Enclosure 2 to Appendix L of In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions

1. Is there a legally marketed predicate device?
   

   YES   _____

   NO    _____
   

    

2. Does the new device have the same intended use or indications for use of the predicate device?
   

   YES   _____

   NO    _____

    

3. If the answer to question #2 is NO, do differences in intended use or indications for use between the new device and the predicate alter the intended therapeutic/diagnostic effect of the new device (consider impact on safety and effectiveness)?
   

   YES   _____

   NO    _____
   

    

4. If the new device has the same intended use or indications for use as the predicate device, or if it does not, and if the differences do not alter the intended therapeutic/diagnostic effect,
   

    

   • Is it a new analyte?     YES   _____     NO   _____

      

   • Does it utilize novel matrix?     YES   _____     NO   _____
     

      

   • Does it utilize novel methodology?     YES   _____     NO   _____

      

   • Does it utilize novel technology?     YES   _____     NO   _____

    

5. If the answer to one of the elements of question #4 is YES, could the change raise new issues of safety and effectiveness?
   

   YES   _____

   NO    _____

    

6. If the answer to all elements of question #4 is NO, is the device intended to be used in:

    

   • Traditional Clinical laboratories?     YES   _____     NO   _____

      

   • Point of Care?     YES   _____     NO   _____

      

   • Physician Office Laboratory?     YES   _____     NO   _____

      

   • Over-the-counter?     YES   _____     NO   _____

    

7. If the device is intended for over-the-counter-use, is the use of the test results well established in lay hands?

   YES   _____

   NO    _____

    

8. If the device is intended for commercial clinical laboratories, does FDA have knowledge/experience with similar devices?

   YES   _____

   NO    _____

    

9. If the FDA has knowledge/experience with similar devices, is the use of the device in clinical practice the major determinant in diagnosis or treatment?

   YES   _____

   NO    _____

RATIONALE FOR THE DCLD DECISION CHART

The decision chart is based on an assessment of risk to the patient associated with the use of the device. If the risk of device use is low and predictable, a low level of premarket review may be required for clearance. If the risk is high or unknown, more data is required and a more intense review of the data is necessary.

The first four criteria in the decision chart deal with WHAT is the device, i.e., what it measures, what matrix it uses, what methodology it utilizes, and what technology it employs, and with WHY is the device indicated for use in the clinical setting. If we do not have a clear understanding of what is the device, its clinical relevance and its role in clinical practice, the risk to the patient associated with the use of the device is unknown.

Next, the DCLD decision chart deals with WHO will use the device. The risk to the patient associated with the use of the device will be directly related to the amount of clinical laboratory training and experience of the person performing the test. As user training and experience increases, device risk tends to become lower and more predictable allowing for a lower level of premarket review. Special attention is needed for products intended for use in lay hands; in these settings premarket review may require evaluation of both technical use of the product and use and interpretation of the information generated from over-the -counter testing.

The repeated exposure of FDA reviewers to a specific type of device will lead to a better understanding of the risks to the patient associated with the use of the device. The better understanding of risks will result from the larger number of known studies available with a particular device and from the higher probability of learning about possible device failures through the medical device adverse event reporting program.

Finally, of importance is HOW will the device be used in clinical practice. This question takes into account the importance of the results of the test in patient management. IVD devices that are a major determinant of diagnosis, treatment, or prognosis are associated with high risk to the patient from using the device and require a more stringent level of data review.

Several workshop panelists commented that this item should be placed earlier on in the decision chart. In reality, what impacts on the tier decision is not where in the chart this element is placed, but how major determinant is defiend. If major determinant is defined as the test that is the major determinant or the sole determinant of diagnosis more IVD products will be placed in tier 1 review. If we define major determinant as proposed, i.e., a major deteminant in diagnosis, therapy, or prognosis, then fewer IVD products will receive tier 1 review.

IVD DEVICES SUBJECT TO TIER 1 REVIEW