← Product Code [PSZ](/productcode/PSZ) · K101461

# BD DIRECTIGEN EX FLU A+B (K101461)

_Becton, Dickinson and Company · PSZ · Jun 24, 2010 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K101461

## Device Facts

- **Applicant:** Becton, Dickinson and Company
- **Product Code:** [PSZ](/productcode/PSZ.md)
- **Decision Date:** Jun 24, 2010
- **Decision:** SESE
- **Submission Type:** Special
- **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 |
| --- | --- | --- | --- | --- | --- |
| K101461 · Jun 24, 2010 | BD DIRECTIGEN EX FLU A+B | Becton, Dickinson and Company | Retrospective, frozen clinical specimens | Retrospective clinical specimens were used to establish the performance characteristics (sensitivity) for the detection of Influenza B using nasopharyngeal swabs. | Retrospective specimens; Influenza B; Performance characteristics |

### Clinical Evidence

| Study Design | Population | Comparator | Key Endpoints |
| --- | --- | --- | --- |
| Retrospective analysis | Symptomatic patients | Not applicable for this study | Sensitivity 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 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. Input: processed respiratory specimens (nasopharyngeal washes/aspirates, nasopharyngeal swabs, throat swabs). Operation: viral antigens bind to anti-influenza antibodies conjugated to visualizing particles; antigen-conjugate complex migrates across test strip to reaction area; captured by antibody line on membrane. Output: visual reddish-purple line at 'T' (Test) and 'C' (Control) positions in read window. Used in clinical settings to aid diagnosis. Healthcare providers interpret visual lines to distinguish influenza A from B. Results inform clinical management, though negative results require cell culture confirmation. Benefits: rapid differentiation of influenza A and B from single sample.

## Clinical Evidence

Bench testing only. Analytical sensitivity (LOD) study conducted using cultured A/California/4/2009 and A/California/7/2009 (2009 H1N1) viruses. Virus identity confirmed via CDC Real-time RT-PCR. TCID50 determined by Reed and Muench method. LOD established as 5.37X10^2 TCID50/mL for A/California/4/09 and 1.86X10^3 TCID50/mL for A/California/7/09. Clinical performance for 2009 H1N1 not established.

## Technological Characteristics

Lateral flow immunoassay; qualitative detection of viral nucleoprotein antigens. No changes to materials or sensing principle. Updated labeling includes analytical sensitivity and strain reactivity tables.

## 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

- BD Directigen™ EZ Flu A+B test ([K063689](/device/K063689.md))
- [K042472](/device/K042472.md)

## Submission Summary (Full Text)

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>
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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K101461

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: BD Directigen™ EZ Flu A+B test (K042472 and K063689)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.

3. The modification of the device consisted of adding new analytical sensitivity data for two strains of 2009 H1N1 virus, A/California/4/2009 and A/California/7/2009. The reactivity table in the package insert was updated to include the said strains of the virus. This modification has not had any effect or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device.

4. Comparison Information (similarities and differences):

a) There were no changes made to the device.

b) Analytical data was generated to determine the reactivity and the minimum level of detection (LOD) of the device with two cultured isolates (A/California/4/09 and A/California/7/09) of the 2009 H1N1 virus.

c) The package insert was revised to reflect the new information: the analytical sensitivity table and the strain reactivity table were updated to include the new information.

d) The following disclaimer was added under each of the revised tables:

Although this test has been shown to detect the 2009 H1N1 virus cultured from a positive human respiratory specimen, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The BD Directigen EZ Flu A+B test can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes."

5. A declaration of conformity with design controls.

Sponsor provided a signed statement that:

a) Verification activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

b) The manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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2-K101461

Sponsor provided a signed Truthful and Accurate Statement, updated 510(k) summary and Indications for Use Enclosures.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. I recommend the device be determined substantially equivalent to the previously cleared device.

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**Source:** [https://fda-staging.innolitics.com/device/K101461](https://fda-staging.innolitics.com/device/K101461)

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