An In-Vitro Diagnostic (IVD) manufacturer intended to market their product in the US; the device used whole blood, blood plasma, or serum to detect HIV in the specimen. The IVD utilized an antigen/antibody (Ag-Ab) combination for detecting the presence of HIV antigens and antibodies in the specimen. The device aided in qualitatively detecting the presence of HIV infection in the specimen and not quantifying the levels of HIV antibodies in the specimen. The diagnostic device had not yet been launched in any other international markets, and the manufacturer sought to establish himself solely in the US.

The Problem:

The manufacturer was encountering some challenges and expected to have better clarity on the requirements, so he turned to Elexes for assistance. Following were the main issues they ran into.
– Product Code and Classification as per the US FDA — The manufacturer sought Elexes’ assistance given that they were unclear about the correct product code and the product classification under the FDA regulations.
– Adverse events or risks associated with similar devices — The manufacturer desired to know about the risks and the adverse events that have been reported for similar devices cleared by the FDA, in order for them to implement better risk mitigation strategies for their product.
– Any applicable special controls for this product — The manufacturer was uncertain of what special controls were applicable for their kind of device.

Approach & Solution

Elexes identified the appropriate product code and classification for the suggested device. Elexes compared the intended use of the product to that of the intended uses of similar devices and concluded that the product code would be MZF. Also, the product classification was determined to be Class II with special controls.

Elexes assessed the adverse events that have been reported for similar devices and provided a list of all such events along with the details of the number of events reported per year. The following device-related errors were identified to be the most frequent, as reported by the users.

  • False positive results
  • False-negative results
  • Incorrect or imprecise results

The last reported adverse events were found to be errors associated with the calibration of the device and the results being non-reproducible.

Fig: Most commonly reported device errors in the past decade (based on the US FDA)

Elexes identified that the applicable regulation number for the product was 21 CFR 866.3956 — Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test. The applicable special controls were as follows:

The manufacturer shall ensure that the labeling bears the following information:

  1. An intended use statement mentions that the device is not intended for donor screening of blood and tissue products.
  2. A complete summary of the result interpretation and further recommended actions based on the results.
  3. A section on limitations with details reflecting the current clinical practices, disease presentation, and management.

The manufacturer shall ensure the following based on the data derived from design verification and validation:

  1. An extensive description of the device, including its components, the auxiliary reagents essential but not supplied, and the procedure. There must be further details pertinent to the technology.
  2. The analytical specificity and sensitivity of the assay must be on a level with or better than that of other tests that have been cleared or approved.
  3. Risk management strategies include Failure Mode Effects Analysis, Hazard Analysis, and Critical Control Point summaries, as well as their effects on test results.
  4. The appropriate and appropriate method(s) for assessing user feedback and complaints to determine when to submit a medical device report.
  5. An extensive document of the results of a multi-site clinical trial. A comparator that has been cleared or approved by the FDA must be used to evaluate performance. The study design ought to be adequate to satisfy the following requirements, including the volume of samples tested.
  • The clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.
  • The clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.

The manufacturers shall submit a complaint log that includes the following information regarding each complaint, if available.

  1. The type of event (e.g., false negative/false nonreactive or false positive/false reactive)
  2. Lot details
  3. Date of the complaint receipt
  4. Which set of populations faced the issue
  5. Whether or not the complaint was reported under part 80 (Medical Device Reporting)
  6. The log must be filed once a year for 5 years following the clearance of a traditional premarket notification.

Key Takeaways

  1. Identifying the correct classification for your product by the FDA is the first step in getting your product marketed in the US. Elexes assisted the client in determining the right product classification for their device, which enabled them to attain their regulatory objectives.
  2. Elexes summarized the list of most commonly reported adverse events associated with such devices. The client took note of the areas that should be improved for their proposed device. The data from these reports aided in addressing the design-related flaws and user-related issues that similar devices have faced and increased the overall safety and efficiency of the device to be marketed.
  3. Elexes made it easy for the client to understand the applicable special controls for their device which need to be complied with when moving forward with the product submission. The client found the requirements to be complicated, and Elexes’ experienced regulatory, quality, and clinical professionals better comprehended them for the client.

Would you like to place your IVD in the US market?

Elexes is here to help you. Our dedicated team has years of experience in supporting IVD manufacturers in this process. Feel free to contact us at to have us review your device and guide you through the next steps.

#elexes #healthcare #regulatory #quality #ivd #ldt #medicaldevice #usfda #biologics #drugs #pharma #adverse #risk

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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