(236 days)
Not Found
No
The device description details a standard immunoassay technique and data analysis based on a calibration curve, with no mention of AI or ML algorithms.
No.
This device is an in vitro diagnostic (IVD) assay designed to quantitatively determine HE4 in human serum, used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. It provides diagnostic information, not therapy.
Yes
The "Intended Use / Indications for Use" states that the assay is to be used "as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer," which directly indicates a diagnostic purpose.
No
The device description clearly outlines a laboratory-based immunoassay involving physical reagents, microstrips, and spectrophotometry, which are hardware components. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of HE4 in human serum" and is used "as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer." This involves testing a sample taken from the human body (serum) outside of the body to provide information about a medical condition.
- Device Description: The description details a laboratory assay (enzyme immunometric assay) performed on serum samples using reagents and a microplate spectrophotometer. This is a typical setup for an in vitro diagnostic test.
- Performance Studies: The performance studies describe testing on "serial serum samples from 80 patients" and analyzing the results in relation to "disease status." This further confirms the use of the device to analyze biological samples for diagnostic purposes.
- Predicate Device: The mention of a predicate device (ABBOTT ARCHITECT CA 125 II Assay) which is also an IVD, suggests that this device falls within the same regulatory category.
All of these points align with the definition of an In Vitro Diagnostic device.
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.
Product codes
OIU
Device Description
The HE4 EIA is a solid-phase, non-competitive immunoassay based upon the direct sandwich technique based on two mouse monoclonal antibodies, 2H5 and 3D8, directed against two epitopes in the C-WFDC domain of HE4. Calibrators, controls and patient samples are incubated together with biotinylated Anti-HE4 monoclonal antibody (MAb) 2H5 in streptavidin coated microstrips. HE4 present in calibrators or samples is adsorbed to the streptavidin coated microstrips by the biotinylated Anti-HE4 MAb during the incubation. The strips are then washed labeled Anti-HE4 MAb 3D8. After washing, buffered and incubated with HRP Substrate/Chromogen reagent (hydrogen peroxide and 3, 3', 5' tetra-methyl-benzidine) is added to each well and the enzyme reaction is allowed to proceed. During the enzyme reaction a blue color will develop if antigen is present. The intensity of the color is proportionate to the amount of HE4 present in the samples. The color intensity is determined in a microplate spectrophotometer at 620 nm (or optionally at 405 nm after addition of Stop Solution),
Calibration curves are constructed for each assay by plotting absorbance value versus the concentration for each calibrator. The HE4 concentrations of patient samples are then read from the calibration curve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical and Hospital laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Precision: A study was performed with the HE4 EIA Kit modeled after the NCCLS (CLSI) guideline EP5-A2. A panel of four serum samples was assayed, using two lots of reagents, in replicates of two, at two separate times per day for 20 days. The HE4 EIA Kit precision is ≤ 15% total CV.
Linearity: A dilution linearity study was conducted for the HE4 EIA Kit modeled affer the NCCLS (CLSI) guideline EP6-A. Serum samples with elevated HE4 values were diluted with HE4 Calibrator A (zero). The HE4 concentration was determined for each dilution and the percent (%) recovery was calculated. The HE4 EIA Kit was determined to have a mean recovery within 15% of the expected result for diluted samples.
Functional Sensitivity: The functional sensitivity of the HE4 EIA Kit is ≤ 25 pM. The functional sensitivity is expressed as the concentration of an analyte at which the CV is 20%. The NCCLS guideline EP5-A2 was used to design the experiments for determination of functional sensitivity. A study was conducted where a five member sensitivity panel was tested in replicates of 4 in 2 runs on twenty separate days with two lots of reagents. The functional sensitivity determined for the HE4 EIA was found to be
§ 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.
0
Image /page/0/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc". The logo consists of a stylized graphic on the left, followed by the company name in bold, uppercase letters. Below the company name, the words "Diagnostics, Inc" are written in a smaller, non-bold 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: K072939
Submitter Information
JUN - 9 2008
Address:
Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
Contact person:
Diana L. Dickson (610) 240-3917 FAX (610) 240-3803 dicksond@fdi.com
Summary preparation date: May 13, 2008
Name of Device
| Trade/Proprietary Name: | HE4 EIA Kit |
|---|---|
| ------------------------- | ------------- |
Common/Usual Name: · HE4 EIA Test Kit
21 CFR 866.6010 Requiation Number:
Regulatory Class: Class II
To be determined Product Code:
Predicate Device
ABBOTT ARCHITECT CA 125 II Assay (K042731)
Device Description
The HE4 EIA is a solid-phase, non-competitive immunoassay based upon the direct sandwich technique based on two mouse monoclonal antibodies, 2H5 and 3D8, directed against two epitopes in the C-WFDC domain of HE4. Calibrators, controls and patient samples are incubated together with biotinylated Anti-HE4 monoclonal antibody (MAb) 2H5 in streptavidin coated microstrips. HE4 present in calibrators or samples is adsorbed to the streptavidin coated microstrips by the biotinylated Anti-HE4 MAb during the incubation. The strips are then washed labeled Anti-HE4 MAb 3D8. After washing, buffered and incubated with HRP Substrate/Chromogen reagent (hydrogen peroxide and 3, 3', 5' tetra-methyl-benzidine) is added to each well and the enzyme reaction is allowed to proceed. During the enzyme reaction a blue color will develop if antigen is present. The intensity of the color is proportionate to the
1
Image /page/1/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left, followed by the company name in bold, black letters. Below the company name, the words "Diagnostics, Inc" are printed in a smaller, non-bold font.
amount of HE4 present in the samples. The color intensity is determined in a microplate spectrophotometer at 620 nm (or optionally at 405 nm after addition of Stop Solution),
Calibration curves are constructed for each assay by plotting absorbance value versus the concentration for each calibrator. The HE4 concentrations of patient samples are then read from the calibration curve.
Reportable Range
The reportable range for the HE4 EIA Kit is 15 - 900 pM
Intended Use
The HE4 ElA 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.
Statement of Substantial Equivalence
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.
As there is no FDA cleared or approved device for the HE4 EIA Kit, substantial equivalence for the HE4 EIA test kit was determined by comparing the clinical performance to the ARCHITECT CA 125 II assay as an aid in monitoring patients with epithelial ovarian cancer.
The requlatory submission will be prepared pursuant to Title 21CFR § 866.6010(b) which states Tumor Markers must comply with the following special controls;
-
- Guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA".
-
- Voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards (NCCLS).
A comparison of the features of the HE4 EIA Kit and the ARCHITECT CA 125 II assay are as follows:
2
: 上
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 company name. The graphic is a combination of black and white shapes with a striped pattern. The text "FUJIREBIO" is in bold, uppercase letters, with "Diagnostics, Inc" in a smaller font size below it.
| Similarities | ||
|---|---|---|
| HE4 EIA Kit | ||
| (Proposed Device) | ARCHITECT CA 125 II | |
| (Predicate Device) | ||
| K042731 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class II | Class II |
| Regulation Number | 21 CFR 866.6010 | 21 CFR 866.6010 |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Aid in monitoring patients with | |
| epithelial ovarian cancer | Aid in monitoring patients with | |
| epithelial ovarian cancer | ||
| Specimen Collection | ||
| Method | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Interpretation of Results | Standard Curve | Standard Curve |
| Differences | ||
|---|---|---|
| HE4 EIA Kit | ||
| (Proposed Device) | ARCHITECT CA 125 II | |
| (Predicate Device) | ||
| K042731 | ||
| Product Code | To be determined | LTK |
| Type of Specimen | Human Serum Only | Human serum or plasma (EDTA, |
| Lithium Heparin, Sodium Heparin) | ||
| Antigen Detected | HE4 | CA 125 |
| Capture Antibody | 2H5 mouse monoclonal | OC 125 mouse monoclonal |
| Detection Antibody | 3D8 mouse monoclonal | M11 mouse monoclonal |
| Calibrators | 6 Levels (0 - 900 pM) | |
| Supplied with Kit | 6 Levels (0 - 1000 U/mL) | |
| Supplied as separate Kit | ||
| Controls | 2 Levels (50 and 400 pM) | |
| Supplied with Kit | 3 Levels (40, 300 and 650 U/mL) | |
| Supplied as separate Kit | ||
| Principle of Operation | Manual | |
| Enzymatic Immunoassay (EIA) | Automated | |
| Chemiluminscent Microparticle | ||
| Immunoassay (CMIA) |
3
Image /page/3/Picture/1 description: The image contains the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left, followed by the company name in bold, sans-serif font. The word "FUJIREBIO" is on the top line, and "Diagnostics, Inc" is on the second line in a smaller font size.
Performance Characteristics
Precision:
A study was performed with the HE4 EIA Kit modeled after the NCCLS (CLSI) guideline EP5-A2. A panel of four serum samples was assayed, using two lots of reagents, in replicates of two, at two separate times per day for 20 days. The HE4 EIA Kit precision is ≤ 15% total CV.
Linearity:
A dilution linearity study was conducted for the HE4 EIA Kit modeled affer the NCCLS (CLSI) guideline EP6-A. Serum samples with elevated HE4 values were diluted with HE4 Calibrator A (zero). The HE4 concentration was determined for each dilution and the percent (%) recovery was calculated.
The HE4 EIA Kit was determined to have a mean recovery within 15% of the expected result for diluted samples.
Functional Sensitivity:
The functional sensitivity of the HE4 EIA Kit is ≤ 25 pM. The functional sensitivity is expressed as the concentration of an analyte at which the CV is 20%. The NCCLS guideline EP5-A2 was used to design the experiments for determination of functional sensitivity. A study was conducted where a five member sensitivity panel was tested in replicates of 4 in 2 runs on twenty separate days with two lots of reagents. The functional sensitivity determined for the HE4 EIA was found to be 25% | 76 | 57 | 133 |
|