Who is the manufacturer of Elecsys FT4 III?

Roche Diagnostics filed the 510(k) submission for Elecsys FT4 III (K181233).

What is the FDA product code for Elecsys FT4 III?

CEC. It is classified under 21 CFR 862.1695 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for Elecsys FT4 III?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Elecsys FT4 III?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Elecsys FT4 III

Q: What are the predicate devices for Elecsys FT4 III?

Elecsys FT4 II Assay (k131244).

K181233 · Roche Diagnostics · CEC · Sep 18, 2018 · Clinical Chemistry

Device Facts

Record ID	K181233
Device Name	Elecsys FT4 III
Applicant	Roche Diagnostics
Product Code	CEC · Clinical Chemistry
Decision Date	Sep 18, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1695
Device Class	Class 2

Intended Use

Assay for the in vitro quantitative determination of free thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

Device Story

Elecsys FT4 III is an in vitro diagnostic immunoassay for quantitative measurement of free thyroxine (fT4) in human serum and plasma. It utilizes electrochemiluminescence immunoassay (ECLIA) technology on the cobas e 411 analyzer. The assay uses streptavidin-coated microparticles, biotinylated T4, and ruthenium-labeled anti-T4 antibodies. The device measures light signals generated during the electrochemical reaction to determine fT4 concentration. It is operated by laboratory professionals in clinical settings. Results assist physicians in diagnosing and managing thyroid disorders. The device is a modification of the predicate Elecsys FT4 II, specifically optimized with reduced D-biotin concentration in the R2 reagent buffer to improve biotin interference resistance. It provides clinicians with quantitative data to assess thyroid function.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (n=84 per sample, CVs 1.7-10.7%). Linearity assessed per CLSI EP06-A (R²=0.9988). LoB (0.03 ng/dL), LoD (0.05 ng/dL), and LoQ (0.101 ng/dL) determined per CLSI EP17-A2. Method comparison with predicate (n=141) showed high correlation (r=0.999). Interference testing confirmed robustness against endogenous substances and common drugs, with specific limitations noted for biotin, thyroid drugs, and autoantibodies.

Technological Characteristics

Quantitative electrochemiluminescent immunoassay (ECLIA). Components: Streptavidin-coated microparticles, ruthenium-labeled polyclonal anti-T4 antibody, biotinylated T4. Instrument: Roche cobas e 411. Measuring range: 0.101–7.7 ng/dL. Traceable to Enzymun Test (standardized via equilibrium dialysis).

Indications for Use

Indicated for in vitro quantitative determination of free thyroxine in human serum and plasma to aid in the diagnosis and treatment of thyroid disease. Intended for use on the cobas e 411 immunoassay analyzer.

Regulatory Classification

Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Predicate Devices

Elecsys FT4 II Assay (k131244)

Related Devices

K220456 — Elecsys FT4 IV · Roche Diagnostics · Apr 7, 2023
K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET · Roche Diagnostics · Jan 27, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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 in blue. Underneath the FDA logo is the text "ADMINISTRATION". September 18, 2018 Roche Diagnostics Reanna Toney Principal, Regulatory Affairs 9115 Hague Road Indianapolis, IN 46250 Re: K181233 Trade/Device Name: Elecsvs FT4 III Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC Dated: August 2, 2018 Received: August 3, 2018 Dear Reanna Toney: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) k181233 Device Name Elecsys FT4 III Indications for Use (Describe) Assay for the in vitro quantitative determination of free thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. The electrochemiluminescence immunoasay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## k181233 Elecsys FT4 III 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. In accordance with 21 CFR 807.87. Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k). The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys FT4 III. {4}------------------------------------------------ | Submitter Name | Roche Diagnostics | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0457 | | Contact | Reanna Toney Phone: (317) 521-4516 FAX: (317) 521-2324 Email: reanna.toney@roche.com Secondary Contact Name Michael Leuther Phone: (317) 521-3930 FAX: (317) 521-2324 Email: Michael.leuther@roche.com | | Date Prepared | September 18, 2018 | | Proprietary Name | Elecsys FT4 III | | Common Name | Free thyroxine | | Classification Name | Radioimmunoassay, Free thyroxine test system | | Product Codes, Regulation Numbers | CEC, 21CFR862.1695 | | Predicate Devices | Elecsys FT4 II (K131244) | | Establishment Registration | For the Elecsys FT4 III, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg, Germany, 9610529. The establishment registration number for Roche Diagnostics in the United States is 1823260 | {5}------------------------------------------------ #### 1. DEVICE DESCRIPTION The Elecsys FT4 III immunoassay is used for the in vitro quantitative determination of free thyroxine in human serum and plasma. It is intended for use on the cobas e 411 immunoassay analyzer. The cobas e family of analyzers uses electrochemiluminescence immunoassay "ECLIA" technology. #### 1.1. Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) - M: Streptavidin-coated microparticles . - R1: Anti-T4-Ab~biotin . - R2: Anti-T4-Ab~Ru(bpy) . #### INDICATIONS FOR USE 2. Assay for the in vitro quantitative determination of free thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer. #### 3. TECHNOLOGICAL CHARACTERISTICS The following tables compare the Elecsys FT4 III with its predicate device, Elecsys FT4 II assay (k131244). {6}------------------------------------------------ | Feature | Predicate Device: Elecsys FT4 II (k131244) | Candidate Device: Elecsys FT4 III | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | Assay for the in vitro quantitative determination of free thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. The electrochemiluminescence immunoassay "ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. | Assay for the in vitro quantitative determination of free thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer. | | Detection Method | Electrochemiluminescent Assay | same | | Applications/Test Time | 18 minute application | same | | Instrument Platform | Elecsys and cobas e | cobas e 411 | | Sample/Reagent Ratio | 15 µL | same | | Sample Type/Matrix | Serum and plasma (Li-heparin, K2-EDTA, K3-EDTA | same | | Reagents | M: Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative R1: Anti T4-Ab~Ru(bpy) (gray cap), 1 bottle, 18 mL: Polyclonal anti-T4- antibody (sheep) labeled with ruthenium complex 75 ng/mL; phosphate buffer 100 mmol/L, pH 7.0; preservative R2: T4~biotin (black cap), 1 bottle, 18 mL: Biotinylated T4 2.5 ng/mL; phosphate buffer 100 mmol/L, pH 7.0; preservative. | M: Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative R1: Anti T4-Ab~Ru(bpy) (gray cap), 1 bottle, 18 mL: Polyclonal anti-T4-antibody (sheep) labeled with ruthenium complex 75 ng/mL; phosphate buffer 100 mmol/L, pH 7.0; preservative R2: T4~biotin (black cap), 1 bottle, 18 mL: Biotinylated T4 2.5 ng/mL; free D-biotin 8 ng/mL; phosphate buffer 100 mmol/L, pH 7.0; preservative. | | Biotin | D-Biotin concentration in the R2 reagent buffer: 50 ng/mL | D-Biotin concentration in the R2 reagent buffer: 8 ng/mL | | Calibrator | FT4 II CalSet | CalSet FT4 III | | Calibration Method | 2-point calibration | same | | Feature | Predicate Device: Elecsys FT4 II (k131244) | Candidate Device: Elecsys FT4 III | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Calibration interval may be extended based on acceptable verification of calibration by the laboratory. Renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot after 7 days (when using the same reagent kit on the analyzer) as required: e.g. quality control findings outside the defined limits | same | | Controls | PreciControl Universal | same | | Traceability/ Standardization | This method has been standardized against the Elecsys FT4 method. The Elecsys FT4 assay is traceable to the Enzymun-Test which was standardized using equilibrium dialysis. | This method has been standardized against the Elecsys FT4 II method. The Elecsys FT4 II assay is traceable to the Enzymun Test which was standardized using equilibrium dialysis | | Reagent Stability | Store at 2 8 °C. Do not freeze. Store the Elecsys reagent kit upright in order to ensure complete availability of the microparticles during automatic mixing prior to use. Unopened at 2-8 °C. up to stated expiration date After opening at 2-8 ℃. 84 days (12 weeks) On the analyzers. 28 days (4 weeks) onboard or 56 days (8 weeks) when stored alternatively in the refrigerator and on the analyzer, with the total time onboard on the analyzer not exceeding 120 hours | same | | Measuring Range | 0.101-7.77 ng/dL (1.3-100 pmol/L | same | | LoB | 0.03 ng/dL (0.4 pmol/L) | 0.02 ng/dL (0.3 pmol/L) | | LoD | 0.05 ng/dL (0.6 pmol/L) | 0.04 ng/dL (0.5 pmol/L) | | LoO | 0.101 ng/dL (1.3 pmol/L) | same | #### Table 1: Assay Comparison {7}------------------------------------------------ {8}------------------------------------------------ | Feature | Predicate Device: Elecsys FT4 II (k131244) | | | Candidate Device: Elecsys FT4 III | | | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------| | Analytical Specificity | The following cross-reactivities were found, tested with fT4 concentrations of approximately 0.974 ng/dL (12.5 pmol/L) and 2.66 ng/dL (34.2 pmol/L): | | | The following cross-reactivities were found, tested with fT4 concentrations of approximately 1.01 ng/dL (13 pmol/L) and 3.03 ng/dL (39 pmol/L): | | | | | Cross- reactant | Concentrat ion tested ng/dL | Cross- reactivity % | Cross- reactant | Concentration tested ng/dL | Cross- reactivity % | | | L-T3 | 50000 | 0.005 | L-T3 | 50000 | 0.005 | | | D-T3 | 50000 | 0.002 | D-T3 | 50000 | 0.002 | | | rT3 | 190000 | 0.007 | rT3 | 190000 | 0.007 | | | 3-iodo-L- tyrosine | 10000000 | 0.000 | 3-iodo-L- tyrosine | 10000000 | 0.000 | | | 3,5-diiodo-L- tyrosine | 10000000 | 0.000 | 3,5-diiodo-L- tyrosine | 10000000 | 0.000 | | | 3,3',5- triiodothyra cetic acid | 100000 | 0.000 | 3,3',5- triiodothyra cetic acid | 100000 | 0.000 | | | 3,3',5,5'- tetraiodothyroaceti c acid | 100000 | 0.001 | 3,3',5,5'- tetraiodothyroacetic acid | 100000 | 0.001 | {9}------------------------------------------------ | Feature | Predicate Device: Elecsys FT4 II (k131244) | Candidate Device: Elecsys FT4 III | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Limitations | The assay is unaffected by icterus (bilirubin < 701 µmol/L or < 41 mg/dL), hemolysis (Hb < 0.621 mmol/L or < 1.0 g/dL), lipemia (Intralipid < 2000 mg/dL), biotin (< 81.8 nmol/L or < 20 ng/mL), albumin < 6.3 g/dL, IgG < 7 g/dL, IgA < 1.6 g/dL and IgM < 1 g/dL. Criterion: Recovery within ± 10 % of initial value. Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration. No interference was observed from rheumatoid factors up to a concentration of 1200 IU/mL and samples from dialysis patients. Any influence that might affect the binding behavior of the binding proteins can alter the result of the fT4 tests (e.g. drugs, NTIs (Non Thyroid Illness) or patients suffering from FDH (Familial Dysalbuminemic Hyperthyroxinemia) or increased TBG in pregnancy). The test cannot be used in patients receiving treatment with lipid-lowering agents containing D T4. If the thyroid function is to be checked in such patients, the therapy should first be discontinued for 4-6 weeks to allow the physiological state to become re-established. Autoantibodies to thyroid hormones can interfere with the assay. In vitro tests were performed on 17 commonly used pharmaceuticals. No interference with the assay was found. | Bilirubin ≤ 701 µmol/L or ≤ 41 mg/dL Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL Intralipid ≤ 2000 mg/dL Rheumatoid factors ≤ 1200 IU/mL IgG ≤ 7 g/dL IgA ≤ 1.6 g/dL IgM ≤ 1 g/dL Criterion: Recovery of ≤ ± 0.6 pmol/L of initial value ≤ 6 pmol/L and ± 10 % of initial value > 6 pmol/L. Any influence that might affect the binding behavior of the binding proteins can alter the result of the fT4 tests (e.g. drugs, NTIs (Non Thyroid Illness) or patients suffering from FDH (Familial Dysalbuminemic Hyperthyroxinemia)). The test cannot be used in patients receiving treatment with lipid-lowering agents containing D T4. If the thyroid function is to be checked in such patients, the therapy should first be discontinued for 4-6 weeks to allow the physiological state to become re-established Autoantibodies to thyroid hormones can interfere with the assay. Pharmaceutical substances In vitro tests were performed on 16 commonly used pharmaceuticals. No interference with the assay was found. | | Feature | Predicate Device: Elecsys FT4 II (k131244) | Candidate Device: Elecsys FT4 III | | Special thyroid drugs | The following special thyroid drugs were tested with concentrations shown in the table below. No interference with the assay was found. Criterion: Recovery within ± 10 % of initial value. | In addition, the following special thyroid drugs were tested. No interference with the assay was found. | | | Drug | Concentration (µg/mL) | | | Iodide | 0.200 | | | Carbimazole | 6 | | | Thiamazole | 80 | | | Propylthiouracil | 300 | | | Perchlorate | 2000 | | | Propranolol | 240 | | | Amiodarone | 200 | | | Prednisolone | 100 | | | Hydrocortisone | 200 | | | Flurocortolone | 100 | | | Octreotide…

Elecsys FT4 III

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