(23 days)
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.
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.
Here's an analysis of the provided text regarding the Remel Xpect® Flu A&B device, structured according to your request:
Acceptance Criteria and Study Details for Remel Xpect® Flu A&B
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on analytical sensitivity as the performance metric for this submission. While a single, overarching acceptance criterion isn't explicitly stated as a pass/fail threshold, the study's purpose is to demonstrate the device's ability to detect various influenza strains, including the newly added A/Anhui/1/2013 (H7N9). The "Detection Limit" column in the table below represents the reported device performance for each strain.
| Influenza Strain | Type | Reported Device Performance (Detection Limit) |
|---|---|---|
| A/Anhui/1/2013 | A (H7N9) | $1.26 x 10^5$ TCID50/ml |
| A/California/04/2009 | A (H1N1) | $4.41 x 10^2$ TCID50/ml |
| A/New Caledonia/20/1999 | A (H1N1) | $1.63 x 10^2$ TCID50/ml |
| A/Puerto Rico/8/34 | A (H1N1) | $8.9 x 10^3$ CEID50/ml |
| A/Fort Monmouth/1/47 | A (H1N1) | $7.9 x 10^1$ CEID50/ml |
| A/New Jersey/8/76 | A (H1N1) | $8.9 x 10^1$ CEID50/ml |
| A/Hong Kong/8/68 | A (H3N2) | $2.8 x 10^1$ CEID50/ml |
| A/Victoria/3/75 | A (H3N2) | $8.9 x 10^2$ CEID50/ml |
| A/Port Chalmers/1/73 | A (H3N2) | $4.0 x 10^1$ CEID50/ml |
| A/BhGoose/QH/1/05 | A (H5N1) | $2.0 x 10^4$ CEID50/ml |
| A/Chicken/WD/98 | A (H9N2) | $3.16 x 10^3$ CEID50/ml |
| B/Lee/40 | B | $7.9 x 10^3$ CEID50/ml |
| B/Allen/45 | B | $4 x 10^0$ CEID50/ml |
| B/Maryland/1/59 | B | $6 x 10^0$ CEID50/ml |
| B/GL/1739/54 | B | $8.9 x 10^1$ CEID50/ml |
| B/Taiwan/2/62 | B | $3 x 10^0$ CEID50/ml |
| B/Hong Kong/5/72 | B | $1.58 x 10^2$ CEID50/ml |
Note: The document explicitly states: "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." This indicates that the analytical sensitivity data presented here is for cultured viral strains, not directly from human clinical samples for the A/H1N1 and A/H7N9 strains mentioned.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The test set for analytical sensitivity consisted of 17 influenza strains (11 influenza A and 6 influenza B).
- Data Provenance: The data comes from laboratory testing of cultured viral strains. The country of origin for the data is not specified, but it is implied to be internal laboratory work conducted by Remel Inc. The study is a prospective experimental study in a controlled laboratory setting, not a retrospective analysis of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Experts are not mentioned in the context of establishing ground truth for the analytical sensitivity test set. The ground truth for this type of test is typically based on the quantitated viral stock concentrations and the known presence/absence of the specific influenza strains.
4. Adjudication Method for the Test Set
Adjudication methods are not applicable and not mentioned for this analytical sensitivity study. The determination of a "positive endpoint" for each viral strain would be based on consistent visual readability of the test line by laboratory personnel following a defined protocol, not by expert consensus or adjudication of ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on analytical sensitivity, not reader performance or human-AI interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The analytical sensitivity study evaluates the device's ability to detect different influenza strains at specified concentrations without human interpretation variability being a primary variable. The Remel Xpect® Flu A&B is a visual read immunochromatographic test, meaning the "algorithm" is the biochemical reaction itself, and the "standalone" performance refers to its ability to react correctly to various concentrations of target analytes. While human visual interpretation is involved, the study assesses the inherent detection capability of the test.
7. The Type of Ground Truth Used
The ground truth used for the analytical sensitivity study is the known concentration (quantitation and titration) of well-characterized influenza viral strains. This is measured as TCID50/ml (50% tissue culture infectious dose) or CEID50/ml (50% chicken embryo infectious dose).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device or study description. The Remel Xpect® Flu A&B is a chemical-biological immunoassay, not a machine learning or AI-driven diagnostic device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As stated above, a training set is not applicable to this device. Therefore, no ground truth for a training set was established.
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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.
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Device Comparison:
| Characteristic | Remel Xpect® Flu A&B | Remel Xpect® Flu A&B |
|---|---|---|
| Similarities | ||
| Intended Use | Remel Xpect® Flu A&B is a rapid invitro immunochromatographic test forthe direct, qualitative detection ofinfluenza A and influenza B viralantigens (nucleoprotein) from nasalwash, nasal swab, and throat swabspecimens from symptomaticpatients. The test is intended as anaid in the rapid diagnosis of influenzaA and influenza B viral infections.Negative tests should be confirmedby cell culture. | Remel Xpect® Flu A&B is a rapid invitro immunochromatographic test forthe direct, qualitative detection ofinfluenza A and influenza B viralantigens (nucleoprotein) from nasalwash, nasal swab, and throat swabspecimens from symptomaticpatients. The test is intended as anaid in the rapid diagnosis of influenzaA and influenza B viral infections. Anegative test is presumptive and it isrecommended these results beconfirmed by virus culture or an FDA-cleared influenza A and B molecularassay. |
| Sample | Qualitative; Influenza A and B viralantigens with differentiation. | Qualitative; Influenza A and B viralantigens with differentiation. |
| TestMethodology | Immunochromatographic membraneassay | Immunochromatographic membraneassay |
| SpecimenType | Nasal wash, nasal swab, and throatswab specimens | Nasal wash, nasal swab, and throatswab specimens |
| Interpretation | Visual read | Visual read |
| Incubation | 15 minutes | 15 minutes |
| Differences | ||
| AnalyticalSensitivity | 17 influenza strains; 11 influenza Aand 6 influenza B | Addition of Influenza A/Anhui/1/2013(H7N9) to total 17 influenza strains;11 influenza A and 6 influenza B |
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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.
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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
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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
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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
§ 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.