← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K133714

# TRU FLU (K133714)

_Meridian Bioscience, Inc. · PSZ · Jan 3, 2014 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K133714

## Device Facts

- **Applicant:** Meridian Bioscience, Inc.
- **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md)
- **Decision Date:** Jan 3, 2014
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3328
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples in symptomatic patients. This test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

## Device Story

TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay; detects influenza A and B viral nucleoprotein antigens in human respiratory samples (nasal wash, nasopharyngeal aspirate, nasal/nasopharyngeal swabs). Device utilizes lateral flow technology; produces visual output (pink-red bands at test/control lines). Used in clinical settings; operated by healthcare professionals. Modification adds Limit of Detection (LoD) data for H7N9 influenza A (A/Anhui/1/2013) to package insert. Device distinguishes influenza A from B but cannot differentiate influenza A subtypes. Negative results require confirmation via cell culture or FDA-cleared molecular assay. Benefits include rapid screening for influenza A/B in symptomatic patients.

## Clinical Evidence

Bench testing only. Analytical reactivity study performed using A/Anhui/1/2013 H7N9 influenza strain. LoD determined via ten-fold and two-fold serial dilutions; confirmed with 20 replicates. LoD established at 1.51 x 10^5 TCID50/mL. No clinical performance data provided for H7N9-positive human specimens.

## Technological Characteristics

Lateral-flow immunochromatographic assay; qualitative detection of viral nucleoprotein antigens.

## 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.

## 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.
>
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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: Meridian Bioscience Inc.

RE: K133714

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device:

TRU FLU

510(k) number: K092553

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, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. Description of the device MODIFICATION(S):

The modification presented in this special 510(k) consisted of an expanded LoD table to include information for the H7N9 influenza A virus. The firm tested the ability of the TRU FLU rapid influenza test to detect H7N9 influenza A virus. The virus used (A/Anhui/1/2013) was obtained from the Centers for Disease Control and Prevention by a contracted third party laboratory where it was propagated and retitered. An LoD study was performed with the A/Anhui/1/2013 influenza strain by first estimating the empirical LoD using ten-fold dilutions, followed by two-fold serial dilutions. Each dilution was tested with three replicates. Once the target LoD was identified, confirmatory testing using 20 replicates was performed at that dilution plus one dilution above and below it. The target LoD was confirmed correct when all 20 replicates were determined to be positive for the virus with the assay.

The LoD concentration was determined to be $1.51 \times 10^{5} \mathrm{TCID}_{50} / \mathrm{mL}$. The TRU FLU package insert has been updated to include the additional LoD information.

4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

5. Comparison Information

Similarities

|   | Predicate Device | Modified Device  |
| --- | --- | --- |
|   | TRU FLU (Unmodified) (K092553) | TRU FLU (K133714)  |
|  Intended Use | TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human | TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human  |

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Page 2 of 3

|   | nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples in symptomatic patients. This test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by cell culture. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. | nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples in symptomatic patients. This test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.  |
| --- | --- | --- |
|  Reagents /Supplies | Test Device
Conjugate Tube
Sample Diluent
Transfer pipettes | Same  |
|  Marketing of system | All reagents and components listed above are marketed as a test kit | Same  |
|  Assay Type | Lateral flow immunochromatography | Same  |
|  Sample Type | Nasal and nasopharyngeal swab, nasal wash/aspirate | Same  |
|  Sample Preparation | 6 steps: Nasal wash/aspirate or nasal swab in transport medium
4 steps: Nasal swabs without transport medium | Same  |
|  Test Method | 11 Steps (see package insert) | Same  |
|  Endpoint | Positive = Pink-red band at test and control lines
Negative = Pink-red band at control line only | Same  |

# Differences

The package insert has been updated to include detection of the A/Anhui/1/2013 H7N9 virus in the LoD information section:

A/Anhui/1/2013 - A - H7N9 - 1.51x10 $^{5}$  TCID $_{50}$ /mL

{2}

Although this test has been shown to detect influenza A (H7N9) virus cultured from positive human respiratory specimens, the performance characteristics of this device with clinical specimens that are positive for H7N9 influenza viruses have not been established. The TRU FLU test can distinguish between influenza A and B viruses, but it cannot differentiate influenza A subtypes.

## 6. Design Control Activities Summary:

Analytical Reactivity Testing was conducted as described in Section 3, page 2 of the submission, “Summary of Design Control Activities”.

A “Declaration of Conformity” statement was submitted for the manufacturing facility and validation activities and signed by the Executive Vice President of Research and Development and the Senior Director of Regulatory Affairs and Design Assurance. The statements indicate that:

1. 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.
2. The validation activities, as required by the risk analysis, for the modification were performed by the designated individuals and the results demonstrated that the predetermined acceptance criteria were met.

In conclusion, based on the results of the analytical reactivity testing the modified labeling is truthful and accurate. The changes do not affect the performance of the test and it is therefore substantially equivalent to the current cleared test.

## 7. Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure.

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. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K133714](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K133714)

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