K Number

Device Name

IMMUNOCARD STAT! FLU A & B

Manufacturer

MERIDIAN BIOSCIENCE, INC.

Date Cleared

2005-03-16

(273 days)

Product Code

PSZ GNX

Regulation Number

866.3328

Intended Use

ImmunoCard STAT!® Flu A&B is a rapid, qualitative, lateral-flow immunoassay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples. It is designed to test samples from symptomatic patients. It is recommended that all negative test results be confirmed by cell culture.

Device Description

ImmunoCard STAT! Flu A & B is distributed as a test kit that includes the following reagents: ImmunoCard STAT! Flu A & B Test Device: A chromatography strip housed in a plastic frame and enclosed in a foil pouch with a desiccant. The strip contains immobilized monoclonal antibody at the CONTROL line. The strip also contains colloidal gold conjugated anti-mouse antibody at the CONTROL line. The strip also contains colloidal gold conjugated anti-influenza A and anti-influenza B as the detection antibodies. A buffered protein solution containing sodium azide (0.095%) as a preservative. Positive Control: Inactivated influenza A and influenza B virus in a buffered solution containing sodium azide (0.095%) as a preservative.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K021649, K021646, K001364, K023556, K031899, K031565, K982429

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a lateral-flow immunoassay, which is a chemical-based test and does not involve computational analysis or algorithms.

Therapeutic

No
This device is an immunoassay designed for detecting influenza A and B viral antigens. It provides a diagnosis but does not offer any therapeutic intervention.

Diagnostic

Yes

The device detects "influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples" from "symptomatic patients" to aid in the identification of flu, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description clearly states it is a test kit including physical reagents and a chromatography strip housed in a plastic frame, indicating it is a hardware-based immunoassay, not software only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states that it is for "detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples." This involves testing samples taken from the human body in vitro (outside the body) to provide diagnostic information.
Device Description: The description details a "test kit" with reagents and a "chromatography strip" designed to perform a test on biological samples.
Performance Studies: The document describes clinical trials where the device was used to test human samples and the results were compared to a "gold standard" (cell culture) to evaluate its performance in a diagnostic context.
Predicate Devices: The listing of predicate devices, which are also IVDs, further confirms the classification of this device.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ImmunoCard STAT!® Flu A&B is a rapid, qualitative, lateral-flow immunoassay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal Inflammation A and Innuchiza D Mar naoloop swab samples. It is designed to test samples from aspirate and nuour and has navymanded that all negative test results be confirmed by cell culture.

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

GNX

Device Description

ImmunoCard STAT! Flu A & B is distributed as a test kit that includes the following reagents: ImmunoCard STAT! Flu A & B Test Device, Sample Diluent, and Positive Control. The Test Device is a chromatography strip housed in a plastic frame and contains immobilized monoclonal antibody at the CONTROL line, colloidal gold conjugated anti-mouse antibody at the CONTROL line, and anti-influenza A and anti-influenza B as the detection antibodies. The Sample Diluent is a buffered protein solution containing sodium azide (0.095%) as a preservative. The Positive Control contains inactivated influenza A and influenza B virus in a buffered solution with sodium azide (0.095%) as a preservative. No instruments or other medical devices are used with this product. The assay includes an internal CONTROL line and uses supplied Positive Control Reagent and Sample Diluent (for negative control) as external controls.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human nasal wash, nasopharyngeal aspirate, nasopharyngeal swab, nasal swab

Indicated Patient Age Range

Not Found

Intended User / Care Setting

laboratory professionals under the normal environmental conditions.

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

Three independent laboratories and Meridian's Development Laboratory performed testing on archival frozen (retrospective) or fresh (prospective) samples collected from symptomatic patients. Each lab compared ImmunoCard STAT! Flu A & B and culture results against Binax NOW Flu A and NOW Flu B (substantially equivalent devices).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Clinical trials and Reproducibility study.
Clinical Trials Sample Size:
Wash/Aspirate: 215 samples for Flu A, 215/214 samples for Flu B.
Swab: 428/427 samples for Flu A, 428/427 samples for Flu B.
Fresh Wash/Aspirate: 133 samples for Flu A, 133/132 samples for Flu B.
Fresh Swab: 271/270 samples for Flu A, 271/270 samples for Flu B.
Frozen Wash/Aspirate: 82 samples for Flu A, 82 samples for Flu B.
Frozen Swab: 157 samples for Flu A, 157 samples for Flu B.

Key Results (Clinical Trials):
Performance of ImmunoCard STAT! Flu A & B in comparison to culture for wash/aspirate and swab samples, broken down by prospective (freshly collected) vs. retrospective (archival frozen) samples. Discordant results were characterized, including False Negatives (FN) and False Positives (FP), with PCR results provided where available.

Reproducibility Study Sample Size: 14 coded specimens sent to three clinical sites.
Key Results (Reproducibility): Reproducibility and inter-assay reproducibility of 100% was observed.
High dose hook effect: No high dose hook effect was observed in verification or clinical testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical Trials (Excerpted Data from Tables):

Wash/Aspirate Specimens against Tissue Culture (Std):

ICS Flu A:
- Sensitivity: 35/39 (Pos/Total Tissue Culture Pos)
- Specificity: 162/176 (Neg/Total Tissue Culture Neg)
ICS Flu B:
- Sensitivity: 4/7 (Pos/Total Tissue Culture Pos)
- Specificity: 208/208 (Neg/Total Tissue Culture Neg)

Swab Specimens against Tissue Culture (Std):

ICS Flu A:
- Sensitivity: 66/90 (Pos/Total Tissue Culture Pos)
- Specificity: 329/338 (Neg/Total Tissue Culture Neg)
ICS Flu B:
- Sensitivity: 25/37 (Pos/Total Tissue Culture Pos)
- Specificity: 391/391 (Neg/Total Tissue Culture Neg)

Fresh samples - Wash/Aspirate against Tissue Culture (Std):

ICS Flu A:
- Sensitivity: 12/15
- Specificity: 110/118
ICS Flu B:
- Sensitivity: 2/5
- Specificity: 128/128

Fresh samples - Swab against Tissue Culture (Std):

ICS Flu A:
- Sensitivity: 29/40
- Specificity: 229/231
ICS Flu B:
- Sensitivity: 19/25
- Specificity: 246/246

Frozen samples - Wash/Aspirate against Tissue Culture (Std):

ICS Flu A:
- Sensitivity: 23/24
- Specificity: 52/58
ICS Flu B:
- Sensitivity: 2/2
- Specificity: 80/80

Frozen samples - Swab against Tissue Culture (Std):

ICS Flu A:
- Sensitivity: 37/50
- Specificity: 100/107
ICS Flu B:
- Sensitivity: 6/12
- Specificity: 145/145

Limit of Detection (LOD): (Virions/mL or TCID50/mL)

Flu B VR-102: 533 v/mL
Flu B VR823: 630,000 v/mL
Flu B VR101: 530,000 v/mL
Flu B VR295: 187 v/mL
Flu B VR790: 15,000 v/mL
Flu A VR-822: 74,000 v/mL
Flu A VR97: 5,300 v/mL
Flu A VR95: 35,000 v/mL
Flu A VR547: 8,800 v/mL
Flu A VR544: 890 v/mL
Flu A VR897: 5,600 v/mL

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K021649, K021646, K001364, K023556, K031899, K031565, K982429

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3328 Influenza virus antigen detection test system.

(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.

Summary

MAR 1 6 2005

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 Official Correspondent

DATE SUMMARY PREPARED: March 11, 2005

TRADE NAME: ImmunoCard STAT! Flu A & B

COMMON NAME: Rapid, qualitative lateral-flow immunoassay for the detection of Influenza A and B antigen

CLASSIFICATION NAME: Antigen, CF (including CF control), influenza virus A, B, C

REGULATION: 866.3330

INTENDED USES:

ImmunoCard STAT!® Flu A&B is a rapid, qualitative, lateral-flow immunoassay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal Influenza A and Innuchiza D Mar naoloop swab samples. It is designed to test samples from aspirate and nuour and has navymanded that all negative test results be confirmed by cell culture.

PREDICATE DEVICES:

ImmunoCard STAT! Flu A & B is intended to detect the same analytes as other cleared devices including:

· Binax NOW® Flu A + B [a rapid lateral-flow immunoassay cleared to market under 510(k)s K021649 and K021646] (Binax, Inc. South Portland, ME)
BD Directigen® Flu A+B [a rapid enzyme immunoassay cleared to market under 510(k) K001364) (Becton Dickinson & Co., Sparks, MD)
· (Dector) Dicklinsdir & Oct, Open to market under 510(K) K023556] (Thermo-Biostar Inc., 1 Louisville, CO)
Quickyue® Influenza A+ B Test [a rapid lateral-flow immunoassay cleared to market under 510(k) K031899] (Quídel, Inc., San Diego, CA)
· Xpext® Flu A/B [a rapid immunochromatographic assay cleared to market under 510(k) K031565] (Remel, Inc., Lenexa, KS)

Zstatflu® Test for Influenza types A & B Virus [an endogenous viral-encoded enzyme assay cleared to market under 510(k) K982429] (ZymeTx, Inc., Oklahoma City, OK)

BACKGROUND:

Influenza is a highly contagious, epidemic to pandemic acute viral respiratory disease caused by into he rera for the Orthornyxoviridae family. Influenzavirus A and Influenzavirus B are the two general most commonly associated with disease in humans. (1,2) Influenza infection rates tend to be highest in pediatric populations, while serious complications from influenza disease are more common in the elderly. (2) Clinical signs and symptoms begin after a 1-4 day incubation period and include cough, fever, myalgia and malaise. The clinical presentation of influenza can range from asymptomatic infection to fatal pneumonia. (1) Influenza co-circulates with other respiratory pathogens, hence it is important to differentiate influenza from other respiratory diseases. (2) Antiviral drugs in general have shown more significant clinical benefit when administered within 48 hours of the appearance of symptoms, which obviates the need for the rapid detection of influenza. Not all antiviral drugs are effective against both influenza A and influenza B, therefore it is important to distinguish between the two. (2.4)

Influenza A and B can be detected in human respiratory samples by a variety of methods including cell culture, immunofluorescent assay and enzyme immunoassay. Cell culture isolation remains the gold standard for the detection of influenza, yet the procedure can take 7 days to complete. (1) Immunofluorescent antibody-based tests are moderately sensitive, yet highly dependent on specimen quality and preparation. The rapid detection of influenza using enzyme and microparticle-based immunoassays has become an important aspect of patient management in patients of all ages with acute respiratory disease due to influenza. (1,3,4) The results from this test are used to support data available from the patient's clinical evaluation and assist the physician in determining the course of action.

Type of test

ImmunoCard STAT! Flu A & B is a rapid, qualitative lateral-flow immunoassay screening test.

Specimen type

The following specimens have been found compatible with ImmunoCard STAT! Flu A & B

1. Nasal wash
1. Nasopharyngeal aspirate
1. Nasopharyngeal swab
1. Nasal swab

Conditions for use

ImmunoCard STAT! Fly A & B is designed for use by laboratory professionals under the normal environmental conditions. 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

lmmunoCard STAT! Flu A & B is distributed as a test kit that includes the following reagents:

ImmunoCard STAT! Flu A & B Test Device: A chromatography strip housed in a plastic ImmunoCard STAT! Fid A & B Test Bevice. "A childners application carries immobilized frame and enclosed in a for poden with a declosen... " http://www.nation.com/sident.com/wated monoconal antibody at the CONTROL ine. The strip an contains colloidal gold conjugated
anti-mouse antibody at the CONTROL line. The strip and continentials a anti-influenza anti-influenza A and anti-influenza B as the detection antibodies.

A buffered protein solution containing sodium azide (0.095%) as a Sample Diluent: preservative.

Positive Control: Inactivated influenza A and influenza B virus 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

Whole blood, at concentrations greater than 0.5% may interfere with the interpretation of test results.

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 rne assury frolded an menter and that the conjugated detector antibody is active at the time appliou, that knowled on the background around the Flu A and Flu B 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! Flu A & B uses specific monoclonal antibodies directed at the nucleoproteins of ImmunoCard STAT! Flu A & B uses specific and detector antibodies. Motorclonal influenza A and influenza A or influenza B as the capitire and celest device at the reaction site marked
monoclonal influenza B are immobilized on the membrane of the test device at monoclonal influenza B are immobilized on the infunza B coniugated to colloidal gold
FLU A and FLU B, respectively. Monoclonal influenza B consignted to coloider one of FLU A and FLU B, respectively. Monocolial infrience A Caral Wash, nasopharyngeal
are suspended within the membrane. Toly in Cristilitad with Sample (nasely to the are suspended within the membrane. I to pendint the test, sample the same of the raded to the aspirate, nasopharyngeal swap, historial swap, be new os infor sample bind the conjugate
sample port of the Test Device. Influenza A or influenza A antigens A-cold conjug sample port of the Test Device. Thinderizates of through the shileniza A-gold conjugate
detector antibodies as the sample migrates through the society on visible a pinkdetector antibodies as the sample migrates in rough the similary and line. Similarly, a pinkcomplex will bind at the window site maked FLO A producing a winds alth e window site marked FLU
red line will appear when the influenza B-gold conjugate complex bindex fil.U red line will appear when the militenza b-gold conjugate out province.
B. In the absence of antigen, no pink-red line appears at either the FLU A or FLU B sites.

Goat antibody is bound at the membrane site marked "Control". A visible pink-red line Goat anti-mouse antibody is bound at the memblance ot in tested. Failure to obtain a should appear at this position cadin time a sample an indication of assay failure.

DEMONSTRATION OF EQUIVALENCE TO PREDICATE DEVICES

The Limit of Detection (LOD)

To determine the LOD, the assay was evaluated with influenza A and influenza B antigen preparations To delemine the LOD, the assay was Crained with intessed im azide (PBSA). Table 6-1 shows (ATCC) differ the strains of influenza tested. For the purposes of this evaluation, virions/mL is the same as TCID50/mL.

Strain ID	Strain Type	Limit of Detection (LOD)
VR-102	Flu B	533 v/mL
VR823	Flu B	630,000 v/mL
VR101	Flu B	530,000 v/mL
VR295	Flu B	187 v/mL
VR790	Flu B	15,000 v/mL
VR-822	Flu A	74,000 v/mL
VR97	Flu A	5,300 v/mL
VR95	Flu A	35,000 v/mL
VR547	Flu A	8,800 v/mL
VR544	Flu A	890 v/mL
VR897	Flu A	5,600 v/mL

Table 6-1. LOD determination for ImmunoCard STAT! Flu A & B.

Legend: v/mL = virions per milliliter

Clinical trials

Three independent laboratories and Meridian's Development Laboratory performed testing on archival frozen (retrospective) or fresh (prospective) samples collected from symptomatic patients. Each Irozen (restospedito) or Troon (prosposor) in A and NOW Flu B and ImmunoCard STAT! Flu A & B (substantially equivalent devices), ImmunoCard STAT! Flu A & B and culture.

Meridian Bioscience, Inc. Cincinnati, OH
The data in Table 6-2 shows the overall sensitivity of ImmunoCard STAT! Flu A&B in
The data in Table Station of Canainte and surph somnles . In Table 6-3, the The data in Table 6-2 shows the overall sensults. In Table 6-3, the data is futher divided to
comparison to culture with wash/aspirate and swabserty, In Table shoples, comparison to culture with wash/aspirate and swab samples. In Tuble of the many of the manages.
show the performance of prospective (freshly collected) versus retrospective

Table 6-2 Performance of Wash/Aspirate Vs Swab samples

Wash/Aspirate Specimens	ICS Flu A			Binax Flu A			ICS Flu B			Binax Flu B*
	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total
Tissue Culture Pos (Std)	35	4	39	34	5	39	4	3	7	4	3	7
Tissue Culture Neg (Std)	14	162	176	10	166	176	0	208	208	2	205	207
Total	49	166	215	44	171	215	4	211	215	6	208	214

*1 Binax Flu B Invalid

Swab Specimens	ICS Flu A			Binax Flu A*			ICS Flu B			Binax Flu B*
	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total
Tissue Culture Pos (Std)	66	24	90	53	37	90	25	12	37	13	24	37
Tissue Culture Neg (Std)	9	329	338	4	333	337	0	391	391	31	359	390
Total	75	353	428	57	370	427	25	403	428	44	383	427

Total Total Total Total

Table 6-3 Performance of prospective and retrospective samples

| Fresh samples -

Wash/Aspirate	ICS Flu A			Binax Flu A			ICS Flu B			Binax Flu B*
	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total
Tissue Culture Pos (Std)	12	3	15	11	4	15	2	3	5	2	3	5
Tissue Culture Neg (Std)	8	110	118	5	113	118	0	128	128	1	126	127
Total	20	113	133	16	117	133	2	131	133	3	129	132

*1 Binax Flu B Invalid

	ICS Flu A			Binax Flu A*			ICS Flu B			Binax Flu B*
Fresh samples - Swab	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total
Tissue Culture Pos (Std)	29	11	40	19	21	40	19	6	25	9	16	25
Tissue Culture Neg (Std)	2	229	231	2	228	230	0	246	246	0	245	245
Total	31	240	271	21	249	270	19	252	271	9	261	270

*1 Binax Flu A Invalid, 1 Binax Flu B Invalid

| Frozen samples -

Wash/Aspirate	ICS Flu A			Binax Flu A			ICS Flu B			Binax Flu B
	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total
Tissue Culture Pos (Std)	23	1	24	23	1	24	2	0	2	2	0	2
Tissue Culture Neg (Std)	6	52	58	5	53	58	0	80	80	1	79	80
Total	29	53	82	28	54	82	2	80	82	3	79	82
Frozen samples -- Swab	ICS Flu A			Binax Flu A			ICS Flu B			Binax Flu B
	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total	Pos	Neg	Total
Tissue Culture Pos (Std)	37	13	50	34	16	50	6	6	12	4	8	12
Tissue Culture Neg (Std)	7	100	107	2	105	107	0	145	145	31	114	145
Total	44	113	157	36	121	157	6	151	157	35	122	157

Characterization of samples producing discordant results

The data collected during clinical trials is shown in the spreadsheets provided at the end of these The data collected Gunny Cliniour that 10-10-10-10-10-11
sections The results can be summarized as follows:

Table 6-4. Samples producing discrepant results.

| Sample
Number | ICSFAB
Results | Culture
Results | | Comments
PCR Results |
|------------------|---- | 1-100 | Neg | 1-178 | Neg | 1-180 | Neg | 1-193 | Neg | 1-198 | Neg | 1-20 | A Pos | 1-205 | Neg | 1-206 | Neg | 1-21 | Neg | 1-216 | Neg | 1-220 | Neg | 1-224 | Neg | 1-233 | Neg | 1-24 | A Pos | 1-251 | Neg | 1-259 | Neg | 1-26 | Neg | 1-263 | Neg | 1-269 | Neg | 1-27 | Neg | 1-270 | Neg | 1-271 | A Pos | 1-278 | Neg | 1-288 | Neg | 1-289 | Neg | 1-29 | Neg | 2-08 | A Pos | 2-101 | A Pos | 2-106 | A Pos | 2-15 | A Pos | 2-52 | A Pos | 2-54 | A Pos | 2-61 | Neg | 2-62 | A Pos | 3-120 | Neg | 3-121 | Neg | 3-123 | Neg | 3-14 | Neg | 3-20 | Neg | 3-22 | A Pos | 3-31 | A Pos | 3-4 | Neg | 3-48 | A Pos | 3-5 | Neg | 3-52 | A Pos | 3-8 | Neg | 3-82 | A Pos | 4-137 | Neg | 4-142 | A Pos | 4-152 | Neg | 4-171 | Neg | 4-180 | Neg | 4-182 | Neg | 4-188 | A Pos | 4-191 | A Pos | Sample
Number | ICSFAB
Results | Culture
Results | | Comments
PCR Results |
| 4-216 | A Pos | 4-39 | A Pos | 4-52 | A Pos | 4-58 | A Pos | 4-64 | Neg | 4-68 | Neg | 4-69 | Neg | 4-70 | Neg | 4-71 | Neg | 4-82 | A Pos | 4-89 | Neg | 2-25 | A Pos | 2-31 | A Pos | 2-50 | Neg | 2-57 | Neg | 2-60 | A Pos ---------------|--------------------|-----------|-------------------------|
| A Pos | FN | Pos (Flu A) |
| A Pos | FN | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| B Pos | FN | Neg |
| A Pos | FN | Pos (Flu A) |
| Neg | FP | Pos (Flu A) |
| B Pos | FN | No PCR |
| A Pos | FN | No PCR |
| A Pos | FN | No PCR |
| A Pos | FN | No PCR |
| A Pos | FN | No PCR |
| B Pos | FN | No PCR |
| A Pos | FP | No PCR |
| Neg | FP | No PCR |
| B Pos | FN | Pos (Flu A) |
| A Pos | FN | Pos (Flu A) |
| A Pos | FN | Pos (Flu A) |
| A Pos | FN | No PCR |
| B Pos | FN | No PCR |
| A Pos | FN | No PCR |
| A Pos | FN | Pos (Flu A) |
| Neg | FP | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| A Pos | FN | No PCR |
| B Pos | FN | No PCR |
| A Pos | FN | No PCR |
| Neg | FP | Pos (Flu A) |
| Neg | FP | No PCR |
| Neg | FP | Pos (Flu A) |
| Neg | FP | Pos (Flu A) |
| Neg | FP | Pos (Flu A) |
| Neg | FP | Pos (Flu A) |
| A Pos | FN | Pos (Flu A) |
| Neg | FP | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| B Pos | FN | No PCR |
| A Pos | FN | Pos (Flu B) |
| A Pos | FN | No PCR |
| Neg | FP | Pos (Flu B) |
| Neg | FP | Pos (Flu B) |
| A Pos | FN | Pos (Flu B) |
| Neg | FP | No PCR |
| A Pos | FN | Pos (Flu B) |
| Neg | FP | Pos (Flu B) |
| A Pos | FN | No PCR |
| Neg | FP | Pos (Flu B) |
| A Pos | FN | Pos (Flu B) |
| Neg | FP | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| A Pos | FN | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| B Pos | FN | Pos (Flu A) |
| Neg | FP | No PCR |
| Neg | FP | No PCR |
| Neg | FP | No PCR |
| Neg | FP | No PCR |
| Neg | FP | Pos (Flu A) |
| Neg | FP | Neg |
| A Pos | FN | Pos (Flu A) |
| A Pos | FN | No PCR |
| A Pos | FN | No PCR |
| A Pos | FN | No PCR |
| B Pos | FN | Neg |
| Neg | FN | Neg |
| A Pos | FN | Neg |
| Overgrown | Overgrown | Pos (Flu A) |
| Overgrown | Overgrown | Pos (Flu A) |
| Overgrown | Overgrown | Neg |
| Overgrown | Overgrown | Neg |
| Overgrown | Overgrown | Pos (Flu A) |

Meridian Bioscience, Inc. Cincinnati, OH

Table 6-4 Continued

Legend: FN = false negative, FP = false positive

Reproducibility

A reproducibility panel, consisting of 14 coded specimens, were sent to three climical sites. Ten of these A reproducibility parti, consisting of 14 coded specificals, word NOW Flu B as positive. Two samples were classilled by the predicate devices binese from A & B and two samples were additional samples were at the limit of Geloor of in intersours of rative result. Even though the tital sites negalive. The samples were expected to produce a positive the strength of a positive readion that was were instructed to grade reactions, there were no ontent regaranty and inter-assay reproducibility of 100%.

High dose hook effect

There was no high dose hook effect observed in verification or clinical testing performed with this assay.

CONCILUSIONS

ImmunoCard STAT! Flu A & B:

Our CTAT: ha Fra L.
Can be used reliably for the rapid detection of influenza B antigens in human 1. respiratory specimens
Performs similarly to the predicate devices Binax NOW Flu A and NOW Flu B. 2.

		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 Flu A	3	8	7	2	1	5	4	Pos	5
2 LP Flu A	3	3	3	2	0.5	1	3.5	Pos	4
3 LP Flu B	0.5	1	1	0.5	0.5	0.5	3	1	2
4 LP Flu B	3	4	4	1	2	3	6	Pos	5
5 MP Flu A	4	5	4	4	3	5	5	Pos	6
6 MP Flu A	4	3	4	2	3	3	6.5	2	1
7 MP Flu B	3	4	3	3	3	4	4.5	Pos	5
8 MP Flu B	5	5	6	3	5	4	5	6	6.5
9 HP Flu A	7	6	6	7	5	5	6.5	2	6.5
10 HP Flu B	9	9	8	7	8	8	9	10	10
11 N	0	0	0	0	0	0	0	0	0
12 N	0	0	0	0	0	0	0	0	0
13 Limit of detect A	1	2	2	1	0.5	1	2.5	2	1.5
14 Limit of detect B	0	0	0	0	0	0	0	1	1
Total positive score	42.5	50.0	48.0	32.5	31.5	39.5	55.5	24	53.5
Average positive score	3.5	4.2	4.0	2.7	2.6	3.3	4.6	3.4	4.5
Percent correlation	100%	100%	100%	100%	100%	100%	100%	100%	100%

Table 6 6 . Results with reproducibility test panel #1

Percent (x)relation
Legend: I.P = low positive, MP = moderate positive, HP = high positive, N = negative,

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle.

MAR 16 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Susan Rolih MS. Susan Komi
Vice President, Regulatory Affairs and Quality Assurance Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244

K041626 Re:

K041620
Trade/Device Name: ImmunoCard STAT! Flu A&B PLUS Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Code: GNX Dated: February 28, 2005 Received: March 1, 2005

Dear Ms. Rolih:

We have reviewed your Section 510(k) premarket notification of intent to market the devices indication we have reviewed your Section > ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device American be on to commerce provide way 28, 1976, the encordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costlience Act (Act) that do not require the general controls provisions of the Act. The f ou may, therefore, market the device, editor equirements for annual registration, listing of general controls provisions of the res, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 dooro) in the subject to subject and affecting your device It may be subject to such additional comiser Listions (CFR), Paris 800 to 895. In addition, FDA can be found in This 21, Cours announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuants of rour device complies with other requirements of the Act that I DA has made a decerminations administered by other Federal agencies. You must of any recetal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Ave Brequire. Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing war antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalias and this p premarket notification. The PDA Inding of Subscantar of Marice and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, and If you desire specific information advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please contact th or questions on the promotion and advertising of your active of 50-0484. Also, please note the Vitro Diagnosic Device Lyanadion and barey at (21). " (210FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification and real regulation entitled, "Misoranting by reichers on your responsibilities under the Act from the You may obtain other general informations on your reopsitions of the manager Division of Siman (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Saly, a Forg

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

Indications for Use ImmunoCard STAT! Flu A&B PLUS

510(k) Number (if known): _K041626

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

ImmunoCard STAT! Flu A&B PLUS is a rapid, qualitative, lateral-flow immunoassy for Immunocard STAT: TG A&D F EOS is a rapid, quality antigens in human nasal delecting both Innuenza / Cand Inndonia = a = a = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = aspirate, nasopharyngoal aspiratematic patients. It is recommended that all negative test results be confirmed by cell culture.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sallath
Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) _______________________________________________________________________________________________________________________________________________________________________ K641626