(587 days)
Not Found
No
The device description and performance studies describe a standard immunoassay kit for measuring cortisol levels, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in-vitro diagnostic test kit used to measure cortisol levels in saliva, aiding in the diagnosis of Cushing Syndrome and Addison's Disease. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease." This directly indicates its purpose as a diagnostic tool.
No
The device description clearly outlines a physical kit containing a microplate, calibrators, controls, antibodies, and solutions, indicating it is a hardware-based in-vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease." The phrase "in-vitro diagnostic" is a direct indicator.
- Purpose: The device is designed to measure a substance (cortisol) in a sample taken from the human body (saliva) to provide information for the diagnosis and treatment of specific medical conditions (disorders of the adrenal gland, Cushing Syndrome, and Addison's Disease). This aligns perfectly with the definition of an in vitro diagnostic device.
- Device Description: The description details a kit containing reagents and components used to perform a laboratory test on a biological sample.
- Performance Studies: The document includes details of analytical performance studies (precision, linearity, recovery, method comparison, interference) which are typical for IVD devices to demonstrate their analytical validity.
N/A
Intended Use / Indications for Use
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
Product codes (comma separated list FDA assigned to the subject device)
NHG
Device Description
The basis of the Cortisol Enzyme Immunoassay (EIA) is the quantitative relation between ligand concentration and the proportion of Cortisol (analog) enzyme conjugate bound to the antiserum. For example: Cortisol in the calibrators and unknowns compete with Cortisol coupled to peroxidase for antibody binding sites. After incubation, unbound components are washed away. The reaction between Cortisol peroxidase with the substrate (TMB) produces a blue color. The pre-determined time of incubation the reaction is stopped and a yellow color is formed. The optical density (read at 450 nm) is inversely proportional to the cortisol of calibrators, saliva samples and saliva controls.
The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva (human)
Indicated Patient Age Range
The expected reference values were obtained from subjects aged 23-68 years.
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)
I. Analytical Performance
-
a. Precision/Reproducibility
- (i) Intra-assay precision: Determined from 20 replicates of low, medium and high samples.
- Low: Mean 0.627 ng/mL, SD 0.034 ng/mL, %CV 5.4
- Medium: Mean 3.995 ng/mL, SD 0.266 ng/mL, %CV 6.7
- High: Mean 25.232 ng/mL, SD 1.579 ng/mL, %CV 6.3
- (ii) Inter-assay precision: Determined from the mean of average duplicates for twelve (12) separate assays.
- Low: Mean 0.587 ng/mL, SD 0.037 ng/mL, %CV 6.3
- Medium: Mean 4.163 ng/mL, SD 0.301 ng/mL, %CV 7.2
- High: Mean 25.126 ng/mL, SD 0.712 ng/mL, %CV 2.8
- (iii) Inter-lot or between-lot variation: Determined by duplicate measurements of five (5) pools of saliva samples and three (3) saliva controls using three (3) different lots. Concluded a %CV of ≤10% for each sample tested.
- (iv) Repeatability: Conducted over 20 days of testing with 2 assays performed daily. Used 3 different reagent lots and 3 saliva pools (low, medium, high concentration).
- Low Concentration: Concentration 0.600 ng/ml, SD 0.0141. Total Device Precision: SD 0.0538, %CV 9.09.
- Medium Concentration: Concentration 4.0 ng/ml, SD 0.0894. Total Device Precision: SD 0.1869, %CV 4.56.
- High Concentration: Concentration 25 ng/ml, SD 0.5477. Total Device Precision: SD 0.8185, %CV 3.24.
- (i) Intra-assay precision: Determined from 20 replicates of low, medium and high samples.
-
b. Linearity
- Ten (10) sample concentrations spanning the assay measuring range were performed per EP6-A. Recoveries ranged from 93.0% to 101.4%.
-
c. Recovery
- Ten (10) saliva samples with endogenous cortisol were spiked with known quantities of cortisol and assayed. Recoveries ranged from 93.7% to 103.9%.
-
d. Traceability/Reagent Stability/Sample Stability/Expected Values
- Calibrators and controls traced to NIST cortisol.
- Reagents stored at 2-8°C are stable for 9 months. Opened vial and working Cortisol-HRP Conjugate solution are stable for 31 days at 2-8°C.
- Sample stability:
- Room Temperature (20-30°C): Up to 7 days
- 37°C: Up to 7 days
- 2-8°C: Up to 7 days
§ 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
K102841 510(k) Summary
| Submitted By: | Pantex, Division of Bio-Analysis, Inc.
1701 Berkeley Street
Santa Monica, CA 90404
USA
(310) 828-7423 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Romulo Garza, Ph.D., President/Senior Scientist |
| Date Summary Prepared: | 4-3-12 |
| Trade Name: | Pantex AM/PM Salivary Cortisol EIA Kit |
| Common Name: | Enzyme immunoassay, cortisol, salivary |
| Regulation Number and Panel: | 862.1205-Clinical Chemistry |
| Classification Product Code: | NHG |
| Classification: | Class II |
| Substantially Equivalent Device: | K011323 Salimetrics HS Salivary Cortisol EIA
Kit Item No. 1-3102 (single) 96 well kit |
| Device Description: | |
A. Test principle.
The basis of the Cortisol Enzyme Immunoassay (EIA) is the quantitative relation between ligand concentration and the proportion of Cortisol (analog) enzyme conjugate bound to the antiserum. For example: Cortisol in the calibrators and unknowns compete with Cortisol coupled to peroxidase for antibody binding sites. After incubation, unbound components are washed away. The reaction between Cortisol peroxidase with the substrate (TMB) produces a blue color. The pre-determined time of incubation the reaction is stopped and a yellow color is formed. The optical density (read at 450 nm) is inversely proportional to the cortisol of calibrators, saliva samples and saliva controls.
B. Kit Description.
The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.
C. Intended Use/Indications for Use:
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
Predicate Device:
The predicate device for substantial equivalence in this submission is:
1
| Device Name | Salimetrics Salivary Cortisol HS EIA Kit |
|---|---|
| Company | Salimetrics |
| 510(k) reference | K011323 |
Technology Comparison:
| Predicate Device: | New Device: | |
|---|---|---|
| Salimetrics Salivary Cortisol HS | ||
| EIA Kit | ||
| (K011323) | Pantex AM/PM Salivary | |
| Cortisol EIA Kit | ||
| (K102841) pending | ||
| Indications for use | For the in-vitro diagnostic | |
| quantitative determination of free | ||
| and protein bound salivary | ||
| cortisol in human saliva as an aid | ||
| in the assessment of Cushing | ||
| Syndrome and Addison's Disease. | ||
| Measurement s of cortisol in | ||
| saliva are used in the diagnosis | ||
| and treatment of disorders of the | ||
| adrenal gland. | For the in-vitro diagnostic | |
| quantitative determination of | ||
| free and protein bound | ||
| salivary cortisol in human | ||
| saliva as an aid in the | ||
| assessment of Cushing | ||
| Syndrome and Addison's | ||
| Disease. | ||
| Measurement s of cortisol in | ||
| saliva are used in the diagnosis | ||
| and treatment of disorders of | ||
| the adrenal gland. | ||
| Analyte | Free and Protein-bound | |
| Cortisol | Free and Protein-bound | |
| Cortisol | ||
| Sample Type | Saliva | Saliva |
| Method | Enzyme immunoassay | Enzyme immunoassay |
| Detection Method | Colormetric microplate reader | Colormetric microplate reader |
| Test Principle | Cortisol in the sample competes | |
| with Cortisol-enzyme conjugate | ||
| for binding sites to antibody | ||
| bound to a microwell. Unbound | ||
| components are washed away and | ||
| enzyme is measured by a colored | ||
| reaction with the TMB substrate. | Cortisol in the sample | |
| competes with cortisol- | ||
| enzyme conjugate for binding | ||
| sites to the antibody (rabbit | ||
| anti cortisol) bound to a | ||
| GARGG microplate. | ||
| Unbound components are | ||
| washed away and enzyme is | ||
| measured by a colored | ||
| reaction with the TMB | ||
| substrate. | ||
| Calculations | Quantitative determination | |
| with standard curve | Quantitative determination | |
| with standard curve | ||
| Quality Control | Use of reference controls is | |
| recommended | Use of reference controls is | |
| recommended | ||
| Analytical Measuring | ||
| Range (AMR) | 0.12 ng/ml - 30.0 ng/ml | 0.1 ng/ml - 30.0 ng/ml |
| Expected Values | ||
| (Normal range) | N=192 | |
| Ages: 18-70 | ||
| AM range: 0.8 - 15.5 ng/ml | ||
| PM range: II) | No | |
| Claim Accepted (I Yes |
4
| Precision Low Concentration Pool | ||
|---|---|---|
| Standard Deviation, SD) | (% Coefficient of Variation CV) | |
| Within Run | 0.0224 | 3.79 |
| Between Run | 0.0462 | 7.80 |
| Repeatability | 0.0162 | 2.73 |
| Total Device Precision | 0.0538 | 9.09 |
.
and the comments of the comments of the comments of
| Repeatability Medium Concentration | |
|---|---|
| Concentration (ng/ml) | 4.0 ng/ml |
| Standard Deviation | 0.0894 |
| (I) (User Variance/Claim Variance) x R | 63.073 |
| (II) Critical Chi-square | 65.171 |
| Claim Rejected (I>II) | No |
| Claim Accepted (I Yes |
| Precision Medium Concentration Pool | ||
|---|---|---|
| Standard Deviation, SD) | (% Coefficient of Variation CV) | |
| Within Run | 0.1475 | 3.60 |
| Between Run | 0.0514 | 1.26 |
| Repeatability | 0.1025 | 2.50 |
| Total Device Precision | 0.1869 | 4.56 |
| Repeatability High Concentration | |
|---|---|
| Concentration (ng/ml) | 25 ng/ml |
| Standard Deviation | 0.5477 |
| (I) (User Variance/Claim Variance) x R | 62.035 |
| (II) Critical Chi-square | 65.171 |
| Claim Rejected (I>II) | No |
| Claim Accepted (I Yes |
| Precision High Concentration Pool | ||
|---|---|---|
| Standard Deviation, SD | (% Coefficient of Variation CV) | |
| Within Run | 0.4442 | 1.176 |
| Between Run | 0.2915 | 1.15 |
| Repeatability | 0.62276 | 2.46 |
| Total Device Precision | 0.8185 | 3.24 |
.
5
b. Linearity
Ten (10) sample concentrations that span the assay measuring range were performed Per EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures.
S=10 samples (dilutions) Concentration = (C1V1+C10V10)/(V1+V10)
| | C1
ng/ml | V1
ng/ml | C10
ng/ml | V10
ng/ml | Calculated
Concentration
ng/ml | Obtained
Concentration
ng/ml | Recovery
% |
|----|-------------|-------------|--------------|--------------|--------------------------------------|------------------------------------|---------------|
| 1 | 0.093 | * | | | 0.100 | 0.093 | 93.0 |
| 2 | 0.093 | 0.889 | 33.788 | 0.111 | 3.833 | 3.729 | 97.3 |
| 3 | 0.093 | 0.778 | 33.788 | 0.222 | 7.573 | 7.620 | 100.6 |
| 4 | 0.093 | 0.667 | 33.788 | 0.333 | 11.313 | 10.842 | 95.8 |
| 5 | 0.093 | 0.556 | 33.788 | 0.444 | 15.054 | 14.350 | 95.3 |
| 6 | 0.093 | 0.444 | 33.788 | 0.556 | 18.827 | 18.313 | 97.3 |
| 7 | 0.093 | 0.333 | 33.788 | 0.667 | 22.568 | 21.547 | 95.5 |
| 8 | 0.093 | 0.222 | 33.788 | 0.778 | 26.308 | 24.694 | 93.9 |
| 9 | 0.093 | 0.111 | 33.788 | 0.889 | 30.048 | 30.459 | 101.4 |
| 10 | | | | * | 35.000 | 33.788 | 96.5 |
*Targets of low and high sample concentrations
c. Recovery:
Ten (10) saliva samples containing different levels of endogenous cortisol were spiked with known quantities of cortisol and assayed.
| Sample | Endogenous
(ng/ml) | Added
(ng/ml) | Expected
(ng/ml) | Observed
(ng/ml) | Recovery
(%) |
|--------|-----------------------|------------------|---------------------|---------------------|-----------------|
| 1 | 0.493 | 0.250 | 0.743 | 0.739 | 99.5 |
| 2 | 0.878 | 0.500 | 1.378 | 1.291 | 93.7 |
| 3 | 1.551 | 1.000 | 2.551 | 2.641 | 103.5 |
| 4 | 1.850 | 2.000 | 3.850 | 3.958 | 102.8 |
| 5 | 0.936 | 4.000 | 4.936 | 4.951 | 100.3 |
| 6 | 1.042 | 8.000 | 9.042 | 9.394 | 103.9 |
| 7 | 0.691 | 16.000 | 16.691 | 17.165 | 102.8 |
| 8 | 0.622 | 20.000 | 20.622 | 19.997 | 97.0 |
| 9 | 2.057 | 24.000 | 26.057 | 24.938 | 95.7 |
| 10 | 0.348 | 28.000 | 28.348 | 28.943 | 102.1 |
d. Traceability/Reagent Stability/Sample Stability/Expected Values
The calibrators and controls are prepared from stock cortisol (Steraloids) and are gravimetrically weighed and prepared. Concentration of stock cortisol (Steraloids) concentrations were confirmed by comparison to NIST cortisol (y=1.029 x-0.2195. R20.9924)
6
Summary of the stability results
Real time stability studies are conducted to determine the reagent and kit shelf life (expiration date). Expiration date of the Pantex AM/PM Salivary Cortisol EIA Kit. Cat 631, is determined by results of shelf life studies and is based on the reagent that has the shorter assigned expiration day.
-
- The reagents stored at 2-8°C are stable for 9 months; therefore, the expiration date of the kit components is established at 9 months from the manufacturing date. We are basing the 9 month stability claim based on the results obtained with the real time stability study when stored at 2-8°C, supported by the reagents stored at room temperature (20 -28°C) and in reference to the stress chart that predicts reagents year stability at +5℃, by Kennon, L. "Use of models in determining chemical pharmaceutical stability".
Sample stability
| 1 ปี 1 ปี 2017 คนนิสเทคร กิน ที่ 11 ของแล้ว ค.ศ. 2017 ค.ศ. 2010 พ.ศ. 25 เมตร พ.ศ. 2010 พ.ศ. 25 | ||||||
|---|---|---|---|---|---|---|
| Storage | Room | 37 °C | 2-8 °C | 10% cross reaction prednisolone is a potential interfering substance. |
8
- II. Method Comparison Studies
Tests were conducted for comparison between the Pantex AM/PM Salivary Cortisol EIA Kit, Cat and the predicate assay , Salimetrics HS Salivary Cortisol results of 160 samples were compared . Comparison of the Pantex AM/PM Salivary Cortisol EIA Kit (new device) and the Salimetrics HS Salivary Cortisol EIA (predicate) demonstrated acceptable regression and correlation statistics and appears to be substantially equivalent to the FDA cleared predicate device.
| Pantex AM/PM Salivary Cortisol EIA versus Salimetrics HS Salivary Cortisol EIA | |
|---|---|
| Linear Regression equation | $Y = 1.0269x + 0.0994$ |
| Correlation (r²) | 0.9797 |
III. Interferences Studies.
An in-vitro experiment was performed by spiking three (3) levels of Cortisol (low, medium and high) with high concentrations of five (5) potentially interfering substances: alcohol, coffee (as caffeine), cigarette (as nicotine) and food and gum extracts. The results obtained appear to demonstrate no significant interference of the substances tested in this study with the measurement of Cortisol in saliva using the Pantex AM/PM Salivary Cortisol EIA Kit, Cat #631.
In-vitro experiment results:
| Pools | Potential Interferent Caffeine Added (ug/mL) | Obtained Value (ng/mL) | Recovery from Control (%) |
|---|---|---|---|
| Low Pool | 0 | 1.420 | 100 |
| Low Pool | 800 | 1.444 | 101.7 |
| Low Pool | 400 | 1.438 | 101.3 |
| Low Pool | 200 | 1.477 | 104.0 |
| Middle Pool | 0 | 4.932 | 100 |
| Middle Pool | 800 | 5.143 | 104.3 |
| Middle Pool | 400 | 5.063 | 102.7 |
| Middle Pool | 200 | 4.539 | 92.0 |
| High Pool | 0 | 28.302 | 100 |
| High Pool | 800 | 26.010 | 91.9 |
| High Pool | 400 | 26.811 | 94.7 |
| High Pool | 200 | 27.563 | 97.4 |
9
| Pools | Potential Interferent
Food Added
(mg/mL) | Obtained Value
(ng/mL) | Recovery from
Control
(%) |
|-------------|------------------------------------------------|---------------------------|---------------------------------|
| Low Pool | 0.000 | 1.345 | 100 |
| | 426 | 1.340 | 99.6 |
| | 213 | 1.332 | 99.0 |
| | 106.5 | 1.291 | 96.0 |
| Middle Pool | 0.000 | 4.739 | 100 |
| | 426 | 4.730 | 99.8 |
| | 213 | 4.834 | 102.0 |
| | 106.5 | 4.835 | 102.0 |
| High Pool | 0.000 | 26.447 | 100 |
| | 426 | 27.495 | 104.0 |
| | 213 | 26.283 | 99.4 |
| | 106.5 | 28.055 | 106.1 |
| Pools | Potential Interferent NicotineAdded (ug/mL) | Obtained Value (ng/mL) | Recovery from Control (%) |
|---|---|---|---|
| Low Pool | 0 | 1.362 | 100 |
| 800 | 1.436 | 101.7 | |
| 600 | 1.437 | 101.3 | |
| 400 | 1.4345 | 104.0 | |
| 200 | 1.317 | 96.7 | |
| Middle Pool | 0 | 4.871 | 100 |
| 800 | 5.243 | 107.6 | |
| 600 | 5.258 | 107.9 | |
| 400 | 5.087 | 104.4 | |
| 200 | 5.155 | 105.8 | |
| High Pool | 0 | 25.503 | 100 |
| 800 | 27.033 | 106.0 | |
| 600 | 26.397 | 103.5 | |
| 400 | 25.642 | 100.6 | |
| 200 | 24.928 | 97.8 |
.
.
·
·
10
| Pools | Potential Interferent
Gum Added
(mg/mL) | Obtained Value
(ng/mL) | Recovery from
Control
(%) |
|-------------|-----------------------------------------------|---------------------------|---------------------------------|
| Low Pool | 0 | 1.289 | 100 |
| | 270 | 1.346 | 104.4 |
| | 135 | 1.286 | 99.8 |
| | 67.5 | 1.248 | 96.8 |
| | 33.75 | 1.280 | 99.3 |
| Middle Pool | 0 | 4.843 | 100 |
| | 270 | 4.957 | 102.4 |
| | 135 | 4.845 | 100 |
| | 67.5 | 4.712 | 97.3 |
| | 33.75 | 4.764 | 98.4 |
| High Pool | 0 | 28.367 | 100 |
| | 270 | 29.419 | 103.7 |
| | 135 | 29.247 | 103.1 |
| | 67.5 | 27.870 | 98.3 |
| | 33.75 | 28.216 | 99.5 |
| Pools | Potential Interferent
Ethanol Added
(%) | Obtained Value
(ng/mL) | Recovery from
Control
(%) |
|-------------|-----------------------------------------------|---------------------------|---------------------------------|
| Low Pool | 0 | 1.268 | 100 |
| | 0.025 | 1.267 | 104.4 |
| | 0.050 | 1.230 | 99.8 |
| | 0.100 | 1.213 | 96.8 |
| Middle Pool | 0 | 4.539 | 100 |
| | 0.025 | 4.403 | 102.4 |
| | 0.050 | 4.320 | 100 |
| | 0.100 | 4.490 | 97.3 |
| High Pool | 0 | 26.272 | 100 |
| | 0.025 | 28.362 | 108.0 |
| | 0.050 | 28.744 | 109.4 |
| | 0.100 | 28.750 | 109.4 |
Concluding Statement:
Taken together, the performance characteristics, comparison studies with a predicate device and acceptable statistical performance studies in this 510(k) submission demonstrates that the Pantex AM/PM Salivary Cortisol EIA Kit, Cat #631, is safe and effective for its intended use and is substantially equivalent to the predicate device.
11
Image /page/11/Picture/0 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 an image of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Pantex, Division of Bio-Analysis, Inc c/o Romulo Garza 1701 Berkeley Street Santa Monica, CA 90404
MAY - 8 2012
Re: K102841 ·
Trade Name: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay Regulation Number: 21 CFR §862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Codes: NHG Dated: April 3, 2012 Received: May 2, 2012
Dear Dr. Garza:
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 (1 wr 1), it 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
12
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 Jou ability of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
N.
Steven H. Liao, Ph.D.
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
13
Indications for Use
K102841 510(k) Number (if known):
Device Name: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay
Indications For Use:
For the in-vitto diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
× Prescription Use (21 CFR Part 801 Subpart D) .
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Ruto Chem
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 102841
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