IMMUNOCARD STAT! RSV MODEL #750630

• K Number: K041445
• Device Name: IMMUNOCARD STAT! RSV MODEL #750630
• Manufacturer: MERIDIAN BIOSCIENCE, INC.
• Date Cleared: 2004-08-13 ( 73 days)
• Product Code: GQG
• Regulation Number: 866.3480

Intended Use

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.

Device Description

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.

Predicate Devices

K032166

Reference Devices

K022133J, K023779

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies describe a standard lateral-flow immunoassay and its comparison to traditional methods and predicate devices. There is no mention of AI or ML in the text.

Therapeutic

No Yes.

This device is a diagnostic immunoassay designed to detect RSV antigens, not to treat a condition or restore function.

Diagnostic

Yes

The device is a rapid immunoassay for detecting RSV antigens in human samples, and its intended use is to confirm the presence of a pathological condition (RSV infection), which aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a test kit including physical components like a chromatography strip, plastic frame, foil pouch, desiccant, and reagents. This indicates it is a hardware-based diagnostic device, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is for the "detection of Respiratory Syncytial Virus (RSV) antigens... in human Nasal Wash, Nasopharyngeal Aspirate and Nasal and Nasopharyngeal Swab Samples." This involves testing human specimens in vitro (outside the body) to provide diagnostic information.
• Device Description: The description details the components of a test kit designed to perform this in vitro analysis, including a test device, sample diluent, and positive control.
• Performance Studies: The document describes clinical trials where the device was used to test human samples and the results were compared to reference methods (tissue culture and PCR) and predicate devices. This is typical for the validation of an IVD.
• Key Metrics: The performance metrics provided (Sensitivity, Specificity, Predictive values) are standard measures used to evaluate the accuracy and reliability of diagnostic tests.

All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GQG

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nasal, Nasopharyngeal

Indicated Patient Age Range

neonatal and pediatric patients. The age of the patients included in the clinical trial ranged from

Regulation Number and Section

§ 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.

Summary

0

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: [phone]

FAX NUMBER: [phone]

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

1

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.
• 2. Nasopharyngeal aspirate
• 3. 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.

2

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.

3

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 | Meridian
ICSRSV | Binax NOW
RSV | Directigen
EZ RSV | Thermobiostar
RSV 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 x
10⁴ TCID₅₀ | 400-790 TCID50 | 1 x 10⁹ - 1 x
10¹⁰⁹⁵% TCID₅₀ |
| Assay cutoff | N/A | N/A | N/A | N/A |

4

Characteristic	ICSRSV	Binax NOW RSV	BD Directogen EZ RSV
Intended use	Qualitative detection of
RSV in specimens from
neonatal and pediatric
patients	Qualitative detection of
RSV in specimens from
pediatric patients	Qualitative detection of
RSV in specimens from
pediatric patients
Specimen Required	1. Nasal wash

2. Nasopharyngeal
   aspirate
3. Nasal and
   nasopharyngeal swabs | 1. Nasal wash | 1. Nasal wash
4. Nasal swab
5. Nasopharyngeal
   aspirate
6. Nasopharyngeal swab
7. sputum
8. Tracheal aspirates
9. 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 to
   a tube
10. Add 150 uL sample and vortex
    to mix
11. Add 150 uL diluted specimen
    to Test Device.
12. Incubate 15 min., 20-26 C.
13. Read at end of incubation | 1. Add 100uL diluted specimen to
    Test Device.
14. Incubate 15 min., 20-26 C.
15. Read at end of incubation | 1. Add 3 drops sample diluent to
    a tube
16. Add 250 uL sample and vortex
    to mix
17. Add 3 drops diluted specimen
    to Test Device.
18. Incubate 15 min., 20-26 C.
19. Read at end of incubation |
    | End point | Visible pink-red line | Visible purple-pink line | Visible reddish purple |
    | Interpretation of test
    result | Positive = appearance of pink-red
    test and control lines (indicated
    presence of RSV antigens)
    Negative = no test line color with
    pink-red control line (indicates
    absence of RSV antigen | Positive = appearance of purple-
    pink test and control lines
    (indicated presence of RSV
    antigens)
    Negative = no test line color with
    purple -- pink control line (indicates
    absence of RSV antigen | Positive = appearance of red-
    purple test and control lines
    (indicated presence of RSV
    antigens)
    Negative = no test line color with
    red-purple control line (indicates
    absence 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 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 | 15 Yrs | Not defined |

Site protocol did not require grading of reaction strengths.

6

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

7

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 1

ICS 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% CI
90.1% - 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 %)

8

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
Clinical
site 2 data
AFTER
correction 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 against

PCR 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:

| Sample
Number | ICS RSV
Results | Culture Results | | Comments
PCR 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 Specimens

Not 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 Specimens

Resolved	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.
• 2. 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 [phone]. 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 [phone] or [phone] 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