(44 days)
Abbott Axsym CA 125 assay
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No
The device description and performance studies focus on a standard immunoassay technology for measuring CA 125 levels, with no mention of AI or ML.
No
The device is an in vitro diagnostic immunoassay used for quantitative determination of CA 125 antigen levels to aid in the management of ovarian cancer patients. It is not designed to provide therapy.
Yes
The device is described as an "immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma" and is "indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients," which clearly defines it as a diagnostic device used to measure biomarkers for disease management.
No
The device description clearly states it is a paramagnetic particle, chemiluminescent immunoassay, which is a laboratory test method involving physical and chemical components, 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 CA 125 antigen levels in human serum and plasma". This indicates it's used to test samples taken from the human body.
- Device Description: The description confirms it's an "immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma". This further supports its use with biological samples.
- Clinical Data: The performance studies involve testing "human serum samples" and "female subjects who where diagnosed with ovarian cancer". This demonstrates its application in a clinical setting using human biological specimens.
The definition of an In Vitro Diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. This device clearly fits that description.
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Intended Use / Indications for Use
The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Product codes
LTK
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
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
Specificity: There was no significant interference from therapeutic drugs or similar compounds using the Access OV Monitor. The following compounds were tested: doxorubicin at 100 µg/mL, amthopterin at 500 μg/mL, carboplatin at 1000 μg/mL, cyclophosphamide at 1000 μg/mL, 5-fluorouracil at 1000 µg/mL, cisplatin at 2000 µq/mL, melphalan at 100 µg/mL, acetominopehn at 200 µg/mL, aspirin at 500 µg/mL, paclitaxel at 10 ng/mL, biotin at 50 ng/mL and vitamin D2 at 1 U/mL. In addition, there was no significant interference (
§ 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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Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The company name is written in bold, black letters, with "BECKMAN" on top and "COULTER" on the bottom.
DEC 1 1 2002
510(k) Summary K023597
Intended Use
The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Summary of Studies
Specificity: There was no significant interference from therapeutic drugs or similar compounds using the Access OV Monitor. The following compounds were tested: doxorubicin at 100 µg/mL, amthopterin at 500 μg/mL, carboplatin at 1000 μg/mL, cyclophosphamide at 1000 μg/mL, 5-fluorouracil at 1000 µg/mL, cisplatin at 2000 µq/mL, melphalan at 100 µg/mL, acetominopehn at 200 µg/mL, aspirin at 500 µg/mL, paclitaxel at 10 ng/mL, biotin at 50 ng/mL and vitamin D2 at 1 U/mL.
In addition, there was no significant interference (