(72 days)
K982315, ProSpecT Campylobacter EIA
Bacterial culture
No
The device description and performance studies focus on an immunochromatographic rapid test for antigen detection, with no mention of AI or ML technologies.
No.
The device is a diagnostic test used to detect specific Campylobacter antigens. It provides information for diagnosis but does not treat or prevent disease.
Yes
The device is explicitly described as a "rapid test for the qualitative detection of specific Campylobacter antigens in human stool." It is used "to diagnose Campylobacter infection" and its results are "to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures," all of which point to its role in diagnosing a medical condition.
No
The device description clearly states it is an immunochromatographic rapid test consisting of physical components like test devices, sample diluent, and positive control. This indicates it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of specific Campylobacter antigens in human stool." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a patient's health.
- Device Description: It describes a test that uses antibodies and colloidal gold to detect antigens in a stool sample, which is a classic method for in vitro diagnostic testing.
- Anatomical Site: The sample is human stool, which is a biological specimen.
- Intended User / Care Setting: While not for point-of-care, it's intended for use in laboratory settings (hospital, reference, etc.), which are typical environments for IVD testing.
- Performance Studies: The document details clinical trials and performance metrics (Sensitivity, Specificity), which are standard for evaluating the accuracy and reliability of IVD devices.
- Predicate Device(s): The mention of predicate devices (ProSpecT Campylobacter EIA; Premier CAMPY) which are also IVDs, further supports that this device falls into the same category.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient 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.
Product codes
LQP
Device Description
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
human stool
Indicated Patient Age Range
The age groups of the patients ranged from less than one month of age to 95 years.
Intended User / Care Setting
The device is intended for use in clinical hospital, reference, regional, private or state laboratory settings.
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to predicate device:
The ImmunoCard STAT! CAMPY is a qualitative diagnostic lateral flow assay without calibrators, intended to detect C. jejuni and C. coli in human stool. It uses mouse monoclonal antibodies for capture and detection.
Performance comparison - Nonclinical tests:
Interference testing: Selected drugs and nonmicrobial substances (Barium sulfate, fecal fat, hemoglobin, Imodium AD®, Kaopectate®, mucin, Mylanta®, Pepto-Bismol®, Prilosec®, Tagamet®, TUMS®, urine, whole blood) were added to positive and negative samples, then inoculated with C. jejuni near the assay's limit of detection (LoD). None of the substances met the criteria for an interferent.
Crossreactivity study: Microorganisms (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) were tested at specified concentrations in human stool. None of these organisms reacted with ImmunoCard STAT! CAMPY.
Performance comparison - Clinical tests:
The performance was established in clinical trials using bacterial culture as the reference comparator method.
Sample size: 421 qualified patient samples from three independent test sites (189 retrospective frozen samples; 49% in Cary Blair-based transport, rest unpreserved).
Key results:
Combined Sites: Sensitivity 98.1% (90.1-99.7% CI), Specificity 95.9% (93.4-97.5% CI).
No differences in test performance were observed based on patient age or gender.
Analytical sensitivity: C. jejuni 1.2 x 10 cells/mL; C. coli 3.0 x 10' cells/mL (stated probability 95%).
Reproducibility: Evaluated with a reference panel (moderate positive, negative, high negative, low positive samples) over five days, twice daily, at three sites by at least two technologists. Expected results were obtained 99.7% of the time across all sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Combined Sites:
Sensitivity: 98.1%
Specificity: 95.9%
Site 1:
Sensitivity: 100% (95% CI: 81.6-100%)
Specificity: 96.8% (95% CI: 91.1-98.9%)
Site 2:
Sensitivity: 94.7% (95% CI: 75.4-99.1%)
Specificity: 96.3% (95% CI: 91.6-98.4%)
Site 3:
Sensitivity: 100% (95% CI: 81.6-100%)
Specificity: 94.9% (95% CI: 89.9-97.5%)
Predicate Device(s)
K982315, ProSpecT Campylobacter EIA
Reference Device(s)
Bacterial culture
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| 510(k) number: | K090700 | |
|---|---|---|
| Submitter: | Meridian Bioscience: Inc. | MAY 28 2009 |
| Submitter's address: | 3471 River Hills Drive | |
| Cincinnati, 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 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. | |
| Intended use: | ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the
detection 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.
1
Comparison to predicate device:
・
| Item | ImmunoCard
STATI CAMPY | Predicate device
ProSpecT
Campylobacter | Predicate Device
Premier
CAMPY | |
|-------------------------------------------------|--------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------|
| Manufacturer | Meridian
Bioscience | Remel | Meridian
Bioscience | |
| Assay type | Lateral flow | EIA | EIA | |
| Intended use | | | | |
| Qualitative/Quantitative | Qualitative | Qualitative | Qualitative | |
| Screening, diagnostic
or identification test | Diagnostic | Diagnostic | Diagnostic | |
| Calibrator | No | No | No | |
| Monitoring therapy | No | No | No | |
| Reagents/components | | | | |
| Microwells | No | Yes | Yes | |
| Sample Diluent | Yes | Yes | Yes | |
| Enzyme Conjugate | No | Yes | Yes | |
| Wash Buffer | No | Yes | Yes | |
| Substrate | No | Yes | Yes | |
| Stop Solution | No | Yes | Yes | |
| Positive Control | Yes | Yes | Yes | |
| Negative Control | Yes | Yes | Yes | |
| Test Device | Yes | No | No | |
| 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 line
Neg = no line | Pos = yellow color
Negative =
colorless | Pos = definite
yellow color
Neg = colorless to
very faint yellow | |
| Calibrator | No | No | No | |
| Comparison
to predicate
cont'd | Item | ImmunoCard
STAT! CAMPY | Predicate device
ProSpecT
Campylobacter | Predicate device
Premier CAMPY |
| | Equipment | Not needed | General laboratory
semiautomated
washer (optional) | General laboratory
semiautomated
washer (optional) |
| | | | General laboratory
spectrophotometer
(optional) | General laboratory
spectrophotometer
(optional) |
| | | | | StatFax microplate
incubator/shaker
(optional) |
| | Antibody sources | | | |
| | Capture | Mouse
monoclonal | Rabbit polyclonal | Mouse
monoclonal |
| | Detector | Mouse
monoclonal | Rabbit polyclonal | Mouse
monoclonal |
| | Sample Types | | | |
| | Human stool (direct) | Yes | Yes | Yes |
| | Broth culture | No | Yes | No |
| | Endpoint determinations | | | |
| | Visible? | Yes - pink-red line | Yes - yellow color | Yes - yellow color |
| | Positive (dual
wavelength) | N/A | Yes ≥ 0.140 | Yes ≥ 0.100 |
| | Negative (dual
wavelength) | N/A | Yes 1 month to
2 years | 2/2 | 100% | 34.2-100% | | 66/68 | 97.1% | 89.9-99.2% |
| > 2 years to
12 years | 5/5 | 100% | 56.6-100% | | 88/93 | 94.6% | 88.0-97.7% |
| > 12 years to
21 years | 1/1 | 100% | 20.7-100% | | 40/42 | 95.2% | 84.2-98.7% |
| > 21 years | 27/28 | 96.4% | 82.3-99.4% | | 158/164 | 96.3% | 92.2-98.3% |
| Not Defined | 17/17 | 100% | 81.6-100% | | 0/0 | N/A | N/A |
4
| Positive Samples | Negative Samples | |||||
|---|---|---|---|---|---|---|
| Specimen | ||||||
| Type | ||||||
| Preserved | ICS/ | |||||
| Culture | Sensitivity | |||||
| % | 95% CI | ICS/ | ||||
| Culture | Specificity | |||||
| % | 95% CI | |||||
| Site 1 | 12/12 | 100% | 75.8-100% | 92/95 | 96.8% | 91.1-98.9% |
| Site 2 | 13/14 | 92.9% | 68.5-98.7% | 61/66 | 92.4% | 83.5-96.7% |
| Site 3 | 17/17 | 100% | 81.6-100% | 1/1 | 100% | 20.7-100% |
| Specimen | ||||||
| Type | ||||||
| Unpreserved | ICS/ | |||||
| Culture | Sensitivity | |||||
| % | 95% CI | ICS/ | ||||
| Culture | Specificity | |||||
| % | 95% CI | |||||
| Site 1 | 5/5 | 100% | 56.6-100% | 0/0 | N/A | N/A |
| Site 2 | 5/5 | 100% | 56.6-100% | 69/69 | 100% | 94.7-100% |
| Site 3 | 0/0 | N/A | N/A | 130/137 | 94.9% | 89.8-97.5% |
Table 3 – Performance characteristics by sample type (preserved vs unpreserved)
Table 4 – Performance characteristics of fresh and frozen samples
| Specimen
Type 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% | | |
| Specimen
Type Frozen | ICS/
Culture | Sensitivity
% | 95% CI | ICS/
Culture | Specificity
% | 95% CI | | |
| Site 1 | 17/17 | 100% | 81.6-100% | 1/1 | 100% | 20.7-100% | | |
| Site 2 | 16/16 | 100% | 80.6-100% | 0/0 | N/A | N/A | | |
| Site 3 | 17/17 | 100% | 81.6-100% | 131/138 | 94.9% | 89.9-97.5% | | |
| Total Frozen | 50/50 | 100% | 92.9-100% | 132/139 | 95.0% | 90.0-97.5% | | |
: : : :
:
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 | Sample
Qual.
Result | Day 1
Run 1
DH | Day 1
Run 2
AML | Day 2
Run 1
DH | Day 2
Run 2
AML | Day 3
Run 1
DH | Day 3
Run 2
AML | Day 4
Run 1
DH | Day 4
Run 2
AML | Day 5
Run 1
DH | Day 5
Run 2
AML | |
|----------------------------------|---------------------------|----------------------|-----------------------|----------------------|-----------------------|----------------------|-----------------------|----------------------|-----------------------|----------------------|-----------------------|--------|
| Positive Control | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Negative Control | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | 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 | Sample
Qual.
Result | Day 1
Run 1
DM | Day 1
Run 2
JM | Day 2
Run 1
DM | Day 2
Run 2
JM | Day 3
Run 1
DM | Day 3
Run 2
JM | Day 4
Run 1
DM | Day 4
Run 2
JM | Day 5
Run 1
DM | Day 5
Run 2
JM | Sample ID | Sample
Qual.
Result | Site 3 data generated with lot 751530.001 | | Day 1
Run 1
KC | Day 1
Run 2
KMA | Day 2
Run 1
KC | Day 2
Run 2
KMA | Day 3
Run 1
KC | Day 3
Run 2
KMA | Day 4
Run 1
KC | Day 4
Run 2
KMA | Day 5
Run 1
KC | Day 5
Run 2
KMA |
|----------------------------------|---------------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------------------|---------------------------|-------------------------------------------|-----|----------------------|-----------------------|----------------------|-----------------------|----------------------|-----------------------|----------------------|-----------------------|----------------------|-----------------------|
| Positive Control | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | 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