(60 days)
Not Found
No
The device description details a standard immunoassay kit and analysis method based on optical density readings and a standard curve, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) measurement kit used to quantitatively measure salivary cortisol for diagnostic purposes (e.g., screening for Cushing's and Addison's disease), not to provide treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is "specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol" and "may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease".
No
The device is a laboratory-based immunoassay kit consisting of physical components (microtitre plate, calibrators, controls, reagents) used to measure salivary cortisol. It requires a standard plate reader for optical density readings, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states: "Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol." This is the most direct indicator.
- Measurement of a Biomarker: The device measures the amount of cortisol in a biological sample (saliva).
- Diagnostic Purpose: The intended use includes measuring adrenal cortical function and screening for Cushing's and Addison's disease, which are diagnostic purposes.
- Use with Biological Samples: The device is designed to be used with saliva samples, which are biological specimens.
- Device Description: The description details a laboratory-based assay (microtitre plate, reagents, plate reader) used to analyze a biological sample.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.
Product codes
NHG
Device Description
Test Principle- A microtitre plate is coated with rabbit antibodies to cortisol. Cortisol in standards and unknowns compete with cortisol linked to horseradish peroxidase for the antibody binding sites. After incubation, unbound components are washed away. Bound cortisol peroxidase is measured by the reaction of the peroxidase enzyme on the substrate tetramethylbenzidine (TMB). This reaction produces a blue color. A vellow color is formed after stopping the reaction with sulfuric acid. Optical density is read on a standard plate reader at 450 nm. The amount of cortisol peroxidase detected is inversely proportional to the amount of cortisol present. The optical density readings of the calibrators are used to form a standard curve to which the optical densities of the controls and samples are compared.
Kit Description- The kit consists of an antibody coated 96 well plate, six calibrators at a concentration of 1.800, 0.600, 0.200, 0.067. 0.022, and 0.007 µg/dL of NIST(National Institute of Standards and Technology) cortisol, two controls representing a high (1.00 ug/dL) and low (0.100 ug/dL) level of salivary cortisol, the enzyme conjugate (1600X concentrate), assay diluent containing a pH indicator, wash buffer(10X concentrate), tetramethylbenzidine substrate solution, stop solution, and kit insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Intra-assay precision was determined from the mean of 12 replicates.
Inter-assay precision was determined from the mean of average duplicates for 12 separate runs.
Sensitivity: The lower limit of sensitivity was determined by interpolating the mean minus 2 standard deviations for 10 sets of duplicates at 0 ug/dL standard. The minimal concentration of cortisol that can be distinguished from 0 is
§ 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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JUN 1 0 2003
Image /page/0/Picture/2 description: The image shows the logo for "SALIMETRICS LLC". The logo is black with white text. To the left of the text is a grid of nine dots, arranged in a 3x3 pattern.
PO Box 395 • State College PA 16801-0395 • 814.234.7748 • Fax 814.234.1608 www.salimetrics.com
Summary of Safety and Effectiveness
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 K011323.
I. General Information
Submitter:
Eve Schwartz Salimetrics, LCC 101 Innovation Blvd. Suite 302 State College, Pa. 16803 P (814)234-7748 F (814)234-1608
Date of 510(k) preparation:
| Device Trade Name: | HS(high sensitivity) Salivary Cortisol Enzyme
Immunoassay |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic Name: | Immunoassay for the in vitro quantitative determination
of cortisol in saliva |
| Predicate Device: | The HS Salivary Cortisol EIA is substantially
equivalent to the Diagnostic Systems Laboratory Active
Cortisol EIA, which was approved by FDA (K850141)
for IVD use. |
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VI. Intended Use
Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. Saliva values may be converted into serum values using the equation y(serum ug/dL)= 5.177+15.132x(saliva ug/dL). This kit is not intended for use with serum or plasma samples.
III. Device Description
Test Principle- A microtitre plate is coated with rabbit antibodies to cortisol. Cortisol in standards and unknowns compete with cortisol linked to horseradish peroxidase for the antibody binding sites. After incubation, unbound components are washed away. Bound cortisol peroxidase is measured by the reaction of the peroxidase enzyme on the substrate tetramethylbenzidine (TMB). This reaction produces a blue color. A vellow color is formed after stopping the reaction with sulfuric acid. Optical density is read on a standard plate reader at 450 nm. The amount of cortisol peroxidase detected is inversely proportional to the amount of cortisol present. The optical density readings of the calibrators are used to form a standard curve to which the optical densities of the controls and samples are compared.
Kit Description- The kit consists of an antibody coated 96 well plate, six calibrators at a concentration of 1.800, 0.600, 0.200, 0.067. 0.022, and 0.007 µg/dL of NIST(National Institute of Standards and Technology) cortisol, two controls representing a high (1.00 ug/dL) and low (0.100 ug/dL) level of salivary cortisol, the enzyme conjugate (1600X concentrate), assay diluent containing a pH indicator, wash buffer(10X concentrate), tetramethylbenzidine substrate solution, stop solution, and kit insert.
IV. Prior Marketing History
The HS Salivary Cortisol EIA has been sold as a research tool since November of 1998. The device was cleared for diagnostic use in December of 2001 and afterwards marketed as such. There have been no withdrawals of this device from any country related to safety and effectiveness.
VII. Contraindications, Warnings and Precautions
- . This kit is designed to measure cortisol levels in saliva and should not be used to measure serum or plasma levels.
- . A pH value should be obtained on samples that appear vellow or purple after assay diluent is added and the plate is mixed. Samples with pH values > than 9 or 3 and dfbeta > 1 (N = 3) were removed to minimize influential observations.
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Since both serum (skew = 1.325) and saliva (skew = 1.793) are skewed, after taking a log transformation, the R2 was only slightly reduced, with logged saliva explaining 74.7% of the variance in logged serum, E(1,63) = 185.530, p Trade/Device Name: HS Salivary Cortisol Enzyme Immunoassay Kit Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: NHG Dated: May 28, 2003 Received: May 30, 2003
Dear Ms. Schwartz:
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 (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 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/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/10/Picture/0 description: The image shows the logo for Salimetrics LLC. The logo is black with white text. The text is "SALIMETRICS LLC" in all caps. There are white dots on the left side of the logo.
PO Rox 395 · State College PA 16801-0395 814 234 7748 · Fax 814 234 1608
INDICATIONS FOR USE STATEMENT
510(k) number: K011323
Device Name: _ HS Salivary Cortisol Enzyme Immunoassay Kit
Indications for Use:
Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.
Stan Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031348
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
Over-the-Counter Use