510K required for Herpes Test At-Home Collection Kit – Any Advice?

Hi everyone,

I’m hoping someone here has advice or experience with this situation.

We sell at-home self-collection kits for CLIA lab-processed testing. One of our products, a Herpes (HSV-1 & HSV-2) sample collection kit, was recently flagged as a “professional-use-only medical device” and deactivated (case ID 17981032621).

We’ve submitted multiple appeals explaining:

✅ This is a self-collection kit only—customers send their sample to CLIA-certified lab for testing under Laboratory-Developed Test (LDT) protocols.

✅ LDTs are CMS-regulated under CLIA, not subject to FDA premarket clearance or 510(k).

✅ The kit includes FDA-cleared components for safe sample collection

✅ No diagnostic results are generated at home; all analysis is performed in the lab( not a standalone OTC diagnostic device).

We also provided:

Photos of product packaging & IFU

510(k) summaries for FDA-cleared components in the kit

CLIA certificate for our lab

But Amazon keeps responding asking for the 510(k) for the entire kit, which doesn’t exist (nor is it required under current FDA guidance for LDT-based tests).

There are also comparable self-collection kits for lab-processed STD testing currently active on Amazon:

For example:

myLAB Box Herpes STD Test Kit at Home for Women & Men B07KY5SS48

Everlywell at Home STD Test for Women & Men Tests for 5 Common STDs B076QHDHN3

Simple HealthKit At-Home Common STD Test Kit (Chlamydia, Gonorrhea & Trich) B0CL7L52M2

These products use the same regulatory model: at-home sample collection → CLIA lab processing → results provided securely. None of these are FDA 510(k)-cleared as standalone OTC diagnostic devices, which is OK as they are not subject to FDA premarket clearance or 510(k) but under Laboratory-Developed Test (LDT) protocols, just like our test kit.

My Questions:

1. Has anyone successfully appealed a similar removal for a CLIA lab-based DTC test kit?

2. Is there a specific Amazon team (Category Managers?) that can handle these regulatory distinctions?

3. Would re-listing with different language (e.g., “At-Home Blood Collection Kit for Lab Processing”) reduce compliance flags?

Any insight would be hugely appreciated.

Thanks in advance.