(50 days)
For in vitro quantitative measurement of cortisol in human serum, plasma (EDTA or heparin) or urine.
For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of cortisol in human serum, plasma (EDTA or heparin) or urine.
The VITROS Immunodiagnostic Products Cortisol assay is an in vitro quantitative measurement of cortisol in human serum or plasma (EDTA or heparin) or urine. The system is comprised of three main elements: The VITROS Immunodiagnostic Products (Reagent Pass, Calibrators, and Controls), the VITROS Immunodiagnostic System instrumentation, and common reagents used by the VITROS System in each assay.
Acceptance Criteria and Study for VITROS CORTISOL assay (K983990)
This submission describes the VITROS CORTISOL assay which is intended for the in vitro quantitative measurement of cortisol in human serum or plasma (EDTA or heparin) or urine. The study presented aims to demonstrate substantial equivalence to the predicate device, the ABBOTT TDx Cortisol assay.
1. Acceptance Criteria and Reported Device Performance
The provided document details a comparison between the VITROS CORTISOL assay and the predicate device, ABBOTT TDx Cortisol assay, rather than explicit acceptance criteria with pre-defined thresholds. The primary method for demonstrating substantial equivalence was a Deming's Regression analysis and a comparison of analytical characteristics.
| Device Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (VITROS CORTISOL assay) |
|---|---|---|
| Calibration Range | Comparable to predicate (3 - 1655 nmol/L) | 3 - 1700 nmol/L (Comparable to predicate) |
| Basic Principle | Solid phase immunoassay (Same as predicate) | Solid phase immunoassay (Same as predicate) |
| Tracer | No specific numerical criterion, but expected to be effective. | Enzyme labeled (Predicate is Fluorescein labeled - a difference but deemed acceptable) |
| Instrumentation | Immunodiagnostic System (Named Abbott TDx for predicate) | VITROS Immunodiagnostic System (Specific to device) |
| Sample Type | Serum, plasma or urine (Same as predicate) | Serum, plasma (EDTA or heparin) or urine (Same as predicate, with specific anticoagulants mentioned) |
| Antibody | No specific numerical criterion, but expected to be effective. | Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (Predicate uses Mouse monoclonal and Goat polyclonal anti-cortisol antibody reagent) |
| Regression Analysis | Correlation and close agreement with predicate. | VITROS Cortisol assay = 0.83 x Abbott TDx Cortisol assay = 16.1 nmol/L |
| Analytical Performance | Demonstrated analytical sensitivity, specificity, precision, dilution, and expected values comparable to predicate. | Tests were performed to obtain analytical sensitivity, specificity, precision, dilution, and expected values. (Specific results not provided in this summary, but referenced in the package insert). |
Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" rather than pre-defined quantitative acceptance criteria. The performance of the VITROS Cortisol assay, as described by the Deming's Regression and the qualitative comparisons, was deemed sufficiently similar to the predicate to establish equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "samples from a variety of clinical categories" were used for the regression analysis and other performance tests. However, the exact numerical sample size for the test set is not explicitly provided in the summary.
- Data Provenance: The document does not specify the country of origin for the data. The data is stated to be from "patient specimens covering a variety of clinical categories," implying retrospective clinical samples were likely used for method comparison and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This specific study is an in vitro diagnostic device (IVDD) assay for measuring a biochemical analyte (cortisol). The "ground truth" for such assays is typically established by reference methods or comparison to a cleared predicate device, rather than expert human interpretation of images or clinical assessments.
Therefore, the concept of "number of experts used to establish the ground truth" and their "qualifications" as it applies to image-based diagnostics does not apply in the same way to this type of IVDD study. The accuracy of the measured cortisol level itself is the ground truth, assessed through its correlation with the predicate device and other analytical validations.
4. Adjudication Method for the Test Set
Given that this is an IVDD assay for quantitative measurement of cortisol, and the "ground truth" is established by comparison to a predicate device and analytical validation, an "adjudication method" in the context of expert review (e.g., 2+1, 3+1 for imaging studies) is not applicable. The comparison is based on quantitative analytical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic devices where human readers interpret results, such as imaging or pathology, and the AI's role is to assist or replace human interpretation. The VITROS CORTISOL assay is an automated in vitro quantitative measurement system, not a device requiring human interpretation in the same manner. Therefore, the effect size of human readers improving with AI assistance is not relevant or measurable in this context.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in essence. The entire evaluation of the VITROS CORTISOL assay, as described, is a standalone performance assessment of the an algorithm/system only (the immunoassay process and instrumentation). There is no "human-in-the-loop" once the sample is loaded and the assay begins. The performance characteristics (regression, analytical sensitivity, specificity, etc.) are inherent to the device and its reagents operating independently.
7. Type of Ground Truth Used
The "ground truth" for the test set was implicitly established by:
- Comparison to a legally marketed predicate device: The ABBOTT TDx Cortisol assay's measurements served as the primary reference for demonstrating agreement (via Deming's regression).
- Analytical validation: The study also conducted tests to obtain "analytical sensitivity, specificity, precision, dilution and expected values." These analytical performance characteristics, based on established reference materials and methods, contribute to the determination of the assay's accuracy and reliability, forming a scientific basis for its performance.
8. Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. This is common for predicate-based IVDD submissions that rely on established biochemical principles and comparisons rather than machine learning algorithms requiring explicit training data. The development of such an assay involves extensive formulation, reagent optimization, and internal validation, but this is not typically referred to as a "training set" in the same way as for AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of an AI/ML algorithm, the question of how its ground truth was established is not applicable. The "ground truth" for establishing the assay's performance was, as described above, based on comparison with a predicate device and rigorous analytical validation.
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1. Chapter 1 - Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in
t CHP 807 97 100 1000 1000 1000 and 21 CHP 807 92 This summary of STO(L) salety and CHOCHO. 1990 and 21 CFR 807.92
The assigned 510(k) number is: 4983990
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3607
Contact Person: Anne Zavertnik
Date 510(k) prepared: November 6, 1998
2. Device Name
- Device Name Common Name: Cortisol assay Common Name: Corusol assay for the in virro quantitative measurement of cortisol
Classification Name: CORTISOL assay for the in virro quantitative measurement of cortisol Classification Nama (heparin or EDTA) or urine.
3. Predicate Device
- Predicate Device
The VITROS Immunodiagnostic Products Cortisol assay is substantially equivalent to ABBOTT TDx Cortisol assay.
4. Device Description
- Device Description and semi-quantitative determination of selected analytes in human body fluids, commonly and semi-qualifiative technination of verse of the solid phase separation system.
The system is comprised of three main elements:
-
e system is complised of the main creatures (in this case VITROS Immunodiagnostic The VITROS Immunodiagnosa Prosic VITROS Immunodiagnostic Products CORTISOL Products Cortisor Reagent Pass, VITROS of Continent Metabolism Controls, which are Canbiators, and VITROS Immunodiagnostic System to perform the VITROS Cortisol assay).
1-1
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510K Summary, Continued
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated
System of the Children Carmers of Campension System was cleared for The VITROS immunodiagnostic System - Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- The VITROS Immunodiagnostic System instrumentation, which provides automated
-
- Common reagents used by the VITROS System in each assay. The VITROS Common reagents used by the VIS TICS ent, VTTROS Immundiagnostic Products Immunodiagnosus Products of gian Reagents "Products Tigh Sample Diluent B
Universal Wash Reagent and VITROS Immunodiagnostic Hish Sample Dilucy I Universal Wash Reagent and VITROS Immunodiagnostic Products Total T3 510(k) premarket notification (K984310).
- Common reagents used by the VITROS System in each assay. The VITROS Common reagents used by the VIS TICS ent, VTTROS Immundiagnostic Products Immunodiagnosus Products of gian Reagents "Products Tigh Sample Diluent B
The VITROS System and common reagents are dedicated specifically only for use with the The VITROS Uyoton answic Products range of immunoassay products.
5. Device Intended Use
The VITROS CORTISOL assay is intended for the in vitro quantitative measurement of cortisol in human serum or plasma (EDTA or heparin) or urine.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products Cortisol assay is substantially equivalent Abboth The VITROS immunodiagnostic I rocess Corress and over of DA (K854419) for IVD use. =
The relationship between the VITROS Cortisol assay and the predicate device, determined by Deming's Regression, is:
VITROS Cortisol assay = 0.83 x Abbott TDx Cortisol assay = 16.1 nmol/L VITROS Cortisons of the VITROS Cortisol assay and the predicate device were performed with samples from a variety of clinical categories.
In addition to the study mentioned above, tests were performed to obtain analytical sensitivity, spficity, prsion, dilution and expected values. Refer to the VITROS Cortisol assay package insert for VITROS Cortisol assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS CORTISOL assay with the predicate device, Abbott TDX Cortisol assay.
| DeviceCharacteristic | VITROS CORTISOLassay | PredicateDevice |
|---|---|---|
| Calibration range | 3 - 1700 nmol/L | 3- 1655 nmol/L |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Fluorescein labeled |
Table 1 List of the assay characteristics
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510K Summary, Continued
| Table 1 (continued) | ||
|---|---|---|
| DeviceCharacteristic | VITROS CORTISOLassay | PredicateDevice |
|---|---|---|
| Instrumentation | VITROSImmunodiagnostic System | Abbott TDx |
| Sample type | Serum, plasma (EDTA orheparin) or urine | Serum, plasma or urine |
| Antibody | Sheep polyclonal anti-cortisol antibodybiotinylated antibodyreagent. | Mouse monoclonal andGoat polyclonal anti- cortisol antibody reagent. |
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS Cortisol assay performs substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.
The data presented in the premarket notification provide a reasonable assurance that the VITROS Cortisol assay is safe and effective for the stated intended use.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEC 29 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Canal Ponds Rochester, NY 14626-5101
K983990 Re:
R963790
Trade Name: Vitros Immunodiagnostic Products Cortisol Assay Regulatory Class: II Product Code: CGR Dated: December 8, 1998 Received: December 9, 1998
Dear Ms. Zavertnik:
We have reviewed your Section 510(k) notification of intent to market the device esferenced We have reviewed your Security notificals to substantially equivalent (for the indications for above and we nave determined the covices in ed predicate devices marketed in interstate use stated in the enclosure) to logally manacted produced be dedical Device Amendments, commerce prior to May 26, 1770, the characerdance with the provisions of the Federal
or to devices that have been reclassified in accordance with the device, whices to or to devices that have been reclassince in association withing of the devices anbiect to the Food, Drug, and Cosment Act (Act. The general controls provisions of the Act include general collulus provisions of the relises, 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 (Premarket Approval), it may of sucree to ved in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Fars 800 to 695. Tr subscribed in the requirements, as set forth in the Quality System Current Good Manufacturing Provation (21 CFR Part 820) and that, Regulation (QS inspections, the Food and Drug Administration (FDA) will verify such unfough periode QS mspocation, as e e GMP regulation may result in regulatory action. In assumptions. I and o to ish further announcements concerning your device in the Federal addition, I DA may pather farmse 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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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device Under the Clinical Laboratory improvement Annelation of if it does, you should contact
may require a CLLA complexity categorization. To determine if it index.7655. may require a CLIA complexity calogorization (CDC) at (770)488-7655.
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) This letter will allow you to begin mailscang your actively of your device to a
premarket notification. The FDA finding of substantial equivalence of your device to a premarket notification. The FUA industry of substancial equivalence of 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
CFF Partification in the discussion line lausses, please sentest the Office of If you desire specific anyon in your disgustic devices), please contact the Office of
and additionally 809.10 for in 2001 in Hilmolic devices on the promotion and and additionally 809.10 for in vita untile of coussions on the promotions and Compliance at (301) 5944386. Auduction the Office of Compliance at (301) 594-4639.
advertising of your device, please contractive becames as premarket Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CPR 807.97). Other general information on your responsibilities under the notification" (21 CFK 807.77). Other gealited intonation on on Assistance at its toll free Act may be obtained from the DNA of ST or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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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Statement of Intended Use
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| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K 983990 |
| Device Name: | VITROS Immunodiagnostic Products Cortisol Reagent Packsand VITROS Immunodiagnostic Products Cortisol Calibrators. |
| VITROS Immunodiagnostic Products Metabolism Controls | |
| Indications for Use: | For in vitro quantitative measurement of cortisol in humanserum, plasma (EDTA or heparin) or urine. |
| For in vitro use in monitoring the performance of the VITROSImmunodiagnostic System when used for the measurement ofcortisol in human serum, plasma (EDTA or heparin) or urine. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number K983950 | |
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use(Optional Format 1-2-96) |
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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.