We get calls pretty regularly with questions regarding the use of our pH test strips and litmus papers to test bodily fluids, such as urine, saliva, sweat, and blood. We get these questions so often, we thought it was about time we address them in a blog post.

First, let’s start off with our disclaimer, which can be found on our website. Precision Laboratories products are not approved for use as medical devices. Products and product information is for informational purposes only and not intended for use to diagnose, treat, cure or prevent any medical condition. Consult a medical doctor when needed.

It’s fair to assume that when we get calls from customers trying to test their bodily fluids with our pH test strips, they are trying to do one of the following:

  • Monitor, diagnose, or treat a medical condition
  • Gauge the success of a dietary regime
  • Monitor the body’s condition during exercise

While these are worthwhile goals, devices (including test strips) used to conduct this type of testing normally fall under the jurisdiction of the Food and Drug Administration. The FDA considers these medical devices.

There are three classes of medical devices, ranging from simple (Class I – tongue depressors, for example) to very complicated (Class III – artificial heart). Test strips usually fall under either Class I or Class II depending on their intended usage. Note, pH test strips are considered Class I.

Class I medical devices do not typically require any per-market approval (PMA) or pre-market notification (510k), which can be very costly and typically involve extensive clinical trials. However, Class I devices do still require the medical device manufacturer to register with the FDA as a manufacturing facility. This registration requires that the manufacturing facility follow certain procedures and the products follow strict Current Good Manufacturing Practices (cGMPs).

The cost of registering a facility with the FDA and maintaining the policies and procedures required adds quite a bit to the cost of producing the medical device. Because of these costs, medical device manufacturers normally charge a fairly high price for the devices.

In many cases, Precision’s test strips are based upon the same chemical principles used with medical device test strips. While Precision Laboratories manufactures the strips using a cGMP compliant approach, it has been determined that our core markets do not require FDA approval and will not accept the unnecessary added expense. For this reason, we have not pursued registration with the FDA.

So, in answer to the initial question, we discourage the use of our pH test strips to test bodily fluids. In addition, our Glucose and Urine Analysis test strips are for educational use only, and should not be used to diagnose any medical conditions. And what will happen if you call us and ask us about the results you received on your test strip after testing a bodily fluid? We’ll give you the same answer and reasoning as above.