Who is the manufacturer of XPECT INFLUENZA A/B?

Remel, Inc. filed the 510(k) submission for XPECT INFLUENZA A/B (K031565).

What is the FDA product code for XPECT INFLUENZA A/B?

PSZ. It is classified under 21 CFR 866.3328 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for XPECT INFLUENZA A/B?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like XPECT INFLUENZA A/B?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XPECT INFLUENZA A/B

K031565 · Remel, Inc. · PSZ · Jul 17, 2003 · Microbiology

Device Facts

Record ID	K031565
Device Name	XPECT INFLUENZA A/B
Applicant	Remel, Inc.
Product Code	PSZ · Microbiology
Decision Date	Jul 17, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3328
Device Class	Class 2

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 Story

Xpect™ Flu A/B is a rapid, qualitative, immunochromatographic membrane assay for detecting influenza A and B viral nucleoprotein antigens. Input: nasal wash, nasal swab, or throat swab specimens. Operation: specimen diluted and added to device sample well; capillary action moves sample across membrane strips. If antigens present, they bind to anti-influenza conjugated antibodies; complex captured in test region (T) forming visible black-colored band. Control region (C) captures unbound particles to verify test performance. Output: visual interpretation of black bands (two bands = positive; one band in C = negative; no band in C = invalid). Used in clinical settings by healthcare professionals. Results aid rapid diagnosis of influenza infections; negative results require confirmation by cell culture.

Clinical Evidence

Clinical trial at three U.S. sites (children's hospital, university hospital, reference lab) compared Xpect™ Flu A/B to cell culture. Overall sensitivity: 92.2% (71/77) for influenza A, 97.8% (45/46) for influenza B. Overall specificity: 100% for both. Discrepant analysis via RT-PCR performed on available samples. Analytical sensitivity evaluated using 12 influenza strains. Cross-reactivity tested against 36 microorganisms; no cross-reactivity observed. Interfering substances (blood, mouthwash, throat drops, nasal sprays, common OTC medications) showed no interference.

Technological Characteristics

Immunochromatographic membrane assay. Device incorporates separate membrane strips for influenza A and B. Qualitative detection via antibody-antigen-antibody complex captured on membrane. Visual readout via colored particles. Standalone test device.

Indications for Use

Indicated for symptomatic patients requiring rapid qualitative detection of influenza A and B viral nucleoprotein antigens from nasal wash, nasal swab, or throat swab specimens. Aid in diagnosis; negative results require cell culture confirmation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

BD Directigen Flu A+B

Related Devices

K131804 — REMEL XPECT FLU A&B · Remel, Inc. · Jul 12, 2013
K092349 — CLEARVIEW EXACT II INFLUENZA A & B TEST · Inverness Medical, Inc. · May 10, 2010
K092423 — XPECT FLU A & B · Thermo Fisher Scientific · Aug 26, 2009
K092223 — MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST · Binax, Inc. · Aug 12, 2009
K251563 — WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test · Wondfo USA Co, Ltd. · Aug 20, 2025

Submission Summary (Full Text)

{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 | {5}------------------------------------------------ ## 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 | |--------|----------| |--------|----------|