Predicate Devices

BD Directigen Flu A+B

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard immunochromatographic assay based on antibody-antigen binding and visual line interpretation, with no mention of AI or ML technologies.

Therapeutic

No
The device is an in vitro diagnostic test for detecting influenza antigens, intended to aid in diagnosis, not to treat or cure a condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the test "is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections."

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical chromatographic immunoassay test strip, which is a hardware component, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The description explicitly states it is an "in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen... from nasal wash, nasal swab, and throat swab specimens from symptomatic patients." This clearly indicates it is used to test samples taken from the body, but outside the body (in vitro), to diagnose a condition.
Device Description: The description details a "chromatographic immunoassay" that analyzes a "patient specimen" to detect "viral antigens." This is a typical description of an in vitro diagnostic test.
Performance Studies: The document describes clinical trials and analytical studies evaluating the device's performance in detecting influenza in patient samples, which is standard for IVD validation.

The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to provide information for diagnosis, monitoring, or screening purposes. The Xpect™ Flu A/B fits this definition perfectly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

REMEL's Xpect™ Flu A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.

Product codes

GNX

Device Description

The Xpect™ Flu A/B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral antigens. The test device incorporates separate membrane strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample well of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibody-antigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.

A positive test is indicated by two black-colored bands; one in the (T) region and one in the (C) region. A negative test is indicated by only one black-colored band in the control (C) region. An invalid test occurs when no black-colored bands appear in the control (C) region.

A procedural control is included in the test. A colored band appearing on the control band (C) region is considered an internal positive procedural control, indicating proper performance and reactive reagents. A clear background in the results area is considered an internal negative control. If the test has been performed correctly and reagents are working properly, the background will clear to give a discernible result. It is recommended that Positive and Negative controls be run with each new test kit lot number. Each laboratory should follow their state and local requirements.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nasal, throat

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

The performance of the Xpect™ Flu A/B was evaluated at three sites located in the north, south, and east regions of the United States. The clinical trial sites included a Children's hospital (pediatric), a University hospital (primarily adult population), and a reference laboratory (adult and pediatric (60/40) population). The overall sensitivity of the Xpect™ Flu A/B test when compared to culture was 92.2% (71/77) for influenza A and 97.8% (45/46) for influenza B. The overall specificity was 100% for both influenza A (314/314) and influenza B (345/345). 6 samples were culture positive and Xpect™ Flu A/B negative for influenza A. 1 sample was culture positive and Xpect™ Flu A/B negative for influenza B. Four of five discrepant samples available for analysis were positive by RT-PCR.

Nasal Wash (n=239)
Influenza A: 92.5% Sensitivity (37/40), 95% Cl = 79.6-98.4%; 100% Specificity (199/199), 95% Cl = 98.2-100%.
Influenza B: 100% Sensitivity: (36/36), 95% CI = 90.3-100%; 100% Specificity (203/203), 95% Cl = 98.2-100%.

Throat Swabs (n=30)
Influenza A: 100% Sensitivity (10/10), 95% CI = 69.2-100%; 100% Specificity (20/20), 95% CI = 83.2-100%.
Influenza B: 100% Sensitivity; (4/4), 95% Cl = 39.8-100%; 100% Specificity (26/26), 95% CI = 86.8-100%.

Nasal Swab (n=122)
Influenza A: 88.9% Sensitivity (24/27), 95% CI = 70.8-97.7%; 100% Specificity (95/95), 95% CI = 96.2-100%.
Influenza B: 83.3% Sensitivity; (5/6), 95% CI = 35.9-99.6%; 100% Specificity (116/116), 95% CI = 96.9-100%.

Analytical sensitivity was evaluated using 12 influenza strains (6 influenza A and 6 influenza B) by CEID50 determinations and titration to positive endpoint.

Cross-reactivity: Thirty-six microorganisms were evaluated; no cross-reactivity was observed for influenza A or B. Bacteria and yeast isolates were tested at 10^6 colony-forming units/ml, viral isolates at concentrations of 10 to 10^8 TCID50/ml.

Interfering Substances: No interference was observed with whole blood (2%), 3 mouthwashes (25%), 3 throat drops (25%), 3 nasal sprays (25%), 4-acetamidophenol (acetaminophen) (10 mg/ml), acetylsalicylic acid (20 mg/ml), chlorpheniramine (5 mg/ml), dextromethorphan (10 mg/ml), diphenhydramine (5 mg/ml), guaiacol glyceryl ether (guaifenesin) (20 mg/ml), oxymetazoline (10 mg/ml), phenylephrine (25 mg/ml), pheny|propanolamine (20 mg/ml).

Reproducibility: Tested at four sites (including one in-house) on four separate days with six blinded samples (weakly positive or negative). 99% of 96 samples produced the expected result.

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

Overall Sensitivity: Influenza A: 92.2% (71/77); Influenza B: 97.8% (45/46)
Overall Specificity: Influenza A: 100% (314/314); Influenza B: 100% (345/345)

Nasal Wash:
Influenza A: 92.5% Sensitivity; 100% Specificity
Influenza B: 100% Sensitivity; 100% Specificity

Throat Swabs:
Influenza A: 100% Sensitivity; 100% Specificity
Influenza B: 100% Sensitivity; 100% Specificity

Nasal Swab:
Influenza A: 88.9% Sensitivity; 100% Specificity
Influenza B: 83.3% Sensitivity; 100% Specificity

Predicate Device(s)

BD Directigen Flu A+B

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

510(k) SUMMARY

«

| Contact Information: | Mary Ann Silvius
Business Development Manager
Remel Inc.
12076 Santa Fe Drive
Lenexa, KS 66215
Phone: (913) 895-4054
Fax: (913) 895-4054
email: msilvius@remel.com |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 14, 2003 |
| Device Trade Name: | Xpect™ Flu A/B |
| Predicate Device: | BD Directigen Flu A+B |
| Device Classification: | 21 CFR 866.3330; Influenza virus serological reagents |
| Intended Use: | REMEL's Xpect™ Flu A/B is a rapid in vitro
immunochromatographic test for the direct, qualitative
detection of influenza A and influenza B viral antigen
(nucleoprotein) from nasal wash, nasal swab, and throat
swab specimens from symptomatic patients. The test is
intended as an aid in the rapid diagnosis of influenza A and
influenza B viral infections. Negative tests should be
confirmed by cell culture. |
| Device Description: | The Xpect™ Flu A/B is a chromatographic immunoassay for
the qualitative detection of influenza A and influenza B viral
antigens. The test device incorporates separate membrane
strips for influenza A and for influenza B. To perform the
test, the patient specimen is diluted and added to the sample
well of the device. The mixture moves along the membranes
by capillary action. If present, influenza A or B viral antigens
in the patient sample bind anti-influenza A or B conjugated
antibodies. A visible line forms as a complex of antibody-
antigen-antibody coated colored particles is captured in the
test region (T). Antibody coated colored particles not bound
at the test line are later captured in the control region (C)
containing goat anti-mouse antibody. A visible line will
always appear in the control region indicating that the test is
working properly. The presence of a control line combined
with the absence of a visible test line is interpreted as a
negative test result. |

1

A positive test is indicated by two black-colored bands; one in the (T) region and one in the (C) region. A negative test is indicated by only one black-colored band in the control (C) region. An invalid test occurs when no black-colored bands appear in the control (C) reqion.

A procedural control is included in the test. A colored band appearing on the control band (C) region is considered an internal positive procedural control, indicating proper performance and reactive reagents. A clear background in the results area is considered an internal negative control. If the test has been performed correctly and reagents are working properly, the background will clear to give a discernible result. It is recommended that Positive and Negative controls be run with each new test kit lot number. Each laboratory should follow their state and local requirements.

Characteristic	Directigen Flu A+B	Xpect™ Flu A/B
Intended Use	The Directigen Flu A+B test is a rapid in
vitro immunoassay membrane test for the
direct and qualitative detection of influenza
A and B viral antigens from
nasopharyngeal wash, nasopharyngeal
aspirate, nasopharyngeal swab, lower
nasal swab, throat swab and
bronchoalveolar lavage specimens of
symptomatic patients. The Directigen Flu
A+B test is a differentiated test, and
therefore influenza A viral antigens can be
distinguished from influenza B viral
antigens in a single test. The test is used
as an aid in the diagnosis of influenza A
and B viral infections. Negative test
results should be confirmed by cell culture.	REMEL's Xpect™ Flu A/B is a rapid in
vitro immunochromatographic test for
the direct, qualitative detection of
influenza A and influenza B viral antigen
(nucleoprotein) from nasal wash, nasal
swab, and throat swab specimens from
symptomatic patients. The test is
intended as an aid in the rapid diagnosis
of influenza A and influenza B viral
infections. Negative tests should be
confirmed by cell culture.
Detection	Qualitative; Influenza A and B viral
antigens with differentiation.	Qualitative; Influenza A and B viral
antigens with differentiation.
Technology	Enzyme Immunoassay (EIA) membrane
assay	Immunochromatographic membrane
assay
Specimen Type	Nasopharyngeal wash, nasopharyngeal
aspirate, nasopharyngeal swab, lower
nasal swab, throat swab and
bronchoalveolar lavage specimens	Nasal wash, nasal swab, and throat
swab specimens

Device Comparison:

Summary of Performance Data:

Clinical Accuracy:

The performance of the Xpect™ Flu A/B was evaluated at three sites located in the north, south, and east regions of the United States. The clinical trial sites included a Children's hospital (pediation), a University hospital (primarily adult population), and a reference laboratory (adult and pediatric (60/40) population). For all

2

specimens evaluated, the overall sensitivity of the Xpect™ Flu A/B test when compared to culture was 92.2% (71/77) for influenza A and 97.8% (45/46) for influenza B. The overall specificity was 100% for both influenza A (314/314) and influenza B (345/345). For influenza A, there were 6 samples that were culture positive and Xpect™ Flu A/B neqative. For influenza B, there was 1 sample that was culture positive and Xpect™ Flu A/B negative. Four of five discrepant samples available for analysis were positive by RT-PCR.

Nasal Wash (n=239)

Influenza A 92.5% Sensitivity (37/40): 95% Cl = 79.6-98.4% 100% Specificity (199/199); 95% Cl = 98.2-100%

Influenza B

100% Sensitivity: (36/36); 95% CI = 90.3-100% 100% Specificity (203/203); 95% Cl = 98.2-100%

		Culture Results
OVERALL		A+ / B-	A- / B+	A- / B-
Xpect™ Flu	A+ / B-	37	0	0
A/B Results	A- / B+	0	36	0
	A- / B-	3*	0	163

*RT-PCR was performed on the three discrepant results. One of the three specimens was negative by PCR, two were positive.

Test performance by individual site:

FLU A	Sensitivity			Specificity
Site	#	%	95% CI	#	%	95% CI
1	0/0	NA	NA	1/1	100	NA
2	3/5	60.0	14.7-94.7	69/69	100	94.8-100
3	34/35	97.1	85.1-99.9	129/129	100	97.2-100

FLU B	Sensitivity			Specificity
Site	#	%	95% CI	#	%	95% CI
1	0/0	NA	NA	1/1	100	NA
2	0/0	NA	NA	74/74	100	95.1-100
3	36/36	100	90.3-100	128/128	100	97.2-100

Throat Swabs (n=30)

Influenza A 100% Sensitivity (10/10): 95% CI = 69.2-100% 100% Specificity (20/20); 95% CI = 83.2-100%

3

Influenza B 100% Sensitivity; (4/4); 95% Cl = 39.8-100% 100% Specificity (26/26); 95% CI = 86.8-100%

		Culture Results
OVERALL		A+ / B-	A- / B+	A- / B-
Xpect™ Flu
A/B Results	A+ / B-	10	0	0
	A- / B+	0	4	0
	A- / B-	0	0	16

Test performance by individual site:

FLU A	Sensitivity			Specificity
Site	#	%	95% CI	#	%	95% CI
1	10/10	100	69.2-100	18/18	100	81.5-100
2	0/0	NA	NA	2/2	100	15.8-100
3	NA	NA	NA	NA	NA	NA

FLU B	Sensitivity			Specificity
Site	#	%	95% CI	#	%	95% CI
1	4/4	100	39.8-100	24/24	100	85.8-100
2	0/0	NA	NA	2/2	100	15.8-100
3	NA	NA	NA	NA	NA	NA

Nasal Swab (n=122)

Influenza A 88.9% Sensitivity (24/27); 95% CI = 70.8-97.7% 100% Specificity (95/95); 95% CI = 96.2-100%

Influenza B 83.3% Sensitivity; (5/6); 95% CI = 35.9-99.6% 100% Specificity (116/116); 95% CI = 96.9-100%

		Culture Results
		A+ / B-	A- / B+	A- / B-
Xpect™ Flu
A/B Results	A+ / B-	24	0	0
	A- / B+	0	5	0
	A- / B-	3*	1*	89

*RT-PCR was performed on two of the four discrepant specimens that were available (one influenza A and one influenza B). Both specimens were positive by PCR.

4

FLU A	Sensitivity			Specificity
Site	#	%	95% CI	#	%	95% CI
1	24/27	88.9	70.8-97.7	91/91	100	96.0-100
2	0/0	NA	NA	4/4	100	39.8-100
3	NA	NA	NA	NA	NA	NA

Test performance by individual site:

FLU B	Sensitivity			Specificity
Site	#	%	95% CI	#	%	95% CI
1	5/6	83.3	35.9-99.6	112/112	100	96.8-100
2	0/0	NA	NA	4/4	100	39.8-100
3	NA	NA	NA	NA	NA	NA

Analytical Sensitivity:

The analytical sensitivity was evaluated using 12 influenza strains; 6 influenza A and 6 influenza B. Each viral strain was quantitated by CEIDso determinations and titrated until a positive endpoint was reached using the Xpect™ Flu A/B test. The amount of virus at the endpoint dilution, expressed as CEIDso per test, was calculated as a measure of analytical sensitivity.

| Influenza Strain | Type | Detection Limit
CEID50 |
|-----------------------------|------|---------------------------|
| A/Puerto Rico/8/34 (H1N1) | A | 8.9 x 103 |
| A/Fort Monmouth/1/47 (H1N1) | A | 7.9 x 101 |
| A/New Jersey/8/76 (H1N1) | A | 8.9 x 101 |
| A/Hong Kong/8/68 (H3N2) | A | 2.8 x 101 |
| A/Victoria/3/75 (H3N2) | A | 8.9 x 102 |
| A/Port Chalmers/1/73 (H3N2) | A | 4.0 x 101 |
| B/Lee/40 | B | 7.9 x 103 |
| B/Allen/45 | B | 4 |
| B/Maryland/1/59 | B | 6 |
| B/GL/1739/54 | B | 8.9 x 101 |
| B/Taiwan/2/62 | B | 3 |
| B/Hong Kong/5/72 | B | 1.58 x 102 |

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Cross-Reactivity:

Thirty-six microorqanisms were evaluated with the Xpect™ Flu A/B test. No crossreactivity was observed for influenza A or influenza B. Bacteria and yeast isolates were tested at 10° colony-forming units per ml concentration. Viral isolates were tested at concentrations of 10 to 108 TCID50 (tissue culture infectious dose) per ml concentration. The following organisms were tested in the Xpect™ Flu A/B test.

Acinetobacter baumanni	Serratia marcescens
Bordetella pertussis	Staphylococcus aureus (Cowan)
Candida albicans	Staphylococcus epidermidis
Enterococcus faecalis	Streptococcus mutans
Escherichia coli	Streptococcus pneumoniae
Gardnerella vaginalis	Streptococcus pyogenes Group A
Haemophilus influenzae	Streptococcus, Group B
Klebsiella pneumoniae	Streptococcus, Group C
Lactobacillus casei	Streptococcus, Group F
Legionella pneumophila	Adenovirus, Type 5
Listeria monocytogenes	Coronavirus
Moraxella catarrhalis	Coxsackievirus B5
Neisseria gonorrhoeae	Cytomegalovirus
Neisseria meningitidis	Parainfluenza (Sendai), Type 1
Neisseria sicca	Parainfluenza, Type 2
Neisseria subflava	Parainfluenza, Type 3
Proteus vulgaris	Respiratory Syncytial Virus, A
Pseudomonas aeruginosa	Rhinovirus, Type 14

Interfering Substances:

The following substances were tested with the Xpect™ Flu A/B test and no interference was observed in the assay for any substance tested at the indicated levels: whole blood (2%), 3 mouthwashes (25%), 3 throat drops (25%), 3 nasal sprays (25%), 4acetamidophenol (acetaminophen) (10 mg/ml), acetylsalicylic acid (20 mg/ml), chlorpheniramine (5 mg/ml), dextromethorphan (10 mg/ml), diphenhydramine (5 mg/ml), guaiacol glyceryl ether (guaifenesin) (20 mg/ml), oxymetazoline (10 mg/ml), phenylephrine (25 mg/ml), pheny|propanolamine (20 mg/ml).

Reproducibility:

Reproducibility testing was conducted at four sites, including one in-house site, on four separate days with six blinded samples. The liquid samples consisted of diluted influenza A and influenza B antigens intended to read weakly positive or negative with the Xpect™ Flu A/B test. Ninety-nine percent of the 96 samples tested produced the expected result.

6

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 17 2003

Ms. Mary Ann Silvius Business Development Manager Remel Inc. 12076 Santa Fe Drive Lenexa, KS 66215

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K031565

Trade/Device Name: Xpect™ Flu A/B Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: May 14, 2003 Received: May 20, 2003

Dear Ms. Silvius:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

7

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). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

8

INDICATIONS FOR USE

KD31565 510(k) Number (if known):_______

Device Name: Xpect™ Flu A/B

Indications For Use: - REMEL's Xpect™ Flu A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use

(Per 21 CFR 801.109)
------------------------------------------	--

OR

Over-The-Counter Use
----------------------	--

Division Sign-Off
-------------------	--

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)	K03 1565
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