Hi Kevin,
Thanks for your response. My biochemistry is far back in time. Would 'nucleophilic aromatic substitution reagent be appropriate in all the cases where referenced in EMDN? There are dozens of references, used for almost every reagent detection system.
Non-exhaustive examples from EMDN list:
IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS
GONOCOCCAL DETECTION BY NA REAGENTS
SYPHILIS DETECTION BY NA REAGENTS
- PYLORI DETECTION BY NA REAGENTS
LEGIONELLA DETECTION BY NA REAGENTS
LYME DETECTION BY NA REAGENTS
MYCOBACTERIAL DETECTION BY NA REAGENTS
MYCOPLASMA DETECTION BY NA REAGENTS
PSEUDOMONAS DETECTION BY NA REAGENTS
SALMONELLA DETECTION BY NA REAGENTS
STREPTOCOCCAL DETECTION BY NA REAGENTS
STREP. A DETECTION BY NA REAGENTS
STREP. B DETECTION BY NA REAGENTS
STREP. PNEUMONIAE DETECTION BY NA REAGENTS
SAPHYLOCOCCAL DETECTION BY NA REAGENTS
LISTERIA DETECTION BY NA REAGENTS
CAMPYLOBACTER DETECTION BY NA REAGENTS
- COLI DETECTION BY NA REAGENTS
OTHER BACTERIOLOGY - NA REAGENTS
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BRUCELLA - NA REAGENTS
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COXIELLA BURNETII (Q FEVER) - NA REAGENTS
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LEPTOSPIRA - NA REAGENTS
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RICKETTSIA - NA REAGENTS
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YERSINIA - NA REAGENTS
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BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
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DIPHTERIA (CORYNEBACTERIUM D.) - NA REAGENTS
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TETANUS (CLOSTRIDIUM T.) - NA REAGENTS
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HAEMOPHILUS INFLUENZAE - NA REAGENTS
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NEISSERIA MENINGITIDIS - NA REAGENTS
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PROTEUS - NA REAGENTS
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PSEUDOMONAS - NA REAGENTS
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SHIGELLA - NA REAGENTS
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BACTERIOLOGY - NA REAGENTS - OTHER
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C.DIFFICILE BY NA REAGENTS
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HEPATITIS A VIRUS - NA REAGENTS
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HEPATITIS B VIRUS - NA REAGENTS
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HEPATITIS B VIRUS - GENOTYPING - NA REAGENTS
HEPATITIS C VIRUS - NA REAGENTS
HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
HEPATITIS DELTA VIRUS - NA REAGENTS
HEPATITIS E VIRUS - NA REAGENTS
HEPATITIS G VIRUS - NA REAGENTS
HEPATITIS X VIRUS - NA REAGENTS
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HIV 1 - NA REAGENTS
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HIV 1 GENOTYPING - NA REAGENTS
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HIV 2 - NA REAGENTS
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HIV 2 GENOTYPING - NA REAGENTS
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HIV P24 - NA REAGENTS
HIV MULTIPLE - NA REAGENTS
HTLV I - NA REAGENTS
HTLV II - NA REAGENTS
------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States
------------------------------
Original Message:
Sent: 11-Jun-2021 12:54
From: Kevin Randall
Subject: EMDN Codes ... Finally
The English phrase "NA Reagents" in the EMDN code list comes from the Italian "Reagenti NAS" in the context of IVDs. In Italy's associated definitions and glossary documents at https://www.salute.gov.it/portale/temi/p2_6.jsp?id=328&area=dispositivi-medici&menu=classificazione, the phrase "Ricerca con Reagenti NAS" (Research with NAS Reagents) is used. Accordingly, in this context, I would say that NAS appears to be a reference to Nucleophilic Aromatic Substitution reagents (such as Sanger's Reagent).
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 11-Jun-2021 10:46
From: Corey Jaseph
Subject: EMDN Codes ... Finally
Hi Richard,
Thanks for your quick response. My instinct was to assign the hardware code, so thanks for the confirmation. I guess we'll wait for clarification on 'na reagent.' :)
------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States
Original Message:
Sent: 11-Jun-2021 06:14
From: Richard Vincins
Subject: EMDN Codes ... Finally
Hi Corey,
I actually was trying to figure out the NA Reagents phrase myself and thinking maybe it means Not Assigned Reagent or Non-Applicable Reagent. Personally I think it means Not Assigned Reagent, because if you look at the listing, as an example, Legionella, there is Legionella Antigen, Legionella Antibody, Legionella NA Reagent, and Legionella Other. All of them have this, so thinking if the test is using not assigned reagents meaning not listed there. However, there is also "Other" under each one as well. This might also be some poor translation because if you click on one of them the term in Italian says 'LEGIONELLA, RICERCA CON REAGENTI NAS' which in Italian NAS means Nucleo Antisofisticazioni Sanità which is a review group in Italy similar to a kind-of US FDA/USDA. Though all conjecture because NAS may mean something completely different - Network Access Storage device :).
We often put multiple EMDN/GMDN codes for a Technical Documentation file when the "system" is composed of multiple parts. This is quite normal in my experience, of course you should try to get as specific as possible having 1 EMDN code, but if the system is truly composed of different devices to clearly describe what is contained in the system, multiple numbers may be used. If you are talking about instruments though unless the software is sold or used completely separate (SaMD) then I would still say the instrument should only have 1 EMDN code. If it does help clarify the system, then in my experience including is helpful to show the composition of the system.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
Original Message:
Sent: 10-Jun-2021 17:46
From: Corey Jaseph
Subject: EMDN Codes ... Finally
Hey all,
Working on trying to assign EMDN codes. I have a few questions.
1. What is 'na reagent'? It's used often. I don't know what this is.
2. Can an IVD instrument have multiple EMDN codes, even if single technical file? For instance we have both hardware and software in our instruments and there are separate codes for each.
Thanks so much,
------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States
Original Message:
Sent: 07-May-2021 09:50
From: Richard Vincins
Subject: EMDN Codes ... Finally
Greetings all,
For those of you who have not seen it yet, the European Commission opened their website for the EMDN codes a couple days ago European Medical Device Nomenclature (EMDN). There is a review/comment period, but EMDN away !
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Richard Vincins RAC
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