(289 days)
Not Found
No
The device uses a fixed mathematical formula (logistic regression equations) derived from a training set, not a system that learns or adapts over time.
No.
The device is an in vitro diagnostic test that aids in assessing the likelihood of malignancy in women with an ovarian adnexal mass. It does not directly treat or prevent a medical condition.
Yes
The document explicitly states its "Intended Use / Indications for Use" as: "ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery." Diagnostic devices are used to detect or aid in the detection of a condition. Furthermore, the first line states "For In Vitro Diagnostic Use Only," directly identifying it as a diagnostic device.
No
The device description explicitly states that the "test system consists of the assays, reagents, software and instrument used to obtain the ROMA result." This indicates that the device includes hardware components (assays, reagents, and instruments) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The very first line of the "Intended Use / Indications for Use" section states: "For In Vitro Diagnostic Use Only." This is a clear and direct declaration.
- Nature of the Test: The device is a "qualitative serum test" that analyzes biomarkers (HE4 and CA 125) in a biological sample (serum) outside of the body. This is the fundamental definition of an in vitro diagnostic test.
- Purpose: The test is intended to "aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery." This is a diagnostic purpose, providing information to help clinicians make decisions about patient management.
- Components: The device description mentions "assays, reagents, software and instrument used to obtain the ROMA result," which are typical components of an IVD test system.
The information provided strongly indicates that this device is designed and intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use Only.
The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score.
ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA 125 II) should not be used without an independent clinical /radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT CA 125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
Product codes
ONX
Device Description
The Risk of Ovarian Malignancy Algorithm (ROMATM) is a qualitative serum test in the form of a mathematical function combining the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score.
ROMA was developed in a training set using separate logistic regression equations for premenopausal and postmenopausal women:
Premenopausal woman: Predictive Index (PI) = -12.0 + 2.38LN[HE4] + 0.0626LN[CA 125] Postmenopausal woman: Predictive Index (PI) = -8.09 + 1.04LNIHE4] + 0.732LNJCA 125J ROMA = exp(PI) / [1 + exp(PI)] *10
ROMA is used to stratify women into likelihood groups for finding cancer on surgery. In order to provide a specificity level of 75%, a cut point of ≥ 1.31 was used for premenopausal women and ≥ 2.77 was used for postmenopausal women who present with an ovarian adnexal mass. Women with ROMA results above these cut points is at high likelihood of finding malignancy on surgery.
The test system consists of the assays, reagents, software and instrument used to obtain the ROMA result. The ROMA instructions for use are provided with the HE4 EIA Kit. The HE4 EIA and ARCHITECT CA 125 II are performed according to the manufacturers' directions detailed in each product insert. The immunoassays used in ROMA are:
HE4 EIA: The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum.
ARCHITECT CA 125 II: The ARCHITECT CA 125 II assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of OC 125 defined antigen in human serum and plasma on the ARCHITECT i System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ovarian adnexal mass
Indicated Patient Age Range
over age 18
Intended User / Care Setting
Clinical and Hospital laboratories
Description of the training set, sample size, data source, and annotation protocol
ROMA was developed in a training set using separate logistic regression equations for premenopausal and postmenopausal women.
No further details on sample size, data source, or annotation protocol are provided in the document.
Description of the test set, sample size, data source, and annotation protocol
A total of 461 women were evaluable in the study. For each patient, an initial cancer risk assessment (ICRA) was completed by a non-gynecological oncologist, providing the assessment of the patient's mass as benign (negative) or malignant (positive) based upon the information available to the non-gynecological oncologist during their work-up of the patient. The corresponding histopathology reports were collected after surgery. Using a preoperatively collected serum sample, ROMA was determined and the patient was stratified into a low or a high likelihood group for finding malignancy on surgery. The study was a prospective, multi-center, blinded clinical trial.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, multi-center, blinded clinical trial.
Sample Size: 461 women were evaluable (240 premenopausal, 221 postmenopausal).
Standalone Performance:
The effectiveness of ROMA was determined for premenopausal and postmenopausal women presenting with an adnexal mass requiring surgical intervention.
The following cut-points were used to provide a specificity level of 75%:
- Premenopausal women: ROMA value ≥ 1.31 = High likelihood of finding malignancy; ROMA value
§ 866.6050 Ovarian adnexal mass assessment score test system.
(a)
Identification. An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document,see § 866.1(e).(c)
Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act these devices are subject to the following restriction: A warning statement must be placed in a black box and must appear in all advertising, labeling, and promotional material for these devices. That warning statement must read:
0
Image /page/0/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized, abstract symbol on the left, followed by the company name in bold, sans-serif font. Below the company name, the words "Diagnostics, Inc." are printed in a smaller font size.
510(k) SUMMARY
SEP = 1 2011
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.
Fujirebio Diagnostics, Inc.
The assigned 510(k) number is: K103358
Submitter Information
Address:
| | 201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|-----------------------------------------------------------------------------------------|
| Contact person: | Diana L. Dickson
dicksond@fdi.com |
| Summary preparation date: | August 31, 2011 |
| Name of Device | |
| Trade/Proprietary Name: | ROMATM (HE4 EIA + ARCHITECT CA 125 IITM) |
| Common/Usual Name: | ROMA
(Risk of Ovarian Malignancy Algorithm)
using HE4 EIA and ARCHITECT CA 125 II |
| Regulation Number: | 21 CFR 866.6050 |
| Regulatory Class: | Class II |
| Product Code: | ONX |
Predicate Device
OVA1™ Test (K081754)
1
Image /page/1/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 company name is written in a bold, sans-serif font, with "Diagnostics, Inc." appearing in a smaller font size below "FUJIREBIO".
Intended Use
For In Vitro Diagnostic Use Only.
The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score.
ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA 125 II) should not be used without an independent clinical fradiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT CA 125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
Device Description
The Risk of Ovarian Malignancy Algorithm (ROMATM) is a qualitative serum test in the form of a mathematical function combining the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score.
ROMA was developed in a training set using separate logistic regression equations for premenopausal and postmenopausal women:
Premenopausal woman: Predictive Index (PI) = -12.0 + 2.38LN[HE4] + 0.0626LN[CA 125] Postmenopausal woman: Predictive Index (PI) = -8.09 + 1.04LNIHE4] + 0.732LNJCA 125J ROMA = exp(PI) / [1 + exp(PI)] *10
ROMA is used to stratify women into likelihood groups for finding cancer on surgery. In order to provide a specificity level of 75%, a cut point of ≥ 1.31 was used for premenopausal women and ≥ 2.77 was used for postmenopausal women who present with an ovarian adnexal mass. Women with ROMA results above these cut points is at high likelihood of finding malignancy on surgery.
2
Image /page/2/Picture/1 description: The image contains the logo for FUJIREBIO Diagnostics, Inc. The logo features a stylized graphic to the left of the company name. The graphic is a three-part design with a white circle in the center. The company name is in bold, black letters, with "Diagnostics, Inc." in a smaller font size below.
The test system consists of the assays, reagents, software and instrument used to obtain the ROMA result. The ROMA instructions for use are provided with the HE4 EIA Kit. The HE4 EIA and ARCHITECT CA 125 II are performed according to the manufacturers' directions detailed in each product insert. The immunoassays used in ROMA are:
| HE4 EIA | The HE4 EIA is an enzyme immunometric assay for the quantitative
determination of HE4 in human serum. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ARCHITECT CA 125 II | The ARCHITECT CA 125 II assay is a Chemiluminescent
Microparticle Immunoassay (CMIA) for the quantitative determination
of OC 125 defined antigen in human serum and plasma on the
ARCHITECT i System. |
Substantial Equivalence
. '
| Similarities | ||
|---|---|---|
| ROMA | ||
| (HE4 EIA + | ||
| ARCHITECT CA 125 II) | ||
| (Proposed Device) | OVA1™ Test | |
| (Predicate Device) | ||
| K081754 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class II | Class II |
| Regulation Number | 21 CFR 866.6050 | 21 CFR 866.6050 |
| Product Usage | Ovarian adnexal mass | |
| assessment score test system | ||
| Clinical and Hospital laboratories | Ovarian adnexal mass | |
| assessment score test system | ||
| Clinical and Hospital laboratories | ||
| Product Code | ONX | |
| Serum, algorithm, ovarian cancer | ||
| assessment test | ONX | |
| Serum, algorithm, ovarian cancer | ||
| assessment test | ||
| Panel | Immunology (82) | Immunology (82) |
| Serum Analyte | CA 125 | CA 125 |
| Use | The information provided by the | |
| ROMA Test should be used by the | ||
| physician only as an adjunctive | ||
| test to complement, not replace, | ||
| other diagnostic and clinical | ||
| procedures. | The information provided by the | |
| OVA1 Test should be used by the | ||
| physician only as an adjunctive | ||
| test to complement, not replace, | ||
| other diagnostic and clinical | ||
| procedures. |
3
Premarket Notification (510(k)) ROMA (HE4 EIA + ARCHITECT CA 125 II)
Image /page/3/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a black and white abstract shape. The text "FUJIREBIO" is in bold, black letters, and "Diagnostics, Inc." is in a smaller font size below it.
| Differences | ||
|---|---|---|
| ROMA | ||
| (HE4 EIA + | ||
| ARCHITECT CA 125 II) | ||
| (Proposed Device) | OVA1™ Test | |
| (Predicate Device) | ||
| K081754 | ||
| Intended Use | For In Vitro Diagnostic Use Only. | |
| The Risk of Ovarian Malignancy | ||
| Algorithm (ROMA™) is a | ||
| qualitative serum test that | ||
| combines the results of HE4 EIA, | ||
| ARCHITECT CA 125 II™ and | ||
| menopausal status into a | ||
| numerical score. | ||
| ROMA is intended to aid in | ||
| assessing whether a | ||
| premenopausal or | ||
| postmenopausal woman who | ||
| presents with an ovarian adnexal | ||
| mass is at high or low likelihood of | ||
| finding malignancy on surgery. | ||
| ROMA is indicated for women who | ||
| meet the following criteria: over | ||
| age 18; ovarian adnexal mass | ||
| present for which surgery is | ||
| planned, and not yet referred to an | ||
| oncologist. ROMA must be | ||
| interpreted in conjunction with an | ||
| independent clinical and | ||
| radiological assessment. The test | ||
| is not intended as a screening or | ||
| stand-alone diagnostic assay. | The OVA1™ Test is a qualitative | |
| serum test that combines the | ||
| results of five immunoassays into | ||
| a single numerical score. It is | ||
| indicated for women who meet the | ||
| following criteria: over age 18; | ||
| ovarian adnexal mass present for | ||
| which surgery is planned, and not | ||
| yet referred to an oncologist. The | ||
| OVA1 Test is an aid to further | ||
| assess the likelihood that | ||
| malignancy is present when the | ||
| physician's independent clinical | ||
| and radiological evaluation does | ||
| not indicate malignancy. The test | ||
| is not intended as a screening or | ||
| stand-alone diagnostic assay. | ||
| Measurand | Score based on 2 analytes | Score based on 5 serum analytes |
| Type of Test | Software algorithm and 2 | |
| immunoassays | Software algorithm and 5 | |
| immunoassays | ||
| Serum Analyte | HE4 | Transthyretin, Apolipoprotein A-1, |
| β2-microglobulin, Transferrin |
:
、
:
.
:
:
4
Image /page/4/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized, abstract shape 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 line below.
Use of ROMA for the likelihood of malignancy assessment in women presenting with an adnexal mass who will undergo surqical intervention
ROMA takes into account the results of HE4 EIA and the results of ARCHITECT CA 125 II as well as the menopausal status of the woman. The ROMA value is used to aid in assessing whether a woman is at high or low likelihood of finding malignancy on surgery.
The effectiveness of ROMA was determined in a prospective, multi-center, blinded clinical trial for premenopausal and postmenopausal women presenting with an adnexal mass requiring surgical intervention.
A total of 461 women were evaluable in the study. For each patient, an initial cancer risk assessment (ICRA) was completed by a non-gynecological oncologist, providing the assessment of the patient's mass as benign (negative) or malignant (positive) based upon the information available to the non-gynecological oncologist during their work-up of the patient. The corresponding histopathology reports were collected after surgery.
Using a preoperatively collected serum sample, ROMA was determined and the patient was stratified into a low or a high likelihood group for finding malignancy on surgery.
The histopathological classifications of the 461 evaluable patients are summarized below:
| Histopathological classification | All | Premenopausal | Postmenopausal | |||
|---|---|---|---|---|---|---|
| N | % | N | % | N | % | |
| Benign Pathology | 375 | 81.3 | 220 | 91.7 | 155 | 70.1 |
| Low Malignant Potential (LMP) / | ||||||
| Borderline | 18 | 3.9 | 7 | 2.9 | 11 | 5.0 |
| Epithelial Ovarian Cancer | 48 | 10.4 | 9 | 3.7 | 39 | 17.6 |
| Non-Epithelial Ovarian Cancer | 2 | 0.4 | 0 | 0.0 | 2 | 0.9 |
| Other Gynecological Cancer | 10 | 2.2 | 3 | 1.2 | 7 | 3.2 |
| Other Cancer | 7 | 1.5 | 1 | 0.4 | 6 | 2.7 |
| Metastatic Cancer | 1 | 0.2 | 0 | 0.0 | 1 | 0.5 |
| Total | 461 | 100.0 | 240 | 23.3 | 221 | 76.7 |
Histopathological classification of the multi-center study patients
5
Image /page/5/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 line below.
Use of ROMA for stratification into low likelihood and high likelihood groups for finding malignancy on surgery
The following cut-points were used in order to provide a specificity level of 75%: Premenopausal women
ROMA value ≥ 1.31 = High likelihood of finding malignancy
ROMA value