(215 days)
The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.
The Fujirebio Diagnostics Tumor Marker Controls are used for validation of each HE4 EIA assay series. The HE4 EIA results should be considered valid if the mean HE4 values of control duplicates are within the specified HE4 EIA ranges indicated on the Assigned Value Sheet provided with the Fujirebio Diagnostics Tumor Marker Controls.
This submission is for a control device (Fujirebio Diagnostics Tumor Marker Control) intended to replace existing controls for the HE4 EIA kit. Therefore, the "device" in question is the control material itself, not a diagnostic test that detects a medical condition. As such, concepts like "test set," "ground truth," "expert consensus," "MRMC study," and "standalone performance" are not applicable in their usual diagnostic sense. The study focuses on verifying the control's performance to ensure it effectively monitors the precision of the HE4 EIA assay.
Here's an analysis based on the provided document, addressing the closest equivalent concepts for a control device:
Acceptance Criteria and Device Performance Study for Fujirebio Diagnostics Tumor Marker Control
The purpose of this 510(k) submission is to replace the current HE4 EIA kit controls with the Fujirebio Diagnostics Tumor Marker Control. The study focuses on demonstrating that the new control material performs equivalently and reliably to the predicate controls for monitoring the precision of the HE4 EIA assay.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported performance relate to the value assignment process for the control materials. The key performance indicators are related to the precision and stability of the control material when assayed with the HE4 EIA kit.
| Acceptance Criteria (for Value Assignment (K101809)) | Reported Device Performance (K101809) |
|---|---|
| CV |
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.