(67 days)
Not Found
No
The device description and performance studies describe a standard enzyme immunoassay (EIA) for antigen detection, with no mention of AI/ML algorithms or data processing beyond standard statistical analysis of clinical trial results.
No.
This device is an in vitro diagnostic device used to detect specific Campylobacter antigens in stool samples. It provides diagnostic information, but it does not treat or cure a disease, which is the function of a therapeutic device.
Yes
The device description explicitly states, "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..." It is used in conjunction with clinical symptoms and other tests to diagnose Campylobacter infection.
No
The device description clearly states it is a "microwell-based enzyme-linked immunoassay" and lists various reagents and components, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "Premier™ CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples..."
Furthermore, the "Device Description" section also begins with: "Premier CAMPY is an in vitro diagnostic, microwell-based enzyme-linked immunoassay..."
These statements clearly identify the device as an in vitro diagnostic.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LQP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
less than one month of age to 97 years
Intended User / Care Setting
hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The performance of Premier CAMPY was established in clinical trials using bacterial culture as the reference comparator method. Four independent test sites located in the Western, 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 10^8 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.
Clinical tests:
The performance of Premier CAMPY was established in clinical trials using bacterial culture as the reference comparator method. Four independent test sites tested a total of 2073 qualified patient samples.
Sensitivity and Specificity results based on clinical site, patient age, and sample type were provided in tables.
Site 1: Sensitivity 95.7% (22/23), Specificity 97.9% (189/193)
Site 2: Sensitivity N/A (0/0), Specificity 100% (51/51)
Site 3: Sensitivity 96.3% (26/27), Specificity 94.6% (1429/1511)
Site 4: Sensitivity 100% (11/11), Specificity 99.2% (255/257)
Total Sites: Sensitivity 96.7% (59/61), Specificity 95.6% (1924/2012)
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 10^6 cells/mL; C. coli 8.0 x 10^5 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. The expected results were obtained 100% of the time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 96.7% (95% CI: 88.8 – 99.1%)
Specificity: 95.6% (95% CI: 94.6 – 96.4%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 | |
|---|---|---|---|
| ProSpecT | |||
| Campylbacter | |||
| Assay type | EIA | EIA | |
| Intended use | |||
| Qualitative/Quantitative | Qualitative | Qualitative | |
| Screening, diagnostic | |||
| or 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 = definite | ||
| yellow color | |||
| Neg = Colorless to | |||
| very faint yellow | Pos = yellow color | ||
| Negative = Colorless | |||
| Calibrator | No | No | |
| Equipment | General laboratory | ||
| semiautomated | |||
| washer (optional) | |||
| General laboratory | |||
| spectrophotometer | |||
| (optional) | General laboratory | ||
| semiautomated | |||
| washer (optional) | |||
| General laboratory | |||
| spectrophotometer | |||
| (optional) | |||
| StatFax microplate | |||
| incubator/shaker | |||
| (optional) | |||
| Comparison to | |||
| predicate cont'd | Item | Premier CAMPY | Predicate Device |
| ProSpecT | |||
| Campylobacter | |||
| Antibody sources | |||
| Solid phase | |||
| (microplate) | Mouse monoclonal | Rabbit polyclonal | |
| Enzyme | |||
| conjugate | Mouse monoclonal | Rabbit polyclonal | |
| Sample Types | |||
| Human stool | |||
| (direct) | Yes | Yes | |
| Broth culture | No | Yes | |
| Endpoint | |||
| determinations | |||
| Positive (dual | |||
| wavelength) | Yes ≥ 0.100 | Yes ≥ 0.140 | |
| Negative (dual | |||
| wavelength) | Yes 1 month to | ||
| 2 years | 3/3 | 100% | 43.9 - 100% |
| >2 years to | |||
| 12 years | 5/5 | 100% | 56.6 – 100% |
| >12 years to | |||
| 21 years | 2/2 | 100% | 34.2 - 100% |
| >21 years | 32/34 | 94.1% | 80.9 - 98.4% |
| Not Defined | 17/17 | 100% | 81.6 - 100% |
4
| Positive Samples | Negative Samples | |||||
|---|---|---|---|---|---|---|
| Specimen | ||||||
| Type | 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 | Sample
Qual.
Result | Lot under test - 618096.003 | | Day 1
Run 1
TECH 1 | Day 1
Run 2
TECH 2 | Day 2
Run 1
TECH 1 | Day 2
Run 2
TECH 2 | Day 3
Run 1
TECH 1 | Day 3
Run 2
TECH 2 | Day 4
Run 1
TECH 1 | Day 4
Run 2
TECH 2 | Day 5
Run 1
TECH 1 | Day 5
Run 2
TECH 2 | Sample ID | Qual.
Result | | Day 1
Run 1
TECH 3 | Day 1
Run 2
TECH 4 | Day 2
Run 1
TECH 3 | Day 2
Run 2
TECH 4 | Day 3
Run 1
TECH 3 | Day 3
Run 2
TECH 5 | Day 4
Run 1
TECH 3 | Day 4
Run 2
TECH 4 | Day 5
Run 1
TECH 3 | Day 5
Run 2
TECH 6 | Sample ID | Sample
Qual.
Result | Day 1
Run 1
TECH 7 | Day 1
Run 2
TECH 8 | Day 2
Run 1
TECH 7 | Day 2
Run 2
TECH 8 | Day 3
Run 1
TECH 7 | Day 3
Run 2
TECH 8 | Day 4
Run 1
TECH 7 | Day 4
Run 2
TECH 8 | Day 5
Run 1
TECH 7 | Day 5
Run 2
TECH 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
| Panel
Members | Sample
N | Grand
Mean
AL | Between-Day
SD | Between-Day
%CV | Between-Run
SD | Between-Run
%CV | Between-Site
SD | Between-Site
%CV | Total
SD | 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
| Panel
Members | Sample
N | Grand
Mean
AL | 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
9
- B. Site B
·
| Panel
Members | Sample
N | Grand
Mean
AL | 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
| Panel
Members | Sample
N | Grand
Mean
AL | 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
10
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
11
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
12
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