pHizatest from Micro Essential FDA approved?
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It was recently brought to our attention that the Nitrazine test product we are currently using is not on the FDA approved list. We use pHizatest by Micro Essential. Does anyone else use this brand and test? If it isn't FDA approved, is it considered lab developed testing, high complexity?
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Amy,
Contact the manufacturer and ask them for their 510K. We came across a similar problem with pH Hydrion paper from microessentials that we use for tear drop pH in the ED.
Below is their reply - if you go to the link, you are taken to a PDF - go to bottom of page 16 - and voila!
From: Paresh [mailto:paresh@microessentiallab.com]
Sent: Tuesday, March 05, 2019 1:04 PM
To: Khan, Adil
Subject: RE: your HydrionTM pH paper 510 K number
EXTERNAL MESSAGE. DO NOT open attachments or click links from unknown senders or unknown emails.
Good afternoon Adil,
According to Centers for Medicare & Medicaid Services (CMS), the organization that regulates, through CLIA (Clinical Laboratory Improvement Amendments ), all laboratory testing (except research) performed on humans in the U.S, all qualitative color comparison pH testing of body fluids (other than blood), are waived.
I have attached a pdf of the specific page (the specific code, 83986QW, can be found on page 52. Note it includes "various" manufacturers as the whole category is waived), but the complete document can be found here: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf.
Please let us know if you have further questions.
Paresh Shah , Ch. Eng.
Manager, Technical Services
Micro Essential Laboratory, Inc.
4224 Avenue H
718-338-3618
Hydrion® pH and sanitizer test kits since 1934
Hi Amy,
Where did you hear this? Their brochure says they are FDA listed
https://www.phizatest.com/pHizatest-brocure.pdf
We had heard from micro essentials that the pHizatest has approval from FDA for "medical device" status. I hope that is correct since we are using it.
We use AmnioTest. We consider the test Mod. Complex. Could it be Waived according to this list?
Unfortunately, AmnioTest is mod complex. Even though it's a piece of pH paper on a stick. I think the company just declined to submit for waiver. It's a bummer, but we got cited for this about 4 years ago.
We received an email saying that facilities in other states than mine had been cited, so we wanted to look into it before we received a citation.
Thank you all for the information. Now I have something to show an inspector who may question the approval.