(84 days)
Beckman Access® Cortisol assay
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No
The device description and performance studies focus on a standard immunoassay technology (FPIA) and statistical analysis of results, with no mention of AI or ML algorithms.
No
The device is an in vitro diagnostic (IVD) assay designed to measure Cortisol levels to aid in diagnosis and treatment, not to actively treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "to aid in the diagnosis and treatment of adrenal disorders." This directly indicates its role in diagnosis.
No
The device description clearly outlines a physical assay process involving pipetting reagents and samples into a Reaction Vessel (RV), transferring the RV to a Processing Center, and using an FPIA optical assembly to measure polarized fluorescent light. This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative measurement of Cortisol in human serum, plasma or urine... to aid in the diagnosis and treatment of adrenal disorders." This clearly indicates the device is used to test samples taken from the human body (in vitro) to provide information for medical diagnosis and treatment.
- Device Description: The description details the process of analyzing human serum, plasma, or urine samples using a specific immunoassay technology (FPIA) and reagents. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The performance studies describe testing the device with human specimens (serum, plasma, urine) and comparing the results to a predicate device, which is standard practice for validating IVDs.
- Predicate Device: The mention of a "Predicate Device(s)" which is another Cortisol assay, further confirms that this device is intended to perform a diagnostic test on human samples, similar to existing IVD devices.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.
Product codes
JFT, JIT, JJX
Device Description
The AxSYM Cortisol assay utilizes Fluorescence Polarization Immunoassay (FPIA) The AxSYM Cortisol Reagents and sample are pipetted in the following technology. sequence:
- Sample and all AxSYM Cortisol Reagents required for one test are pipetted by the sampling probe into various positions of a Reaction Vessel (RV).
- Sample, the Cortisol Antiserum (antibody), pretreatment solution and Solution 4 (Line Diluent) are pipetted into one well of the RV.
- Additional pretreatment solution 4 (Line Diluent) are pipetted to the cuvette of the RV.
- The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
In the processing center, an aliquot of the predilution mixture and Solution 4 (Line Diluent) are transferred to the cuvette of the RV and the blank intensity of the sample is measured. A second aliquot of the predilution mixture is transferred to the cuvette along with the Cortisol Fluorescein Tracer. Cortisol from the sample and the Cortisol Fluorescein Tracer compete for binding sites on the antibody molecule. The intensity of polarized fluorescent light is measured by the FPIA optical assembly.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility:
Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Three buffer-based panel members (1, 2, and 3) were assayed, in replicates of two, at two separate times per day, for 20 days. Three reagent lots were tested using two instruments, with a single standard calibration per reagent pack. The total precision was determined by calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.
The total precision %CV of the AxSYM® Cortisol assay was determined to be less than or equal to 15.0.
Comparison Study:
A total of 130, endogenous and cortisol-spiked serum and sodium heparin plasma specimens and 150, endogenous and cortisol-spiked urine specimens were tested using the AxSYM Cortisol assay and a Competitor Cortisol assay. Least squares and Passing-Bablok linear regression analyses were performed on all specimens with concentration values within the dynamic range of both assays (0 - 60ug/dL for the both the AxSYM and the Competitor Cortisol assavs).
Least squares linear regression analysis comparing the AxSYM® Cortisol assay to the Beckman Access® Cortisol assay for serum and plasma yielded a correlation coefficient of 0.96, a slope of 0.87 and Y-axis intercept of -0.74. Least squares linear regression analysis for urine vielded a correlation coefficient of 0.79 and Y-axis intercept of -0.59.
Passing-Bablok linear regression analysis comparing the AxSYM Cortisol assay to the Beckman Access Cortisol assay for serum and plasma vielded a correlation coefficient of 0.96, a slope of 0.93, and Y-axis intercept -2.39. Passing-Bablok linear regression analysis for urine yielded a correlation coefficient of 0.98, a slope of 0.79, and Y-axis intercept -0.48.
Expected Values:
A study was conducted to establish the normal range for a given population using the AxSYM® Cortisol assay. A total of 50 serum (AM and PM collections) and 49 urine (24 hour collection) specimens from apparently healthy individuals were evaluated using the AxSYM® Cortisol assay.
In the population tested, the 95% confidence limit for the normal range of AM and PM cortisol in the serum specimens was determined to be 4.2 to 38.4 µg/dL (median value 10.8 µg/dL) and 1.7 to 16.6 ug/dL (median value 6.7 ug/dL) respectively. It is recommended that each laboratory establish its own range.
The 95% confidence limit for the normal range of cortisol in urine specimens was determined to be 32 to 243 µg/24 hour (median value 88 µg/24 hours). It is recommended that each laboratory establish its own range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient, slope, Y-axis intercept, standard deviation (SD), percent coefficient of variation (%CV), 95% confidence limit, median value.
Predicate Device(s)
Beckman Access® Cortisol assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.
0
FEB 2 0 2004
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: __ ____________________________________________________________________________________________________________________________________________
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Kimberly Peterson, (610) 240-3828 |
| Summary preparation date: | November 26, 2003 |
| Name of Device | |
| Trade/Proprietary Name: | AxSYM® Cortisol assay |
| Common/Usual Name: | Cortisol Assay |
| Classification Name: | Cortisol (hydrocortisone and hydroxycorticosterone) tes
system |
Predicate Device
Beckman Access® Cortisol assay
Device Description
The AxSYM Cortisol assay utilizes Fluorescence Polarization Immunoassay (FPIA) The AxSYM Cortisol Reagents and sample are pipetted in the following technology. sequence:
- · Sample and all AxSYM Cortisol Reagents required for one test are pipetted by the sampling probe into various positions of a Reaction Vessel (RV).
- Sample, the Cortisol Antiserum (antibody), pretreatment solution and Solution 4 (Line . Diluent) are pipetted into one well of the RV.
- · Additional pretreatment solution 4 (Line Diluent) are pipetted to the cuvette of the RV.
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- · The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
In the processing center, an aliquot of the predilution mixture and Solution 4 (Line Diluent) are transferred to the cuvette of the RV and the blank intensity of the sample is measured. A second aliquot of the predilution mixture is transferred to the cuvette along with the Cortisol Fluorescein Tracer. Cortisol from the sample and the Cortisol Fluorescein Tracer compete for binding sites on the antibody molecule. The intensity of polarized fluorescent light is measured by the FPIA optical assembly.
Intended Use
The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.
Summary of Performance characteristics
Reproducibility:
Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Three buffer-based panel members (1, 2, and 3) were assayed, in replicates of two, at two separate times per day, for 20 days. Three reagent lots were tested using two instruments, with a single standard calibration per reagent pack. The total precision was determined by calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.
The total precision %CV of the AxSYM® Cortisol assay was determined to be less than or equal to 15.0.
Comparison Study
A total of 130, endogenous and cortisol-spiked serum and sodium heparin plasma specimens and 150, endogenous and cortisol-spiked urine specimens were tested using the AxSYM Cortisol assay and a Competitor Cortisol assay. Least squares and Passing-Bablok linear regression analyses were performed on all specimens with concentration values within the dynamic range of both assays (0 - 60ug/dL for the both the AxSYM and the Competitor Cortisol assavs).
Least squares linear regression analysis comparing the AxSYM® Cortisol assay to the Beckman Access® Cortisol assay for serum and plasma yielded a correlation coefficient of 0.96, a slope of 0.87 and Y-axis intercept of - 0.74. Least squares linear regression analysis for urine vielded a correlation coefficient of 0.79 and Y-axis intercept of - 0.59.
Passing-Bablok linear regression analysis comparing the AxSYM Cortisol assay to the Beckman Access Cortisol assay for serum and plasma vielded a correlation coefficient of
2
0.96, a slope of 0.93, and Y-axis intercept -2.39. Passing-Bablok linear regression analysis for urine yielded a correlation coefficient of 0.98, a slope of 0.79, and Y-axis intercept -0.48.
Expected Values:
A study was conducted to establish the normal range for a given population using the AxSYM® Cortisol assay. A total of 50 serum (AM and PM collections) and 49 urine (24 hour collection) specimens from apparently healthy individuals were evaluated using the AxSYM® Cortisol assay.
In the population tested, the 95% confidence limit for the normal range of AM and PM cortisol in the serum specimens was determined to be 4.2 to 38.4 µg/dL (median value 10.8 µg/dL) and 1.7 to 16.6 ug/dL (median value 6.7 ug/dL) respectively. It is recommended that each laboratory establish its own range.
The 95% confidence limit for the normal range of cortisol in urine specimens was determined to be 32 to 243 µg/24 hour (median value 88 µg/24 hours). It is recommended that each laboratory establish its own range.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 0 2004
Ms. Kimberly M. Peterson Manager, Regulatory Affairs Fuiirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
K033731 Re:
Trade/Device Name: AxSYM® Cortisol assay Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: JFT; JIT; JJX Dated: November 26, 2003 Received: December 15, 2003
Dear Ms. Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we 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 conniered pror to ritle) 2011-11-11, accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , are expressions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or babyer to back of Federal Regulations (CFR), Parts 800 to 895. 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 r lease be devilsed that i bromination that your device complies with other requirements of the Act that I Dr. I has matures 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his lotter will and in yourse FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tour may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K033731
Page 1 of 1
Device Name: AxSYM® Cortisol assay
The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.
prescription
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
Carol Benson
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)K033731
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