(122 days)
No
The device description explicitly states that the ROMA score is calculated using a "Lumipulse G ROMA Calculator Tool," which combines the results of two immunoassays and menopausal status into a numerical score. This suggests a deterministic algorithm or formula, not an AI/ML model that learns from data. There is no mention of AI, ML, or training/test sets for model development.
No.
This device is an in vitro diagnostic test used to aid in assessing the likelihood of malignancy in ovarian adnexal masses, not to treat a condition.
No
The "Intended Use" section clearly states: "The test is not intended as a screening or stand-alone diagnostic assay." It also specifies that it "must be interpreted in conjunction with an independent clinical and radiological assessment." The "PRECAUTION" reiterates: "Lumipulse G ROMA 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." These statements indicate that it is an aid or an adjunctive tool, not a diagnostic device on its own.
No
The device description explicitly states that the test system consists of Lumipulse G HE4, Lumipulse G CA 125 II, the Lumipulse G ROMA Calculator Tool, and the LUMIPULSE G1200 System. The Lumipulse G HE4 and Lumipulse G CA 125 II are immunoassays performed on the LUMIPULSE G System, which is a hardware component. While there is a "Calculator Tool" which is likely software, the overall device system includes hardware components for performing the assays.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative serum and plasma test" that "combines the results of Lumipulse G CA 1251 and menopausal status into a numerical score" to "aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery." This clearly indicates it's a test performed on biological samples (serum and plasma) to provide information about a patient's health status.
- Device Description: The description details the components of the test system, including immunoassays (Lumipulse G HE4 and Lumipulse G CA 125 II) and a calculator tool, all designed to analyze biological samples and produce a numerical score for diagnostic purposes.
- Performance Studies: The document describes clinical trials where the device was used to test patient samples (serum) and the results were compared to histopathology reports (the gold standard for diagnosis). This is typical of performance studies for IVDs.
- Predicate Device: The mention of a predicate device (ROMA™) which is also an IVD further supports this classification.
The core function of the device is to analyze biological samples (serum and plasma) to provide information that aids in a clinical diagnosis (assessing the likelihood of malignancy). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lumipulse® G Risk of Ovarian Malignancy Algorithm (ROMA®) is a qualitative serum and plasma (lithium heparin or dipotassium EDTA) test that combines the results of Lumipulse G HE4, Lumipulse G CA125II and menopausal status into a numerical score.
Lumipulse G 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. Lumipulse G 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. Lumipulse G 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: Lumipulse G ROMA 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 Lumipulse G ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
ONX
Device Description
Lumipulse GROMA is a qualitative serum and plasma test that combines the results of 2 analytes, HE4 (Lumipulse G HE4) and CA125 (Lumipulse G CA 125 II) and menopausal status into a numerical score between 0.00 and 10.00. The premenopausal status must be based on ovarian function determined with information available from clinical evaluation and medical history.
The test system consists of Lumipulse G HE4, Lumipulse G CA 125 II, the Lumipulse G ROMA Calculator Tool and the LUMIPULSE G1200 System. The LUMIPULSE G1200 System is not capable of calculating the ROMA score. The immunoassays are performed according to the directions detailed in each product insert.
Both Lumipulse G HE4 and Lumipulse G CA 125 Il are previously 510(k) cleared Class II devices (K151378 and K142895 respectively). The Lumipulse G HE4 assay is a chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of HE4 antigen in human serum and plasma (lithium heparin or dipotassium EDTA) on the LUMIPULSE G System. 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. Lumipulse G CA 125 II assay is a chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Lumipulse G ROMA scores (numerical score from 0.00 -10.00) for both premenopausal and postmenopausal women are calculated using the Lumipulse G ROMA Calculator Tool to indicate a low likelihood or high likelihood for finding malignancy on surgery using the value of the 2 immunoassays (Lumipulse G HE4 and Lumipulse G CA125II).
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
The effectiveness of Lumipulse G 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 450 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, Lumipulse G ROMA was determined and the patient was stratified into a low or a high likelihood group for finding malignancy on surgery.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Reproductive performance (Lot-to-Lot Precision)
Sample Size: N=120 for each panel (Premenopausal ROMA Score), N=120 for each panel (Postmenopausal ROMA Score)
Key Results: Summarized in tables for "Lot-to-Lot Variability Premenopausal ROMA Score" and "Lot-to-Lot Variability for Postmenopausal ROMA Score" showing Mean, SD, and %CV for various components of variability (Between Lots, Between Days Within Lots, Between Runs Within Days Within Lot, Within Runs, Total).
Study Type: Reproducibility (Site-to-Site Variability)
Sample Size: N=120 for each panel (Premenopausal ROMA Score), N=40 for each panel (Postmenopausal ROMA Score)
Key Results: Summarized in tables for "Site-to-Site Variability for Premenopausal ROMA Score" and "Site-to-Site Variability for Postmenopausal ROMA Score" showing Mean, SD, and %CV for various components of variability (Between Sites, Between Days Within Sites, Between Runs Within Days Within Lot, Within Runs, Total).
Study Type: Analytical Specificity (Interference Testing)
Sample Size: Not explicitly given, but 4 serum panels were used.
Key Results: Mean percent (%) differences of Pre and Post-Menopausal Lumipulse G ROMA Scores for endogenous interferents were generally low (0% to -2%).
Study Type: Method Comparison (Lumipulse G ROMA vs. ROMA (HE4 EIA + ARCHITECT CA 125 II))
Sample Size: 53 for Premenopausal Women, 115 for Postmenopausal Women
Key Results: High correlation coefficients (0.9977 for Premenopausal, 0.9953 for Postmenopausal) indicating strong agreement with predicate device. Slopes and intercepts generally close to 1 and 0, respectively.
Study Type: Matrix Comparison (Serum vs K2 EDTA Plasma)
Sample Size: 86 matched sets of serum and K2 EDTA plasma samples
Key Results: Demonstrated equivalency between matrices with high correlation coefficients (r=0.9983 for Premenopausal, r=0.9988 for Postmenopausal) and regression equations close to y=x.
Study Type: Clinical Study (Effectiveness of Lumipulse G ROMA for stratification)
Sample Size: 450 evaluable women
Key Results:
- For epithelial ovarian cancer (EOC) only (premenopausal n=232, postmenopausal n=181):
- Premenopausal: Sensitivity 100.0% (9/9), Specificity 74.9% (167/223), TP-FP 74.9%, PPV 13.8% (9/65), NPV 100.0% (167/167).
- Postmenopausal: Sensitivity 92.1% (35/38), Specificity 77.6% (111/143), TP-FP 69.7%, PPV 52.2% (35/67), NPV 97.4% (111/114).
- For adjunctive use of Lumipulse G ROMA with Initial Cancer Risk Assessment (ICRA) (total n=450, all malignancies and LMP):
- ICRA: Sensitivity 72.6% (61/84), Specificity 84.2% (308/366), TP-FP 56.8%, PPV 51.3% (61/119), NPV 93.1% (308/331).
- Lumipulse G ROMA Alone: Sensitivity 82.1% (69/84), Specificity 76.0% (278/366), TP-FP 58.1%, PPV 43.9% (69/157), NPV 94.9% (278/293).
- Adjunctive (Lumipulse G ROMA and/or ICRA positive): Sensitivity 88.1% (74/84), Specificity 67.5% (247/366), TP-FP 55.6%, PPV 38.3% (74/193), NPV 96.1% (247/257).
- Adding Lumipulse G ROMA to ICRA produced a statistically significant improvement in the negative predictive value. The NPV for correctly classifying benign patients into the low likelihood group increased from 93.1% to 96.1%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For epithelial ovarian cancer (EOC) only:
- Premenopausal:
- Sensitivity: 100.0% (9/9)
- Specificity: 74.9% (167/223)
- TP-FP: 74.9%
- PPV: 13.8% (9/65)
- NPV: 100.0% (167/167)
- Postmenopausal:
- Sensitivity: 92.1% (35/38)
- Specificity: 77.6% (111/143)
- TP-FP: 69.7%
- PPV: 52.2% (35/67)
- NPV: 97.4% (111/114)
For adjunctive use of Lumipulse G ROMA with Initial Cancer Risk Assessment (ICRA) (all malignancies and LMP):
- ICRA alone:
- Sensitivity: 72.6% (61/84)
- Specificity: 84.2% (308/366)
- TP-FP: 56.8%
- PPV: 51.3% (61/119)
- NPV: 93.1% (308/331)
- Lumipulse G ROMA alone:
- Sensitivity: 82.1% (69/84)
- Specificity: 76.0% (278/366)
- TP-FP: 58.1%
- PPV: 43.9% (69/157)
- NPV: 94.9% (278/293)
- Adjunctive (Lumipulse G ROMA and/or ICRA positive):
- Sensitivity: 88.1% (74/84)
- Specificity: 67.5% (247/366)
- TP-FP: 55.6%
- PPV: 38.3% (74/193)
- NPV: 96.1% (247/257)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ROMA™ (HE4 EIA + ARCHITECT CA 125 II), K103358
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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:
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2016
Fujirebio Diagnostics, Inc. Ms. Diana Dickson Director, Clinical and Regulatory Science 201 Great Valley Parkway Malvern PA 19355
Re: K160090
Trade/Device Name: Lumipulse® G ROMA® Regulation Number: 21 CFR 866.6050 Regulation Name: Ovarian adnexal mass assessment score test system Regulatory Class: II Product Code: ONX Dated: April 14, 2016 Received: April 15, 2016
Dear Ms. Dickson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kelly Oliner -S
For.
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160090
Device Name Lumipulse® G ROMA®
Indications for Use (Describe)
Lumipulse® G Risk of Ovarian Malignancy Algorithm (ROMA®) is a qualitative serum and plasma (lithium heparin or dipotassium EDTA) test that combines the results of Lumipulse G CA 1251 and menopausal status into a numerical score.
Lumipulse G ROMA is intended to aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. Lumipulse G 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. Lumipulse G 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: Lumipulse G ROMA 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 Lumipulse G ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) Number:
Purpose for Submission:
New device
Measurand:
ROMA (Risk of Ovarian Malignancy Algorithm) - Ovarian adnexal mass assessment score based on 2 analytes
Type of Test:
Software algorithm and 2 immunoassays
Applicant:
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|-----------------|------------------------------------------------------------------------------|
| Contact person: | Diana Dickson
(610) 240-3917
dicksond@fdi.com |
Summary preparation date: May 16, 2016
Proprietary and Established Names:
Lumipulse® G ROMA®
Regulatory Information:
- Regulation section: 1. 21 CFR §866.6050 - Ovarian adnexal mass assessment score test system
-
- Classification: Class II
-
- Product code: ONX; Ovarian adnexal mass assessment score test system
-
- Panel: 82, Immunology
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Intended Use:
-
- Intended use(s): For In Vitro Diagnostic Use Only.
Lumipulse® G Risk of Ovarian Malignancy Algorithm (ROMA®) is a qualitative serum and plasma (lithium heparin or dipotassium EDTA) test that combines the results of Lumipulse G HE4, Lumipulse G CA125II and menopausal status into a numerical score.
- Intended use(s): For In Vitro Diagnostic Use Only.
Lumipulse G 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. Lumipulse G 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. Lumipulse G 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: Lumipulse G ROMA 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 Lumipulse G ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
-
- Indication(s) for use: Same as Intended Use.
-
- Special conditions for use statement(s): Prescription use only
-
- Special instrument requirements: LUMIPULSE G1200 system
Device Description:
Lumipulse GROMA is a qualitative serum and plasma test that combines the results of 2 analytes, HE4 (Lumipulse G HE4) and CA125 (Lumipulse G CA 125 II) and menopausal status into a numerical score between 0.00 and 10.00. The premenopausal status must be based on ovarian function determined with information available from clinical evaluation and medical history.
The test system consists of Lumipulse G HE4, Lumipulse G CA 125 II, the Lumipulse G ROMA Calculator Tool and the LUMIPULSE G1200 System. The LUMIPULSE G1200 System is not capable of calculating the ROMA score. The immunoassays are performed according to the directions detailed in each product insert.
Both Lumipulse G HE4 and Lumipulse G CA 125 Il are previously 510(k) cleared Class II devices (K151378 and K142895 respectively). The Lumipulse G HE4 assay is a chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of HE4 antigen in human serum and plasma (lithium heparin or dipotassium EDTA) on the LUMIPULSE G System. 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
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conjunction with other clinical methods used for monitoring ovarian cancer. Lumipulse G CA 125 II assay is a chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Lumipulse G ROMA scores (numerical score from 0.00 -10.00) for both premenopausal and postmenopausal women are calculated using the Lumipulse G ROMA Calculator Tool to indicate a low likelihood or high likelihood for finding malignancy on surgery using the value of the 2 immunoassays (Lumipulse G HE4 and Lumipulse G CA125II).
Substantial Equivalence Information:
-
- Predicate device name(s): ROMA™ (HE4 EIA + ARCHITECT CA 125 II)
-
- Predicate 510(k) number(s): K103358
-
- Comparison with predicate:
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| Similarities | ||
|---|---|---|
| Lumipulse® G ROMA® | ||
| (Proposed Device) | ROMA (HE4 EIA + | |
| ARCHITECT CA 125 II) | ||
| (Predicate Device) | ||
| K103358 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class II | Class II |
| Regulation Number | 21CFR § 866.6050 | |
| Ovarian adnexal mass | ||
| assessment score test | ||
| system | 21CFR § 866.6050 | |
| Ovarian adnexal mass | ||
| assessment score test | ||
| system | ||
| Product Usage | Clinical and Hospital | |
| laboratories | Clinical and Hospital | |
| laboratories | ||
| Intended Use | Lumipulse G Risk of Ovarian | |
| Malignancy Algorithm | ||
| (ROMA) is a qualitative | ||
| serum and plasma (lithium | ||
| heparin or dipotassium | ||
| EDTA) test that combines the | ||
| results of Lumipulse G HE4, | ||
| Lumipulse G CA 125 II™ and | ||
| menopausal status into a | ||
| numerical score. | ||
| Lumipulse G 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. | ||
| Lumipulse G 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. | ||
| Lumipulse G 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 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. | ||
| Similarities | ||
| Lumipulse® G ROMA® | ||
| (Proposed Device) | ROMA (HE4 EIA + | |
| ARCHITECT CA 125 II) | ||
| (Predicate Device) | ||
| K103358 | ||
| Black box warning | ||
| (PRECAUTION) | 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 carries the risk of | ||
| unnecessary testing, surgery, | ||
| and/or delayed diagnosis | 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 carries the risk of | ||
| unnecessary testing, surgery, | ||
| and/or delayed diagnosis | ||
| Specimen Collection Method | Routine Phlebotomy | |
| Techniques | Routine Phlebotomy | |
| Techniques | ||
| Serum Analyte | HE4 and CA125 | HE4 and CA125 |
| Device Type | Algorithm | |
| (Qualitative, numeric) | Algorithm | |
| (Qualitative, numeric) | ||
| Equation used for test | Premenopausal woman: | |
| Predictive Index (PI) = -12.0 + | ||
| $2.38LN[HE4] +0.0626LN[CA 125]$ | ||
| Postmenopausal woman: | ||
| Predictive Index (PI) = -8.09 + | ||
| $1.04LN[HE4] + 0.732LN[CA125]$ | ||
| $ROMA = exp(PI) / [1 +exp(PI)] *10$ | Premenopausal woman: | |
| Predictive Index (PI) = - 12.0 + | ||
| $2.38LN[HE4] +0.0626LN[CA 125]$ | ||
| Postmenopausal woman: | ||
| Predictive Index (PI) = -8.09 + | ||
| $1.04LN[HE4] + 0.732LN[CA125]$ | ||
| $ROMA = exp(PI) / [1 +exp(PI)] *10$ | ||
| Clinical Cut-off | Premenopausal: | |
| Lumipulse G ROMA score ≥ | ||
| 1.31 = High likelihood of | ||
| finding malignancy | ||
| Lumipulse G ROMA score |