known organisms and substances were introduced to assess their impact on the device's accuracy.
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| 510(k) number: | K090700 | |
|---|---|---|
| Submitter: | Meridian Bioscience: Inc. | MAY 28 2009 |
| Submitter's address: | 3471 River Hills DriveCincinnati, OH 45244 | |
| Contact: | Susan Rolih | |
| Contact number: | (513) 271 3700. | |
| Date of preparation: | March 16, 2009 | |
| Device name: | ImmunoCard STAT! CAMPY | |
| Common name: | Rapid immunochromatographic assay for Campylobacter | |
| Classification name: | Campylobacter ssp.LQP, CFR section 866.3110 | |
| Predicate device: | K982315, ProSpecT Campylobacter EIA | |
| Reference comparator | Bacterial culture | |
| Description of the device: | ImmunoCard STAT! CAMPY is an immunochromatographic, rapid test for thedetection of specific Campylobacter antigens in stool samples from patientswith signs and symptoms of Campylobacteriosis. The assay is intended to beused by hospital and reference laboratories to test for bacterial colonization. Itis used in conjunction with information obtained from the patient's clinicalsymptoms and with other tests to diagnose Campylobacter infection. Theassay consists of ImmunoCard STAT! Test Devices (containing specificcapture antibodies and colloidal gold-antibody conjugate detector antibodies),ImmunoCard STAT! CAMPY Sample Diluent/Negative Control andImmunoCard STAT! CAMPY Positive Control.No calibrators are used with this device. | |
| Intended use: | ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for thedetection of specific Campylobacter antigens in human stool. |
he ol. 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 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.
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Comparison to predicate device:
・
| Item | ImmunoCardSTATI CAMPY | Predicate deviceProSpecTCampylobacter | Predicate DevicePremierCAMPY | |
|---|---|---|---|---|
| Manufacturer | MeridianBioscience | Remel | MeridianBioscience | |
| Assay type | Lateral flow | EIA | EIA | |
| Intended use | ||||
| Qualitative/Quantitative | Qualitative | Qualitative | Qualitative | |
| Screening, diagnosticor 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 | |
| Species detected | ||||
| C. jejuni | Yes | Yes | Yes | |
| 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 lineNeg = no line | Pos = yellow colorNegative =colorless | Pos = definiteyellow colorNeg = colorless tovery faint yellow | |
| Calibrator | No | No | No | |
| Comparisonto predicatecont'd | Item | ImmunoCardSTAT! CAMPY | Predicate deviceProSpecTCampylobacter | Predicate devicePremier CAMPY |
| Equipment | Not needed | General laboratorysemiautomatedwasher (optional) | General laboratorysemiautomatedwasher (optional) | |
| General laboratoryspectrophotometer(optional) | General laboratoryspectrophotometer(optional) | |||
| StatFax microplateincubator/shaker(optional) | ||||
| Antibody sources | ||||
| Capture | Mousemonoclonal | Rabbit polyclonal | Mousemonoclonal | |
| Detector | Mousemonoclonal | Rabbit polyclonal | Mousemonoclonal | |
| 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 (dualwavelength) | N/A | Yes ≥ 0.140 | Yes ≥ 0.100 | |
| Negative (dualwavelength) | N/A | Yes < 0.100 | Yes < 0.100 | |
| Indeterminant (dualwavelength) | N/A | Yes 0.100 to0.139 | None |
:
.
{2}------------------------------------------------
Performance comparison - Nonclinical tests
Interference testing
Selected drugs and other nonmicrobial substances that might be present in stool samples from healthy persons or patients with signs and symptoms of gastroenteritis were added to three positive and three negative samples. The samples were inoculated with C. jejuni near the assay's limit of detection (LoD). The final concentrations of the substances in the samples were as follows: Barium sulfate (5 mg/mL); fecal fat (equivalent to 2.65 mg stearic plus 1.3 mg palmitic acids per mL), hemoglobin) (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-Bismol® (0.87 mg/mL), Prilosec® (0.5 mg/mL), Tagamet® (0.5 mg/mL), TUMS® (0.5 mg/mL), urine (5% V/V), and whole blood (5% v/v). The spiked samples were tested in parallel with an unspiked dilution control for reference. None of the potentially interfering substances met the criteria for an interferent.
Crossreactivity study
Microorqanisms that were present as normal intestinal flora or associated with gastroenteritis were evaluated as to their effects on assay performance. Fungus and bacteria were tested at final concentrations in human stool of 1.1 x 10° CFU/mL. Viruses were tested at final concentrations of 1.3 x 10 to 3.1 x 10 TCID5JmL. None of the following organisms in stool reacted with ImmunoCard STAT! CAMPY:
{3}------------------------------------------------
510(k) SUMMARY - ImmunoCard STAT! CAMPY
Aeromonas hydrophila, Bacteroides fragilis, Campylobacter fetus, Candida albicans, Citrobacter freundi, Clostridium difficile, C. perfringens, Enterobacter cloacae, Enterococcus faecalis, Escherichia coli, E. coli O157:H7, E. fergusonii, E. hermannii, Helicobacter pylori, Klebsiella pneumoniae, Lactococcus lactis, Listeria monocytogenes, Peptostreptococcus anaerobius, Plesiomonas shigelloides, Proteus vulgaris, Pseudomonas aeruginosa, P. fluorescens, Salmonella Groups B-E, Serratia marcescens, Shigella boydii, S. flexneri, S. sonnei, Staphylococcus aureus, S. epidermidis, Vibrio parahaemolyticus, Yersinia enterocolitica, Adenovirus Types 40 and 41, Coxsackievirus, Echovirus, Rotavirus
Performance comparison - Clinical tests
The performance of ImmunoCard STAT! CAMPY was established in clinical trials using bacterial culture as the reference comparator method. Three independent test sites located in the Midwestern and Southeastern regions of the United States tested a total of 421 qualified patient samples. Of these, 189 were retrospective frozen samples. Forty-nine percent were collected in a Cary Blair-based transport and preservative medium. The remaining samples were tested in the unpreserved state. Samples were collected from males (44%) and females (52%). In the case of 4% of the patients, the gender was not known. The age groups of the patients ranged from less than one month of age to 95 years. No differences in test performance were observed based on patient age or gender. The following tables show the assay performance by clinical site, patient age and sample type.
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% |
| CombinedSites | 52/53 | 98.1% | 90.1-99.7% | 353/368 | 95.9% | 93.4-97.5% |
Table 2 - Performance characteristics by patient age
| Patient Age | ICS/Culture | Positive Samples | Negative Samples | ||||
|---|---|---|---|---|---|---|---|
| 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 to2 years | 2/2 | 100% | 34.2-100% | 66/68 | 97.1% | 89.9-99.2% | |
| > 2 years to12 years | 5/5 | 100% | 56.6-100% | 88/93 | 94.6% | 88.0-97.7% | |
| > 12 years to21 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 |
{4}------------------------------------------------
| Positive Samples | Negative Samples | |||||
|---|---|---|---|---|---|---|
| SpecimenTypePreserved | 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% |
| SpecimenTypeUnpreserved | 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 3 – Performance characteristics by sample type (preserved vs unpreserved)
Table 4 – Performance characteristics of fresh and frozen samples
| SpecimenType Fresh | ICS/Culture | Positive Samples | Sensitivity% | 95% CI | Negative Samples | 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% | ||
| SpecimenType 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% |
: : : :
:
{5}------------------------------------------------
510(k) SUMMARY - ImmunoCard STAT! CAMPY
Analytical sensitivity
The analytical sensitivity of this assay for C. jejuni and C. coli was based on 45 tests for each measurand and with a stated probability (eg, 95%) of obtaining positive responses at the following levels of the measurands: C. jejuni 1.2 x 10 cells/mL; C. coli 3.0 x 10' cells/mL.
Reproducibility
Assay precision, 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 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.
As can be seen in Tables 5 - 9, the expected results were obtained 99.7% of the time.
{6}------------------------------------------------
Table 5. Site 1 data
| Sample ID | SampleQual.Result | Day 1Run 1DH | Day 1Run 2AML | Day 2Run 1DH | Day 2Run 2AML | Day 3Run 1DH | Day 3Run 2AML | Day 4Run 1DH | Day 4Run 2AML | Day 5Run 1DH | Day 5Run 2AML | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Pos |
| Moderate Positive 2 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 2 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 2 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Low Negative 2 | Neg | Neg | 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% | 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% | 100.0% |
Legend: DH etc = initials of person performing the test, Pos = positive, Neg = negative
.
Page 7 of 9
.
{7}------------------------------------------------
510(k) Summary -- Premier CAMPY
.
Table 6. Site 2 data
| Sample ID | SampleQual.Result | Day 1Run 1DM | Day 1Run 2JM | Day 2Run 1DM | Day 2Run 2JM | Day 3Run 1DM | Day 3Run 2JM | Day 4Run 1DM | Day 4Run 2JM | Day 5Run 1DM | Day 5Run 2JM | Sample ID | SampleQual.Result | Site 3 data generated with lot 751530.001 | Day 1Run 1KC | Day 1Run 2KMA | Day 2Run 1KC | Day 2Run 2KMA | Day 3Run 1KC | Day 3Run 2KMA | Day 4Run 1KC | Day 4Run 2KMA | Day 5Run 1KC | Day 5Run 2KMA | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive Control | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | 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 | 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 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 | Pos | Moderate Positive 2 | Pos | 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 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 | Pos | Low Positive 2 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | ||
| Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 3 | Pos | 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 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 2 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |||
| High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 3 | Neg | 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 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 | Low Negative 2 | Neg | 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% | 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% | 83.3% | 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
.
{8}------------------------------------------------
510(k) Summary -- Premier CAMP
Table 7. Site 3 data
egend: DH etc = initials of person performing the test, Pos = positive, Neg = negativ
Conclusions
Immunocorp STI. CAMPY.
-
lmmunoCard STAT! CAMPY:
{9}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
MAY 28 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Susan Rolih Senior Vice President, RA/QA Meridian Bioscience, Inc 3471 River Hills Drive Cincinnati, OH 45244
K090700 Re:
Trade/Device Name: ImmunoCard STAT! CAMPY Regulation Number: 21 CFR § 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LQP Dated: April 15th, 2009 Received: May 13th, 2009
Dear Ms. Rolih:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{10}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attajina
Sally A. Hojvat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Indication for Use
510(k) Number (if known):
KO90700
Device Name: ImmunoCard STAT! CAMPY
Indication 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.
Prescription Use × (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Conqurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Keddle W. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090700
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).