A Dual Submission should contain the same information as a complete 510(k) and CLIA Waiver by Application. Content related to the comparison and reproducibility studies may overlap and, therefore, a single set of comparison and reproducibility studies may be used to support both 510(k) clearance and CLIA Waiver by Application. All other content that would otherwise be included in separate, sequential 510(k) and CLIA Waiver by Application submissions should be included in a Dual Submission.
In addition to the information required in a 510(k) provided in 21 CFR 807.87, the following FDA guidances are applicable:
Additionally, FDA recommends you include the following in a Dual Submission:
- Device Description and Determination That Device is “Simple”
A description of your device that demonstrates it is simple to use.
- Risk Analysis
The results of a risk analysis, including the identification of potential sources of error for your device.
- Failure-Alert and Fail-Safe Mechanisms
The results of risk evaluation and control, including a description of (1) measures you have implemented to mitigate the risk of errors, and (2) validation and/or verification studies demonstrating the ability of failure alerts, fail-safe mechanisms, and other control measures that you have incorporated into your device to mitigate the risk of errors, even under conditions of stress.
- Flex Studies
The results of flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress.
- Analytical Studies
A description of the design and results of analytical studies of the device conducted at an internal site including, but not limited to, the following:
- Analytical sensitivity (Limit of Detection (LoD) or C5-C95 for qualitative tests);
- Measuring interval (Limit of Quantitation (LoQ) and Limit of Blank (LoB)/LoD, if applicable, for quantitative tests);
- Analytical specificity (interferences, cross-reactivity,etc.);
- Linearity (for quantitative tests);
- Precision (if needed for lot-to-lot variability and/or other issues);
- Carry-over (if applicable);
- Reagent stability; and
- Sample stability.
- Comparison Study
A description of the study design and results of comparison studies you conducted to demonstrate that the device has an insignificant risk of an erroneous result when performed by untrained operators.
- Reproducibility Study
A description of the study design and results of reproducibility studies of the device performed by untrained operators.
- Clinical Performance Study
Most IVD 510(k) submissions do not include a clinical performance study. However, for some devices, a clinical performance study may be needed for either a 510(k) or Dual Submission (please contact FDA through a Pre-Submission for further discussion).
Proposed device labeling, including instructions for use consistent with a device that is “simple.”