← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K132692

# BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132692)

_Becton, Dickinson and Company · PSZ · Sep 23, 2013 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K132692

## Device Facts

- **Applicant:** Becton, Dickinson and Company
- **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md)
- **Decision Date:** Sep 23, 2013
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3328
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinquished 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. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDAcleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens. Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

## Device Story

Rapid chromatographic immunoassay for qualitative detection of influenza A and B viral nucleoprotein antigens; utilizes nasal or nasopharyngeal swab samples; processed sample analyzed via BD Veritor System Reader; provides differentiated results distinguishing influenza A from B in 10 minutes; used in clinical settings to aid diagnosis; negative results require confirmation by culture or molecular assay; modification updates labeling to include analytical reactivity data for H3N2v and H7N9 strains; does not change fundamental scientific technology.

## Clinical Evidence

No clinical data provided in this submission; substantial equivalence based on analytical strain reactivity updates to labeling.

## Technological Characteristics

Rapid chromatographic immunoassay; utilizes lateral flow technology; read by BD Veritor System Reader; provides qualitative results; includes positive and negative control swabs; no changes to materials or sensing principle.

## 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 Veritor™ System for Rapid Detection of Flu A+B POC kit (k112277, k132239)

## 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/).

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SPECIAL 510(k): Device Modification Decision Summary

To: BD Diagnostics

RE: K132692

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II 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:

Trade Name: BD Veritor™ System Flu A+B assay

510(k) number: k112277, k1322159

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.

3. A description of the device MODIFICATION(S). The modification presented in this 510(k) consisted of expanded reactivity table to include reactivity information for the H3N2v influenza A virus and minimal concentration detected for all viruses in the reactivity table. The submitter tested the ability of the BD Veritor™ System Flu A+B assay to detect influenza A virus; 6 H3N2v strains as well as 4 H1N1 strains, 1 H3N2 strain and 12 influenza B strains. BD diagnostics re-tested the non H3N2v strains using a dilution series protocol to maintain consistent testing protocols for all viruses listed in the reactivity table. The following tables show in *italics* the viruses tested for this submission and the minimal detected concentration:

|  Strain | Subtype | Minimal Detected Concentration  |
| --- | --- | --- |
|  A/Brisbane/59/2007 | H1N1 | 3.3 x 10^{7} TCID_{50}/mL  |
|  A/California/7/2009 | H1N1 | 5.0 x 10^{7} TCID_{50}/mL  |
|  A/Denver/1/57 | H1N1 | 4.45 x 10^{4} CEID_{50}/mL  |
|  A/FM/1/47 | H1N1 | 7.91 x 10^{4} CEID_{50}/mL  |
|  A/Mal/302/54 | H1N1 | 2.22 x 10^{7} CEID_{50}/mL  |
|  A/New Caledonia/20/1999 | H1N1 | 2.5 x 10^{7} TCID_{50}/mL  |
|  A/New Jersey/8/76 | H1N1 | 1.58 x 10^{7} CEID_{50}/mL  |
|  A/NWS/33 | H1N1 | 1.58 x 10^{4} CEID_{50}/mL  |
|  A/PR/8/34 | H1N1 | 6.31 x 10^{7} TCID_{50}/mL  |
|  A/Solomon Island/03/2006 | H1N1 | 2.5 x 10^{7} TCID_{50}/mL  |
|  A/Weiss/43 | H1N1 | 7.03 x 10^{7} CEID_{50}/mL  |
|  A/WS/33 | H1N1 | 7.91 x 10^{7} CEID_{50}/mL  |
|  A/Aichi/2/68 | H3N2 | 7.91 x 10^{7} CEID_{50}/mL  |
|  A/Brisbane/10/2007 | H3N2 | 7.27 x 10^{7} TCID_{50}/mL  |
|  A/Hong Kong/8/68 | H3N2 | 8.89 x 10^{4} CEID_{50}/mL  |
|  A/Moscow/10/99 | H3N2 | 5.8 x 10^{8} TCID_{50}/mL  |
|  A/Perth/16/2009 | H3N2 | 1.0 x 10^{8} TCID_{50}/mL  |
|  A/Port Chalmers/1/73 | H3N2 | 3.95 x 10^{4} CEID_{50}/mL  |
|  A/Wisconsin/67/2005 | H3N2 | 2.5 x 10^{7} TCID_{50}/mL  |
|  A/Victoria/3/75 | H3N2 | 3.11 x 10^{7} CEID_{50}/mL  |
|  A/Indiana/08/2011 | H3N2v | 1 x 10^{4} TCID_{50}/mL  |
|  A/Indiana/10/2011 | H3N2v | 7.9 x 10^{8} CEID_{50}/mL  |
|  A/Kansas/13/2009 | H3N2v | 1.0 x 10^{3} TCID_{50}/mL  |
|  A/Minnesota/11/2010 | H3N2v | 7.9 x 10^{5} CEID_{50}/mL  |
|  A/Pennsylvania/14/2010 | H3N2v | 1.26 x 10^{5} CEID_{50}/mL  |
|  A/West Virginia/06/2011 | H3N2v | 7.9 x 10^{3} TCID_{50}/mL  |
|  A/Anhui/1/2013 | H7N9 | 5.42 x 10^{5} CEID_{50}/mL  |

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|  Strain | Minimal Detected Concentration  |
| --- | --- |
|  B/Brazil/178/96 | 2.32 x 10^{4} TCID_{50}/mL  |
|  B/Brisbane/60/2008 | 7.42 x 10^{3} TCID_{50}/mL  |
|  B/Brisbane/72/97 | 1.00 x 10^{4} TCID_{50}/mL  |
|  B/Canada/548/99 | >0.64 HA  |
|  B/Egypt/393/99 | >1.28 HA  |
|  B/Florida/2/2006 | 1.08 x 10^{5} TCID_{50}/mL  |
|  B/Florida/4/2006 | 1.30 x 10^{3} TCID_{50}/mL  |
|  B/Fujian/93/97 | 3.95 x 10^{5} TCID_{50}/mL  |
|  B/Fukushima/220/99 | 9.33 x 10^{3} TCID_{50}/mL  |
|  B/GuangXi/547/98 | 2.32 x 10^{5} TCID_{50}/mL  |
|  B/Hawaii/01/97 | >6.4 HA  |
|  B/Hong Kong/5/72 | 1.11 x 10^{4} CEID_{50}/mL  |
|  B/Hong Kong/219/98 | >1 HA  |
|  B/Jiangsu/10/2003 | 1.16 x 10^{4} TCID_{50}/mL  |
|  B/Johannesburg/5/99 | 3.95 x 10^{4} TCID_{50}/mL  |
|  B/Lee/40 | 4.44 x 10^{4} CEID_{50}/mL  |
|  B/Lisbon/03/96 | >0.08 HA  |
|  B/Malaysia/2506/2004 | 5.0 x 10^{4} TCID_{50}/mL  |
|  B/Maryland/1/59 | 3.51 x 10^{2} CEID_{50}/mL  |
|  B/Mass/3/66 | 1.58 x 10^{5} CEID_{50}/mL  |
|  B/Ohio/11/96 | >0.16 HA  |
|  B/Ohio/1/05 | 1.34 x 10^{3} TCID_{50}/mL  |
|  B/Puerto Mont/10427/98 | 0.02 HA  |
|  B/Russia/69 | 3.9 x 10^{2} TCID_{50}/mL  |
|  B/Shangdong/7/97 | 1.58 x 10^{6} TCID_{50}/mL  |
|  B/Shanghai/04/97 | 1.58 x 10^{3} TCID_{50}/mL  |
|  B/Shenzhen/135/97 | 3.16 x 10^{4} TCID_{50}/mL  |
|  B/Sichuan/116/96 | 0.016 HA  |
|  B/Taiwan/2/62 | 2.81 x 10^{2} CEID_{50}/mL  |
|  B/Victoria/504/00 | 4.64 x 10^{4} TCID_{50}/mL  |
|  B/Yamagata/16/88 | 9.75 x 10^{3} TCID_{50}/mL  |
|  B/Yamanashi/166/98 | 4.88 x 10^{4} TCID50/mL  |

The BD Veritor™ System Flu A+B assay package insert has been updated to include the additional analytical reactivity information and to list the minimal detected concentration for all viruses listed in the reactivity table.

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

5. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics:

Similarities

|  Features | BD Veritor™ System Flu A+B | BD Veritor™ System Flu A+B  |
| --- | --- | --- |
|  Intended Use | The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD | Same  |

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3

|   | Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) 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. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. |   |
| --- | --- | --- |
|  Read Results | BD Veritor System Reader | Same  |
|  Specimen Types | Nasal swab, nasopharyngeal swab | Same  |
|  Read Result Time | 10 minutes | Same  |
|  External Controls | Test kit contains Positive and Negative Control swabs | Same  |

## Differences

The package insert has been updated to include detection of the influenza A H3N2v strains in the analytical reactivity information section and minimal detected concentration information has been listed for all viruses in the reactivity table:

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|  Strain | Subtype | Minimal Detected Concentration  |
| --- | --- | --- |
|  A/Brisbane/59/2007 | H1N1 | 3.3 x 10^{7} TCID_{50}/mL  |
|  A/California/7/2009 | H1N1 | 5.0 x 10^{7} TCID_{50}/mL  |
|  A/Denver/1/57 | H1N1 | 4.45 x 10^{4} CEID_{50}/mL  |
|  A/FM/1/47 | H1N1 | 7.91 x 10^{4} CEID_{50}/mL  |
|  A/Mai/302/54 | H1N1 | 2.22 x 10^{7} CEID_{50}/mL  |
|  A/New Caledonia/20/1999 | H1N1 | 2.5 x 10^{3} TCID_{50}/mL  |
|  A/New Jersey/8/76 | H1N1 | 1.58 x 10^{3} CEID_{50}/mL  |
|  A/NWS/33 | H1N1 | 1.58 x 10^{4} CEID_{50}/mL  |
|  A/PR/8/34 | H1N1 | 6.31 x 10^{3} TCID_{50}/mL  |
|  A/Solomon Island/03/2006 | H1N1 | 2.5 x 10^{3} TCID_{50}/mL  |
|  A/Weiss/43 | H1N1 | 7.03 x 10^{6} CEID_{50}/mL  |
|  A/WS/33 | H1N1 | 7.91 x 10^{3} CEID_{50}/mL  |
|  A/Aichi/2/68 | H3N2 | 7.91 x 10^{3} CEID_{50}/mL  |
|  A/Brisbane/10/2007 | H3N2 | 7.27 x 10^{3} TCID_{50}/mL  |
|  A/Hong Kong/8/68 | H3N2 | 8.89 x 10^{4} CEID_{50}/mL  |
|  A/Moscow/10/99 | H3N2 | 5.8 x 10^{5} TCID_{50}/mL  |
|  A/Perth/16/2009 | H3N2 | 1.0 x 10^{6} TCID_{50}/mL  |
|  A/Port Chalmers/1/73 | H3N2 | 3.95 x 10^{4} CEID_{50}/mL  |
|  A/Wisconsin/67/2005 | H3N2 | 2.5 x 10^{3} TCID_{50}/mL  |
|  A/Victoria/3/75 | H3N2 | 3.11 x 10^{3} CEID_{50}/mL  |
|  A/Indiana/08/2011 | H3N2v | 1 x 10^{4} TCID_{50}/mL  |
|  A/Indiana/10/2011 | H3N2v | 7.9 x 10^{5} CEID_{50}/mL  |
|  A/Kansas/13/2009 | H3N2v | 1.0 x 10^{3} TCID_{50}/mL  |
|  A/Minnesota/11/2010 | H3N2v | 7.9 x 10^{3} CEID_{50}/mL  |
|  A/Pennsylvania/14/2010 | H3N2v | 1.26 x10^{5} CEID_{50}/mL  |
|  A/West Virginia/06/2011 | H3N2v | 7.9 x 10^{3} TCID_{50}/mL  |
|  A/Anhui/1/2013 | H7N9 | 5.42 x 10^{5} CEID_{50}/mL  |

{4}

|  Strain | Minimal Detected Concentration  |
| --- | --- |
|  B/Brazil/178/96 | 2.32 x 10^4 TCID50/mL  |
|  B/Brisbane/60/2008 | 7.42 x 10^3 TCID50/mL  |
|  B/Brisbane/72/97 | 1.00 x 10^4 TCID50/mL  |
|  B/Canada/548/99 | >0.64 HA  |
|  B/Egypt/393/99 | >1.28 HA  |
|  B/Florida/2/2006 | 1.08 x 10^5 TCID50/mL  |
|  B/Florida/4/2006 | 1.30 x 10^3 TCID50/mL  |
|  B/Fujian/93/97 | 3.95 x 10^5 TCID50/mL  |
|  B/Fukushima/220/99 | 9.33 x 10^2 TCID50/mL  |
|  B/GuangXi/547/98 | 2.32 x 10^5 TCID50/mL  |
|  B/Hawaii/01/97 | >6.4 HA  |
|  B/Hong Kong/5/72 | 1.11 x 10^4 CEID50/mL  |
|  B/Hong Kong/219/98 | >1 HA  |
|  B/Jiangsu/10/2003 | 1.16 x 10^4 TCID50/mL  |
|  B/Johannesburg/5/99 | 3.95 x 10^4 TCID50/mL  |
|  B/Lee/40 | 4.44 x 10^4 CEID50/mL  |
|  B/Lisbon/03/96 | >0.08 HA  |
|  B/Malaysia/2506/2004 | 5.0 x 10^4 TCID50/mL  |
|  B/Maryland/1/59 | 3.51 x 10^2 CEID50/mL  |
|  B/Mass/3/66 | 1.58 x 10^5 CEID50/mL  |
|  B/Ohio/11/96 | >0.16 HA  |
|  B/Ohio/1/05 | 1.34 x 10^5 TCID50/mL  |
|  B/Puerto Mont/10427/98 | 0.02 HA  |
|  B/Russia/69 | 3.9 x 10^2 TCID50/mL  |
|  B/Shangdong/7/97 | 1.58 x 10^6 TCID50/mL  |
|  B/Shanghai/04/97 | 1.58 x 10^5 TCID50/mL  |
|  B/Shenzhen/135/97 | 3.16 x 10^4 TCID50/mL  |
|  B/Sichuan/116/96 | 0.016 HA  |
|  B/Taiwan/2/62 | 2.81 x 10^2 CEID50/mL  |
|  B/Victoria/504/00 | 4.64 x 10^4 TCID50/mL  |
|  B/Yamagata/16/88 | 9.75 x 10^3 TCID50/mL  |
|  B/Yamanashi/166/98 | 4.88 x 10^4 TCID50/mL  |

Although this test has been shown to detect novel avian influenza A (H7N9) and H3N2v cultured viruses the performance characteristics of this device with clinical specimens that are positive for novel avian influenza A (H7N9) and H3N2v influenza viruses has not been established. The BD Veritor™ System Flu A+B assay can distinguish between influenza A and B viruses, but it cannot differentiate influenza A subtypes.

# 6. Design Control Activities Summary:

a) Analytical Reactivity Testing was conducted as described in section 3, Device Modifications.
b) Declaration of Conformity

A "Declaration of Conformity" statement was submitted for the manufacturing facility and validation activities and signed by the Director of Quality Assurance and the Senior Director of Technical Operations respectively. 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.

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6

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. A Truthful and Accurate Statement, a 510(k) Summary, 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 and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. On this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K132692](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K132692)

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