← Product Code [PSZ](/productcode/PSZ) · K063689 # BD DIRECTIGEN EZ FLU A+B TEST (K063689) _Becton, Dickinson & CO · PSZ · Mar 7, 2007 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K063689 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [PSZ](/productcode/PSZ.md) - **Decision Date:** Mar 7, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3328 - **Device Class:** Class 2 - **Review Panel:** Microbiology - **Attributes:** Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K063689 · Mar 7, 2007 | BD DIRECTIGEN EZ FLU A+B TEST | Becton, Dickinson & CO | Retrospective, frozen nasopharyngeal swab specimens | Retrospective clinical specimens were used to supplement prospective clinical study data to establish performance characteristics for Influenza B detection. | Retrospective specimens; Influenza B; Nasopharyngeal swabs | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Retrospective nasopharyngeal swab study; Retrospective analysis of frozen specimens; Study Period: 2005 respiratory season | Patients from the 2005 respiratory season (pediatric and adult); Sample Size: 59 | Viral cell culture | Positive and negative agreement for Influenza B | ## Indications for Use The BD Directigen™ EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Users may wish to establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens. ## Device Story Rapid chromatographic immunoassay for qualitative detection of influenza A and B viral antigens; differentiates A from B in single processed sample. Used in clinical settings to aid diagnosis. Input: nasopharyngeal washes/aspirates, nasopharyngeal swabs, or throat swabs. Output: visual qualitative result. Healthcare providers use results to guide clinical management; negative results require confirmation by cell culture. ## Clinical Evidence Multi-center study using 456 prospective and 59 retrospective nasopharyngeal swab specimens. Compared to viral cell culture. Prospective sensitivity/specificity: Influenza A (90.7%/93.2%), Influenza B (100%/100%). Retrospective agreement: Influenza A (85.7% positive/96.2% negative), Influenza B (74.4% positive/100% negative). ## Technological Characteristics Rapid chromatographic immunoassay; lateral flow format. Differentiates influenza A and B antigens. Standalone, manual test device. No electronic components or software algorithms. ## Regulatory 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 - Viral cell culture - direct fluorescent antibody (DFA) tests - BD Directigen™ EZ Flu A+B test ([K001364](/device/K001364.md)) - BinaxNow Influenza A&B ([K053126](/device/K053126.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K063689 B. Purpose of Submission: Addition of a new specimen type claim (nasopharyngeal swab) to the currently marketed device K042472 C. Analyte: Influenza A and B viral antigens D. Type of Test: Rapid chromatographic immunoassay that differentiates influenza A viral antigens from influenza B viral antigens E. Applicant: Becton, Dickinson and Company. F. Proprietary and Established Names: BD Directigen™ EZ Flu A+B Kit G. Regulatory Information: 1. Regulation section: 21 CFR§866.3330 2. Classification: I 3. Product Code: GNX – Antigens, CF (including CF controls), Influenza Virus A, B, C. 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The BD Directigen™ EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Users may wish to establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab 2. Indication(s) for use: {1} Page 2 of 5 Same as above 3. Special condition for use statement(s): For Prescription Use Only 4. Special instrument Requirements: Not applicable I. Device Description: See: http://www.fda.gov/cdrh/reviews/K042472.pdf J. Substantial Equivalence Information: 1. Predicate device name(s): Viral cell culture, direct fluorescent antibody (DFA) tests, BD Directigen™ EZ Flu A+B test (K001364), and BinaxNow Influenza A&B (K053126). 2. Predicate K number(s): K001364, K053126, 3. Comparison with predicate(s): See: http://www.fda.gov/cdrh/reviews/K042472.pdf K. Standard/Guidance Document referenced (if applicable): Not applicable L. Test Principle: See: http://www.fda.gov/cdrh/reviews/K042472.pdf M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: See: http://www.fda.gov/cdrh/reviews/K042472.pdf b. Linearity/assay reportable range: Not applicable c. Traceability (controls, calibrators, or method): Not applicable d. Detection limit: See: http://www.fda.gov/cdrh/reviews/K042472.pdf e. Analytical specificity: Evaluation of media for preservation and transport of respiratory specimens: See: http://www.fda.gov/cdrh/reviews/K042472.pdf Cross reactivity Study: See: http://www.fda.gov/cdrh/reviews/K042472.pdf Interference study: See: http://www.fda.gov/cdrh/reviews/K042472.pdf {2} f. Assay cut-off Not applicable. # 2. Comparison studies: a. Method comparison with gold standard: see clinical studies b. Matrix comparison: Not applicable # 3. Clinical studies: See: http://www.fda.gov/cdrh/reviews/K042472.pdf. In addition, the following clinical studies were performed in support of the new specimen types, nasopharyngeal swab specimens: The performance characteristics of the BD Directigen EZ Flu A+B test as compared to viral cell culture were determined using 456 prospective nasopharyngeal swab specimens. The sensitivity and specificity of the BD Directigen EZ A+B test for influenza A were $90.7\%$ (146/161) and $93.2\%$ (275/295), respectively. For influenza B, the sensitivity and specificity were $100.0\%$ (1/1) and $100.0\%$ (455/455), respectively. To augment the study with an adequate number of positive samples for influenza B, 59 retrospective nasopharyngeal swab specimens were tested with the BD Directigen EZ Flu A+B test and compared to viral cell culture. Note: Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Therefore, users should establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens. The positive and negative agreement of the BD Directigen EZ A+B test for influenza A with the retrospective nasopharyngeal swab specimens were $85.7\%$ (6/7) and $96.2\%$ (50/52). The positive and negative agreement for influenza B with the retrospective nasopharyngeal swab specimens were $74.4\%$ (32/43) and $100.0\%$ (16/16), respectively. The performance characteristics as compared to cell culture for nasopharyngeal swab specimens are presented in Tables 1, 2, 3 and Table 4: Table 1: Summary of the Performance of the Directigen EZ Flu A+B Test Compared to Culture for Prospective Nasopharyngeal Swabs - Influenza A Combined 2003-2004, 2004-2005 and 2006 Respiratory Seasons | Cell Culture | | | | | --- | --- | --- | --- | | Specimen Type | Directigen™ EZ Flu A+B Test | P | N | | Nasopharyngeal swabs | P | 146 | 20 | | | N | 15 | 275 | | Sensitivity: 91% (95% CI: 85% - 95%)Specificity: 93% (95% CI: 90% - 96%) | | | | {3} Table 2: Summary of the Performance of the Directigen EZ Flu A+B Test Compared to Culture for Prospective Nasopharyngeal Swabs - Influenza B Combined 2003-2004, 2004-2005 and 2006 Respiratory Seasons | | | Cell Culture | | | --- | --- | --- | --- | | Specimen Type | Directigen™EZ Flu A+B Test | P | N | | Nasopharyngeal swabs | P | 1* | 0 | | | N | 0 | 455 | | Sensitivity: 100% (95% CI: 3% - 100%)Specificity: 100% (95% CI: 99% - 100%) | | | | *Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Therefore, users should establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens Table 3: Summary of the Performance of the Directigen EZ Flu A+B Test Compared to Culture for Retrospective Nasopharyngeal Swabs - Influenza B from 2005 Respiratory Season | | | Cell Culture | | | --- | --- | --- | --- | | Specimen Type | Directigen™EZ Flu A+B Test | P | N | | Nasopharyngeal swabs | P | 32* | 0 | | | N | 11 | 16 | | Positive agreement: 74% (95% CI: 59% - 87%)Negative agreement: 100% (95% CI: 79% - 100%) | | | | *Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Therefore, users should establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens Table 4: Summary of the Performance of the Directigen EZ Flu A+B Test Compared to Culture for Retrospective Nasopharyngeal Swabs by Population - Influenza B from 2005 Respiratory Season | Cell Culture | | | | | | | --- | --- | --- | --- | --- | --- | | Specimen Type | Directigen™EZ Flu A+B Test | Pediatric(≤ 21 years) | | Adult(> 21 years) | | | | | P | N | P | N | | Nasopharyngeal swabs | P | 20 | 0 | 12 | 0 | | | N | 6 | 10 | 5 | 6 | | Positive agreement: Pediatric: 77% (95% CI: 56% - 91%); Adult: 71% (95% CI: 44% - 90%)Negative agreement: Pediatric: 100% (95% CI: 69% - 100%); Adult: 100% (95% CI: 54% - 100%) | | | | | | b. Clinical specificity: {4} Refer to (a.) above c. Other clinical supportive data (when a and b is not applicable) Clinical Specimens Stability Study: See: http://www.fda.gov/cdrh/reviews/K042472.pdf 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: (Interpretive Criteria) Not applicable. N. The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this Premarket notification is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/device/K063689](https://fda.innolitics.com/device/K063689) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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