Those of you who work in the medical field may have known about what is called a “Clinical” drug testing. You may be asking yourself “how are these two categories different?” It’s all about how the results are used. A better description would be that:
- A “Clinical” test is used for medical purposes, such as in helping to diagnose and determine how to treat a patient. These tests are needed to test for some of the most commonly prescribed pain medications.
- A “Forensic” test is used for detecting licit and illicit substances in those who should not be using them. These tests may have cutoff levels that may not be low enough for clinical testing needs.
If you look at the products on our website, you will notice that some of them will have the words “For Forensic Use Only” listed at the top of the item description. You may ask yourself why it is we do that? Well the answer to that is a simple, but complicated one. Simply put, it’s not our decision to have it that way or else we would be selling those products to anyone who wanted to purchase them. None of our products are harmful, unless you actually try to swallow one or stab someone with one of them. Otherwise, our products are just tools to help fight against drug and alcohol abuse.
For the products we sell that are “For Forensic Use Only”, we have a simple message that reads: “All Products labeled as “Forensic Use Only” are only sold or distributed to Criminal Justice and Law Enforcement Agencies, for example Prisons, Sheriffs’ Departments and Drug Courts. We do not sell or distribute to facilities such as Hospitals, Pain Clinics, or Employment Agencies. We do not sell this product for use at Home or to Private Individuals. We will not ship this test to a residence. Orders will be verified before shipping.”
The term “For Forensic Use Only” simply means that the drug testing device or supplies is not what is called “FDA 510(k) Cleared”. Obtaining such a clearance certifies that the employee drug testing device passes FDA standards. I realize that might sound like a bunch of gibberish and confusing to you, but the best way I can explain is that under Section 510(k) of the Food, Drug, and Cosmetic Act, it is required for manufacturers to notify the Food and Drug Administraton (FDA) at least 90 days in advance of their intent to market a medical device. This allows FDA to determine whether the device is up to their standards for the general public. So basically, an FDA 510k Clearance certifies that the employee drug testing device passes current FDA standards.
Why is this so important for a manufacturer’s drug testing product to become 510(k) cleared? Well obviously to get their products out to more people outside of the limited group allowed without the clearance. Fortunately / unfortunately, whichever side of the line you are on about the issue, this could be quite expensive and a manufacturer has to be very patient. On average, it may cost to the upwards of $30,000.00 just to have a product prepared and reviewed before they can be submitted to the FDA. If the product is from outside the country, it should be approved by that countries regulating guidelines and that will carry additional costs. If not, expect it to be even pricier because the manufacture will have to conduct various product tests for usage, performance, safety, bio-compatibility, electrical, and technical research.
How long does it take for the FDA to clear 510(k) submissions? Around 6 months, on average. For all the manufacturers and developers out there who are reading this and starting to feel a little discouraged, then maybe you should consider this as a glimmer of hope: Should your product be similar to what is already cleared, it would make sense that the FDA will have next to no choice but to approve any new product that is almost the same as the product already approved on the market. This includes possibly skipping out on all the testing, documentation, and registration processes that go with it. I’m not saying it would 100%, but the less you have to do, the less time and money it would cost out of your pocket.
So as you can understand, without having the clearance, the tests can only be sold to those companies or agencies associated with the Criminal Justice System. These agencies include, but are not limited to, all law enforcement, correction, probation, courts, jails, government agencies such as the Coast Guard, DOD, Navy, Air force, Army (Hoa!), and Marines. This means that products categorized as “Forensic Use Only” cannot be distributed for “over the counter” (OTC) use within the country or its territories. If you go to our website, you’ll notice some of the products that Rapid Detect sells are intended for Forensic Use Only and have a drop-down menu for the buyer to explain who will be using them:
- Corrections / Prisons
- Drug Court
- Forensic Labs
- Police or Sheriff Departments
- Security Firms and Companies
Which products that we carry fall under this category? Mostly our saliva/oral drug tests and our K2/Spice drug tests. Any device on our site that is for forensic use only will be labeled as such on the product’s page. For a quick rundown of what products are listed as “Forensic Use Only”, they are:
- Rapid Detect Dip Drug Test 6 Panel (with K2 / Spice detection)
- Rapid Detect K2 Drug Test
- iScreen Oral Fluid 5
- iScreen Oral Fluid 6
- Rapid Detect SDS 7 Panel
- Rapid Detect SDS 10 Panel
- OrAlert 6 Oral Drug Screen
It’s obvious that trends in drug usage and abuse evolve as time goes by and can dictate when a change is needed in drug testing devices. The technology for drug testing evolves quickly with new testing devices become available as the older tests are updated as required by demand. Rapid Detect, INC offers several “Forensic Only” drug testing kits. Call to speak with one of our friendly knowledgeable sales consultants at (888) 404-0020 weekdays between 8am and 4pm or send an email to firstname.lastname@example.org
Know more about Rapid Detect: The Rapid Detect Blog - Forensic Drug Testing