Who is the manufacturer of ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET?

Roche Diagnostics filed the 510(k) submission for ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244).

What is the FDA product code for ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET?

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 II ASSAY, ELECSYS FT4 II CALSET?

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

What are the predicate devices for ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET?

Elecsys FT4 Assay (k961489); Elecsys FT4 CalSet (k961489).

Who can help prepare an FDA 510(k) submission like ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET?

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 II ASSAY, ELECSYS FT4 II CALSET

K131244 · Roche Diagnostics · CEC · Jan 27, 2014 · Clinical Chemistry

Device Facts

Record ID	K131244
Device Name	ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
Applicant	Roche Diagnostics
Product Code	CEC · Clinical Chemistry
Decision Date	Jan 27, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1695
Device Class	Class 2

Intended Use

The Elecsys FT4 II assay is 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 Elecsys and cobas e immunoassay analyzers. The Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys FT4 II Assay is a two-step competitive immunoassay used for the quantitative determination of free thyroxine (FT4) in human serum and plasma. The device utilizes streptavidin-coated microparticles, a T4-specific polyclonal anti-T4 antibody (sheep) labeled with a sulfonyl-ruthenium complex, and electrochemiluminescence (ECLIA) detection. The assay is performed on automated Elecsys and cobas e immunoassay analyzers. The system requires 15 µL of sample and has a total assay duration of 18 minutes. Results are calculated via a master curve stored on the reagent barcode, adjusted by a two-point calibration using the Elecsys FT4 II CalSet. The output is a quantitative concentration of FT4, which clinicians use to diagnose and monitor thyroid diseases. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP5-A2, EP17-A2, EP6-A, C28-A3c). Precision studies (n=84) showed repeatability CVs of 0.9-4.0% and intermediate precision CVs of 1.8-7.6%. LoB ≤ 0.03 ng/dL, LoD ≤ 0.05 ng/dL, and LoQ 0.1 ng/dL. Linearity confirmed from 0.096 to 8.20 ng/dL. Method comparison (n=170) against the predicate showed Passing/Bablok slope 1.00 ± 0.05 and correlation r ≥ 0.95. Reference range validation (n=60) confirmed the established range of 0.93-1.7 ng/dL.

Technological Characteristics

Competitive immunoassay using electrochemiluminescence (ECLIA). Reagents: streptavidin-coated microparticles, sheep polyclonal anti-T4 antibody labeled with sulfonyl-ruthenium complex. Sample volume: 15 µL. Calibration: two-point, master curve via barcode. Platform: automated Elecsys and cobas e immunoassay analyzers. Stability: 84 days opened at 2-8°C; 28 days onboard. Sterilization: N/A (reagent kit).

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 diseases. For use by clinical laboratory professionals on Elecsys and cobas e immunoassay analyzers.

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 Assay (k961489)
Elecsys FT4 CalSet (k961489)

Related Devices

K961489 — ELECSYS FT4 ASSAY · Boehringer Mannheim Corp. · Jun 11, 1996
K220456 — Elecsys FT4 IV · Roche Diagnostics · Apr 7, 2023
K961490 — ELECSYS T4 ASSAY · Boehringer Mannheim Corp. · Jun 13, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ CONFIDENTIAL JAN 2 7 2014 ### 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Name, Address, Contact Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Contact Person: Edie Eads - Phone: (317) 521-4668 . - . FAX: (317) 521-2324 - Email: edie.eads@roche.com . Date Prepared: January 21, 2014 1823260. | Device Name | Proprietary name: | (1) Elecsys FT4 II Assay (2) Elecsys FT4 II CalSet | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | | Common name: | (1) FT4 II Assay (2) FT4 II Calibrator | | | Classification name: | (1) Radioimmunoassay, Free thyroxine test system (2) Calibrator | | | Product Codes: | (1) CEC, 21 CFR 862.1695 (2) JIT, 21 CFR 862.1150 | | | Predicate Devices: | (1) Elecsys FT4 Assay (K961489) CEC, 21 CFR 862.1695 (2) Elecsys FT4 CalSet (K961489) JIS, 21 CFR 862.1150 | | Establishment Registration | For the Elecsys FT4 II Assay and the Elecsys FT4 II CalSet, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for Penzberg, Germany, is 9610529. | | The establishment registration number for Roche Diagnostics United States is , t {1}------------------------------------------------ . · | Device Description | 1) The Elecsys F4 II Assay is a quantitative test for determination of free thyroxine in human serum and plasma. The total duration of the assay is 18 minutes. Elecsys FT4 II is a two-step competitive immunoassay with streptavidin microparticles, T4-specific polyclonal anti-T4-antibody (sheep) labeled with a sulfonyl-ruthenium complex, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument- specifically generated by a two-point calibration and a master curve provided via the reagent barcode. (2) The Elecsys FT4 II CalSet is a ready-for-use buffer/protein (bovine serum albumin) matrix with added L-Thyroxine in two concentration ranges. FT4 II Cal1: 2 bottles, each containing 1.0 mL of calibrator 1 FT4 II Cal2: 2 bottles, each containing 1.0 mL of calibrator 2 Note: The reagent and calibrator are packaged separately. | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | Elecsys FT4 II Reagent: The Elecsys FT4 II Assay is 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 Elecsys and cobas e immunoassay analyzers. - Elecsys FT4 II CalSet: Elecsys FT4 II CalSet is used for calibrating . the quantitative Elecsys FT4 11 assay on the Elecsys and cobas e immunoassay analyzers. {2}------------------------------------------------ CONFIDENTIAL # 510(k) Summary, continued | Substantial Equivalence | The Elecsys FT4 II Test System is substantially equivalent to other devices legally marketed in the United States. (1) Elecsys FT4 II Assay is equivalent to the Elecsys FT4 Assay (K961489). (2) Elecsys FT4 II CalSet is equivalent to the Elecsys FT4 CalSet (K961489). | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence - Comparison | The following tables compare the Elecsys FT4 II Test System and the Elecsys FT4 II CalSet with their predicates. | ## Comparison of Assays-Similarities and Differences | Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Assay Features | | | | Intended Use/ Indications for Use | The FT4 II Assay is 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 Elecsys and cobas e immunoassay analyzers. | Immunoassay for the in vitro quantitative determination of free Thyroxine in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. | | Assay Protocol | Quantitative electrochemiluminescence immunoassay | Same | | Detection Protocol | Electrochemiluminescence | Same | | Applications | 18-minute application | Same | | Assay Comparison | | | | Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) | | General Assay Features | | | | Instrument Platform | cobas e 411, | cobas e 411, Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601 and cobas e 602 | | Sample Volume | 15 µL | Same | | Sample Type | Undiluted human serum and undiluted plasma treated with Li-heparin, K2-EDTA, and K3-EDTA. | Undiluted human serum and undiluted plasma treated with Li-, Na-, NH+4 - heparin, K3-EDTA, sodium citrate, and sodium fluoride/potassium oxalate. | | Reagents | The Elecsys FT4 II assay is a competitive immunoassay which includes a specific polyclonal anti-T4- antibody (sheep) labeled with a sulfonyl-ruthenium complex, thyroxine labeled with biotin and streptavidin coated microparticles. | The Elecsys FT4 assay is a competitive immunoassay which includes a specific anti-T4 antibody labeled with a ruthenium complex, thyroxine labeled with biotin and streptavidin coated microparticles. | | Calibrator | Elecsys FT4 II CalSet, 2 levels | Elecsys FT4 CalSet, 2 levels | | Calibration Interval | Calibration of an Elecsys FT4 II reagent lot is recommended every 28 days. During that time period, fresh reagent kits of the same lot can be used without calibration by using the calibration curve of the Day 0 reagent kit. 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 specified limits | Same | | Controls | Elecsys PreciControl Universal or other suitable control material | Same | | Assay Comparison | | | | Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) | | General Assay Features | | | | Traceability / Standardization | The Elecsys FT4 II Assay has been standardized against the Elecsys FT4 method. The Elecsys FT4 assay is traceable to the Enzymun-Test which was standardized using equilibrium dialysis. | The Elecsys FT4 Assay has been standardized against the Enzymun-Test FT4 method, which was standardized using equilibrium dialysis. | | Reagent Stability | Unopened at 2-8 °C—up to stated expiration date | Same | | | After opening at 2-8 °C—84 days (12 weeks) | Same | | | On the Elecsys and cobas e immunoassay analyzers – 28 days (4 weeks) onboard or 56 days when stored alternatively in the refrigerator and on the analyzer, with the total time onboard the analyzer not exceeding 120 hours. | On the Elecsys and cobas e immunoassay analyzers – 4 weeks onboard | {3}------------------------------------------------ . 4 # 510(k) Summary, continued ## Comparison of Assays-Similarities and Differences, continued {4}------------------------------------------------ ## Comparison of Assays-Similarities and Differences, continued {5}------------------------------------------------ | Assay Comparison | | | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) | | | Labeled Performance Characteristics | | | Measuring Range | 0.1 ng/dL to 7.77 ng/dL (1.3 - 100 pmol/L) | 0.300-100 pmol/L | | Precision | cobas e 411: Within-run (will be labeled Repeatability) n=84, human sera HS 1: 4.0% CV @ 0.138 ng/dL (1.78 pmol/L) HS 2: 1.3% CV @ 1.03 ng/dL (13.3 pmol/L) HS 3: 1.3% CV @ 1.90 ng/dL (24.5 pmol/L) HS 4: 1.7% CV @ 4.93 ng/dL (63.5 pmol/L) HS 5: 1.8% CV @ 7.09 ng/dL (91.2 pmol/L) Total (will be labeled Intermediate) HS 1: 7.6% CV @ 0.138 ng/dL (1.78 pmol/L) HS 2: 2.3% CV @ 1.03 ng/dL (13.3 pmol/L) HS 3: 2.1% CV @ 1.90 ng/dL (24.5 pmol/L) HS 4: 3.3% CV @ 4.93 ng/dL (63.5 pmol/L) HS 5: 4.5% CV @ 7.09 ng/dL (91.2 pmol/L) | Elecsys 2010 and cobas e 411: Within-run (will be labeled Repeatability) n=60, human sera HS 1: 1.6% CV @ 8.7 pmol/L HS 2: 1.7% CV @ 21.1 pmol/L HS 3: 2.9% CV @ 50.8 pmol/L Total (will be labeled Intermediate) HS 1: 3.5% CV @ 8.7 pmol/L HS 2: 3.3% CV @ 21.1 pmol/L HS 3: 6.6% CV @ 50.8 pmol/L MODULAR ANALYTICS E170, cobas e 601 , and cobas e 602: Within-run (will be labeled Repeatability) n=60, human sera HS 1: 1.4% CV @ 9.15 pmol/L HS 2: 1.8% CV @ 16.9 pmol/L HS 3: 2.0% CV @ 34.2 pmol/L Total (will be labeled Intermediate) HS 1: 2.7% CV @ 14.9 pmol/L HS 2: 2.6% CV @ 17.5 pmol/L HS 3: 3.6% CV @ 42.7 pmol/L | | Assay Comparison | | | | Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) | | Analytical Sensitivity | Limit of Blank (LoB): 0.03 ng/dL (0.4 pmol/L) Limit of Detection (LoD): 0.05 ng/dL (0.6 pmol/L) Limit of Quantitation (LoQ) (Functional Sensitivity) 0.1 ng/dL (1.3 pmol/L) with an intermediate precision of ≤ 20% | Lower Detection Limit: 0.300 pmol/L | | Analytical Specificity | Cross Reactant L-T3 D-T3 rT3 3-iodo-L-trosine 3,5-diiodo-L-tyrosine 3,3',5- triiodohyoacetic acid 3,3',5,5'- tetraiodothyroacetic acid | Cross Reactivity (%) L-T4 100 D-T4 100 L-T3 1.53 D-T3 1.38 3-iodo-L-tyrosine 0.002 3,5-diiodo-L-tyrosine 0.01 3,3',5,5;- tetraiodothyroacetic acid 38.5 | | | Cross Reactivity (%) ≤ 0.005 ≤ 0.001 ≤ 0.003 ≤ 0.000 ≤ 0.000 ≤ 0.0002 <0.001 | | | Hook Effect | There is no high-dose hook effect since the Elecsys FT4 II assay is a competitive assay | Same | | 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 IgM < 1 g/dL | The assay is unaffected by: Icterus (bilirubin < 701 µmol/L or < 41 mg/dL) Hemolysis (Hb < 1.2 mmol/L or < 2 g/dL) Lipemia (Intralipid < 2000 mg/dL) Biotin (< 409 nmol/L or < 100 ng/mL) IgG < 7 g/dL IgM < 2 g/dL. | | Characteristic | CalSet for Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) | | Intended Use | Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers. | Same | | Levels | Two | Same | | Matrix | Buffer/protein (bovine serum albumin) matrix | Same | | Format | Liquid | Same | | Stability | Unopened: • Store at 2 - 8°C up to the stated expiration date. After opening/in aliquots: • At 2 - 8°C: 12 weeks • On Elecsys 2010/cobas e 411 at 20°C: Up to 5 hours. • On MODULAR ANALYTICS E170/cobas e 601 and cobas e 602: Use only once. | Same | | Handling | The calibrators are supplied ready-for -use in bottles compatible with the system | Same | ### Comparison of Assays-Similarities and Differences, continued Continued on next page :: {6}------------------------------------------------ ### Comparison of Assays-Similarities and Differences, continued {7}------------------------------------------------ ## 510(k) Summary, continued ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ ### Comparison of Assays-Similarities and Differences, continued {8}------------------------------------------------ . . # 510(k) Summary, continued . | Standard/ Guidance Document Reference | In addition to FDA guidance regarding 510(k) submissions, the following standards were used for the performance studies. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI document EP5-A2, Volume 24, No. 25, August 2004. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition. CLSI document EP 17-A2, Volume 32, No. 8, June 2012. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI document EP6-A, Volume 23, No. 16, April 2003. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition. CLSI document C28-A3c, Volume 28, No. 30, October 2010 (corrected version). | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Studies Summary | The Elecsys FT4 II Assay was evaluated for several performance characteristics, including precision, limit of blank, limit of detection, limit of quantitation, linearity, method comparison, interfering substances, and calibration and reagent stability. There were no modifications to the Elecsys FT4 II CalSet from the Elecsys FT4 CalSet other than the name and catalog number. 1. Precision (CLSI EP5-A2): The precision of the Elecsys FT4 II assay was evaluated on one cobas e 411 Immunoassay Analyzer according to CLSI EP5-A2 guideline. Repeatability and Intermediate precision were calculated according to EP5-A2. The protocol consisted of testing 2 replicates of each human serum sample and control per run, two (2) runs per day (whereas the runs were divided by dummy samples) for 21 days. Specification for Repeatability/within-run precision: Concentrations of ≤ 0.4 ng/dL: SD ≤ 0.02 ng/dL Concentrations of > 0.4-7.77 ng/dL: CV ≤ 5% Specification for Intermediate/within-laboratory precision: Concentrations of ≤ 0.4 ng/dL: SD ≤ 0.03 ng/dL Concentrations of > 0.4-7.77 ng/dL: CV ≤ 8% | {9}------------------------------------------------ Performance Studies Summary, continued The table below summarizes the results of the precision studies performed with the Elecsys FT4 II test system. Based on these data, the precision meets the specifications. | Sample | Mean (ng/dL) | Repeatability | | | Intermediate Precision | | | n | |--------|-----------------|---------------|-----------|-----------------------------|------------------------|-----------|-----------------------------|----| | | | SD (ng/dL) | CV (%) | 95% UCL* (% or ng/dL) | SD (ng/dL) | CV (%) | 95% UCL* (% or ng/dL) | | | PCU 1 | 1.22 | 0.011 | 0.9 | 1.1 | 0.022 | 1.8 | 2.4 | 84 | | PCU 2 | 3.11 | 0.032 | 1.0 | 1.3 | 0.089 | 2.9 | 3.9 | 84 | | HS 1 | 0.138 | 0.006 | 4.0 | 0.007 ng/dL | 0.011 | 7.6 | 0.014 ng/dL | 84 | | HS 2 | 1.03 | 0.013 | 1.3 | 1.6 | 0.023 | 2.3 | 2.9 | 84 | | HS 3 | 1.90 | 0.024 | 1.3 | 1.6 | 0.040 | 2.1 | 2.8 | 84 | | HS 4 | 4.93 | 0.082 | 1.7 | 2.1 | 0.163 | 3.3 | 4.4 | 84 | | HS 5 | 7.09 | 0.127 | 1.8 | 2.3 | 0.319 | 4.5 | 6.2 | 84 | * Upper confidence limit - 2. Limit of Blank (LoB) (CLSI EP17-A2): LoB of the Elecsys FT4 II assay on two cobas e 411 Immunoassay Analyzers has been determined according to CLSI EP17-A2 using three reagent lots. The distribution of values for one analyte-free human serum sample has been determined on two cobas e 411 Immunoassay Analyzers over four days, one or two runs per day with five-fold determination in each run: (total 60 determinations). Since there are no natural human samples without FT4 analyte, the analyte-free sample was created by depleting T4. As the analyzers do not report negative sample concentrations, the data set is truncated and the data were evaluated according to EP17-A2. 5.3.3.1 as the linear interpolation of the 57th and 58th ranked observation. The LoB claim in the package insert will be set to ≤ 0.03 ng/dL. - 3. Limit of Detection (LoD) (CLSI EP17-A2): LoD of the Elecsys FT4 II assay has been determined according to CLSI EP17-A2, 5.3.3.2. The distribution of values for five low-level human serum samples has been determined on two cobas e 411 immunoassay analyzers over four days, one or two runs per day with a single measurement per run. A pooled estimate of the precision (SDota) for the 5 low level samples was calculated: LoD = LoB + 1.653 x SD total (of low analyte samples) The LoD claim in the package insert will be set to ≤ 0.05 ng/dL. {10}------------------------------------------------ 4. LoQ / Functional Sensitivity (CLSI EP17-A2): The LoQ of the Elecsys FT4 II assay was determined on the cobas e 411 immunoassay analyzer according to CLSI Guideline EP17-A2. A Low-Level Sample Set of 8 samples was prepared by diluting native human serum samples with an analyte-free human serum matrix and were tested in single replicates for four days, one or two runs per day on two cobas e 411 immunoassay analyzers. Each run was calibrated separately using a two-point calibration in combination with the master curve stored on the reagent barcode. The Elecsys PreciControl Universal was tested and evaluated for each run to determine assay validity. The mean, standard deviation and coefficient of variation for each sample were calculated. Functional sensitivity as the concentration corresponding to a coefficient of variation of 20% was obtained from plotting the %CV (y-axis) vs. measured FT4 values (x-axis). #### Acceptance criterion: - Interassay coefficient of variation ≤ 20% . The Limit of Quantitation/Functional sensitivity claim in the package insert will be set to 0.1 ng/dL. The following results were obtained: | Lot MP02: | Functional sensitivity = 0.059 ng/dL | |-----------|--------------------------------------| | Lot P2: | Functional sensitivity = 0.069 ng/dL | | Lot P3: | Functional sensitivity = 0.080 ng/dL | {11}------------------------------------------------ ### 510(k) Summary, continued 5. Linearity (CLSI EP6-A): Linearity of the Elecsys FT4 II assay was Performance assessed on the cobas e 411 Immunoassay Analyzer according to CLSI Studies Summary, EP6-A. continued Three high analyte serum sample pools (spiked with L-Thyroxine) were diluted with fT4 depleted human serum. For each sample pool, 13 concentrations (11 dilutions) throughout the measuring range were prepared. Samples were assayed in 3-fold determination within a single run. The linearity data were analyzed with regards to linear, quadratic and cubic polynomials according to CLSI EP6-A. In the first step, a linearity check was performed with a first order (linear) regression and then with higher order models (quadratic and cubic). Acceptance criteria: Significance level for deviation to higher order polynomial: 5% Limits for deviation of higher order polynomial regression: 0.1 - 0.388 ng/dL: -±0.078 ng/dL . > 0.388 -- 7.77 ng/dL: ± 10% Repeatability for linearity: ±0.039 ng/dL 0.1 - 0.388 ng/dL: . ± 5 % > 0.388 - 7.77 ng/dL: . Linearity was confirmed in the range from 0.096 to 8.20 ng/dL 6. Specificity/Cross Reactivity: The specificity of the Elecsys FT4 II assay was determined using native human serum samples or human serum samples spiked with L-Thyroxine (single donors) spiked with potential cross-reactant compounds tested in duplicate on cobas e 411 Immunoassay Analyzer. In the labeling. Roche will report the maximum cross-reactivity found and the highest concentration tested. See table below. | Cross Reactant | Cross Reactivity (%) | |-------------------------------------|----------------------| | L-T3 | ≤ 0.005 | | D-T3 | ≤ 0.001 | | rT3 | ≤ 0.003 | | 3-iodo-L-trosine | ≤ 0.000 | | 3,5-diiodo-L-tyrosine | ≤ 0.000 | | 3,3',5-triiodohyroacetic acid | ≤ 0.000 | | 3,3',5,5'-tetraiodothyroacetic acid | ≤ 0.001 | Continued on next page CONFIDENTIAL {12}------------------------------------------------ 7. Exogenous Interferences - Drugs: 17 pharmaceutical compounds Performance (concentration defined as x times the maximum daily dose according Studies to the SOP) and 12 thyroid drugs and Furosemide were spiked into Summary, human serum samples (human serum pools spiked with L-Thyroxine) continued and tested with the Elecsys FT4 II assay on the cobas e 411 Immunoassay Analyzer. Two samples with approximately1.1 ng/dL and 2.6 ng/dL of fT4 were divided into aliquots and spiked with potential interferents. The reference sample, without interferents, was spiked with the respective amount of solvent only. The fT4 concentration of the spiked aliquots was determined in triplicate and compared to the fT4 concentration determined for the reference aliquot (6-fold determination) on one cobas e 411 Immunoassay Analyzer. Acceptance criterion: 100 ± 10% of the reference value (unspiked sample) Each compound, except Levothyroxine and Furosemide, was found to be non-interfering at the concentration listed below. Levothyroxine and Furosemide will be listed as interfering substances in the "Limitations - Interference" section of the package insert. 8. Exogenous Interferences - Anticoagulants: The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys FT4 II Immunoassay was determined by comparing values obtained from native samples or samples spiked with L-Thyroxine (single donors) drawn into serum, Li-Heparin, K2-EDTA-, and K3-EDTA-plasma primary tubes, and Li-Heparin Plasma Separation Tubes. Between 53 and 63 serum/plasma pairs per sample material were tested in single determination with one reagent lot on one cobas e 411 Immunoassay Analyzer. Potential effects are assessed by Passing/Bablok regression and linear regression analysis. Acceptance criteria: . Slope 0.9 - 1.1 Intercept < ± 0.05 ng/dL Coefficient of correlation r ≥ 0.95 . Continued on next page {13}------------------------------------------------ ### CONFIDENTIAL # 510(k) Summary, continued | Performance Studies Summary, continued | Acceptance criterion for single pairs: • LoD < 0.3 ng/dL: ± 0.05 ng/dL • ≥ 0.3 - 7.77 ng/dL: ± 10 % of reference value Conclusion: The specifications were met for all anti-coagulants. The resulting data support the package insert claim that serum, Li-Heparin, K2-EDTA-, and K3-EDTA-plasma specimens are acceptable sample types for use with the Elecsys FT4 II Immunoassay. | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | 9. Endogenous Interferences: Effect on quantitation of analyte in the presence of endogenous interfering substances using the Elecsys FT4 II Immunoassay was determined on the cobas e 411 Immunoassay Analyzer using pooled human serum samples spiked with L- Thyroxine. For each interfering substance, 3 serum samples containing low, mid, and high concentrations of fT4 were tested. | Acceptance criterion: Recovery of 100 ± 10% of unspiked reference value. | | | | 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. | | | | 10. Method Comparison: A method comparison study was performed to compare the FT4 II assay on the cobas e 411 (Y) with the FT4 assay on the cobas e 411 (X) Immunoassay Analyzer (predicate test system). | | | | A total of 170 human serum samples obtained from serum from commercial vendors or remnant clinical samples with fT4 values from 0.161 - 7.05 ng/dL were measured. Out of the 170 serum samples, 11 samples were spiked with analyte and 4 samples were diluted with an FT4 free serum. The results were calculated using the Passing/Bablok and Linear Regression analysis. | | | | Acceptance criteria for Passing/Bablok regression: Slope: 1.00 ± 0.05 Intercept: ± 0.04 ng/dL Correlation: r ≥ 0.95 Bias at medical decision points: ±10% at 0.93 ng/dL ±10% at 1.7 ng/dL | | | Performance Studies Summary, continued | 11. Calibration Stability: Calibration of an Elecsys FT4 II reagent lot is recommended every 28 days. During that time period, fresh reagent kits of the same lot can be used without calibration by using the calibration curve of the Day 0 reagent kit. | | | | Elecsys FT4 II was calibrated with a fresh reagent kit on Day 0 using a cobas e 411 Immunoassay Analyzer. After 29 days, a new reagent kit of the same lot was used and recovery of samples was determined using the calibration curve of Day 0. Samples tested included five human serum (HS) samples spiked with L-Thyroxine and two controls. Each sample was tested in duplicate. | | | | Acceptance criteria for recovery compared to day 0 value: Concentrations of LoD - 0.3 ng/dL: ± 0.05 ng/dL > 0.3 – 7.77 ng/dL: 100 ± 10 % | | | | 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 specified ● limits | | | | 12. Reagent On-Board Stability: Elecsys FT4 II reagent kits can be stored on board of the analyzers for up to 28 days and for 56 days when stored alternatively in the refrigerator and on the analyzer, with the total time on the analyzer not exceeding 120 hours. A new calibration of the kit kept on-board is recommended every 7 days. | | | | Acceptance criteria for recovery of samples compared to day 1: Concentrations from LoD to 0.3 ng/dL: ± 0.05 ng/dL Concentration of >0.3 to 7.77 ng/dL: 100±10% | | | | 13. Reagent Accelerated Stability: Elecsys FT4 II reagent kits have a shelf life of ≥ 12 months when stored at 2-8°C. | | | | Accelerated reagent stability to estimate real time stability for the Elecsys FT4 II assay was tested on one cobas e 411 Immunoassay Analyzer. | | | | A kit was stored at 35℃ for 3 weeks and recovery of human samples and controls were tested compared to a fresh kit stored at 2-8 ℃. | | | Performance Studies Summary, continued | Samples tested included five human serum (HS) samples spiked with L-Thyroxine, and two controls. Each sample was tested in two-fold determination. | | | | Acceptance criteria for recovery of samples compared to day 0:…

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

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ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

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