(73 days)
ImmunoCard STAT!® RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein and internal protein) in human Nasal Wash, Nasopharyngeal Aspirate and Nasal and Nasopharyngeal Swab Samples. It is designed to test specimens from symptomatic neonatal and pediatric patients. It is recommended that all negative test results be confirmed by cell culture.
ImmunoCard STAT! RSV is distributed as a test kit that includes the following reagents: ImmunoCard STAT! RSV Test Device: A chromatography strip housed in a plastic frame and enclosed in a foil pouch with a desiccant. The membrane carries immobilized monoclonal antibodies to RSV fusion and internal proteins at the TEST line and goat anti-mou nonotibordu at the CONTROL line. The strip also contains colloidal gold conjugated to monoconnal anti-RSV fusion protein and anti-RSV internal protein as the detector antibodies. Sample Diluent: A buffered protein solution containing sodium azide (0.095%) as a preservative. Positive Control: Inactivated RSV in a buffered solution containing sodium azide (0.095%) as a preservative.
Here's a breakdown of the acceptance criteria and the study details for the ImmunoCard STAT! RSV device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets (e.g., "Sensitivity must be >85%"). Instead, the study aims to demonstrate substantial equivalence to predicate devices, which implies that the device's performance should be comparable to or better than the predicates. The performance metrics presented below are directly from the clinical trials that serve as the basis for proving equivalence.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | ImmunoCard STAT! RSV Reported Performance (Total Sites Combined, Resolved PCR Data) |
|---|---|---|
| Overall Agreement with Ground Truth | Comparable to predicate devices (e.g., Binax NOW RSV) | 92.1% (95% CI: 88.1% - 95.9%) |
| Sensitivity | Comparable to predicate devices | 85.9% (95% CI: 78.0% - 94.0%) |
| Specificity | Comparable to predicate devices | 96.3% (95% CI: 92.3% - 99.7%) |
| Positive Predictive Value (PPV) | Comparable to predicate devices | 93.8% (95% CI: 88.3% - 99.7%) |
| Negative Predictive Value (NPV) | Comparable to predicate devices | 91.2% (95% CI: 85.7% - 96.3%) |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set Sample Size:
- Total Samples (Combined Sites, unresolved): 174 (Table 6-5E)
- Total Samples (Combined Sites, resolved against PCR data at Site 2): 178 (Table 6-5F)
- Specific breakdown by sample type (resolved/unresolved not always distinct):
- Wash/Aspirate (unresolved): 48 (28 positive, 20 negative by culture)
- Wash/Aspirate (resolved): 52 (34 positive, 18 negative by culture)
- Swab (unresolved): 126 (37 positive, 89 negative by culture)
-
Data Provenance: Retrospective and prospective. Samples were collected from symptomatic patients.
- "archival (retrospective) or fresh (prospective) samples collected from symptomatic patients."
- The study involved three independent clinical laboratories, implying data from different geographical locations, though specific countries are not mentioned beyond "USA alone" in the background section regarding RSV hospitalization statistics.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of individual experts or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the primary ground truth.
- The ground truth methods used were tissue culture and PCR. These are laboratory-based diagnostic methods, not typically assessed by individual "experts" in the same way an image interpretation might be. The performance of these methods is inherent to the laboratory performing the assays, rather than a single individual's expertise. Clinical site 2 also performed PCR analysis for specimens with overgrowth in tissue culture or discrepant results, indicating a further analytical step by laboratory personnel.
4. Adjudication Method for the Test Set
- Primary Adjudication: Clinical Site 2 performed PCR analysis on specimens that exhibited overgrowth in tissue culture or showed discrepant results between the immunoassay and initial tissue culture. This PCR data was then used to "correct" or resolve the initial tissue culture ground truth for those specific samples. This acts as an adjudication step specifically for cases where the primary ground truth (tissue culture) was problematic or led to discordance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic immunoassay (a rapid test for antigen detection), not an imaging device or algorithm requiring human interpretation. Therefore, assessing how human readers improve with AI assistance is not applicable. The comparison is between the device's performance and established laboratory reference methods (tissue culture, PCR).
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone performance study was done. The entire clinical trial evaluates the ImmunoCard STAT! RSV device as a standalone diagnostic tool. Its performance (sensitivity, specificity, etc.) is directly compared against the established ground truth (tissue culture, sometimes resolved by PCR) without human interpretation as part of the device's output. The device itself produces a visual pink-red line for a positive result, and this is read directly.
7. Type of Ground Truth Used
- Tissue Culture: This was the primary diagnostic test standard for RSV detection.
- PCR (Polymerase Chain Reaction): Used as a secondary, confirmatory, or resolving ground truth for specific samples, particularly those with initial discrepant results or overgrowth in tissue culture.
8. Sample Size for the Training Set
- Not explicitly stated. The document describes clinical trials for performance evaluation (test set) but does not provide details on a specific training set size or methodology for the development of the ImmunoCard STAT! RSV assay. Immunoassays typically rely on antibody development and binding characteristics, rather than a machine learning "training set" in the computational sense. The "training" in this context would likely refer to the iterative development and optimization of the assay components and parameters.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly described. As mentioned above, the concept of a "training set" with ground truth in the context of an immunoassay development differs from that of an AI algorithm. The development of the assay would have involved characterization of the monoclonal antibodies (directed at fusion and internal proteins of RSV) and optimization of the test device's chemical and physical properties to ensure reliable binding and signal generation. This process would inherently use characterized RSV samples (positive and negative) to establish optimal performance parameters, but these are not typically referred to as a "training set" with established "ground truth" in the same formal way as in AI/ML studies.
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K04-1445
ImmunoCard STAT! RSV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
IDENTIFICATION INFORMATION
SUBMITTER'S INFORMATION
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.20.
SUBMITTER'S NAME AND ADDRESS: Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244
PHONE NUMBER: (513) 271-3700
FAX NUMBER: (513) 272-5213
CONTACT PERSON: Susan Rolih Vice President, Regulatory Affairs and Quality Assurance Official Correspondent
DATE SUMMARY PREPARED: August 5, 2004
NAME OF DEVICE: ImmunoCard STAT!® RSV
COMMON NAME: Reagent, Respiratory Syncytial Virus antigens
CLASSIFICATION NAME: Antigens, CF, Respiratory Syncytial Virus [83(GQG)]
REGULATION: 866.3480
INTENDED USES
ImmunoCard STAT!® RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein and internal protein) in human Nasal Wash, Nasopharyngeal Aspirate and Nasal and Nasopharyngeal Swab Samples. It is designed to test specimens from symptomatic neonatal and pediatric patients. It is recommended that all negative test results be confirmed by cell culture.
PREDICATE EQUIVALENT DEVICES:
ImmunoCard STAT! RSV is intended to detect the same analyte as other cleared devices including:
- · Binax NOW® RSV [a rapid lateral-flow immunoassay cleared to market under 510(k) K032166] (Binax, Inc. South Portland, ME)
- BD Directigen® EZ RSV [a rapid enzyme immunoassay cleared to market under 510(k) K022133J (Becton Dickinson & Co., Sparks, MD)
· RSV OIA® [an optical immunoassay cleared to market under 510(k) K023779] (Thermo-Biostar Inc., Louisville, CO)
BACKGROUND:
Respiratory Syncytial Virus (RSV) is the most important cause of pneumonia and bronchiolitis in infants and small children. Approximately 90,000 children are hospitalized each year due to RSV in the USA alone. Hospitalization due to RSV is more frequently associated with children that have underlying disease or premature birth. Mortality rates are estimated to be between 1 and 3% for children that are hospitalized with RSV.(1) RSV is also being recognized more frequently as a cause of significant
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respiratory disease in the elderly. RSV causes a wide range of respiratory symptoms that can be difficult to distinguish clinically from symptoms caused by other respiratory viruses such as influenza. Because of its high infectivity, the potential for prolonged patient shedding and the ability of the virus to survive for hours on environmental surfaces, RSV has emerged as a serious cause of nosomal infection. RSV can be detected in human respiratory samples by a variety of methods including tissue culture, immunofluorescent assay and enzyme immunoassay. Although tissue culture is still annsidered the diagnostic test standard, it requires tissue culture facilities and may take a week to complete. Immunofluorescent antibody-based tests are reasonably sensitive, yet highly dependent on specimen quality and preparation. Enzyme and microparticle-based immunoassays have become one the most frequently used methods for the detection of RSV. ImmunoCard STAT! RSV is a lateral from the nosed immunoassay for the rapid detection of RSV in human respiratory samples. The results from this test are used to support data available from the patient's clinical evaluation and assist the physician in determining a course of action.
Type of test
ImmunoCard STAT! RSV is a rapid, qualitative lateral-flow immunoassay screening test designed for use in clinical and doctor office laboratories.
Specimen type
The following specimens have been found compatible with ImmunoCard STAT! RSV.
- Nasal wash 1.
-
- Nasopharyngeal aspirate
-
- Nasal and nasopharyngeal swabs
Conditions for use
ImmunoCard STAT! RSV is designed to be used under the normal environmental conditions existing in hospital and reference laboratories. The assay, which is stored at 2-8 C when not in use, is brought to room temperature prior to use. Normal laboratory lighting, humidity and temperature do not affect the performance of the assay.
Contraindications
There are no contraindications associated with the use of this product.
Special instrument requirements
No instruments are used with this product.
Combination with other medical devices
No other medical devices are used in combination with this device.
DEVICE DESCRIPTION AND TECHNOLOGICAL PRINCIPLES
Reagents
ImmunoCard STAT! RSV is distributed as a test kit that includes the following reagents:
ImmunoCard STAT! RSV Test Device: A chromatography strip housed in a plastic frame and enclosed in a foil pouch with a desiccant. The membrane carries immobilized monoclonal antibodies to RSV fusion and internal proteins at the TEST line and goat anti-mou nonotibordu at the CONTROL line. The strip also contains colloidal gold conjugated to monoconnal anti-RSV fusion protein and anti-RSV internal protein as the detector antibodies.
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Sample Diluent: A buffered protein solution containing sodium azide (0.095%) as a preservative.
Positive Control: Inactivated RSV in a buffered solution containing sodium azide (0.095%) as a preservative.
Equipment needed to use the device
There is no equipment needed to use this device.
Interfering substances
There are no known interfering substances that affect the performance of this device with the exception of whole blood at contaminating concentrations greater than 5%.
Calibrators
There are no calibrators used with this device.
Controls
The assay includes an internal CONTROL line that is used to demonstrate that sample has been applied, that it has flowed correctly and that the conjugated detector antibody is active at the time of testing. A clear, colorless background around the TEST and CONTROL. lines serves as a negative control and indicates that reagents were performing correctly at the time of use.
Positive Control Reagent and Sample Diluent (used for a negative control reagent) are supplied as external controls. These reagents also serve as indicators that the test was performed correctly, that the capture and detector antibodies were active at the time of use, and that the membrane supports proper sample flow.
Failure of the internal and external control to produce the expected results suggests the test was not performed correctly (ie, incorrect volume of reagents added; incorrect incubation temperature or times used or that reagents were not brought to room temperature prior to testing).
Technological principles
ImmunoCard STAT! RSV uses specific monoclonal antibodies directed at the fusion and internal proteins of RSV as the capture and detector antibodies are bound to the membrane of the Test Device at the reaction site marked TEST. Monoclonal anti-RSV fusion and anti-RSV internal protein antibodies are conjugated to colloidal gold and are suspended within the conjugate part. To perform the test, sample (nasal wash, nasopharyngeal aspirate, nasal and nasopharyngeal swabs) is first diluted with Sample Diluent, then added to the sample port of the Test Device. Antigens in the sample bind the conjugate detector antibodies as the sample migrates through the device. The RSVgold conjugate complexes will bind to the capture antibodies at the window site marked "Test" producing a visible pink-red line. In the absence of antigen, no pink-red line appears at this point.
Goat anti-mouse antibody is bound at the membrane site marked "Control". A visible pink-red line should appear at this position each time a sample or control reagent is tested. Failure to obtain a visible pink-red control line invalidates the test and is an indication of assay failure,
SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICES
The performance characteristics of ImmunoCard STAT! RSV were compared to several predicate devices. The comparison is shown in the next two tables.
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The predicate devices to which ImmunoCard STAT! RSV was compared are as follows: Binax NOW® RSV (Binax, Inc.) BD Directigen® EZ RSV (Becton Dickinson, Inc.) RSV OIA® (ThermoElectron Corp.)
| Characteristics | MeridianICSRSV | Binax NOWRSV | DirectigenEZ RSV | ThermobiostarRSV OIA® |
|---|---|---|---|---|
| Device Type | ||||
| In vitro diagnostic device | Yes | Yes | Yes | Yes |
| Control | No | No | No | No |
| Calibrator | No | No | No | No |
| Intended Use | ||||
| Detection RSV in nasal samples | Yes | Yes | Yes | Yes |
| Screening test | Yes | Yes | Yes | Yes |
| Diagnostic test | No | No | No | No |
| Monitoring therapy | No | No | No | No |
| Acceptable Sample | ||||
| Nasal wash | Yes | Yes | Yes | Yes |
| Nasopharyngeal aspirate | Yes | No | Yes | Yes |
| Nasal and nasopharyngeal swabs | Yes | No | Yes | No |
| Nasal wash or swab in transport medium | Yes | No | Yes | Yes |
| Performance Characteristics (rounded) in | Meridian | Binax NOW | Directigen | Thermobiostar |
| Direct Comparison to Clinical Status or | ICSRSV | RSV | EZ RSV | RSV OIA® |
| Condition | ||||
| Sensitivity (wash/aspirate) | 23/28 (82%) | 88% | 76.9-87.2% | 86.8% |
| Sensitivity (swab) | 32/37 (87%) | 93% | 66.7-71.8% | 66.7% |
| Specificity (wash/aspirate) | 15/20 (75%) | 98% | 85.5-91.6% | 83.2% |
| Specificity (swab) | 86/89 (97%) | 93% | 95.0-91.6% | 96.4% |
| Predictive Value of a Positive Test (wash/aspirate) | 23/28 (82%) | ND | ND | ND |
| Predicate Value of a Positive Test (swab) | 32/35% (91%) | ND | ND | ND |
| Predictive Value of a Negative Test (wash/aspirate) | 15/20 (75%) | ND | ND | ND |
| Predicate Value of a Negative Test (swab) | 86/91 (95%) | ND | ND | ND |
| Agreement (wash/aspirate) | 38/48 (79%) | 93-96% | ND | ND |
| Agreement (swab) | 118/126 (94%) | ND | ND | ND |
| Laboratory Equivalence with (Predicate | (culture) | (culture) | (culture) | (culture) |
| Device) combined totals | ||||
| Concordance of positive tests with culture (wash/aspirate) | 23/28 (82%) | 45/51 (88%) | ND | ND |
| Concordance of positive tests with culture (swab) | 32/37 (86%) | ND | ND | ND |
| Discordance of positive tests with culture (wash/aspirate) | 5/28 (18%) | 6/51 (12%) | ND | ND |
| Discordance of positive tests with culture (swab) | 5/37 (14%) | ND | ND | ND |
| Concordance of negative tests with culture (wash/aspirate) | 15/20 (75%) | 196/199 (98%) | ND | ND |
| Concordance of negative tests with culture (swab) | 86/89 (97%) | ND | ND | ND |
| Discordance of negative tests with culture (wash/aspirate) | 5/20 (25%) | 3/199 (2%) | ND | ND |
| Discordance of negative tests with culture (swab) | 3/89 (3%) | ND | ND | ND |
| Performance characteristics | ||||
| Precision/Reproducibility (intra-assay) | 94-100% | 100% | 99.1% | 95% |
| Precision/Reproducibility (inter-assay) | 100% | 100% | 99.1% | 95% |
| Linearity/reportable range | N/A | N/A | N/A | N/A |
| Limit of detection | 10-10,000 v/mL | 1.56 x 10⁴ - 5 x10⁴ TCID₅₀ | 400-790 TCID50 | 1 x 10⁹ - 1 x10¹⁰⁹⁵% TCID₅₀ |
| Assay cutoff | N/A | N/A | N/A | N/A |
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| Characteristic | ICSRSV | Binax NOW RSV | BD Directogen EZ RSV |
|---|---|---|---|
| Intended use | Qualitative detection ofRSV in specimens fromneonatal and pediatricpatients | Qualitative detection ofRSV in specimens frompediatric patients | Qualitative detection ofRSV in specimens frompediatric patients |
| Specimen Required | 1. Nasal wash2. Nasopharyngealaspirate3. Nasal andnasopharyngeal swabs | 1. Nasal wash | 1. Nasal wash2. Nasal swab3. Nasopharyngealaspirate4. Nasopharyngeal swab5. sputum6. Tracheal aspirates7. Other swabs |
| Technology | Lateral flow, colloidal gold-based immunoassay | Lateral flow, colloidal gold-based immunoassay | Lateral flow, colloidal gold-based immunoassay |
| Level of skill required | Complexity: Moderate | CLIA waived | Moderate complexity |
| Assay steps | 1. Add 4 drops sample diluent toa tube2. Add 150 uL sample and vortexto mix3. Add 150 uL diluted specimento Test Device.4. Incubate 15 min., 20-26 C.5. Read at end of incubation | 1. Add 100uL diluted specimen toTest Device.4. Incubate 15 min., 20-26 C.5. Read at end of incubation | 1. Add 3 drops sample diluent toa tube2. Add 250 uL sample and vortexto mix3. Add 3 drops diluted specimento Test Device.4. Incubate 15 min., 20-26 C.5. Read at end of incubation |
| End point | Visible pink-red line | Visible purple-pink line | Visible reddish purple |
| Interpretation of testresult | Positive = appearance of pink-redtest and control lines (indicatedpresence of RSV antigens)Negative = no test line color withpink-red control line (indicatesabsence of RSV antigen | Positive = appearance of purple-pink test and control lines(indicated presence of RSVantigens)Negative = no test line color withpurple -- pink control line (indicatesabsence of RSV antigen | Positive = appearance of red-purple test and control lines(indicated presence of RSVantigens)Negative = no test line color withred-purple control line (indicatesabsence of RSV antigen |
Comparison of Assay Methods
DEMONSTRATION OF EQUIVALENCE Clinical trials
Two independent laboratories and Meridian's Development Laboratory performed testing on archival (retrospective) or fresh (prospective) samples collected from symptomatic patients and that had been submitted because of a respiratory syndrome. Each laboratory tested the samples by its own reference method (if applicable), the predicate device Binax NOW RSV and ImmunoCard STAT! RSV.
Investigators were required to record the age and sex of the patient, and the type and age of each specimen at the time of testing, if available. Samples were tested fresh (stored at 2-8 C for no more than 72 hours) or after frozen storage at < -20 C.
Patient characteristics (patient age, sex) and sample type
Patient characteristics and sample characteristics are shown in the following tables. The age of the patients included in the clinical trial ranged from <1 to 71 years, and as expected, the majority of tests were performed on samples less than 6 years of age. Males and female patients were equally represented. Table 6-1 shows there were no significant differences in test results were no patient age or sample storage. Table 6-2shows patient sex had no affect on test results. Tables 6-3
absence of RSV antigen
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and 6-4 show there was no significant affect of sample source (or type), sample storage parameters or patient gender on test outcomes.
Table 6-1. Patient age, sample storage statistics and mean positive reaction strengths
| Patient Age and Sample Storage | <1 Yr. | 1-5 Yrs | 6-15 Yrs | > 15 Yrs | Not defined |
|---|---|---|---|---|---|
| Clinical site 1 | |||||
| Total tested Fresh | 36 | 12 | 1 | 5 | 0 |
| Mean positive reaction strength | 3.0 | 4.0 | No pos | No pos | N/A |
| Positive reaction range | 1-6 | 4 | N/A | N/A | N/A |
| Total tested Frozen | 20 | 3 | 0 | 0 | 0 |
| Mean positive reaction strength | 3.6 | 1.0 | N/A | N/A | N/A |
| Positive reaction range | 1-7 | 1 | N/A | N/A | N/A |
| Clinical site 2 | |||||
| Total tested Fresh | 29 | 5 | 0 | 0 | 0 |
| Mean positive reaction strength | Not Recorded* | Not Recorded | N/A | N/A | N/A |
| Positive reaction range | Not Recorded | Not Recorded | N/A | N/A | N/A |
| Total tested Frozen | 0 | 0 | 0 | 0 | 0 |
| Mean positive reaction strength | N/A | N/A | N/A | N/A | N/A |
| Positive reaction range | N/A | N/A | N/A | N/A | N/A |
| Clinical site 3 | |||||
| Total tested Fresh | 0 | 0 | 0 | 0 | 0 |
| Mean positive reaction strength | N/A | N/A | N/A | N/A | N/A |
| Positive reaction range | N/A | N/A | N/A | N/A | N/A |
| Total tested Frozen | 0 | 0 | 0 | 0 | 68 |
| Mean positive reaction strength | N/A | N/A | N/A | N/A | 4.2 |
| Positive reaction range | N/A | N/A | N/A | N/A | 0.5-9 |
| Clinical site Totals | |||||
| Total tested Fresh | 65 | 17 | 1 | 5 | 0 |
| Mean positive reaction strength | 3 | 4 | No pos | No pos | N/A |
| Positive reaction range | 1-6 | 4 | N/A | N/A | N/A |
| Total tested Frozen | 20 | 3 | 0 | 0 | 68 |
| Mean positive reaction strength | 3.6 | 1 | N/A | N/A | 4.2 |
| Positive reaction range | 1-7 | 1 | N/A | N/A | 0.5-9 |
| Patient Age and Sample Storage | <1 Yr. | 1-5 Yrs | 6-15 Yrs | > 15 Yrs | Not defined |
Site protocol did not require grading of reaction strengths.
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Table 6-2. Patient gender statistics and mean positive reaction strengths
| Male | Female | Not defined | |
|---|---|---|---|
| Clinical site 1 | |||
| Total tested | 47 | 30 | 0 |
| Mean positive reaction strength | 3.3 | 3.4 | N/A |
| Positive reaction range | 1-6 | 1-7 | N/A |
| Clinical site 2 | |||
| Total tested | 24 | 10 | 0 |
| Mean positive reaction strength | Not Recorded | Not Recorded | N/A |
| Positive reaction range | Not Recorded | Not Recorded | N/A |
| Clinical site 3 | |||
| Total tested | 0 | 0 | 68 |
| Mean positive reaction strength | N/A | N/A | 4.2 |
| Positive reaction range | N/A | N/A | 0.5-9 |
| Clinical site Totals | |||
| Total tested | 71 | 40 | 68 |
| Mean positive reaction strength | 3.3 | 3.4 | 4.2 |
| Positive reaction range | 1-6 | 1-7 | 0.5-9 |
Table 6-3. Specimen sample type and mean positive reaction strengths
| Specimen Type | ||||
|---|---|---|---|---|
| Swab | Wash | NPA | Not defined | |
| Total tested -- Clinical Site 1 | ||||
| Total tested | 76 | 1 | 0 | 0 |
| Mean positive reaction strength | 3.4 | 2 | N/A | N/A |
| Positive reaction range | 1-7 | 2 | N/A | N/A |
| Total tested -- Clinical Site 2 | ||||
| Total tested | 0 | 34 | 0 | 0 |
| Mean positive reaction strength | N/A | Not Recorded | N/A | N/A |
| Positive reaction range | N/A | Not Recorded | N/A | N/A |
| Total tested -- Clinical Site 3 | ||||
| Total tested | 50 | 0 | 18 | 0 |
| Mean positive reaction strength | 2.2 | N/A | 5 | N/A |
| Positive reaction range | 0.5-5 | N/A | 2-9 | N/A |
| Total tested - All Sites | ||||
| Total tested | 126 | 35 | 18 | 0 |
| Mean positive reaction strength | 3.2 | 2 | 5 | N/A |
| Positive reaction range | 0.5-7 | 2 | 2-9 | N/A |
Legend: NPA = nasopharyngeal aspirate
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Table 6-4. Specimen sample storage parameters and mean positive reaction strengths
| Specimen Type | |||
|---|---|---|---|
| Fresh | Frozen | Not recorded | |
| Total tested -- Clinical Site 1 | |||
| Total tested | 54 | 23 | 0 |
| Mean positive reaction strength | 3.2 | 3.5 | N/A |
| Positive reaction range | 1-6 | 1-7 | N/A |
| Total tested -- Clinical Site 2 | |||
| Total tested | 34 | 0 | 0 |
| Mean positive reaction strength | Not Recorded | N/A | N/A |
| Positive reaction range | Not Recorded | N/A | N/A |
| Total tested -- Clinical Site 3 | |||
| Total tested | 0 | 68 | 0 |
| Mean positive reaction strength | N/A | 4.2 | N/A |
| Positive reaction range | N/A | 0.5-9 | N/A |
| Total tested -- All Sites | |||
| Total tested | 88 | 91 | 0 |
| Mean positive reaction strength | 3.2 | 3.9 | N/A |
| Positive reaction range | 1-6 | 0.5-9 | N/A |
Clinical trial data summarized
The compiled results from clinical trials are summarized as follows:
Table 6-5. Results of clinical evaluations
6-5A
| Clinical site 1ICS RSV | Binax Now RSV | |||||
|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | |
| Tissue Culture Pos | 30 | 4 | 34 | 27 | 6 | 33 |
| Tissue Culture Neg | 0 | 43 | 43 | 0 | 43 | 43 |
| Total | 30 | 47 | 77 | 27 | 49 | 76 |
| Concordant rate (%)Positive | 30/34 (88%) | 27/33 (82%) | ||||
| Negative | 43/43 (100%) | 43/43 (100%) | ||||
| Discordant rate (%)Positive | 4/34 (12%) | 6/33 (18%) | ||||
| Negative | 0/43 (0%) | 0/43 (0%) | ||||
| Agreement | 73/77 (94.8%) | 95% CI90.1% - 99.9% | 70/76 (92.1%) | |||
| Sensitivity | 30/34 (88.2%) | 77.0%-99.0% | 27/33 (81.8%) | |||
| Specificity | 43/43 (100%) | N/A | 43/43 (100%) | |||
| Predictive value positive test | 30/30 (100%) | N/A | 27/27 (100%) | |||
| Predictive value negative test | 43/47 (91.5 %) | 82.8% - 99.2% | 43/49 (87.8 %) |
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6-5B
| Clinical site 2 | ICS RSV | Binax Now RSV | ||||
|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | |
| Tissue Culture Pos | 7 | 2 | 9 | 7 | 2 | 9 |
| Tissue Culture Neg | 5 | 15 | 20 | 5 | 15 | 20 |
| Total | 12 | 17 | 29 | 12 | 17 | 29 |
| Concordant rate (%) | ||||||
| Positive | 7/9 (78%) | 7/9 (78%) | ||||
| Negative | 15/20 (75%) | 15/20 (75%) | ||||
| Discordant rate (%) | ||||||
| Positive | 2/9 (22%) | 2/9 (22%) | ||||
| Negative | 5/20 (25%) | 5/20 (25%) | ||||
| 95% CI | ||||||
| Agreement | 22/29 (75.9%) | 60.5% - 91.5% | 22/29 (75.9%) | |||
| Sensitivity | 7/9 (77.8%) | 51.0% - 100% | 7/9 (77.8%) | |||
| Specificity | 15/20 (75.0%) | 56.0% - 94.0% | 15/20 (75.0%) | |||
| Predictive value positive test | 7/12 (58.3%) | 30.2% - 85.8% | 7/12 (58.3%) | |||
| Predictive value negative test | 15/17 (88.2%) | 72.5% - 100% | 15/17 (88.2%) |
Clinical Site 2 performed PCR analysis on specimens that exhibited overgrowth in tissue culture or discrepant results between Immune on spesiments that cannines overyown in Insure of indicated that culture results were falsely ne 77th . Test results are recalculated based on the PCR data and given in table immediately hegative. Test results are matched to individual samples in Table 6-6.
| 6-5C | ||||||
|---|---|---|---|---|---|---|
| Clinicalsite 2 dataAFTERcorrection to PCR results | ICS RSV | Binax Now RSV | ||||
| Pos | Neg | Total | Pos | Neg | Total | |
| Tissue Culture Pos | 13 | 2 | 15 | 13 | 2 | 15 |
| Tissue Culture Neg | 1 | 17 | 18 | 1 | 17 | 18 |
| Total | 14 | 19 | 33 | 14 | 19 | 33 |
| Concordant rate (%) | ||||||
| Positive | 13/15 (87%) | 13/15 (87%) | ||||
| Negative | 17/18 (94%) | 17/18 (94%) | ||||
| Discordant rate (%) | ||||||
| Positive | 2/15 (13%) | 2/15 (13%) | ||||
| Negative | 1/18 (6%) | 1/18 (6%) | ||||
| 95% CI | ||||||
| Agreement | 30/33 (90.9%) | 81.2% - 100% | 30/33 (90.9%) | |||
| Sensitivity | 13/15 (86.7%) | 70.0% - 100% | 13/15 (86.7%) | |||
| Specificity | 17/18 (94.4%) | 83.0% - 100% | 17/18 (94.4%) | |||
| Predictive value positive test | 13/14 (92.9 %) | 79.7% - 100% | 13/14 (92.9 %) | |||
| Predictive value negative test | 17/19 (89.5%) | 74.9% - 100% | 17/19 (89.5%) |
e-SD
| Clinical site 3 | ICS RSV | Binax Now RSV | ||||
|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | |
| Tissue Culture Pos | 18 | 4 | 22 | 17 | 4 | 21 |
| Tissue Culture Neg | 3 | 43 | 46 | 0 | 46 | 46 |
| Total | 21 | 47 | 68 | 17 | 50 | 67 |
| Concordant rate (%) | ||||||
| Positive | 18/22 (82%) | 17/21 (81%) | ||||
| Negative | 43/46 (93%) | 46/46 (100%) | ||||
| Discordant rate (%) | ||||||
| Positive | 4/22 (18%) | 4/21 (19%) | ||||
| Negative | 3/46 (7%) | 0/46 (0%) | ||||
| 95% CI | ||||||
| Agreement | 61/68 (89.7%) | 82.9% - 97.1% | 63/67 (94.0%) | |||
| Sensitivity | 18/22 (81.8%) | 65.9% - 98.1% | 17/21 (81.0%) | |||
| Specificity | 43/46 (93.5%) | 85.6% - 100% | 46/46 (100%) | |||
| Predictive value positive test | 18/21 (85.7%) | 71.1% - 100% | 17/17 (100%) | |||
| Predictive value negative test | 43/47 (91.5%) | 82.8% - 99.2% | 46/50 (92.0%) |
{9}------------------------------------------------
6-5E
| Total Sites Combined Data - Comparison to Standard | ICS RSV | |||
|---|---|---|---|---|
| Pos | Neg | Total | ||
| Tissue Culture Pos | 55 | 10 | 65 | |
| Tissue Culture Neg | 8 | 101 | 109 | |
| Total | 63 | 111 | 174 | |
| Concordant rate (%) | ||||
| Positive | 55/65 (85%) | |||
| Negative | 101/109 (93%) | |||
| Discordant rate (%) | ||||
| Positive | 10/65 (15%) | |||
| Negative | 8/109 (7%) | |||
| 95% CI | ||||
| Agreement | 156/174 (89.7%) | 88.1% - 94.5% | ||
| Sensitivity | 55/65 (84.6%) | 76.4% - 93.6% | ||
| Specificity | 101/109 (92.7%) | 88.3% - 97.7% | ||
| Predictive value positive test | 55/63 (87.3%) | 78.8% - 95.2% | ||
| Predictive value negative test | 101/111 (91.0%) | 85.7% - 96.3% |
e-5E
| Total Sites Combined Data - Comparison to Standard resolved againstPCR data at Site 2. | ICS RSV | ||
|---|---|---|---|
| Pos | Neg | Total | |
| Tissue Culture Pos | 61 | 10 | 71 |
| Tissue Culture Neg | 4 | 103 | 107 |
| Total | 65 | 113 | 178 |
| Concordant rate (%) | |||
| Positive | 61/71 (86%) | ||
| Negative | 103/107 (96%) | ||
| Discordant rate (%) | |||
| Positive | 10/71 (14%) | ||
| Negative | 4/107 (4%) | ||
| 95% CI | |||
| Agreement | 164/178 (92.1%) | 88.1% - 95.9% | |
| Sensitivity | 61/71 (85.9%) | 78.0% - 94.0% | |
| Specificity | 103/107 (96.3%) | 92.3% - 99.7% | |
| Predictive value positive test | 61/65 (93.8%) | 88.3 % - 99.7% | |
| Predictive value negative test | 103/113 (91.2%) | 85.7% - 96.3% |
Characterization of samples producing discordant results
The data collected during clinical trials is shown in the spreadsheets provided at the end of these sections. The results can be summarized as follows:
| SampleNumber | ICS RSVResults | Culture Results | CommentsPCR Results | |
|---|---|---|---|---|
| 1-4 | Neg | RSV | FN | No repeat testing performed |
| 1-56 | Neg | RSV | FN | No repeat testing performed |
| 1-57 | Neg | RSV | FN | No repeat testing performed |
| 1-61 | Neg | RSV | FN | No repeat testing performed |
| 2-21 | Neg | Overgrown | Overgrown | Neg |
| 2-27 | Pos | Overgrown | Overgrown | Pos RSV A |
| 2-41 | Neg | RSV | FN | Neg |
| 2-42 | Pos | Neg | FP | Pos RSV A |
| 2-44 | Pos | Overgrown | Overgrown | Pos RSV A |
| 2-45 | Pos | Neg | FP | Pos RSV A& B |
| 2-46 | Pos | Neg | FP | Pos RSV A |
| 2-59 | Neg | RSV | FN | No repeat testing performed |
| 2-69 | Neg | Overgrown | Overgrown | Pos RSV A |
| 2-70 | Pos | Overgrown | Overgrown | Equivocal |
| 2-72 | Pos | Neg | FP | Neg |
| 2-73 | Pos | Neg | FP | Pos RSV A |
| 3-7 | Neg | RSV | FN | No repeat testing performed |
| 3-18 | Pos 0/1 | Para 3 | FP | Neg |
| 3-32 | Pos 1 | Neg | FP | Neg |
| 3-39 | Pos 1 | Neg | FP | Neg |
| 3-62 | Neg | RSV | FN | No repeat testing performed |
| 3-64 | Neg | RSV | FN | No repeat testing performed |
| 3-67 | Neg | RSV | FN | No repeat testing performed |
Table 6-6. Samples producing discrepant results.
Legend: ICS RSV = ImmunoCard STAT! RSV, FN = false negative, FP = false positive
{10}------------------------------------------------
The following data sets given in Table 6-7 provide analysis of clinical data by sample type (wash/aspirate vs swab). The data in these tables show there is no significant differences in outcomes of tests performed with wash, aspirate or swab samples.
Table 6-7. Results of comparison to predicate device
6-7A
| Wash/Aspirate SpecimensNot resolved | ICS RSV | Binax Now RSV | ||||
|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | |
| Tissue Culture Pos | 23 | 5 | 28 | 22 | 5 | 27 |
| Tissue Culture Neg | 5 | 15 | 20 | 5 | 15 | 20 |
| Total | 28 | 20 | 48 | 27 | 20 | 47 |
| Concordant rate (%) | ||||||
| Positive | 23/28 (82%) | 22/27 (81%) | ||||
| Negative | 15/20 (75%) | 15/20 (75%) | ||||
| Discordant rate (%) | ||||||
| Positive | 5/28 (18%) | 5/27 (19%) | ||||
| Negative | 5/20 (25%) | 5/20 (25%) | ||||
| Agreement | 38/48 (79.2%) | 37/47 (78.7%) | ||||
| 67.2% - 90.8% | ||||||
| Sensitivity | 23/28 (82.1%) | 22/27 (81.5%) | ||||
| 68.3% - 95.7% | ||||||
| Specificity | 15/20 (75.0%) | 15/20 (75.0%) | ||||
| 55.4% - 94.6% | ||||||
| Predictive value positive test | 23/28 (82.1%) | 22/27 (81.5%) | ||||
| 68.3% - 95.7% | ||||||
| Predictive value negative test | 15/20 (75.0%) | 15/20 (75.0%) | ||||
| 55.4% - 94.6% |
Note to table above: 5 overgrown specimens not included, 1 QNS to run on Binax
6-7B
| Wash/Aspirate SpecimensResolved | ICS RSV | Binax Now RSV | |||||
|---|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | ||
| Tissue Culture Pos | 29 | 5 | 34 | 28 | 5 | 33 | |
| Tissue Culture Neg | 1 | 17 | 18 | 1 | 17 | 18 | |
| Total | 30 | 22 | 52 | 29 | 22 | 51 | |
| Concordant rate (%) | |||||||
| Positive | 29/34 (85%) | 28/33 (85%) | |||||
| Negative | 17/18 (94%) | 17/18 (94%) | |||||
| Discordant rate (%) | |||||||
| Positive | 5/34 (15%) | 5/33 (15%) | |||||
| Negative | 1/18 (6%) | 1/18 (6%) | |||||
| Agreement | 46/52 (88.5%) | 78.2% - 97.8% | 45/51 (88.2%) | ||||
| Sensitivity | 29/34 (85.3%) | 73.2% - 96.8% | 28/33 (84.8%) | ||||
| Specificity | 17/18 (94.4%) | 82.2% - 100% | 17/18 (94.4%) | ||||
| Predictive value positive test | 29/30 (96.7%) | 91.1% - 100% | 28/29 (96.6%) | ||||
| Predictive value negative test | 17/22 (77.3%) | 17/22 (77.3%) |
Note to table above: 1 QNS to run on Binax, 1 Equivocal Specimen after PCR
6-7C
| Swab Specimens | ICS RSV | Binax Now RSV | ||||
|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | |
| Tissue Culture Pos | 32 | 5 | 37 | 29 | 7 | 36 |
| Tissue Culture Neg | 3 | 86 | 89 | 0 | 89 | 89 |
| Total | 35 | 91 | 126 | 29 | 96 | 125 |
| Concordant rate (%) | ||||||
| Positive | 32/37 (86%) | 29/36 (81%) | ||||
| Negative | 86/89 (97%) | 89/89 (100%) | ||||
| Discordant rate (%) | ||||||
| Positive | 5/37 (14%) | 7/36 (19%) | ||||
| Negative | 3/89 (3%) | 0/89 (0%) | ||||
| Agreement | 118/126 (93.7%) | 118/125 (94.4%) | ||||
| Sensitivity | 32/37 (86.5%) | 74.2% - 97.8% | 29/36 (80.6%) | |||
| Specificity | 86/89 (96.6%) | 93.1% - 100% | 89/89 (100%) | |||
| Predictive value positive test | 32/35 (91.4%) | 81.2% - 100% | 29/29 (100%) | |||
| Predictive value negative test | 86/91 (94.5%) | 90.1% - 97.9% | 89/96 (92.7%) |
Note to table above: 1 Binax Invalid Result, No resolved data. PCR was negative for the 3 false positive samples
{11}------------------------------------------------
Reproducibility
Two reproducibility panels, each consisting of eight coded specimens, were sent to the three clinical sites. Five of these samples in each set were classified by the predicate device Binax NOW RSV as positive. One additional sample was at the limit of detect of ImmunoCard STAT! RSV. The samples were expected to produce a positive or negative result. Even though the trial sites were instructed to grade reactions, there were no criteria regarding the strength of a positive reaction that was expected. Tables 6-8 show that all samples in Panel 1 and 7/8 samples in Panel 2 demonstrated intra- and inter-assay reproducibility of 100%. One sample (Panel 2) gave a reproducible rate of 94%.
| Clinical Site 3 | Clinical Site 1 | Clinical Site 2 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample ID | Day 1 | Day 2 | Day 3 | Day 1 | Day 2 | Day 3 | Day 1 | Day 2 | Day 3 |
| 1 LP | 5 | 2 | 1 | 1 | 2 | 1 | 2 | 2 | 2 |
| 2 LP | 3 | 4.5 | 5 | 2 | 2 | 3 | 3 | 1 | 2 |
| 3 MP | 6 | 5 | 5.5 | 3 | 4 | 2 | 3 | 3 | 4 |
| 4 MP | 1 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 1 |
| 5 HP | 7 | 6 | 8 | 4 | 6 | 6 | 5 | 6 | 5 |
| 6 N | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7 N | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8 Limit of detect | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total positive score | 22 | 18.5 | 21.5 | 12 | 16 | 14 | 14 | 13 | 14 |
| Average positive score | 4.4 | 3.7 | 4.3 | 2.4 | 3.2 | 2.8 | 2.8 | 2.6 | 2.8 |
| Percent correlation | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
Table 6-8. Results with reproducibility test panel #1
Legend: LP = low positive, MP = moderate positive, HP = high positive, N = negative,
| Clinical Site 1 | Clinical Site 2 | Clinical Site 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample ID | Day 1 | Day 2 | Day 3 | Day 1 | Day 2 | Day 3 | Day 1 | Day 2 | Day 3 |
| 1 LP | 1 | 4 | 1 | 0 | 1 | 1 | 1.5 | 2 | 1 |
| 2 LP | 4 | 6 | 4 | 3 | 4 | 4 | 1 | 4 | 4 |
| 3 MP | 4 | 4 | 4 | 5 | 6 | 3 | 6.5 | 5 | 7 |
| 4 MP | 5 | 6 | 5 | 5 | 6 | 4 | 7 | 7 | 6.5 |
| 5 HP | 5 | 1 | 1 | 3 | 7 | 6 | 8 | 9 | 7 |
| 6 N | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7 N | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8 Limit of detect | 0 | 0 | 0 | 1 | 0 | 0 | 1.5 | 1 | 8 |
| Total positive score | 19 | 21 | 15 | 16 | 24 | 18 | 24 | 27 | 25.5 |
| Average positive score | 3.8 | 4.2 | 3.0 | 3.2 | 4.8 | 3.6 | 4.8 | 5.4 | 5.1 |
| Percent correlation | 100 | 100 | 100 | 87.5 | 100 | 100 | 100 | 100 | 100 |
Table 6-9. Results with reproducibility test panel #2
Legend: LP = low positive, MP = moderate positive, HP = high positive, N = negative,
High dose hook effect
There was no high dose hook effect observed in verification or clinical testing performed with this assay.
{12}------------------------------------------------
CONCLUSIONS
・
ImmunoCard STAT! RSV:
- Can be used reliably for the rapid detection of RSV antigens in human respiratory samples. 1.
-
- Performs similarly to the predicate device Binax NOW RSV.
| ICS RSV | NOW RSV | |||||
|---|---|---|---|---|---|---|
| Pos | Neg | Total | Pos | Neg | Total | |
| Culture Pos | 55 | 10 | 65 | 51 | 12 | 63 |
| Culture Neg | 8 | 101 | 109 | 5 | 104 | 109 |
| Total | 63 | 111 | 174 | 56 | 116 | 172 |
| Concordance rate (% to culture) | ||||||
| Positive | 55/65 (85%) | 51/63 (81%) | ||||
| Negative | 101/109 (93%) | 104/109 (95%) |
{13}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
AUG 1 3 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Susan Rolih Vice President, Regulatory Affairs/Quality Assurance Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244
Re: K041445
Trade/Device Name: Immuno Card STAT! RSV Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory Syncytial Virus Serological Reagents Regulatory Class: Class I Product Code: GQG Dated: May 28, 2004 Received: June 10, 2004
Dear Ms. Rolih:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected. or substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conninered processified 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). and Cosmetic (1 to (1 to ) that the device, subject to the general controls provisions of the Act. The 1 ou may, incresere, mass 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 nav 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 that I Dr Has Intactions and regulations administered by other Federal agencies. You must or any I catal statutes and enginements, 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).
{14}------------------------------------------------
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Salamatys
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
{15}------------------------------------------------
Meridian Bioscience, Inc. Cincinnati, OH
510(k) Notification ImmunoCard STAT! RSV
INDICATIONS FOR USE STATEMENT ImmunoCard STAT! RSV
510(K) Number: K041445
ImmunoCard STAT! RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Intribution Syncytial Virus (RSV) antigens (fusion protein or internal protein) in human nasal wash, nasophary Gyhoylar Viras (1107) anigene nasopharyngeal swab samples. It is designed to test hasophalyngear aspirate and naddr and necopial yngoal of is recommended that all negative test results be confirmed by cell culture.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
Division Sign Off
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(%) . _ K204 144 S
Tab 8, Page 1
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.