(23 days)
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No
The device description details a chromatographic immunoassay based on antibody-antigen binding and capillary action, which is a traditional biological assay method. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies described are standard analytical sensitivity tests for biological assays.
No
This device is an in vitro diagnostic test designed to detect viral antigens for influenza A and B, aiding in rapid diagnosis rather than providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections."
No
The device description clearly outlines a physical, in vitro diagnostic test kit that uses chromatographic immunoassay technology with physical components (membrane strips, sample wells, colored particles) to detect viral antigens. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens...". The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a test performed on patient specimens (nasal wash, nasal swab, throat swab) outside of the body to detect specific substances (viral antigens). This is the fundamental nature of an IVD.
- Specimen Type: The test uses biological specimens collected from the patient, which are then analyzed in vitro.
Therefore, based on the provided information, the Remel Xpect® Flu A&B device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Remel Xpect® Flu A&B is a in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (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. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.
Product codes (comma separated list FDA assigned to the subject device)
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 wells 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Sensitivity:
The analytical sensitivity was evaluated using 17 influenza strains; 11 influenza A and 6 influenza B. Each viral strain was quantitated and titrated until a positive endpoint was reached using the Xpect® Flu A&B test. The amount of virus at the endpoint dilution, expressed per test, was calculated as a measure of analytical sensitivity.
Key results:
| Influenza Strain | Type | Detection Limit TCID50/ml |
|---|---|---|
| A/Anhui/1/2013 | A (H7N9) | 1.26 x 10^5 |
| A/California/04/2009 | A (H1N1) | 4.41 x 10^2 |
| A/New Caledonia/20/1999 | A (H1N1) | 1.63 x 10^2 |
| Influenza Strain | Type | Detection Limit CEID50/ml |
| A/Puerto Rico/8/34 | A (H1N1) | 8.9 x 10^3 |
| A/Fort Monmouth/1/47 | A (H1N1) | 7.9 x 10^1 |
| A/New Jersey/8/76 | A (H1N1) | 8.9 x 10^1 |
| A/Hong Kong/8/68 | A (H3N2) | 2.8 x 10^1 |
| A/Victoria/3/75 | A (H3N2) | 8.9 x 10^2 |
| A/Port Chalmers/1/73 | A (H3N2) | 4.0 x 10^1 |
| A/BhGoose/QH/1/05 | A (H5N1) | 2.0 x 10^4 |
| A/Chicken/WD/98 | A (H9N2) | 3.16 x 10^3 |
| B/Lee/40 | B | 7.9 x 10^3 |
| B/Allen/45 | B | 4 x 10^0 |
| B/Maryland/1/59 | B | 6 x 10^0 |
| B/GL/1739/54 | B | 8.9 x 10^1 |
| B/Taiwan/2/62 | B | 3 x 10^0 |
| B/Hong Kong/5/72 | B | 1.58 x 10^2 |
Although this test has been shown to detect the influenza A/California/04/2009 (H1N1) and A/Anhui/1/3012 (H7N9) viruses cultured from positive human specimens, the performance characteristics of this device with human specimens infected with these influenza A viruses have not been established. Xpect Flu A&B can distinguish between influenza A and B viruses, but it does not differentiate influenza subtypes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
510(k) SUMMARY
JUL 1 2 2013 Contact Information: Cindy Knapp Director of U.S. Regulatory & Global Clinical Affairs Remel Inc. 12076 Santa Fe Drive Lenexa, KS 66215 Phone: 800-871-8909 ext.322-4117 Fax: 440-703-1596 email: cindy.knapp@thermofisher.com
Date Prepared: June 18, 2013
Remel Xpect® Flu A&B Device Trade Name:
Remel Xpect® Flu A&B (K031565: S&E July 17, 2003) Predicate Device:
21 CFR 866.3330: Influenza virus serological reagents. Device Classification:
Xpect® -Intended Use: Remel Flu A&B is a in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (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. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.
Device Description: The Xpect® Flu A&B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral The test device incorporates separate membrane antigens. strips for influenza A and for influenza B. To perform the test. the patient specimen is diluted and added to the sample wells 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 A visible line forms as a complex of antibodyantibodies. 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
Device Comparison:
| Characteristic | Remel Xpect® Flu A&B | Remel Xpect® Flu A&B |
|---|---|---|
| Similarities | ||
| Intended Use | Remel Xpect® Flu A&B is a rapid in | |
| vitro immunochromatographic test for | ||
| the direct, qualitative detection of | ||
| influenza A and influenza B viral | ||
| antigens (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. | Remel Xpect® Flu A&B is a rapid in | |
| vitro immunochromatographic test for | ||
| the direct, qualitative detection of | ||
| influenza A and influenza B viral | ||
| antigens (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. A | ||
| negative test is presumptive and it is | ||
| recommended these results be | ||
| confirmed by virus culture or an FDA- | ||
| cleared influenza A and B molecular | ||
| assay. | ||
| Sample | Qualitative; Influenza A and B viral | |
| antigens with differentiation. | Qualitative; Influenza A and B viral | |
| antigens with differentiation. | ||
| Test | ||
| Methodology | Immunochromatographic membrane | |
| assay | Immunochromatographic membrane | |
| assay | ||
| Specimen | ||
| Type | Nasal wash, nasal swab, and throat | |
| swab specimens | Nasal wash, nasal swab, and throat | |
| swab specimens | ||
| Interpretation | Visual read | Visual read |
| Incubation | 15 minutes | 15 minutes |
| Differences | ||
| Analytical | ||
| Sensitivity | 17 influenza strains; 11 influenza A | |
| and 6 influenza B | Addition of Influenza A/Anhui/1/2013 | |
| (H7N9) to total 17 influenza strains; | ||
| 11 influenza A and 6 influenza B |
2
Summary of Performance Data: Analytical Sensitivity:
The analytical sensitivity was evaluated using 17 influenza strains; 11 influenza A and 6 influenza B. Each viral strain was quantitated and titrated until a positive endpoint was reached using the Xpect® Flu A&B test. The amount of virus at the endpoint dilution, expressed per test, was calculated as a measure of analytical sensitivity.
| Influenza Strain | Type | Detection Limit |
|---|---|---|
| TCID50/ml | ||
| A/Anhui/1/2013 | A (H7N9) | $1.26 x 10^5$ |
| A/California/04/2009 | A (H1N1) | $4.41 x 10^2$ |
| A/New Caledonia/20/1999 | A (H1N1) | $1.63 x 10^2$ |
| CEID50/ml | ||
| A/Puerto Rico/8/34 | A (H1N1) | $8.9 x 10^3$ |
| A/Fort Monmouth/1/47 | A (H1N1) | $7.9 x 10^1$ |
| A/New Jersey/8/76 | A (H1N1) | $8.9 x 10^1$ |
| A/Hong Kong/8/68 | A (H3N2) | $2.8 x 10^1$ |
| A/Victoria/3/75 | A (H3N2) | $8.9 x 10^2$ |
| A/Port Chalmers/1/73 | A (H3N2) | $4.0 x 10^1$ |
| A/BhGoose/QH/1/05 | A (H5N1) | $2.0 x 10^4$ |
| A/Chicken/WD/98 | A (H9N2) | $3.16 x 10^3$ |
| B/Lee/40 | B | $7.9 x 10^3$ |
| B/Allen/45 | B | $4 x 10^0$ |
| B/Maryland/1/59 | B | $6 x 10^0$ |
| B/GL/1739/54 | B | $8.9 x 10^1$ |
| B/Taiwan/2/62 | B | $3 x 10^0$ |
| B/Hong Kong/5/72 | B | $1.58 x 10^2$ |
TCID - 50% tissue culture infectious dose: CEID - 50% chicken embryo infectious dose
Although this test has been shown to detect the influenza A/California/04/2009 (H1N1) and A/Anhui/1/3012 (H7N9) viruses cultured from positive human specimens, the performance characteristics of this device with human specimens infected with these influenza A viruses have not been established. Xpect Flu A&B can distinguish between influenza A and B viruses, but it does not differentiate influenza subtypes.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized caduceus or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
CINDY KNAPP CIRECTOR OF U.S. REGULATORY & GLOBAL CLINICAL AFFAIRS REMEL INC. I 2076 SANTA FE DRIVE LENEXA KS 66215
Re: K131804
Trade/Device Name: Remel Xpect® Flu A&B Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: 1 Product Code: GNX Dated: June 18, 2013 Received: June 19, 2013
Dear Ms. Knapp:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave teviewed your bection brocd the device is substantially equivalent (for the indications ferenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosury to legally manatible of the Medical Device American of to commerce prior to May 20, 1976. the enastment with the provisions of the Federal Food. Drug. devices that have been recuired in accordable while the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, merefore, market the device, seojos, so urements for annual registration, listing of general controls provisions of the fice labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Fease note. CDNP does not evaluation must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). If your device is classified (see above) in existing major regulations affecting your device can be it may be subject to additional controls. Extrains majar 10 898. 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 Please be advised mat I DA s issualities with other requirements of the Act
that FDA has made a determination that your device complies with other much that PDA has made a decemmation the Jountinistered by other Federal agencies. You must or any rederal statutes and regilations administered of not limited to: registration and listing (2 l comply with an the Act s requirements, netical device reporting (reporting (reporting of CFK Part 807); iabeling (21 CFR Pans 601 and 2001); cood manufacturing practice requirements
medical device-related adverse events) (21 CFR 803); good manufacturing the medical device-related adverse events) (21 CFR Part 820); and if applicable. the as set form in the quality systems (QD) regard (Sections 531-542 of the Act); 21 CFR 1000-1050.
July 12, 2013
4
Page 2-Ms. Knapp
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and If you desire specific advice for your as not receivers, International and Consumer 809), prease contact the Division of Sthan Nameral (196-7100 or at its Internet address of Assistance at its lon-fice number (600) 050 2017 07 (07/11/dustry/default.ling. Also, please note http://www.ida.gov/MedicalDevice.nrtcc.nce to premarket notification" (2) CFR Part the regulation entiled, "Misolanding by reference to promance included the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office illip.7/www.ida.gon.non.gov.notics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may offain other general information on your responsions and its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 036-2041 of (301) 170 - rices/ResourcesSorYou/Industry/default.htm.
Sincerely yours,
Sally A. Hojvat -S
Sally Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number : K131804
Device Name: Xpect® Flu A&B
Indications For Use: Remel Xpect® Flu A&B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (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 B viral infections. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Tamara V. Feldblyum -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)_k131804