(71 days)
For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers - for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
The IMMULITE/IMMULITE® 1000 Cortisol assay is comprised of the following components: Cortisol Test Unit (solid phase) - 1 bead/Test unit, Polyclonal rabbit anti-cortisol antibody. Cortisol Reagent Wedge (liquid phase) - 7.5 mL, Alkaline phosphatase (bovine calf intestine) conjugated to cortisol in buffer, with preservative. Cortisol Adjustors (Low and High) - 3 mL, Cortisol in processed human serum, with preservative.
The document describes the performance characteristics of the IMMULITE/IMMULITE® 1000 Cortisol assay, which is an in vitro diagnostic device. This device measures cortisol in serum to aid in the clinical assessment of adrenal status. The submission is for a modified device with a new supplier for the antibody, maintaining the same intended use.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table labeled "acceptance criteria." Instead, it describes performance characteristics that were evaluated to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion for each characteristic is that the performance of the modified device should be comparable to or within acceptable limits of the predicate device, or meet established clinical laboratory standards (e.g., CLSI guidelines).
Here's a table based on the provided "Performance Characteristics" section, showing the evaluated parameters and their reported outcomes:
| Performance Characteristic | Acceptance Criteria (Implied / Defined by Standard) | Reported Device Performance |
|---|---|---|
| Detection Limits | Defined by CLSI EP17-A2 standards | LoB: 0.008 µg/dL (0.22 nmol/L) LoD: 0.053 µg/dL (1.46 nmol/L) LoQ: 0.2 µg/dL (5.52 nmol/L) Reportable range: 1-50 µg/dL (28-1380 nmol/L) |
| Linearity | Defined by CLSI EP06-A standards | Linear from 0.18 - 50.98 µg/dL. Linearity information in IFU unchanged from K931409 (predicate). |
| Repeatability & Within-Lab Precision | Unchanged from K931409 (predicate) | Repeatability and within-lab precision information in IFU unchanged from K931409. |
| Spike Recovery | Unchanged from K931409 (predicate) | Spike recovery information in IFU unchanged from K931409. |
| Method Comparison (vs. Predicate) | High correlation and acceptable agreement with predicate device (regression equation, r-value). | N=152 patient samples Range: 2.01 – 48.3 µg/dL Regression equation: IMM 1000 (modified) = 0.951 * IMMULITE 1000 commercial (predicate) - 0.155 µg/dL. r=0.991 |
| Specificity (Cross-Reactivity) | % Cross-Reactivity should be within acceptable limits for various compounds. | A detailed table of compounds tested and their % Cross-Reactivity, with most showing "ND" (Not Detected) or very low percentages (e.g., Corticosterone 0.92%, Cortisone 1.77%, Methylprednisolone 1.12%, Prednisolone 16.01%, Allotetrahydrocortisol 2.06%). |
| Interference | % Recovery should be within acceptable limits in the presence of interfering substances. | Biotin: 96.0% observed mean % recovery at 3500ng/mL. Interference information for Bilirubin, Hemolysis, and Lipemia in IFU unchanged from K931409. |
2. Sample size used for the test set and the data provenance:
- Detection Limits (LoB, LoD, LoQ): The sample sizes are not explicitly stated for the determination of LoB, LoD, and LoQ, but these are typically determined using multiple replicates of blank and low-concentration samples. The study was conducted in accordance with CLSI EP17-A2.
- Linearity: The study involved combining a high human serum pool with a low human serum pool to create 9 levels of dilutions. The number of individual samples within these pools is not specified. The provenance is "human serum."
- Method Comparison:
- Sample Size: A total of 152 native patient samples.
- Data Provenance: "native patient samples," indicating human origin. The country of origin is not specified, but the applicant's address is in the UK. The study was retrospective or prospective is not explicitly stated, but "patient samples" typically implies retrospectively collected samples for this type of comparison study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is an in vitro diagnostic (IVD) assay measuring a biomarker (cortisol). The "ground truth" for such devices is established by reference methods or validated higher-order methods, not typically by expert human interpretation (like in imaging AI).
- For Method Comparison, the ground truth is simply the measurement obtained from the predicate device (unmodified IMMULITE 1000 Cortisol Assay), which is presumed to be the accepted standard. No human experts are used for ground truth establishment in this context.
- For Detection Limits, Linearity, Specificity, and Interference, the ground truth is based on the precise preparation of known concentrations of analytes, cross-reactants, or interfering substances, and comparison to the assay's ability to accurately measure them. This does not involve expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As an IVD assay measuring a quantitative biomarker, adjudication by human experts is not part of the ground truth establishment or performance evaluation process. The measurements are objective.
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 is not an AI-assisted diagnostic imaging device for human interpretation, but rather an automated in vitro diagnostic assay measuring a chemical compound. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the performance characteristics described are indeed standalone performance of the device (IMMULITE/IMMULITE® 1000 Cortisol assay) itself. It evaluates the accuracy, precision, limits, and specificity of the biochemical measurement system, without human involvement in the direct measurement or interpretation of the assay's output for diagnostic purposes in the study. The human role is in operating the instrument and interpreting the numerical result in the clinical context, but the study focuses on the analytical performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used for this IVD device is primarily:
- Reference measurements/Predicate device measurements: For the method comparison study, the measurements from the legally marketed predicate device (IMMULITE/IMMULITE® 1000 Cortisol, K931409) serve as the reference or "ground truth" for comparison.
- Prepared known concentrations: For studies like linearity, detection limits, specificity (cross-reactivity), and interference, the ground truth is established by preparing samples with precisely known concentrations of the analyte, cross-reactants, or interfering substances.
- Standardized methods/guidelines: Compliance with CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP17-A2, EP06-A, EP09c, EP07) implies that the ground truth methodology follows accepted laboratory standards for analytical performance.
8. The sample size for the training set:
Not applicable. This document describes a traditional in vitro diagnostic immunoassay, not a machine learning or artificial intelligence algorithm that requires a "training set." The development of such assays involves chemical and biological optimization, not data-driven model training.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of device.
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January 15, 2021
Siemens Healthcare Diagnostics Products Ltd. Malgorzata Robak Regulatory Affairs Supervisor Glyn Rhonwy. Llanberis Caernarfon, Gwynedd LL55 4EL UK
Re: K203270
Trade/Device Name: IMMULITE/IMMULITE® 1000 Cortisol Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (Hydrocortisone And Hydroxycorticosterone) Test System Regulatory Class: Class II Product Code: CGR Dated: November 3, 2020 Received: November 5, 2020
Dear Malgorzata Robak:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203270
Device Name IMMULITE/IMMULITE® 1000 Cortisol
Indications for Use (Describe)
For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers - for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness for IMMULITE/IMMULITE® 1000 Cortisol
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.
- A. 510(k) Number:_k203270
- B. Purpose of the Submission Modified Device - new supplier of the antibody
- C. Applicant:
| Contact: | Malgorzata Robak |
|---|---|
| Regulatory Affairs Supervisor | |
| Address: | Siemens Healthcare Diagnostics Products Limited |
| Glyn Rhonwy | |
| Llanberis, Caernarfon | |
| LL55 4EL | |
| United Kingdom | |
| Phone: | +44 7921 882559 |
| E-mail: | malgorzata.robak@siemens-healthineers.com |
| Date: | January 8, 2021 |
D. Proprietary and Established Name:
IMMULITE/IMMULITE® 1000 Cortisol
E. Measurand
Cortisol
F. Regulatory Information
| Trade Name: | IMMULITE/IMMULITE® 1000 Cortisol |
|---|---|
| Common Name: | Chemiluminescence Immunoassay, for thedetermination of Cortisol |
| Classification Name: | Cortisol Test System |
| FDA Classification: | Class II |
| Review Panel: | Clinical Chemistry |
| Product Code: | CRG |
| Regulation Number: | 21 CFR 862.1205 |
G. Predicate Device:
Device Name: IMMULITE/IMMULITE® 1000 Cortisol
510(k) Number: K931409
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Healthine
H. Intended Use:
Same as Indication for Use
-Indications for Use:
For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers - for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
J. Special Conditions for Use statement(s):
For Prescription Use Only
K. Special Instrument Requirements
For use with IMMULITE/IMMULITE® 1000
L. Device Description
The IMMULITE/IMMULITE® 1000 Cortisol assay is comprised of the following components:
| Component | Volume | Ingredients |
|---|---|---|
| Cortisol Test Unit(solid phase) | 1 bead/Test unit | Polyclonal rabbit anti-cortisol antibody. |
| Cortisol ReagentWedge (liquidphase) | 7.5 mL | Alkaline phosphatase (bovine calfintestine) conjugated to cortisol in buffer,with preservative. |
| Cortisol Adjustors(Low and High) | 3 mL | Cortisol in processed human serum, withpreservative. |
M. Substantial Equivalence Information
The following table demonstrates substantial equivalence between the IMMULITE/IMMULITE® 1000 Cortisol (Candidate Device) with an antibody from a new supplier and the currently marketed IMMULITE/IMMULITE® 1000 Cortisol (Predicate Device) that was cleared under 510 (k) K931409.
| Trade name | Candidate Device (Modified)IMMULITE/IMMULITE®1000 Cortisol | Predicate device(Unmodified)IMMULITE/IMMULITE®1000 Cortisol |
|---|---|---|
| Intended Use | For in vitro diagnostic usewith the IMMULITE® andIMMULITE 1000 Analyzers— for the quantitativemeasurement of cortisol(hydrocortisone, CompoundF) in serum, as an aid in theclinical assessment ofadrenal status. | For in vitro diagnostic usewith the IMMULITE® andIMMULITE 1000 Analyzers— for the quantitativemeasurement of cortisol(hydrocortisone, CompoundF) in serum, as an aid in theclinical assessment ofadrenal status. |
| Analyte | Cortisol | Same |
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| Trade name | Candidate Device (Modified)IMMULITE/IMMULITE®1000 Cortisol | Predicate device(Unmodified)IMMULITE/IMMULITE®1000 Cortisol |
|---|---|---|
| Automated | Automated Assay | Same |
| Measurement | Quantitative | Same |
| Sample Type | Human serum | Same |
| DetectionLimit | LoB: 0.008µg/dL(0.22nmol/L)LoD: 0.053µg/dL(1.46nmol/L)LoQ: 0.2µg/dL(5.52nmol/L) | Analytical Sensitivity: 0.20 µg/dL (5.5 nmol/L)Not ApplicableNot Applicable |
| CalibrationRange | 1-50 µg/dL (28 to 1380nmol/L) | Same |
| OperatingPrinciple | Competitive | Same |
| Technology | Chemiluminescent enzymeimmunoassay | Same |
| Instrument | IMMULITE/MMULITE 1000 | Same |
| SampleVolume | 10 μL | 10 μL |
| Calibrator | Two levels (low & high)cortisol adjustor | Same |
| Controls | Commercial | Commercial |
| DetectionEnzymeconjugate | Alkaline phosphatase(bovine calf intestine)conjugated to cortisol | Same |
| CaptureAntibody | Polyclonal rabbit anti-cortisol | Same |
N. Test Principle
IMMULITE/IMMULITE 1000 Cortisol is a solid-phase, enzyme-labeled chemiluminescent competitive immunoassay. The solid phase (bead) is coated with polyclonal rabbit anti-cortisol antibody. The liquid phase consists of alkaline phosphatase (bovine calf intestine) conjugated to cortisol. The patient sample and the reagent are incubated together with the coated bead for 30 minutes. During this time, cortisol in the sample competes with enzyme-conjugated cortisol in the reagent for a limited number of antibody binding sites on the bead. Unbound patient sample and enzyme conjugate are then removed by centrifugal washes. Finally, chemiluminescent substrate is added to the test unit containing the bead and the signal is generated inversely proportion to the bound enzyme.
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O. Performance Characteristics
The assay principle, design and reagent formulation has not changed from the original device. Substantial equivalence was demonstrated by testing several performance characteristics including detection limits, linearity, precision, spike recovery, method comparison, interfering and cross-reactive substances. All the studies evaluated produced acceptable results when compared to the Predicate device and were deemed verified.
1. Detection Limits
LoB, LoD, and LoQ were determined in accordance with Clinical and Laboratory Standards Institute (CLSI) EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline-Second Edition The LoB/LoD/LoQ estimates are summarized below:
| Limit of Blank (LoB) | 0.008µg/dL (0.22nmol/L) |
|---|---|
| Limit of Detection (LoD) | 0.053µg/dL (1.46nmol/L) |
| Limit of Quantitation (LoQ) | 0.2µg/dL (5.52nmol/L) |
The reportable range of the IMMULITE/IMMULITE 1000 Cortisol assay is 1 to 50 µg/dL (28 to 1380 nmol/L).
2. Linearity
The Linearity study was conducted in accordance with the principles described in CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline. Samples spanning the assay range were prepared by combining a high human serum pool with a low human serum pool for a total of 9 levels of dilutions prepared by mixing the high and low serum pools. The high serum pool consisted of a human serum pool sample spiked with cortisol to obtain a desired concentration at the upper end of the working range of the assay (observed concentration: 50.98µg/dL). The low serum pool consisted of a low-level human serum pool diluted with charcoal-adsorbed human serum in order to achieve a cortisol concentration at the approximate LoQ (observed concentration: 0.18 µg/dL). The modified IMMULITE/IMMULITE 1000 Cortisol assay has been shown to be linear from 0.18 - 50.98 ug/dL. The Linearity information provided in the Instruction for Use for modified IMMULITE/IMMULITE 1000 Cortisol has not changed and are as per K931409.
3. Repeatability and Within-Lab Precision
The repeatability and within-lab precision information provided in the Instruction for Use for modified IMMULITE/IMMULITE 1000 Cortisol has not changed and are as per K931409.
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4. Spike Recovery
The spike and recovery information provided in the Instruction for Use for modified IMMULITE/IMMULITE 1000 Cortisol has not changed and are as per K931409.
5. Method Comparison with predicate device
A method comparison study was performed by comparing the modified device to the currently-marketed predicate device (unmodified IMMULITE 1000 Cortisol Assay) in accordance with CLSI EP09c Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition. A total of 152 native patient samples covering the full range of the assay were assayed in duplicate split across 4 runs, with each run on a different instrument (41 patients on instrument 1-3, and 30 patients on instrument 4).
| SampleCategory | N | Range | Regression equation |
|---|---|---|---|
| Serum | 152 | 2.01 – 48.3 µg/dL | IMM 1000 = 0.951 (IMMULITE 1000 commercial) - 0.155 µg/dL. r=0.991 |
6. Specificity (Cross-Reactivity)
Specificity (cross-reactivity) of the modified IMMULITE/IMMULITE 1000 Cortisol assay to the various compounds listed in the Table below were evaluated. Cross-reactant solutions were prepared by dissolving each crossreactant into an appropriate solvent (ethanol, methanol or NaOH). Each cross-reactant was then spiked at a ratio of 1:19 into an aliquot of a blank sample (charcoal-absorbed human serum) such that the final concentration in the sample was equal to that outlined in Table below. Blank samples were also prepared which consisted of charcoal-adsorbed human serum spiked 1:19 with the solvents used to prepare the cross-reactants. In addition to the cross reactants evaluated in K931409 the following cross reactants were evaluated: Allotetrahydrocortisol, α-Cortol, α-Cortolone, β-Cortol' β-Cortolone, Dehydrocorticosterone 20a-Dihydrocortisol, 203-Dihydrocortisol, 20a-Dihydrocortisone, Estradiol, Fludrocortisone. Complete summary of the results are summarized below.
| Compound | Cross-Reactantadded concentration(µg/dL) | % Cross- Reactivity |
|---|---|---|
| Blank (Methanol) | N/A | N/A |
| Blank (Ethanol) | N/A | N/A |
| Blank (NaOH) | N/A | N/A |
| Aldosterone | 1,000 | ND |
| Androstenedione | 10,000 | ND |
| Compound | Cross-Reactantadded concentration(µg/dL) | % Cross- Reactivity |
| Betamethasone | 1,000 | ND |
| Corticosterone | 400 | 0.92% |
| Cortisone | 400 | 1.77% |
| 11-Deoxycorticosterone | 400 | ND |
| 11-Deoxycortisol | 100 | 4.05% |
| 21-Deoxycortisone | 500 | ND |
| Dexamethasone | 400 | ND |
| DHEA-SO4 | 10,000 | ND |
| Estriol | 100 | ND |
| Estrone | 500 | ND |
| Fludrocortisone | 1,000 | ND |
| Fluticasone | 22 | ND |
| 17α-hydroxyprogesterone | 400 | ND |
| Methotrexate | 100 | ND |
| Methylprednisolone | 200 | 1.12% |
| Prednisolone | 8 | 16.01% |
| Prednisone | 16 | ND |
| Pregnanediol | 2,000 | ND |
| Progesterone | 400 | ND |
| Spironolactone | 1,000 | ND |
| Tetrahydrocortisol | 1,000 | ND |
| Tetrahydrocortisone | 400 | ND |
| Triamcinolone | 5,000 | ND |
| Allotetrahydrocortisol | 100 | 2.06% |
| α-Cortolone | 1,000 | ND |
| α-Cortol | 1,000 | ND |
| β-Cortol | 1,000 | ND |
| β-Cortolone | 1,000 | ND |
| 11-Dehydrocorticosterone | 1000 | ND |
| 20α-dihydrocortisol | 1,000 | 0.28% |
| 20β-dihydrocortisol | 1000 | ND |
| 20α-dihydrocortisone | 1,000 | ND |
| Estradiol | 1,000 | ND |
Siemens Healthcare Diagnostics Products Ltd., Llanberis UK Traditional 510(k): IMMULITE/IMMULITE® 1000 Cortisol - Modified Device
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7. Interference
Interference with the modified IMMULITE/IMMULITE 1000 Cortisol assay was determined for the following substances: conjugated and unconjugated bilirubin, hemolysate, hemoglobin, intralipid and biotin. The paired difference approach was employed for this study as per CLSI EP07: Interference Testing in Clinical Chemistry, 3rd Edition. Working stock solutions of the interfering substance were prepared and spiked into 5 patient samples such that the final interferent concentration in the sample was equal to that found in Table below. The 5 patient samples ranged from 3.3 - 23.1 µg/dL. The interference information for Bilirubin, Hemolysis and Lipemia provided in the Instruction for Use for modified IMMULITE/IMMULITE 1000 Cortisol has not changed and are as per K931409. Information reqarding Biotin interference are summarized below:
| InterferingSubstance | Interferingsubstancespikingconcentration | ObservedMean %Recovery |
|---|---|---|
| Biotin | 3500ng/mL | 96.0% |
8. Clinical Evaluation
Not applicable
P. Conclusion
Based on the results of comparative testing, the modified IMMULITE/ IMMULITE 1000 Cortisol is substantially equivalent to the currently marketed predicate device, IMMULITE/IMMULITE 1000 Cortisol.
§ 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.