(113 days)
No
The summary describes a standard in vitro diagnostic immunoassay for measuring cortisol, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic use, meaning it measures substances in biological samples (like serum) to aid in diagnosis, not to treat or directly manage a condition in the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use."
No
The device description explicitly lists physical components (Cortisol Bead Pack, Cortisol Reagent Wedge, Cortisol Adjustors) which are hardware/reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Measurement of Analyte: The device is designed for the "quantitative measurement of cortisol... in serum". Measuring analytes in biological samples is a core function of IVDs.
- Clinical Assessment: The measurement is intended "as an aid in the clinical assessment of adrenal status", indicating its use in a clinical context for diagnosis or monitoring.
- Device Description: The components described (Bead Pack, Reagent Wedge, Adjustors) are typical reagents and materials used in in vitro diagnostic assays.
- Performance Studies: The document details performance studies like Detection Limits, Linearity, Repeatability, Specificity, and Interference, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Prescription Use Only: This indicates the device is intended for use by trained professionals in a healthcare setting, which is common for IVDs used in clinical laboratories.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers - for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
Product codes (comma separated list FDA assigned to the subject device)
CGR
Device Description
The IMMULITE 2000 Cortisol assay is comprised of the following components:
Component: Cortisol Bead Pack (solid phase)
Volume: 200 beads
Ingredients: Polyclonal rabbit anti-cortisol antibody.
Component: Cortisol Reagent Wedge (liquid phase)
Volume: 11.5 mL
Ingredients: Alkaline phosphatase (bovine calf intestine) conjugated to cortisol in buffer, with preservative.
Component: Cortisol Adjustors (Low and High)
Volume: 3 mL
Ingredients: Cortisol in processed human serum, with preservative.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
-
Detection Limits: LoB, LoD, and LoQ were determined in accordance with Clinical and Laboratory Standards Institute (CLSI) Section 008, p. 17-A2.
- Limit of Blank (LoB): 0.014 µg/dL (0.39 nmol/L)
- Limit of Detection (LoD): 0.07 µg/dL (1.9 nmol/L)
- Limit of Quantitation (LoQ): 0.25 µg/dL (6.9nmol/L)
The reportable range of the IMMULITE 2000 Cortisol assay is 1 to 50 µg/dL (28 to 1380 nmol/L).
-
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. The modified IMMULITE 2000 Cortisol assay has been shown to be linear from 0.19 - 54.7 µg/dL.
-
Repeatability and Within-Lab Precision: The information provided in the Instruction for Use for modified IMMULITE 2000 Cortisol has not changed and are as per K931409.
-
Spike Recovery: The information provided in the Instruction for Use for modified IMMULITE 2000 Cortisol has not changed and are as per K931409.
-
Method Comparison with predicate device: A method comparison study was performed by comparing the modified device to the currently-marketed predicate device (unmodified IMMULITE 2000 Cortisol Assay) in accordance with CLSI EP09c Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition. A total of 149 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.
- Sample Category: Serum
- N: 149
- Range: 1.97 – 48.7 µg/dL
- Regression equation: IMM 2000 = 0.996 (IMMULITE 2000 commercial) - 0.0766 µg/dL. r = 0.981
-
Specificity (Cross-Reactivity): Specificity (cross-reactivity) of the modified IMMULITE 2000 Cortisol assay to various compounds were evaluated. Cross-reactant solutions were prepared and spiked into blank samples. In addition to cross reactants evaluated in K931409 following cross reactants were evaluated: Allotetrahydrocortisol, α-Cortol, α-Cortolone, β-Cortol' β-Cortolone, Dehydrocorticosterone 20a-Dihydrocortisol, 20ß-Dihydrocortisol, 20a-Dihydrocortisone, Estradiol, Fludrocortisone. (Table of compounds and their % Cross-Reactivity is provided in the source document).
-
Interference: Interference with the modified IMMULITE 2000 Cortisol assay was determined for conjugated and unconjugated bilirubin, hemoglobin, intralipid and biotin. The paired difference approach was employed as per CLSI EP07: Interference Testing in Clinical Chemistry, 3rd Edition. Working stock solutions were spiked into 5 patient samples. The 5 patient samples ranged from 3.6 – 22.1 µg/dL. Information regarding Biotin interference:
- Interfering Substance: Biotin
- Interfering substance spiking concentration: 3500ng/mL
- Observed Mean % Recovery: 108%
-
Clinical Evaluation: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoB: 0.014 µg/dL (0.39 nmol/L)
LoD: 0.07 µg/dL (1.9 nmol/L)
LoQ: 0.25 µg/dL (6.9 nmol/L)
Measurement range: The reportable range of the IMMULITE 2000 Cortisol assay is 1 to 50 µg/dL (28 to 1380 nmol/L).
Linearity range: 0.19 - 54.7 µg/dL.
Method Comparison Regression equation: IMM 2000 = 0.996 (IMMULITE 2000 commercial) - 0.0766 µg/dL. r = 0.981
Biotin Interference: 108% recovery at 3500ng/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
January 15, 2021
Siemens Healthcare Diagnostics Products Ltd. Malgorzata Robak Regulatory Affairs Supervisor Glyn Rhonwy. Llanberis Caernarfon, Gwynedd LL55 4EL UK
Re: K202826
Trade/Device Name: IMMULITE® 2000 Cortisol Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (Hydrocortisone And Hydroxycorticosterone) Test System Regulatory Class: Class II Product Code: CGR Dated: September 22, 2020 Received: September 24, 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
1
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
2
Indications for Use
510(k) Number (if known) K202826
Device Name IMMULITE® 2000 Cortisol
Indications for Use (Describe)
For in vitro diagnostic use with the IMMULITE® 2000 Systems 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® 2000 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:_k202826
- 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® 2000 Cortisol
E. Measurand
Cortisol
F. Regulatory Information
Trade Name: | IMMULITE® 2000 Cortisol |
---|---|
Common Name: | Chemiluminescence Immunoassay, for the |
determination of Cortisol | |
Classification Name: | Cortisol Test System |
FDA Classification: | Class II |
Review Panel: | Clinical Chemistry |
Product Code: | CRG |
Requlation Number: | 21 CFR 862.1205 |
G. Predicate Device:
Device Name: IMMULITE® 2000 Cortisol
510(k) Number: K931409
4
Healthine
H. Intended Use:
Same as Indication for Use
-Indications for Use:
For in vitro diagnostic use with the IMMULITE® 2000 Systems 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® 2000
L. Device Description
The IMMULITE 2000 Cortisol assay is comprised of the following components:
Component | Volume | Ingredients |
---|---|---|
Cortisol Bead Pack | ||
(solid phase) | 200 beads | Polyclonal rabbit anti-cortisol antibody. |
Cortisol Reagent | ||
Wedge (liquid | ||
phase) | 11.5 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. |
M. Substantial Equivalence Information
The following table demonstrates substantial equivalence between the IMMULITE 2000 Cortisol (Candidate Device) with an antibody from a new supplier and the currently marketed IMMULITE 2000 (Predicate Device) that was cleared under 510 (k) K931409.
| Trade name | Candidate Device (Modified)
IMMULITE® 2000 Cortisol | Predicate device
(Unmodified)
IMMULITE® 2000 Cortisol |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use
with the IMMULITE® 2000
Systems Analyzers — for
the quantitative
measurement of cortisol
(hydrocortisone, Compound
F) in serum, as an aid in the
clinical assessment of
adrenal status. | For in vitro diagnostic use
with the IMMULITE® 2000
Systems Analyzers — for
the quantitative
measurement of cortisol
(hydrocortisone, Compound
F) in serum, as an aid in the
clinical assessment of
adrenal status. |
| Analyte | Cortisol | Same |
| Automated | Automated Assay | Same |
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| Trade name | Candidate Device (Modified) | Predicate device
(Unmodified) |
|----------------------------------|---------------------------------------------------------------------------|-------------------------------------------------|
| | IMMULITE® 2000 Cortisol | IMMULITE® 2000 Cortisol |
| Measurement | Quantitative | Same |
| Sample Type | Human serum | Same |
| Detection
Limit | LoB: 0.014 µg/dL
(0.39 nmol/L) | Analytical Sensitivity: 0.20 µg/dL (5.5 nmol/L) |
| | LoD: 0.07 µg/dL
(1.9 nmol/L) | Not Applicable |
| | LoQ: 0.25 µg/dL
(6.9 nmol/L) | Not Applicable |
| Calibration
Range | 1-50 µg/dL (28 to 1380 nmol/L) | Same |
| Operating
Principle | Competitive | Same |
| Technology | Chemiluminescent enzyme
immunoassay | Same |
| Instrument | IMMULITE 2000 | Same |
| Sample
Volume | 10 µL | 10 µL |
| Calibrator | Two levels (low & high)
cortisol adjustor | Same |
| Controls | Commercial | Commercial |
| Detection
Enzyme
conjugate | Alkaline phosphatase
(bovine calf intestine)
conjugated to cortisol | Same |
| Capture
Antibody | Polyclonal rabbit anti-cortisol | Same |
N. Test Principle
IMMULITE 2000 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 proportional to the bound enzyme.
O. Performance Characteristics
The assay principle, design and reagent formulation has not changed from the original device. Substantial equivalence was demonstrated by testing several
6
Healthineer
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) Section 008, p. 17-A2. The LoB/LoD/LoQ estimates are summarized below:
Limit of Blank (LoB) | 0.014 µg/dL (0.39 nmol/L) |
---|---|
Limit of Detection (LoD) | 0.07 µg/dL (1.9 nmol/L) |
Limit of Quantitation (LoQ) | 0.25 µg/dL (6.9nmol/L) |
The reportable range of the IMMULITE 2000 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 cortisol concentration at the upper end of the working range of the assay (observed concentration: 54.7ug/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: 0.2 µg/dL).The modified IMMULITE 2000 Cortisol assay has been shown to be linear from 0.19 - 54.7 µg/dL. The Linearity information provided in the Instruction for Use for modified IMMULITE 2000 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 2000 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 2000 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 2000 Cortisol Assay) in accordance with CLSI EP09c Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition. A total of 149 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 (40 patients on instrument 1-3, and 30 patients on instrument 4).
| Sample
Category | N | Range | Regression equation |
---|---|---|---|
Serum | 149 | 1.97 – 48.7 | |
µg/dL | IMM 2000 = 0.996 (IMMULITE 2000 commercial) - | ||
0.0766 µg/dL. r = 0.981 |
6. Specificity (Cross-Reactivity)
Specificity (cross-reactivity) of the modified IMMULITE 2000 Cortisol assay to the various compounds listed in the Table below were evaluated. Crossreactant solutions were prepared by dissolving each cross-reactant 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 (charcoalabsorbed 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 following cross reactants were evaluated: Allotetrahydrocortisol, α-Cortol, α-Cortolone, β-Cortol' β-Cortolone, Dehydrocorticosterone 20a-Dihydrocortisol, 20ß-Dihydrocortisol, 20a-Dihydrocortisone, Estradiol, Fludrocortisone. Complete summary of the results are summarized below.
| Compound | Cross-
Reactant
added
concentration
(ug/dL) | % Cross-
Reactivity |
|------------------------------|---------------------------------------------------------|------------------------|
| Aldosterone | 1000 | ND |
| Androstenedione | 10000 | ND |
| Betamethasone | 1000 | ND |
| Corticosterone | 400 | 0.90% |
| Cortisone | 400 | 1.60% |
| 11-Deoxycorticosterone | 400 | ND |
| Compound | Cross-
Reactant
added
concentration
(µg/dL) | % Cross-
Reactivity |
| 11-Deoxycortisol | 100 | 4.70% |
| 21-Deoxycortisone | 500 | ND |
| Dexamethasone | 500 | ND |
| DHEA-SO4 | 10000 | ND |
| Estriol | 100 | ND |
| Estrone | 500 | ND |
| Fluticasone | 22 | ND |
| 17α-
Hydroxyprogesterone | 400 | ND |
| Methotrexate | 100 | ND |
| Methylprednisolone | 200 | 1.00% |
| Prednisolone | 8 | 23.80% |
| Prednisone | 16 | ND |
| Pregnanediol | 2000 | ND |
| Progesterone | 400 | ND |
| Spironolactone | 1000 | ND |
| Tetrahydrocortisone | 400 | ND |
| Triamcinolone | 5000 | ND |
| Allotetrahydrocortisol | 100 | 2.41% |
| α-Cortolone | 1000 | ND |
| α-Cortol | 1000 | ND |
| β-Cortol | 1000 | ND |
| β-Cortolone | 1000 | ND |
| 11-
Dehydrocorticosterone | 1000 | ND |
| 20α-dihydrocortisol | 1000 | 0.368% |
| 20β-dihydrocortisol | 1000 | ND |
| 20α-dihydrocortisone | 1000 | ND |
| Fludrocortisone | 1000 | ND |
| Estradiol | 1000 | ND |
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7. Interference
Interference with the modified IMMULITE 2000 Cortisol assay was determined for the following substances: conjugated and unconjugated bilirubin, 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
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concentration in the sample was equal to that found in Table below. The 5 patient samples ranged from 3.6 – 22.1 µg/dL. The interference information for Bilirubin, Hemolysis and Lipemia provided in the Instruction for Use for modified IMMULITE 2000 Cortisol has not changed and are as per K931409. Information regarding Biotin interference are summarized below:
| Interfering
Substance | Interfering
substance
spiking
concentration | Observed
Mean %
Recovery |
|--------------------------|------------------------------------------------------|--------------------------------|
| Biotin | 3500ng/mL | 108% |
8. Clinical Evaluation
Not applicable
P. Conclusion
Based on the results of comparative testing, the modified IMMULITE® 2000 Cortisol is substantially equivalent to the currently marketed predicate device, IMMULITE® 2000 Cortisol.