To be legally compliant, the shape and design of cuvettes must have existed prior to March 1976. The genesis of the allowed cuvette design has its genesis with the patent of Emmet Knott and Lester Edblom on September 11, 1928, Patent No. 1,683,877. Custom Glass and Synthetic Design,LLC (CGSD) owns the Superior Cuvette(tm).
• FDA Organization ID Number 538123. As explained below, CGSD is FDA compliant with the Superior Cuvette.
• Currently, no tubular cuvette manufacturers are registered with the FDA.
• Anyone selling round tubular cuvettes are in violation of the Federal Device Registration Act
• There are FDA and FTC complaints against tubular cuvette manufactures
On January 26, 1943, Emmet Knott was issued another patent for an improved cuvette design. see Patent No. 2,309,124. There, Knott described a chamber having a flat “cover therefor permeable to ultra-violet radiation…” The flat structure of the cuvette (or blood chamber) is consistent with the CGSD design.
Thus, the flat design that Knott specified became the standard leading up to March 1976. Therefore, to be legally compliant, the new designs must be consistent with the philosophy articulated in the pre-March 1976 devices, and in particular, in the above referenced patents. Our cuvette is compliant. Tubular cuvettes clearly are not and are in clear violation of the U.S. Medical Device Regulation Act, which in part, addresses the pre-market notification process: For the information on the 1976 Amendment to the Device Regulation Act, see https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states.
It’s in important for practitioners not to overlook the regulatory aspects of UBI medical technology. The 1976 Device Amendment Act allows previous developed devices to be grandfathered in; but only if certain specific aspects of original device are captured. This is especially true when pertaining to the “central mechanistic part” of said device. In simple terms; any use of a “Round Tube” cuvette is not compliant. Knott’s original device used a “Flat Surface” cuvette. To be compliant; device manufactures and practitioners have to use flat cuvettes. To do otherwise violates the Code of Federal Regulations.
There is an additional exemption relating to the distribution of the Superior Cuvette set forth in the Code of Federal Regulations, Section 807.65, Subpart D, subsection c, which allows for the distribution of items, whose uses are generally known by those who purchase them. The Superior Cuvette, which has its applications for UBI as well as many other uses, including research, falls with the scope of this provision. While the company, Custom Glass and Synthetic Design, has properly registered with the FDA, by virtue of the above provision, specific registration of the Superior Cuvette is not required. This provision obviates the requirement to register the actual cuvettes.
Anyone in the UBI treatment business using round cuvettes is doing their clients a disservice by destroying the potential of a positive treatment outcome, while risking the entire UBI industry’s collapse, when the FDA finally puts their foot down. This is a serious situation that needs addressing, and CGSD is doing that. The regulatory aspect of a round tube cuvette is not going to fall under any pre-market approvals or notifications, nor is it going to be 510k exempt. That means that with the round cuvette, you either need a specific FDA clearance, or you are violating the FDA regulations. This is not about blame: the round cuvette was the path of least resistance, inexpensive, easily accessible, but minimally effective. If practitioners and current device manufacturers are litigated against, the collateral damage to themselves, their patients and others will, most likely, undermine the entire UBI industry. To the extent that other exemptions are claimed, there remains the issue that representations as to high levels of transmission in the UV spectrum are false.
The ongoing sale of tubular shaped cuvettes deals a severe, negative blow to the entire industry, while simultaneously causing the practitioner to be inadvertently breaking Federal laws. CGSD has positioned itself to help save an industry, while creating a more effective and safer system for UBI patient treatments, offering something that has never been available before at an affordable price. CGSD could ask and receive more money for its cuvettes. It elects not to in order to make them affordable to practitioners. Be smart; give your patients the treatment outcomes and safety they deserve, while avoiding the FDA red tape. We know you will make the right choice.
If you have any doubt about the contents herein, please contact your round cuvette vendor, and ask if them to put in writing that their cuvettes are FDA compliant and 510k exempt, or just contact the FDA directly. Do your due diligence to confirm the facts. There are pending complaints against tubular cuvette manufacturers. Should any of these tubular cuvette distributors claim transmission results that approach those of the Superior Cuvette, please know that such would contradict Snell's Law, a well known law of optics and physics. Request supporting detail. CGSD will provide supporting test detail to requesting parties.