(46 days)
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No
The summary describes a chemiluminescence immunoassay for measuring cortisol levels. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on traditional analytical validation metrics like precision, recovery, and linearity.
No
This device is an immunoassay for quantitative determination of cortisol, which is used for diagnostic purposes, not for treating a disorder or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland," which indicates a diagnostic purpose.
No
The device description clearly states it is a "Chemilumeniscence assay" intended for use with a "Specialty System," indicating it is a physical assay kit and likely requires a hardware system for analysis, 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's for the "quantitative determination of cortisol concentration in human serum, EDTA plasma, and urine." This involves testing samples taken from the human body (in vitro) to provide information for diagnosis and treatment.
- Diagnosis and Treatment: The intended use also states that the measurements are "used in the diagnosis and treatment of disorders of the adrenal gland." This directly aligns with the purpose of IVD devices, which are used to provide information for diagnostic purposes.
- Device Description: The description refers to it as a "Chemiluminescence immunoassay," which is a common type of test performed on biological samples outside the body.
The definition of an IVD device is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Assay is intended for the quantitative determination of cortisol concentration in human serum. EDTA plasma, and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Product codes
CGR
Device Description
The Nichols Advantage® Chemiluminescence Cortisol Immunoassay (hereinafter referred to as the Assay) is a Chemilumeniscence assay intended for use with the Nichols Advantage® Specialty System.
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
Studies were performed to show the reproducibility, recovery, extraction efficiency, parallelism, effect of potential interferents in urine, and the expected values in normal individuals. The method we use to extract cortisol from urine is accepted and recognized in the literature. The inter-assay precision estimates of 8.6-10.3% CV are typical for an assay that includes a pre-assay organic solvent extraction step. When urine was analytically spiked with known amounts of cortisol. the mean extraction recovery was 102% indicating that the method to extract cortisol from urine is efficient, complete and reproducible. When various quantities of a high and low cortisol sample were mixed, the analytical recovery across the ranges studied showed recoveries of 98 ± 5% (mean ± SD). When urine was diluted after extraction, the linearity/recovery was 99 ± 9% (mean ± SD) across the ranges studied. Potential interference due to protein, urea, creatinine, glucose and sodium chloride were studied, and the data show no observed interference at the pathological concentrations studied.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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KG84520
510(K) Notification Page 91 of 91
510(k) SAFETY AND EFFECTIVENESS SUMMARY
Nichols Advantage® Chemiluminescence Cortisol Immunoassay TRADE NAME:
COMMON NAME: Cortisol
CLASSIFICATION NAME: Cortisol (21 CFR 862.1205)
The Nichols Advantage® Chemiluminescence Cortisol Immunoassay (hereinafter referred to as the Assay) is a Chemilumeniscence assay intended for use with the Nichols Advantage® Specialty System.
INTENDED USE
The Assay is intended for the quantitative determination of cortisol concentration in human serum. EDTA plasma, and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
SUBSTANTIAL EQUIVALENECE
The Assay is identical to the Nichols Advantage® Chemiluminescence Cortisol Assay (K962208 cleared 4/8/97) in its intended use; the use of human serum and EDTA plasma with the added intended use of urine, and sensitivity which is sufficient to measure Cortisol found in patients with disorders of the adrenal gland. Studies were performed to show the reproducibility, recovery, extraction efficiency, parallelism, effect of potential interferents in urine, and the expected values in normal individuals. The method we use to extract cortisol from urine is accepted and recognized in the literature. The inter-assay precision estimates of 8.6-10.3% CV are typical for an assay that includes a pre-assay organic solvent extraction step. When urine was analytically spiked with known amounts of cortisol. the mean extraction recovery was 102% indicating that the method to extract cortisol from urine is efficient, complete and reproducible. When various quantities of a high and low cortisol sample were mixed, the analytical recovery across the ranges studied showed recoveries of 98 ± 5% (mean ± SD). When urine was diluted after extraction, the linearity/recovery was 99 ± 9% (mean ± SD) across the ranges studied. Potential interference due to protein, urea, creatinine, glucose and sodium chloride were studied, and the data show no observed interference at the pathological concentrations studied. All these studies document the performance characteristics of measuring urine cortisol by this assay.
Submitted By: Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675-4703 (949) 240-5260
Contact Person: Jimmy Wong
Date: December 15, 1998
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Image /page/1/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 5 1999
Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, California 92675-4703
Re: K984520
Trade Name: Nichols Advantage® Chemiluminescence Cortisol Immunoassay Regulatory Class: II Product Code: CGR Dated: December 15, 1998 Received: December 21, 1998
Dear Mr. Wong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Nichols Institute Diagnostics Nichols Advantage® Chemiluminescence Cortisol 510(K) Notification Page 5 of 91
INDICATIONS FOR USE STATEMENT
984520
510(k) NUMBER (If Known): Koozzoo (Cicared -
DEVICE NAME: Nichols Advantage® Chemiluminescence Cortisol Immunoassay
INDICATIONS FOR USE:
1
The Nichols Advantage® Chemiluminescence Cortisol Immunoassay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentration in human serum, EDTA plasma, and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Kan. Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K984520 510(k) Number.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)