Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My company was classified as high complexity two months after a 510k clearance. We appealed the decision but lost it. We're wracking our brains trying to figure out what we need to do to meet CLIA requirements as far as documentation. We've scoured the internet, but all we can find is the guidance for CLIA waiver (which we don't need) or requirements related to laboratories, which we are not.

We manufacture an instrument that reads blood values using IR spectrometry. We do not supply samples, reagents, or process specimens. It's just our instrument. What kind of CLIA requirements apply to us? We don't know, at this point, if additional tests are necessary since all we did was add a QC mode to our software to enable the central labs at the hospitals to take readings for calibration purposes (not for human use). 

All I've found online is 42 CFR 493 - quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. That's not us. I printed and reviewed the ENTIRE subpart K - Quality System for Nonwaived Testing and everything seems geared towards laboratories, which we're not.


Can someone please help?

Thank you!
Carol

It sounds like it was your instrument/device, not your company, that was considered to be high complexity, based on the CLIA regulations.  42 CFR 493.17 (Subpart A - Test categorization) lists all the criteria for determining complexity of a device or test system and the scores applied to each.  You should be able to go through that list and determine the score for your device.  Any score higher than a 12 puts your device into high-complexity.  It also describes the process for categorization using that scoring system.

Hope this helps!

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Cheryl Schaaf
Director, Quality and Compliance
Woodinville WA
United States
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Original Message:
Sent: 09-Jul-2018 21:56
From: Anonymous Member
Subject: CLIA High Complexity

This message was posted by a user wishing to remain anonymous

My company was classified as high complexity two months after a 510k clearance. We appealed the decision but lost it. We're wracking our brains trying to figure out what we need to do to meet CLIA requirements as far as documentation. We've scoured the internet, but all we can find is the guidance for CLIA waiver (which we don't need) or requirements related to laboratories, which we are not.

We manufacture an instrument that reads blood values using IR spectrometry. We do not supply samples, reagents, or process specimens. It's just our instrument. What kind of CLIA requirements apply to us? We don't know, at this point, if additional tests are necessary since all we did was add a QC mode to our software to enable the central labs at the hospitals to take readings for calibration purposes (not for human use).

All I've found online is 42 CFR 493 - quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. That's not us. I printed and reviewed the ENTIRE subpart K - Quality System for Nonwaived Testing and everything seems geared towards laboratories, which we're not.


Can someone please help?

Thank you!
Carol