UTM® 2025 Notice Of Change FAQ
March 13, 2022
Contents
- What is the reason for this notice?
- Which product codes are compliant with the new 510(k) clearance?
- Why are certain SKUs being discontinued?
- Will this impact my laboratory’s testing workflow?
- How can I find the updated Instructions for Use (IFU)?
- Can I still order the discontinued SKUs?
- Will pricing be affected by this change?
- My laboratory was using UTM® for molecular testing prior to this. What has changed?
- Who can I contact for more information or support?
What is the reason for this notice?
Copan has received FDA clearance (510(k) number K232357) which updates the intended use of UTM® Universal Transport Medium™ without beads for molecular testing applications. The notice outlines the SKUs which are adopting the FDA 510(k) clearance.
Additionally, Copan is optimizing our product line by consolidating lower-demand SKUs to improve efficiency and product availability.
Which product codes are compliant with the new 510(k) clearance?
The following product codes are adopting 510(k) K232357 and remain available:
| Item | Description |
|---|---|
| 3C047N | UTM 3ML NO BEADS IN BULK 16X100 TUBE |
| 3C057N | UTM 3ML NO BEADS+FLEXIBLE FLOQSWAB BP100 |
| 3C064N | UTM 3ML NO BEADS+REGULAR BP80 FLOQSWABS |
| 3C071N | UTM MINI 3ML ROUND NO BEADS+PROGR. FLOQSWAB BP80 |
| 3C075N | UTM MINI 3ML ROUND NO BEADS IN BULK |
| 3C085N01 | UTM 3ML NO BEADS+PROGR. MINITIP FLOQSWABS BP80 |
| 3C088N01 | UTM MINI 3ML ROUND NO BEADS+REG.FLOQSWAB BP80 |
Why are certain SKUs being discontinued?
The following SKUs are being phased out as part of our product line optimization to reduce redundancy, focus on high-demand products, and ensure better availability of items and continuously improve operational efficiency.
The chart below indicates alternative SKUs which can be substituted for the items that are being phased out.
| Item | Description | Alternative SKU’s |
|---|---|---|
| 3C048N | UTM 3ML NO BEADS+PLASTIC APPL.POLYESTER TIP BP100 | NA |
| 3C058N | UTM 3ML NO BEADS+FOAM MINITIP SWAB BP80 | 3C047N + 502CS01 |
| 3C059N | UTM 3ML NO BEADS+PLASTIC APPL.POLYESTER TIP BP100 | 3C047N + 519CS01 |
| 3C060N | 6ml UTM in 16×100 Tube w/o Beads | NA |
| 3C061N | UTM 3ML NO BEADS+REG. BP80+FLEX. BP100 FLOQ | 3C057N OR 3C064N |
| 3C062N | UTM 6ML NO BEADS+5 REGULAR BP30 FLOQSWABS | 3C047N + 520CS01 |
| 3C072N | UTM 3ML NO BEADS+REG. BP100+FLEX. BP100 FLOQSWABS | 3C047N + 519CS01 OR 503CS01 |
| 3C073N | UTM 3ML NO BEADS+MID TURBINATE FLOQSWAB BP8 | 3C047N + 5638CS01 |
| 3C080N01 | UTM 3ML NO BEADS+CONTOURED FLOQSWAB W/STOPPER BP50 | 3C047N + 56750CS01 |
| 3C083N01 | UTM 3ML NO BEADS W/BARCODE+FLEXIBLE FLOQSWAB BP100 | 3C057N |
| 3C084N01 | UTM 3ML NO BEADS+ULTRA THIN MINITIP FLOQSWAB BP80 | 3C047N + 525CS01 |
| 3C086N01 | UTM 3ML NO BEADS+REG.+PROGR.MINITIP BP80 FLOQSWABS | 3C064N OR 3C047N + 5U088S01 |
Will this impact my laboratory’s testing workflow?
For customers using discontinued SKUs, we encourage transitioning to the compliant product codes. Please reach out to your Copan representative or Copan Customer Service, customerserviceUS@copangroup.com, to assist in identifying suitable alternatives to ensure a seamless transition.
My laboratory was using UTM® for molecular testing prior to this. What has changed?
Copan has applied for and received a new 510(k) to support UTM® Universal Transport Medium™ without beads, specifically for molecular testing.
Under the new 510(k) K232357, the intended use is defined as follows:
UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viral nucleic acids. UTM-RT is intended for use with compatible molecular assays.
Who can I contact for more information or support?
Our dedicated customer service team is available to address any questions you may have about our UTM® products, including the recent 510(k) clearance updates and product line optimization.
They can provide guidance on alternative product recommendations, ordering information, technical specifications, and implementation support.