(12 days)
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The Access Cortiosol reagents, Access Cortisol Calibrators and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.
This document is a 510(k) summary for a device modification, specifically a change to the directional insert of the Access Cortisol assay. It does not present a new study with acceptance criteria and device performance results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance for a new study. Instead, it highlights revisions made to existing sections of the device's directional insert:
- Revised: 'Analytical Specificity / Interferences' section for cross-reactivity of the assay with substances similar to cortisol.
- Revised: 'Expected Values' section for urine cortisol concentration in 24-hour urine samples determined by extracted and unextracted methods.
Since this is a submission for a change in labeling (directional insert) and not a new device or significant modification requiring fresh performance studies, no new acceptance criteria or reported device performance data in the typical sense are presented. The core assay performance is presumed to be covered by the predicate device's clearance (K954733).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes changes to existing product information, not a new study requiring a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set and ground truth were established as part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication was established.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in-vitro diagnostic immunoassay for cortisol levels, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an in-vitro diagnostic immunoassay, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document deals with revisions to "Analytical Specificity / Interferences" and "Expected Values" for an immunoassay. The ground truth for such revisions would typically be established through biochemical and clinical studies relating to the accuracy of cortisol measurement and its physiological ranges, conducted as part of the initial device development and validation (for the predicate device). However, this document does not detail how the revised information was substantiated.
8. The sample size for the training set
Not applicable. This is not a study involving a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not a study involving a training set for an algorithm.
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Image /page/0/Picture/0 description: The image shows a date written in a simple, sans-serif font. The date is "FEB - 9 2005". The month is abbreviated to three letters, and the year is written in full.
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved white lines inside, resembling a stylized eye. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif 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: KO50000
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1323 Fax: (952) 368-7610 Contact: Brent Taber
Date Prepared: January 27, 2005
Device Names
| Proprietary Name: | Cortisol and Cortisol Calibrators on the Access®Immunoassay Systems |
|---|---|
| Common Name: | Cortisol (hydrocortisone and hydroxycorticosterone) test system |
Classification Name: Radioimmunoassay, Cortisol
Predicate Device
Access Cortisol Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
510(k) Number: K954733
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Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved lines inside, resembling a stylized eye. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font.
Device Description
The Access Cortiosol reagents, Access Cortisol Calibrators and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.
Intended Use
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Comparison of Technological Characteristics
| Attribute | Access Cortisol Assay | Cortisol and CortisolCalibrators on the AccessImmunoassay Systems |
|---|---|---|
| Methodology | Competitive bindingimmunoenzymatic assay | Competitive bindingimmunoenzymatic assay |
| Intended Use | Quantitative determination ofcortisol levels in human serum,plasma (heparin, EDTA) andurine | Quantitative determination ofcortisol levels in human serum,plasma (heparin, EDTA) andurine |
| Solid Phase | Paramagnetic particles coatedwith goat anti-rabbit IgG | Paramagnetic particles coatedwith goat anti-rabbit IgG |
| Conjugate | Cortisol-alkaline phosphatase(bovine) conjugate | Cortisol-alkaline phosphatase(bovine) conjugate |
| Calibrators | Human serum containingcortisol (purified chemicalcompound) at levels of 0 andapproximately 2, 5, 10, 25, and60 ug/dL | Human serum containingcortisol (purified chemicalcompound) at levels of 0 andapproximately 2, 5, 10, 25, and60 ug/dL |
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Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle on the left, with two curved white lines running through it. To the right of the circle are the words "BECKMAN" stacked on top of "COULTER", both in a bold, sans-serif font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
Summary of Technological Characteristics
The device modification consists of a change to the directional insert. Crossreactivity of the assay with substances that are similar in structure to cortisol was revised in the 'Analytical Specificity / Interferences' section. Urine cortisol concentration in 24-hour urine samples determined by extracted and unextracted methods was revised in the 'Expected Values' section.
Conclusion
Cortisol and Cortios Calibrators on the Access Immunoassay Systems is substantially equivalent to the Access Cortisol assay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.
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l. continued...
Indications for Use Statement C.
The indications for use statement appears on the following page.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
FEB - 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brent Taber Staff Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K050202
Trade/Device Name: Cortisol and Cortisol Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: CGR, JIS Dated: January 27, 2005 Received: January 28, 2005
Dear Mr. Taber:
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.
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 be found in Title 21. Code 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 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); 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) premarket notification. The 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. 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 Division 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/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean 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
510(k) Number (if known): K050202
Cortisol and Cortisol Calibrators on the Device Name: Access® Immunoassay Systems
Indications For Use:
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benen
Division Sign-Off
Office of in Vita Diagnostic Device Evaluation and Safety
51092 K050202
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§ 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.