IVD 510(k) and Dual CLIA Waiver Submissions via IVD eSTAR

1. Key takeaways

An in vitro diagnostic device (IVD) filing a 510(k) with CDRH uses the dedicated IVD eSTAR template (current version 7.1). Where a CLIA Waiver by Application is sought at the same time, the filing is a dual 510(k)/CLIA waiver submission, and under the FDA eSTAR Program page the use of eSTAR is mandatory. Two regulatory systems therefore meet in a single filing: the device pathway under the FD&C Act framework, and the laboratory framework that governs how the test may be performed after it reaches the market. Preparing the dossier means preparing for both at once, in the template built for exactly that combination. Treating the filing as two projects that share a template, rather than one project with two regulatory faces, is the mental model that keeps the work organized.

• IVD submissions to CDRH use the IVD eSTAR template; the nIVD template must not be substituted.
• Dual 510(k)/CLIA waiver IVD submissions to CDRH are a distinct category in the mandatory-use scope of eSTAR.
• The current IVD eSTAR version is 7.1; version 6.2 was retired on 2026-08-03.
• Evidence is organized as analytical performance plus clinical agreement, with operational simplicity evidence prepared separately where CLIA waiver is sought.
• Version and retirement dates for the IVD template are checked against the FDA page before filing.

2. Legal basis

The instruments listed below, as cited in the source material, cover the eSTAR requirements specific to IVD submissions, the device classification framework, and the CLIA regulation.

3. Expert insights

Insight one: IVD has its own eSTAR template, and the nIVD template must not be used in its place.

According to the FDA eSTAR Program page, the templates are divided into two tracks: the non-in vitro diagnostic (nIVD) eSTAR and the in vitro diagnostic (IVD) eSTAR. IVD products must use the IVD eSTAR. This is the technical difference most easily overlooked before submission, because the two templates look superficially similar and a team that has recently filed a device submission may reach for the file it already knows rather than the file the product requires. The mistake surfaces as a formatting defect at the start of review, which is the most expensive possible moment to learn it. A thirty-second check of the template name at project kickoff eliminates the entire category of risk.

Insight two: the dual 510(k)/CLIA waiver submission is a separate category in the mandatory scope of eSTAR.

The FDA page lists dual 510(k)/Clinical Laboratory Improvement Amendments (CLIA) Waiver in vitro diagnostic (IVD) submissions sent to CDRH separately in the mandatory use section. This means that where a CLIA waiver is sought alongside the 510(k), eSTAR is not an option among others; it is the required vehicle for the combined filing. Planning the CLIA waiver request as an attachment to a separately formatted dossier inverts the requirement, and the inversion is visible to the reviewer from the first page onward.

Insight three: the criteria for CLIA waiver come from 42 CFR Part 493 and belong to a separate rule system from the 510(k).

The 510(k) answers whether the device may be marketed; the CLIA waiver answers whether the test can be operated in a non-complex laboratory setting by non-professional personnel. The two questions are governed by different regulatory systems, but they can be submitted simultaneously. Keeping the two arguments distinct — market authorization on one side, operational simplicity on the other — prevents the evidence for one from being stretched to cover the other, which neither framework accepts. It also allows the two evidence packages to progress on parallel schedules and to be merged only at filing.

Insight four: the center of gravity of IVD performance evidence is analytical performance plus clinical agreement.

Unlike therapeutic devices, the performance evidence in an IVD dossier typically consists of two parts: analytical performance — precision, detection limit, linearity, interference, and stability — and clinical agreement, meaning the comparison against a comparative method or against clinical diagnosis results. Each part answers a different reviewer question, and the dossier is organized to let each part speak for itself rather than blending the two into a single undifferentiated performance story. Splitting the sections this way also makes gaps visible early, because an incomplete precision study cannot hide inside a general claim of agreement.

4. Practical recommendations

• Use the IVD eSTAR (current version 7.1) from the start of the IVD project; do not use the nIVD template.
• Where a CLIA waiver is sought at the same time, prepare as a dual submission, for which eSTAR is mandatory.
• Organize the analytical performance evidence and the clinical agreement evidence separately, each against its own review expectations.
• Prepare the evidence of operational simplicity relevant to CLIA — such as studies on operation by non-professional personnel — as a separate package.
• Before submission, check the current version of the IVD eSTAR and the retirement dates of older versions.

5. Verification checklist

• □ The IVD eSTAR (current version 7.1) has been used
• □ Where a CLIA waiver is sought, the filing has been prepared as a dual 510(k)/CLIA waiver submission
• □ The analytical performance evidence is complete (precision, detection limit, linearity, interference, stability)
• □ The clinical agreement evidence is complete
• □ Where a CLIA waiver is sought, the studies on operation by non-professional personnel have been prepared
• □ The IVD eSTAR version and retirement dates have been checked

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com