ID-Cap System
by Etectrx, Inc. 510(k)
Active
510(k) K183052
Overview
The ID-Cap System is an ingestible event marker designed to verify medication ingestion in real time. Classified as a Class II device under FDA regulation 880.6305, it provides objective confirmation of dose administration, supporting adherence monitoring for patients and healthcare stakeholders.
This single-use, non-sterile device is intended for oral ingestion and detection via a compatible reader. Supplied as part of a system including the marker and reader, it operates outside MRI environments and requires no special storage conditions. Authorized under FDA 510(k) clearance (K183052), it is distributed for use in general hospital settings and research applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183052 | Date6 Dec 2019 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- OZW
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6305
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary purpose of the ID-Cap System and how does it differ from traditional adherence monitoring methods?
The ID-Cap System is designed to provide real-time, objective confirmation that a patient has ingested their medication. Unlike traditional methods—such as patient self-reporting or pill counts—which rely on subjective data, the ID-Cap System uses an ingestible marker detected by a compatible reader to verify dose administration. This helps improve adherence monitoring accuracy for both clinical and research settings, particularly in general hospital environments.
Is the ID-Cap System reusable or single-use, and what are the implications for clinical workflow?
The ID-Cap System is explicitly designed for single-use only, meaning each marker is intended for one ingestion event. This eliminates the need for cleaning or reprocessing, simplifying workflows and reducing the risk of cross-contamination. Clinicians should order replacement markers as needed for each patient’s dosing schedule, ensuring accurate adherence tracking without device reuse.
Does the ID-Cap System require any special handling or storage conditions, and can it be used in all clinical environments?
The ID-Cap System is non-sterile and does not require refrigeration or controlled storage—it can be kept at room temperature. However, it is not compatible with MRI environments, so it should not be used in or near magnetic resonance imaging machines. It is distributed for general hospital settings and research applications, where real-time ingestion verification is needed outside MRI zones.
What sizes or models of the ID-Cap System are available, and how does a clinician determine the correct one for a patient?
The provided specifications do not detail specific sizes or models beyond the core ID-Cap System, which consists of the ingestible marker and a compatible reader. The system is designed as a unified solution for oral ingestion verification, and the marker’s form factor is standardized for compatibility with the reader. Clinicians should confirm with Etectrx, Inc. (contact: Susan Baumgartner) if variations (e.g., for pediatric or specific medication forms) are required, as the data does not specify customizable sizes.
How was the ID-Cap System’s equivalence to existing devices determined, and what does this mean for its regulatory standing?
The ID-Cap System was classified as Substantially Equivalent (SESE) under FDA’s 510(k) process (K183052), meaning it was compared to a legally marketed predicate device and found to have the same intended use and technological characteristics. This determination supports its FDA 510(k) clearance, confirming it meets regulatory requirements for safety and effectiveness as an ingestible event marker for adherence monitoring in general hospital and research contexts. The classification under product code OZW further aligns it with existing ingestion verification devices.