(215 days)
No
The summary describes a standard enzyme immunoassay (EIA) for quantitative determination of a biomarker (HE4) and associated controls. There is no mention of AI, ML, or any computational methods beyond standard assay data processing.
No.
The device is for in vitro diagnostic use only and is used to monitor the precision of laboratory testing procedures, not to treat patients.
No
The device description indicates that the "Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures," and the "Fujirebio Diagnostics Tumor Marker Controls are used for validation of each HE4 EIA assay series." This signifies it is a control or validation device, not one that directly diagnoses. The HE4 EIA, which this device controls, is the diagnostic assay ("aid in monitoring recurrence or progressive disease").
No
The device description clearly states it is an "enzyme immunometric assay" and "control serum," indicating it is a laboratory test kit with physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only."
- Nature of the Assay: The device is an "enzyme immunometric assay for the quantitative determination of HE4 in human serum." This describes a test performed on a biological sample (serum) outside of the body, which is the definition of an in vitro diagnostic.
- Intended Use: The intended use is "as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer." This is a diagnostic purpose.
- Control Serum: The "Device Description" mentions "Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures". Control materials used in laboratory testing for diagnostic purposes are also considered IVDs.
Therefore, based on the provided information, this device is definitively an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
OIU, JJY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Premarket Notification (510(k)) HE4 EIA Control Replacement
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Image /page/0/Picture/2 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic to the left of the company name. The graphic is a geometric shape with black and white sections. The text "FUJIREBIO Diagnostics, Inc." is in a bold, sans-serif font.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K103676
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Diana L Dickson
(610) 240-3917
dicksond@fdi.com |
| Summary preparation date: | July 18, 2011 |
| Name of Device: | |
| 510(k) number: | K072939 |
| Trade/Proprietary Name: | HE4 EIA Kit |
| Common/Usual Name: | Tumor-associated Antigen Immunological Test System. |
| Regulation Number: | 21 CFR §866.6010 |
| Regulatory Class: | Class II |
| Product Code: | OIU, epithelial ovarian tumor associated antigen test (HE4) |
| 510(k) number: | K101809 |
| Trade/Proprietary Name: | Fujirebio Diagnostics Tumor Marker Control |
| Common/Usual Name: | Quality control material (assayed and unassayed). |
| Regulation Number: | 21 CFR 862.1660 |
| Regulatory Class: | Class I, reserved |
| Product Code: | JJY, Multi-Analyte Controls, All kinds, (Assayed) |
| Predicate Device: | |
| HE4 EIA (K072939) | |
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Image /page/1/Figure/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized symbol on the left, followed by the company name in bold, sans-serif font. Below the company name is the text "Diagnostics, Inc." in a smaller font size.
Purpose of Submission
The purpose of the Fujirebio Diagnostics Tumor Marker Control (for use with HE4 EIA) 510(k) submission is to replace the current HE4 EIA kit controls (cleared under K072939) with the Fujirebio Diagnostics Tumor Marker Control (cleared under K101809).
The Fuiirebio 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.
Intended Use of the Fujirebio Diagnostics Tumor Marker Control
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.
A comparison of the features of the Fujirebio Diagnostics Turnor Marker Control and the Predicate Device are as follows:
| Similarities | ||||
|---|---|---|---|---|
| Fujirebio Diagnostics Tumor | ||||
| Marker Control | ||||
| (K101809) | HE4 EIA kit controls | |||
| (K072939) | ||||
| Intended Purpose | 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 E!A | ||||
| ranges | 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 | ||||
| Supplier | Manufactured by Fujirebio | |||
| Diagnostics | Manufactured by Fujirebio | |||
| Diagnostics | ||||
| Matrix | Human Serum | Human Serum | ||
| Form | Lyophilized | Lyophilized | ||
| HE4 Analyte | Purified, recombinant antigen | Purified, recombinant antigen | ||
| Control Levels | 2 | 2 | ||
| Storage (unopened) | Store the kit at 2-8°C. | Store the kit at 2-8°C. | ||
| Shelf Life (unopened) | 18 months | 18 months |
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Premarket Notification (510(k)) HE4 EIA Control Replacement
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Image /page/2/Picture/1 description: The image shows the logo for "FUJIREBIO Diagnostics, Inc.". The logo consists of a stylized graphic to the left of the text. The graphic is a combination of black and white shapes with vertical lines. The text "FUJIREBIO" is in bold, and "Diagnostics, Inc." is below it in a smaller font.
| Differences | ||||
|---|---|---|---|---|
| Fujirebio Diagnostics Tumor | ||||
| Marker Control | ||||
| (K101809) | HE4 EIA kit controls | |||
| (K072939) | ||||
| Controls Supplied | Sold Separately | Sold with HE4 EIA kit | ||
| Analyte (s) | HE4 (Human Epididymis Protein 4) | |||
| AFP (Alpha-Fetoprotein) | ||||
| CA 15-3 | ||||
| CA 19-9 | ||||
| CA 125 | ||||
| CEA (Carcinoembryonic Antigen) | ||||
| Ferritin | ||||
| HE4 (Human Epididymis Protein 4) | ||||
| PSA (Prostate Specific Antigen) | ||||
| Free PSA | HE4 (Human Epididymis Protein 4) | |||
| Target HE4 | ||||
| Concentrations | 75 and 500 pM* | 50 and 400 pM* | ||
| Target HE4 Ranges | Ranges of expected results | |||
| indicated on the Assigned Value | ||||
| Sheet provided with the Fujirebio | ||||
| Diagnostics Tumor Marker | ||||
| Controls. | Ranges of expected results are | |||
| indicated on the vial labels. | ||||
| Reconstitution Volume | 3.0 mL distilled or deionized water | 1.0 mL distilled or deionized water | ||
| Stability after | 14 days at 2-8°C | 4 weeks at 2-8°C | ||
| Reconstitution | 60 days at -20°C or below | 4 months at -20°C or below |
*Target concentration differences are acceptable - the claimed HE4 EIA range is 15 – 900 pM, with an upper limit of normal of 150 pM. (Refer to HE4 E!A package insert)
Value Assignment comparisons:
| Fujirebio Diagnostics Tumor Marker
Control
(K101809) | HE4 EIA kit controls
(K072939) |
|---------------------------------------------------------------------------------|----------------------------------------------------------|
| 24 replicate analyses collected in 4
independent runs | 26 replicate analyses collected in 2
independent runs |
| Different HE4 EIA kit reagent combinations
in each run | Same HE4 EIA kit reagent combination in
each run |
| CV