← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K180438

# BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438)

_Bd · PSZ · Mar 20, 2018 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K180438

## Device Facts

- **Applicant:** Bd
- **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md)
- **Decision Date:** Mar 20, 2018
- **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 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. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. 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 influenza A and B detection; uses nasal/nasopharyngeal swabs. System includes test device and opto-electronic reader (BD Veritor Reader or BD Veritor Plus Analyzer). Reader uses internal camera to scan test device barcode; interprets line intensity via scoring algorithm; reports qualitative result on LCD. BD Veritor Plus Analyzer adds 'Walk-Away' mode (automated timing), optional barcode scanner for operator/specimen ID, and cellular connectivity for LIS/EMR integration. Used in point-of-care settings by clinicians. Output aids diagnosis; negative results require molecular confirmation. Benefits include rapid, standardized interpretation of immunoassay results, reducing technician-to-technician variability.

## Clinical Evidence

Bench testing and clinical performance data provided. Clinical performance summary includes combined U.S. and Japan data (N=736). Flu A: 83.6% PPA (76.1-89.1% CI), 97.5% NPA (95.7-98.5% CI). Flu B: 81.3% PPA (71.1-88.5% CI), 98.2% NPA (95.7-99.3% CI). Statistical analysis utilized over-dispersed binomial model to account for site heterogeneity. Analytical testing confirmed equivalence of BD Veritor Plus Analyzer to predicate Reader using clinical samples (102 negative, 52 Flu A+, 52 Flu B+) and analytical samples (zero, high negative, low positive).

## Technological Characteristics

Immunochromatographic assay; opto-electronic reader for qualitative result interpretation. BD Veritor Plus Analyzer features: Li-ion rechargeable battery, 56mm x 33mm graphical display, 8MB flash memory, USB OTG port, optional barcode scanner, cellular modem (InfoSync). Firmware includes assay positivity algorithm and cutoff thresholds identical to predicate. Cybersecurity controls implemented for data privacy. Sterilization/materials unchanged from predicate.

## 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 – CLIA Waived Kit ([K112277](/device/K112277.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.
>
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SPECIAL 510(K): DEVICE MODIFICATION DECISION SUMMARY

510(k) Number: K180438

This 510(k) submission contains information/data on modifications made to the applicant’s own class II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device.

|  510(k) Number | Device Name | Clearance Date | Primary Reason for 510(k) Submission  |
| --- | --- | --- | --- |
|  K112277 | BD Veritor System for Rapid Detection of Flu A+B – CLIA Waived Kit | 1/4/2012 | Initial 510(k) clearance  |
|  K132259 | BD Veritor System for Rapid Detection of Flu A+B – CLIA Waived Kit | 8/7/2013 | Provided analytical reactivity data for an A/H7N9 strain  |
|  K132256 | BD Veritor System for Rapid Detection of Flu A+B – CLIA Waived Kit | 9/23/2013 | Provided analytical reactivity data for an A/H3N2v strain  |
|  K151301 | BD Veritor System for Rapid Detection of Flu A+B – CLIA Waived Kit | 6/8/2015 | Provided analytical reactivity data for nine additional Flu A strains and five additional Flu B strains  |
|  K152870 | BD Veritor System for Rapid Detection of Flu A+B – CLIA Waived Kit | 10/27/2015 | Provided analytical reactivity data for one additional Flu A strain and five additional Flu B strains  |
|  K160161 | BD Veritor System for Rapid Detection of Flu A+B – CLIA Waived Kit | 2/25/2016 | Provided analytical reactivity data for two additional avian Flu A strains  |

2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed instructions for use.

3. A description of the device MODIFICATION(S) in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

1) The product package insert has been changed for the modified device reflecting the addition of a new performance table and related explanations in the Clinical Performance section. The following new performance table (appears as Table 1) is added in the revised product package insert:

{1}

Note: The data in this table summarizes the performance of the Veritor Flu A + B assay test system across all age groups, clinical testing sites and sample types. The 95% Confidence intervals are calculated using an analysis that accounts for sources of heterogeneity.

Table 1: Summary of Performance Data of the BD Veritor System for Rapid Detection of Flu A + B Compared to PCR for All Swabs - All Sites

|   | Reference PCR |   |   |  |  | Reference PCR  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  POC: BD Flu A | P | N | Total |  | POC: BD Flu B | P | N | Total  |
|  P | 189 | 13 | 202 |  | P | 139 | 10 | 149  |
|  N | 37 | 497 | 534 |  | N | 32 | 555 | 587  |
|  Total | 226 | 510 | 736 |  | Total | 171 | 565 | 736  |
|  Reference Method: PCR PPA: 83.6% (76.1%, 89.1%) NPA: 97.5% (95.7%, 98.5%) |   |   |   |  | Reference Method: PCR PPA: 81.3% (71.1%, 88.5%) NPA: 98.2% (95.7%, 99.3%)  |   |   |   |
|  Wald 95% confidence intervals corrected for overdispersion, where needed, due to potential variability between sites.  |   |   |   |   |   |   |   |   |

The sponsor provided the following justification for this modification:

Estimates of performance for Rapid Influenza Diagnostic Tests (RIDTs) as assessed from prospective clinical studies are subject to numerous sources of variability that are difficult to understand or control. The heterogeneity that is seen across RIDT clinical studies justifies a statistical analytical approach that accounts for additional variability over the basic binomial model, which assumes that all clinical studies and sites have the same performance. Literature supported examples of some of the potential sources of variability leading to the heterogeneity include:

- Variation in circulating influenza strains from within and across seasons since it is known that immunoassays have varying affinity to different strains.
- Age of subjects with younger subjects demonstrating higher assay sensitivity.
- Nostril-to-nostril variance in viral load, within the same subject, as it has been shown that there are significant differences in viral load from one nostril when compared to the other.
- Swab-to-swab variability, since it is difficult to ensure identical quality when multiple swabs are collected, especially when patients may be less cooperative on the second swab.
- Technician-to-technician variability in the way the specimen is collected.
- Variability in time from onset of symptoms to diagnostic testing.
- Positive vaccination status which has been demonstrated to result in reduced viral loads in patients with acute influenza infection, with further variation caused by differences in vaccine effectiveness from season to season.

Provided literature in this submission supports the widely acknowledged observation that RIDT studies are subjected to substantial variability which supports the application of statistical methods that are designed to account for this variability.

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2) In addition to the BD Veritor Reader, a second generation instrument, the BD Veritor Plus Analyzer with the flexibility of an optional bar code scanning module and cellular connectivity designed to facilitate record keeping, was added to the product package insert. The BD Veritor Plus Analyzer also enables the addition of a "Walk Away" workflow mode.

Table 2: Comparison of BD Veritor Reader and BD Veritor Plus Analyzer

|  Product Feature | BD Veritor Reader | BD Veritor Plus Analyzer  |
| --- | --- | --- |
|  GENERAL: |  |   |
|  Appearance and dimensions | -77mm -60mm | Power Button Top Housing Barcode Scanner Bottom Housing  |
|  Intended use | For use with BD Veritor System test devices | Same  |
|  Firmware functional verification | Verification cartridge supplied with each Reader | Same  |
|  Assay type determination | Internal camera reads barcode on test device | Same  |
|  Assay test device compatibility | Original | Same  |
|  Lifetime | 3000 tests 24 months from first use 34 months from date of manufacture | 3500 tests 24 months from first use 34 months from date of manufacture  |
|  Assay workflow options | Original or “Analyze Now”: Assay device is prepared with processed patient sample, user manually times the assay development and inserts assay device when development time is complete. | • Analyze Now: unchanged • Walk-Away: Assay device is prepared with processed patient sample, inserted into the Analyzer immediately. Assay development is automatically timed by the instrument and result is displayed when development time is complete.  |
|  Qualitative or Quantitative Result | Qualitative | Qualitative, unchanged  |
|  Optional modular barcode scanner | Not Present | Captures and records Operator ID, Specimen ID, and/or test device lot information. Can be used to configure display languages.  |
|  Cellular modem available with InfoSync module | Not Present | Using HTTPS secure link, endpoint authentication, receipt confirmation. Automated connection to LIS/EMR.  |
|  Removable module or | Not Present | Analyzers have either a cover plate or are equipped  |

{3}

|  cover plate |  | with optional scanning module.  |
| --- | --- | --- |
|  Printer | Not printer compatible | Compatible with external dedicated printer via USB.  |
|  ELECTRICAL:  |   |   |
|  Batteries | User replaceable alkaline AA batteries | Li-ion rechargeable battery  |
|  AC power adapter | N/A | To charge the Li-ion battery and/or operate the analyzer from facility power.  |
|  Graphical display | 40 mm x 19 mm | 56 mm x 33 mm  |
|  Flash Memory | 4 MB | 8 MB  |
|  FIRMWARE:  |   |   |
|  Assay positivity algorithm | Original | Same  |
|  Assay cutoff thresholds | Original | Same  |
|  Test menu | Original | Same  |
|  Cybersecurity controls | Not Present | To meet requirements for data privacy and anti-hacking protection.  |
|  USB OTG port | Not Present | To connect to printer or to a computer to display or print results. Input firmware or menu updates from flash drive.  |
|  Display languages | English or Japanese only | Six user selectable languages; English, French, Italian, German, Spanish, Swedish. (optional scanning module required for language configuration). Japanese model sold separately.  |

4

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4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device.

|  Item | Previously Cleared Device | Modified Device  |
| --- | --- | --- |
|  Features | BD Veritor System for Rapid Detection of Flu A+B - CLIA Waived Kit (K112277) | BD Veritor System for Rapid Detection of Flu A+B - CLIA Waived Kit (K180438)  |
|  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 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. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. 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. | Unchanged  |
|  Specimen Types | Nasal and nasopharyngeal swabs | Unchanged  |

{5}

|  Item | Previously Cleared Device | Modified Device  |
| --- | --- | --- |
|  Features | BD Veritor System for Rapid Detection of Flu A+B - CLIA Waived Kit (K112277) | BD Veritor System for Rapid Detection of Flu A+B - CLIA Waived Kit (K180438)  |
|  Assay Technology | Immunochromatographic | Unchanged  |
|  Detection Format | An opto-electronic reader determines the line intensity at each of the spatially defined test and control line positions, interprets the results using a scoring algorithm and reports a positive, negative or invalid result on the LCD screen based on pre-set thresholds. | Unchanged  |
|  Qualitative or Quantitative | Qualitative | Unchanged  |
|  Assay Run Time | Approximately 10 minutes | Unchanged  |
|  Control Format | Kit Flu A+/B- dry swab procedural controlKit Flu A-/B+ dry swab procedural controlInternal positive controlInternal negative control | Unchanged  |
|  Product Package Insert | Performance tables based on the clinical study data in the U.S. were presented separately from the performance tables based on the clinical study data in Japan in the Clinical Performance section of the product package insert. | Addition of a new performance table and related explanations in the Clinical Performance section of the product package insert that estimate assay performance based on the combined U.S. and Japan data using an over-dispersed binomial model to account for potential differences/variability between the U.S. and Japan clinical study sites.  |
|  Instrument | BD Veritor Reader | BD Veritor Reader and BD Veritor Plus Analyzer  |

# 5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

BD's Risk Assessment process is based on a BD Product Risk Management procedure which meets the requirement for risk management as set forth in ISO 14971:2007 and EN ISO 14971:2012. Using this procedure, the following are estimated:

the hazard,
the adverse effect (harm to patient),
the potential causes of the hazard,
any existing control measure
the probability of hazard severity and
the probability of occurrence

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

{6}

Based on a resulting calculated risk index, risk control measures are identified, required verification and validation activities are determined, and verification of the effectiveness of risk control measures is determined.

1) The inclusion of the additional performance table in the Clinical Performance section of the BD Veritor System Flu A+ B (CLIA-Waived kit) product package insert (PI) does not create any new product risks. There has been no change in the product formulation. The change is exclusively a labeling change, specifically the addition of a table presenting combined data from both U.S. and Japanese clinical study sites and the resulting sensitivity and specificity calculations. The current performance observed by customers will not change as there is no change to the design or production process for this product. Therefore, because the addition of a new performance table does not impact the risk associated with the device, the current risk assessment table will not change.

A change control will be initiated to document this activity in the design history file and to route the new PI for approval. Modifications to the product package insert will be implemented in accordance to BD Change Control Procedure BDDSQP0402.

2) The risk assessment identified the need to confirm the Veritor Plus Analyzer’s ability to produce assay results equivalent to those obtained with the Veritor Reader in either “Analyze Now” or “Walk Away” workflow mode. The identified studies were performed according to appropriate design control procedures to assess the addition of the Veritor Plus Analyzer in either mode as an interpretation instrument for the Veritor System Flu A + B CLIA-Waived assay product. The results of testing did not identify new issues of safety and effectiveness.

At the BD Diagnostics Systems research and development (R&D) center in San Diego, CA, BD staff performed studies testing both analytical and clinical samples to confirm that the performance of the Veritor Plus Analyzer is equivalent to the Veritor Reader when used in both “Read Now” and “Walk-Away” modes.

BD R&D staff tested the following analytical samples
- Samples with true zero values (no analyte)
- High negative and low positive samples (near cut-off samples)

The data collected testing the analytical samples demonstrated that the average numerical values and percentage positivity for Veritor Plus Analyzers when used in both “Read Now” and “Walk-Away” workflow modes are equivalent to Veritor Readers.

BD R&D staff also tested the following clinical samples:
- 102 Flu A-/B- samples
- 52 Flu A+ samples
- 52 Flu B+ samples

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The data collected with clinical samples also indicate that assay results obtained using Veritor Plus Analyzers (in both “Read Now” and “Walk-Away” workflow modes) are equivalent to Veritor Readers.

The risk assessment also identified the need to confirm that the addition of the bar code scanning functions of InfoScan and InfoSync modules, and any associated screen displays, alerts and error messages had no effect on safety or effectiveness when the Veritor Plus Analyzer was used with the Veritor CLIA-waived Flu A + B Assay. Software verification activities were performed and all testing criteria were met to confirm that changes and additions made to firmware to add new functionality had no impact on the ability of the instrument to generate a correct assay result. Cybersecurity risks and vulnerabilities associated with the use of the InfoSync module were assessed and BD procedures and controls were verified as acceptable to protect user and patient data.

## 6. Conclusion

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modifications. In addition, the applicant’s description of the particular modifications and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant 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 predicate device.

8

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K180438](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K180438)

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