(67 days)
Premier™ CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Premier CAMPY is an in vitro diagnostic, microwell-based enzyme-linked immunoassay for the detection of common antigens found on Campylobacter jejuni and C. coli 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 Premier CAMPY microwells coated with specific antibodies (capture antibodies). Premier CAMPY Enzyme Conjugate, Premier CAMPY Sample Diluent/Negative Control, Premier 20X Wash Buffer III, Premier Substrate Solution I, Premier Stop Solution I and Premier CAMPY Positive Control.
No calibrators are used with this device.
Acceptance Criteria and Device Performance for Premier CAMPY
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Overall) |
|---|---|---|
| Clinical Sensitivity | High (exact numeric not specified, but typically >90% desired for diagnostic tests) | 96.7% (95% CI: 88.8 – 99.1%) |
| Clinical Specificity | High (exact numeric not specified, but typically >90% desired for diagnostic tests) | 95.6% (95% CI: 94.6 – 96.4%) |
| Analytical Sensitivity (C. jejuni) | Achievable at a certain cell/mL concentration | 1.2 x 10^5 cells/mL (with 95% probability of positive response) |
| Analytical Sensitivity (C. coli) | Achievable at a certain cell/mL concentration | 8.0 x 10^5 cells/mL (with 95% probability of positive response) |
| Reproducibility | Expected results obtained consistently (100% agreement shown) | 100% correlation with expected results across sites, days, and technologists. Total CVs for controls and samples generally below 25%, indicating good precision. |
| Interference | No significant interference from common substances in stool | None of the tested substances (Barium sulfate, fecal fat, hemoglobin, Imodium AD®, Kaopectate®, mucin, Mylanta®, Pepto-Bismol®, Prilosec®, Tagamet®, TUMS®, whole blood) met criteria for an interferent. |
| Cross-reactivity | No cross-reactivity with common intestinal flora or other gastroenteritis-associated microorganisms | None of the 30+ tested microorganisms (including other Campylobacter species, common bacteria, fungi, and viruses) reacted with Premier CAMPY. |
Study Proving Device Meets Acceptance Criteria:
The device's performance was established through a series of non-clinical (analytical) tests and clinical trials.
2. Sample Size Used for the Test Set and Data Provenance:
-
Clinical Test Set:
- Total Sample Size: 2073 qualified patient samples.
- Data Provenance: Four independent test sites located in the Western, Midwestern, and Southeastern regions of the United States.
- Retrospective/Prospective: Majority (1862/2073) were collected in a Cary Blair-based transport and preservative medium and tested prospectively (implied by "collected in a Cary Blair-based transport and preservative medium" and "The remaining 211 samples were tested in the unpreserved state"). 166 samples were explicitly stated as retrospective frozen samples.
-
Non-clinical (Interference and Cross-reactivity) Test Set:
- Interference Testing: Not specified as a patient sample size, but involved "three positive and three negative samples" inoculated with C. jejuni, tested in triplicate.
- Cross-reactivity Study: Not specified as a patient sample size, but involved "Microorganisms that were present as normal intestinal flora or associated with gastroenteritis" tested at specific concentrations in human stool. The number of unique organisms tested was over 30.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical test set. The ground truth method, bacterial culture, is typically performed by trained laboratory personnel, but no specifics on expert involvement in interpreting these cultures for ground truth are provided.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the clinical test set. It states that "bacterial culture" was used as the "reference comparator method." This implies that the bacterial culture results were directly used as the ground truth without further expert adjudication or consensus with the Premier CAMPY results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed for laboratory use, not an interpretation aid for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The clinical performance data presented (Sensitivity and Specificity against bacterial culture) reflects the performance of the Premier CAMPY assay as an algorithm-only device, without human intervention in the result interpretation beyond what is inherent in standard laboratory EIA testing procedures (e.g., reading spectrophotometric values).
7. Type of Ground Truth Used:
For the clinical performance evaluation, the ground truth used was bacterial culture.
8. Sample Size for the Training Set:
The document does not specify a training set sample size. As an in vitro diagnostic (EIA) intended for detection of specific antigens, it's unlikely to involve machine learning models that require a distinct "training set" in the conventional sense. The "training" of such assays is defined by their manufacturing process, reagent formulation, and quality control, rather than algorithmic training on patient data.
9. How the Ground Truth for the Training Set was Established:
Since there is no explicit "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for a training set does not directly apply here. The device's performance relies on its biochemical properties and how well its antibodies bind to the target antigens. The development process would involve extensive analytical validation against known positive and negative samples, but these are part of the assay's development and analytical characterization, not typically labeled as a "training set" with ground truth for algorithm learning.
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K0r346y
510(k) SUMMARY - Premier CAMPY
JAN 30 2009
| 510(k) number: | |
|---|---|
| Submitter: | Meridian Bioscience Inc. |
| Submitter's address: | 3471 River Hills Drive |
| Cincinnati, OH 45244 | |
| Contact: | Susan Rolih |
| Contact number: | (513) 271 3700 |
| Date of preparation: | November 18, 2008 |
| Device name: | Premier CAMPY |
| Common name: | EIA for Campylobacter |
| Classification name: | Campylobacter ssp. |
| LQP, CFR section 866.3110 | |
| Predicate device: | K982315, ProSpecT Campylobacter EIA |
| Reference comparator | Bacterial culture |
Premier CAMPY is an in vitro diagnostic, microwell-based enzyme-linked Description of the immunoassay for the detection of common antigens found on Campylobacter device: jejuni and C. coli 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. lt 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 Premier CAMPY microwells coated with specific antibodies (capture antibodies). Premier CAMPY Enzyme Conjugate, Premier CAMPY Sample Diluent/Negative Control, Premier 20X Wash Buffer III, Premier Substrate Solution I, Premier Stop Solution I and Premier CAMPY Positive Control.
No calibrators are used with this device.
Intended use:
Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
{1}------------------------------------------------
Comparison to predicate device:
.
. . . . .
.
.. ---
.
| Item | Premier CAMPY | Predicate Device | |
|---|---|---|---|
| ProSpecTCampylbacter | |||
| Assay type | EIA | EIA | |
| Intended use | |||
| Qualitative/Quantitative | Qualitative | Qualitative | |
| Screening, diagnosticor identification test | Diagnostic | Diagnostic | |
| Calibrator | No | No | |
| Monitoring therapy | No | No | |
| Reagents/components | |||
| Microwells | Yes | Yes | |
| Sample Diluent | Yes | Yes | |
| Enzyme Conjugate | Yes | Yes | |
| Wash Buffer | Yes | Yes | |
| Substrate | Yes | Yes | |
| Stop Solution | Yes | Yes | |
| Positive Control | Yes | Yes | |
| Negative Control | Yes | Yes | |
| Species detected | |||
| C. jejuni | Yes | Yes | |
| C. coli | Yes | Unk | |
| C. lari | No | No | |
| C. fetus | No | No | |
| Reading method | |||
| Visual | Yes | Yes | |
| Spectrophotometric | Yes | Yes | |
| End point | Pos = definiteyellow colorNeg = Colorless tovery faint yellow | Pos = yellow colorNegative = Colorless | |
| Calibrator | No | No | |
| Equipment | General laboratorysemiautomatedwasher (optional)General laboratoryspectrophotometer(optional) | General laboratorysemiautomatedwasher (optional)General laboratoryspectrophotometer(optional)StatFax microplateincubator/shaker(optional) | |
| Comparison topredicate cont'd | Item | Premier CAMPY | Predicate DeviceProSpecTCampylobacter |
| Antibody sources | |||
| Solid phase(microplate) | Mouse monoclonal | Rabbit polyclonal | |
| Enzymeconjugate | Mouse monoclonal | Rabbit polyclonal | |
| Sample Types | |||
| Human stool(direct) | Yes | Yes | |
| Broth culture | No | Yes | |
| Endpointdeterminations | |||
| Positive (dualwavelength) | Yes ≥ 0.100 | Yes ≥ 0.140 | |
| Negative (dualwavelength) | Yes < 0.100 | Yes < 0.100 | |
| Indeterminant(dual wavelength) | None | Yes 0.100 to 0.13 |
... . ........................................................................................................................................................................
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page 2 of 10
and the contract and the same of the comments of the comments
·
.. . . . .
{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), whole blood (5% v/v). The soiked samples were tested in parallel with an unspiked dilution control for reference. All samples were tested in triplicate. None of the potentially interfering substances met the criteria for an interferent.
Crossreactivity study
Microorganisms that were bresent 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 108 CFU/mL. Viruses were tested at final concentrations of 1.3 x 10 to 3.1 x 10 TCIDs (mL. None of the following organisms in stool reacted with Premier CAMPY:
Aeromonas hydrophila, Bacteroides fragilis, Campylobacter fetus, C. lari, Candida albicans, 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 shipelloides. Proteus vulgaris, Pseudomonas aeruginosa, P. fluorescens, Salmonella Groups B-E. Serratia liquefaciens, S. marcescens, Shigella boydii, S. dysenteriae, S. flexneri, S. sonnei, Staphylococcus aureus, S. epidermidis, Vibrio parahaemolyticus, Yersinia enterocolitica, Adenovirus Types 40 and 41, Coxsackievirus, Echovirus, Rotavirus
{3}------------------------------------------------
Performance comparison - Clinical tests
The performance of Premier CAMPY was established in clinical trials using bacterial culture as Four independent test sites located in the Western, the reference comparator method. Midwestern and Southeastern regions of the United States tested a total of 2073 qualified patient samples. Of these, 166 were retrospective frozen samples. The majority (1862/2073) were collected in a Cary Blair-based transport and preservative medium. The remaining 211 samples were tested in the unpreserved state. Samples were collected from males (41%) and females (57%). In the case of 2% of the patients, the sex was not known. The age groups of the palients ranged from less than one month of age to 97 years. No differences in test performance were observed based on patient age or sex. 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 | Premier/Culture | Sensitivity% | 95% CI | Premier/Culture | Specificity% | 95% CI | |
| Site 1 | 22/23 | 95.7% | 79.0 – 99.2% | 189/193 | 97.9% | 94.8 – 99.2% | |
| Site 2 | 0/0 | N/A | N/A | 51/51 | 100% | 93.0 – 100% | |
| Site 3 | 26/27 | 96.3% | 81.7 – 99.3% | 1429/1511 | 94.6% | 93.3 – 95.6% | |
| Site 4 | 11/11 | 100% | 74.1 – 100% | 255/257 | 99.2% | 97.2 – 99.8% | |
| Total Sites | 59/61 | 96.7% | 88.8 – 99.1% | 1924/2012 | 95.6% | 94.6 – 96.4% |
Table 2. Performance characteristics by patient age
| Positive Samples | Negative Samples | |||||
|---|---|---|---|---|---|---|
| Patient Age | Premier/Culture | Sensitivity% | 95% CI | Premier/Culture | Specificity% | 95% CI |
| Birth to 1month | 0/0 | N/A | N/A | 12/13 | 92.3% | 66.7 - 98.6% |
| >1 month to2 years | 3/3 | 100% | 43.9 - 100% | 338/348 | 97.1% | 94.8 - 98.4% |
| >2 years to12 years | 5/5 | 100% | 56.6 – 100% | 374/388 | 96.4% | 94.0 - 97.8% |
| >12 years to21 years | 2/2 | 100% | 34.2 - 100% | 139/145 | 95.9% | 91.3 - 98.1% |
| >21 years | 32/34 | 94.1% | 80.9 - 98.4% | 1052/1109 | 94.9% | 93.4 - 96.5% |
| Not Defined | 17/17 | 100% | 81.6 - 100% | 9/9 | 100% | 70.1 - 100% |
{4}------------------------------------------------
| Positive Samples | Negative Samples | |||||
|---|---|---|---|---|---|---|
| SpecimenType | Premier/Culture | Sensitivity% | 95% CI | Premier/Culture | Specificity% | 95% CI |
| Preserved | 42/43 | 97.7% | 87.9 - 99.6% | 1733/1819 | 95.3% | 94.2 - 96.2% |
| Unpreserved | 17/18 | 94.4% | 74.2 - 99.0% | 191/193 | 99.0% | 96.3 - 99.7% |
Table 3. Performance characteristics by sample type (preserved vs unpreserved)
Table 4. Performance of fresh vs frozen samples
| Positive Samples | Negative Samples | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Fresh/Frozen | Premier/Culture | Sensitivity% | 95% CI | Premier/Culture | Specificity% | 95% CI | |||
| Fresh | 17/18 | 94.4% | 74.2 - 99.0% | 1810/1889 | 95.8% | 94.8 - 96.6% | |||
| Frozen | 42/43 | 97.7% | 87.9 - 99.6% | 114/123 | 92.7% | 86.7 - 96.1% |
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 8.0 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 100% of the time.
{5}------------------------------------------------
510(k) Summary -- Premier CAMPY
Table 5. Site A data
| Sample ID | SampleQual.Result | Lot under test - 618096.003 | Day 1Run 1TECH 1 | Day 1Run 2TECH 2 | Day 2Run 1TECH 1 | Day 2Run 2TECH 2 | Day 3Run 1TECH 1 | Day 3Run 2TECH 2 | Day 4Run 1TECH 1 | Day 4Run 2TECH 2 | Day 5Run 1TECH 1 | Day 5Run 2TECH 2 | Sample ID | Qual.Result | Day 1Run 1TECH 3 | Day 1Run 2TECH 4 | Day 2Run 1TECH 3 | Day 2Run 2TECH 4 | Day 3Run 1TECH 3 | Day 3Run 2TECH 5 | Day 4Run 1TECH 3 | Day 4Run 2TECH 4 | Day 5Run 1TECH 3 | Day 5Run 2TECH 6 | Sample ID | SampleQual.Result | Day 1Run 1TECH 7 | Day 1Run 2TECH 8 | Day 2Run 1TECH 7 | Day 2Run 2TECH 8 | Day 3Run 1TECH 7 | Day 3Run 2TECH 8 | Day 4Run 1TECH 7 | Day 4Run 2TECH 8 | Day 5Run 1TECH 7 | Day 5Run 2TECH 8 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PC | N/A | 2.705 | 1.480 | 2.295 | 2.277 | 2.285 | 1.695 | 2.214 | 2.068 | 2.474 | 2.057 | PC | N/A | 1.577 | 1.686 | 2.117 | 1.974 | 1.278 | 1.802 | 1.747 | 1.548 | 0.922 | 2.051 | PC | N/A | 2.165 | 2.003 | 2.145 | 2.144 | 1.993 | 2.068 | 2.109 | 1.916 | 2.210 | 1.854 | |||
| NC | N/A | 0.020 | 0.017 | 0.025 | 0.019 | 0.020 | 0.019 | 0.023 | 0.025 | 0.021 | 0.021 | NC | N/A | 0.011 | 0.003 | 0.015 | 0.014 | 0.022 | 0.011 | 0.018 | 0.009 | 0.018 | 0.016 | NC | N/A | 0.034 | 0.039 | 0.032 | 0.034 | 0.027 | 0.034 | 0.026 | 0.032 | 0.031 | 0.030 | |||
| MP 1 | 1.725 | 1.743 | 1.767 | 1.620 | 1.718 | 1.931 | 1.948 | 2.098 | 1.851 | 2.170 | MP 1 | 1.635 | 1.769 | 2.542 | 1.977 | 2.017 | 1.853 | 0.820 | 1.661 | 1.515 | 1.542 | MP 1 | 1.952 | 1.035 | 1.179 | 2.293 | 2.144 | 1.584 | 1.610 | 1.957 | 1.442 | 1.836 | 1.614 | |||||
| MP 2 | 1.952 | 1.753 | 1.698 | 1.656 | 1.518 | 1.755 | 1.895 | 1.938 | 1.986 | 1.931 | 2.191 | MP 2 | 1.952 | 1.967 | 1.801 | 2.393 | 2.104 | 1.939 | 1.757 | 1.399 | 1.831 | 1.532 | 1.563 | MP 2 | 1.006 | 1.158 | 2.188 | 2.467 | 1.615 | 1.691 | 2.062 | 1.515 | 1.656 | 1.811 | ||||
| LP 1 | 0.240 | 0.205 | 0.170 | 0.153 | 0.168 | 0.211 | 0.205 | 0.245 | 0.220 | 0.254 | LP 1 | 0.214 | 0.195 | 0.269 | 0.239 | 0.283 | 0.229 | 0.218 | 0.219 | 0.216 | 0.200 | LP 1 | 0.197 | 0.116 | 0.185 | 0.290 | 0.308 | 0.213 | 0.209 | 0.222 | 0.181 | 0.206 | 0.252 | |||||
| LP 2 | 0.197 | 0.186 | 0.196 | 0.153 | 0.164 | 0.146 | 0.191 | 0.225 | 0.225 | 0.172 | 0.234 | LP 2 | 0.197 | 0.242 | 0.177 | 0.292 | 0.245 | 0.264 | 0.276 | 0.179 | 0.216 | 0.222 | 0.178 | LP 2 | 0.128 | 0.159 | 0.310 | 0.327 | 0.232 | 0.212 | 0.239 | 0.195 | 0.213 | 0.223 | ||||
| LP 3 | 0.187 | 0.203 | 0.161 | 0.168 | 0.152 | 0.205 | 0.192 | 0.243 | 0.171 | 0.239 | LP 3 | 0.199 | 0.205 | 0.286 | 0.266 | 0.260 | 0.266 | 0.177 | 0.223 | 0.196 | 0.194 | LP 3 | 0.116 | 0.153 | 0.269 | 0.303 | 0.208 | 0.221 | 0.206 | 0.180 | 0.207 | 0.201 | ||||||
| HN 1 | 0.026 | 0.040 | 0.026 | 0.032 | 0.035 | 0.039 | 0.032 | 0.045 | 0.041 | 0.059 | HN 1 | 0.039 | 0.020 | 0.057 | 0.042 | 0.055 | 0.051 | 0.044 | 0.035 | 0.044 | 0.034 | HN 1 | 0.054 | 0.036 | 0.058 | 0.072 | 0.085 | 0.055 | 0.068 | 0.052 | 0.059 | 0.058 | 0.053 | |||||
| HN 2 | 0.054 | 0.027 | 0.056 | 0.026 | 0.027 | 0.023 | 0.046 | 0.033 | 0.038 | 0.034 | 0.059 | HN 2 | 0.054 | 0.096 | 0.031 | 0.040 | 0.061 | 0.052 | 0.060 | 0.040 | 0.043 | 0.047 | 0.035 | HN 2 | 0.050 | 0.060 | 0.070 | 0.080 | 0.061 | 0.052 | 0.051 | 0.050 | 0.061 | 0.058 | ||||
| HN 3 | 0.026 | 0.038 | 0.026 | 0.029 | 0.019 | 0.047 | 0.026 | 0.040 | 0.039 | 0.062 | HN 3 | 0.068 | 0.017 | 0.048 | 0.036 | 0.049 | 0.041 | 0.048 | 0.053 | 0.048 | 0.038 | HN 3 | 0.045 | 0.064 | 0.070 | 0.066 | 0.055 | 0.055 | 0.053 | 0.047 | 0.059 | 0.048 | ||||||
| WN 1 | 0.013 | 0.016 | 0.014 | 0.017 | 0.014 | 0.014 | 0.011 | 0.023 | 0.018 | 0.012 | WN 1 | 0.034 | -0.008 | 0.014 | 0.013 | 0.018 | 0.010 | 0.018 | 0.017 | 0.018 | 0.010 | WN 1 | 0.019 | 0.028 | 0.034 | 0.027 | 0.031 | 0.025 | 0.027 | 0.032 | 0.026 | 0.029 | 0.028 | |||||
| WN 2 | 0.019 | 0.015 | 0.018 | 0.013 | 0.013 | 0.011 | 0.011 | 0.015 | 0.017 | 0.016 | 0.015 | WN 2 | 0.019 | 0.015 | 0.008 | 0.015 | 0.018 | 0.020 | -0.003 | 0.015 | 0.015 | 0.015 | 0.011 | WN 2 | 0.033 | 0.034 | 0.028 | 0.030 | 0.025 | 0.031 | 0.030 | 0.026 | 0.031 | 0.026 | ||||
| Average high negative value | 0.026 | 0.045 | 0.026 | 0.029 | 0.026 | 0.044 | 0.030 | 0.041 | 0.038 | 0.060 | Average high negative value | 0.068 | 0.023 | 0.048 | 0.046 | 0.052 | 0.051 | 0.044 | 0.044 | 0.046 | 0.036 | Average high negative value | 0.044 | 0.061 | 0.071 | 0.077 | 0.057 | 0.058 | 0.052 | 0.052 | 0.059 | 0.053 | ||||||
| Average low positive value | 0.204 | 0.201 | 0.161 | 0.162 | 0.155 | 0.202 | 0.207 | 0.238 | 0.188 | 0.242 | Average low positive value | 0.218 | 0.192 | 0.282 | 0.250 | 0.269 | 0.257 | 0.191 | 0.219 | 0.211 | 0.191 | Average low positive value | 0.120 | 0.166 | 0.290 | 0.313 | 0.218 | 0.214 | 0.222 | 0.185 | 0.209 | 0.225 | ||||||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 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% | 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% | 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% | tion 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: PC = positive control, NC = negative control; MP = moderate positive; HN = high negative; WN = weak or low negative
Page 6 of 10
{6}------------------------------------------------
510(k) Summary -- Premier CAMPY
、"
์able 6. Site B data
·
Legend: PC = positive control, NC = negative control; MP = moderate positive; HN = high negative; WN = weak or low negative
Page 7 of 10
{7}------------------------------------------------
510(k) Summary -- Premier CAMPY
Table 7. Site C data
· ·
egend: PC = positive control, NC = negative controj; MP = moderate poslive; HN = high negative; WN = weak or low negative
Page 8 of 10
. .
{8}------------------------------------------------
able 8. Intra- and inter-assay variability data for all sites
| PanelMembers | SampleN | GrandMeanAL | Between-DaySD | Between-Day%CV | Between-RunSD | Between-Run%CV | Between-SiteSD | Between-Site%CV | TotalSD | Total%CV |
|---|---|---|---|---|---|---|---|---|---|---|
| PC | 30 | 1.962 | 0.115 | 5.9% | 0.157 | 8.0% | 0.257 | 13.1% | 0.361 | 18.4% |
| MP 1 | 30 | 1.753 | 0.200 | 11.4% | 0.206 | 11.7% | 0.095 | 5.4% | 0.354 | 20.2% |
| MP 2 | 30 | 1.793 | 0.174 | 9.7% | 0.168 | 9.4% | 0.066 | 3.7% | 0.321 | 17.9% |
| LP 1 | 30 | 0.218 | 0.017 | 7.7% | 0.017 | 7.7% | 0.011 | 4.8% | 0.041 | 18.6% |
| LP 2 | 30 | 0.214 | 0.024 | 11.3% | 0.023 | 10.9% | 0.022 | 10.1% | 0.048 | 22.4% |
| LP 3 | 30 | 0.209 | 0.024 | 11.5% | 0.025 | 11.9% | 0.018 | 8.5% | 0.043 | 20.6% |
= low = = =========================================================================================================================================================================
Tables 9A-C. Intra- and inter-assay varlability data by site
A. Site A
| PanelMembers | SampleN | GrandMeanAL | Between-Day | Between-Tech | Total | |||
|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | |||
| PC | 10 | 2.155 | 0.123 | 5.7% | 0.339 | 15.7% | 0.356 | 16.5% |
| MP 1 | 10 | 1.857 | 0.153 | 8.3% | 0.078 | 4.2% | 0.178 | 9.6% |
| MP 2 | 10 | 1.832 | 0.188 | 10.2% | 0.036 | 2.0% | 0.194 | 10.6% |
| LP 1 | 10 | 0.207 | 0.031 | 15.0% | 0.009 | 4.4% | 0.035 | 16.7% |
| LP 2 | 10 | 0.189 | 0.027 | 14.1% | 0.018 | 9.6% | 0.031 | 16.5% |
| LP 3 | 10 | 0.192 | 0.021 | 10.9% | 0.028 | 14.4% | 0.031 | 16.2% |
Page 9 of 10
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- B. Site B
·
| PanelMembers | SampleN | GrandMeanAL | Between-Day | Between-Tech | Total | |||
|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | |||
| PC | 10 | 1.670 | 0.220 | 13.2% | 0.201 | 12.0% | 0.365 | 21.8% |
| MP 1 | 10 | 1.733 | 0.388 | 22.4% | 0.039 | 2.2% | 0.440 | 25.4% |
| MP 2 | 10 | 1.829 | 0.276 | 15.1% | 0.025 | 1.3% | 0.293 | 16.0% |
| LP 1 | 10 | 0.228 | 0.025 | 11.0% | 0.017 | 7.3% | 0.028 | 12.4% |
| LP 2 | 10 | 0.229 | 0.037 | 16.1% | 0.015 | 6.6% | 0.042 | 18.3% |
| LP 3 | 10 | 0.227 | 0.039 | 17.2% | 0.005 | 2.2% | 0.039 | 17.0% |
C. Site C
| PanelMembers | SampleN | GrandMeanAL | Between-Day | Between-Tech | Total | |||
|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | |||
| PC | 10 | 2.061 | 0.054 | 2.6% | 0.090 | 4.4% | 0.116 | 5.6% |
| MP 1 | 10 | 1.669 | 0.396 | 23.7% | 0.101 | 6.1% | 0.399 | 23.9% |
| MP 2 | 10 | 1.717 | 0.443 | 25.8% | 0.016 | 0.9% | 0.445 | 25.9% |
| LP 1 | 10 | 0.218 | 0.054 | 24.6% | 0.012 | 5.7% | 0.055 | 25.4% |
| LP 2 | 10 | 0.224 | 0.062 | 27.8% | 0.001 | 0.4% | 0.060 | 27.0% |
| LP 3 | 10 | 0.206 | 0.054 | 26.3% | 0.007 | 3.6% | 0.053 | 25.6% |
Legend: N = number, AL = all, SD = standard deviation, CV = coefficient of variation, PC = positive control, MP = moderate positive, LP = low positive
Conclusions
. Premier CAMPY:
- Can be used to detect C. jejuni and C. coli. in human stool.
-
2 The test is diagnostic for the presence of C. jejuni and C. coli.
Page 10 of 10
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Susan Rolih Senior Vice President, RA/OA Meridian Bioscience, Inc 3471 River Hills Drive Cincinnati, OH 45244
Re: K083464
Trade/Device Name: Premier CAMPY Regulation Number: 21 CFR § 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LOP Dated: December 15th, 2008 Received: December 19th, 2008
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.
JAN 3 0 2009
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).
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
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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 vours.
Sally attayna
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
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Indication(s) for Use
510(k) Number (if known):
Device Name: Premier CAMPY
Indication For Use:
Premier™ CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Prescription Use X (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)
.
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Lueddie Mc-Cole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083464
§ 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).