Who is the manufacturer of ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS?

Roche Diagnostics filed the 510(k) submission for ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS (K082699).

What is the FDA product code for ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS?

MMI. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS?

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

What are the predicate devices for ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS?

Beckman Coulter Access AccuTnI Immunoassay (K021814); Elecsys PreciControl Cardiac II (K072437); Elecsys proBNP II CalSet (K072437).

Who can help prepare an FDA 510(k) submission like ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS?

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 TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

K082699 · Roche Diagnostics · MMI · Aug 19, 2009 · Clinical Chemistry

Device Facts

Record ID	K082699
Device Name	ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
Applicant	Roche Diagnostics
Product Code	MMI · Clinical Chemistry
Decision Date	Aug 19, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

Elecsys Troponin I Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers. Elecsys Troponin I STAT Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers. Elecsys PreciControl Troponin: The Elecsys PreciControl Troponin I used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and MODULAR Analytics E170 Analyzers. Elecsys Troponin I CalSet: The Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the MODULAR ANALYTICS E170 analyzers. Elecsys Troponin I STAT CalSet: The Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers.

Device Story

The Elecsys Troponin I and Troponin I STAT immunoassays are two-step sandwich immunoassays utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. The device processes human serum or plasma samples on Elecsys or MODULAR Analytics E170 analyzers. Calibration is performed using a 2-point calibration curve and a master curve provided via reagent barcode. The system produces quantitative Troponin I concentration results (ng/mL). These results are used by clinicians in conjunction with patient medical history and clinical examinations to aid in the diagnosis of myocardial infarction. The device is intended for use in clinical laboratory settings by trained laboratory personnel.

Clinical Evidence

Prospective study of 402 patients (chest pain, 24h duration) across 5 sites. AMI diagnosis based on ESC/AHA/ACC criteria. Overall sensitivity 90.11% (95% CI: 82.26-94.71%) and specificity 97.75% (95% CI: 95.43-98.91%). Cut-off study (n=358) used ROC analysis to establish 0.3 ng/mL threshold (AUC 0.9565). Reference range study (n=1,137 healthy individuals) confirmed levels < 0.3 ng/mL.

Technological Characteristics

Two-step sandwich immunoassay; streptavidin-coated microparticles; electrochemiluminescence (ECLIA) detection. Reagents, calibrators, and controls are lyophilized human serum-based products. Analyzers: Elecsys and MODULAR Analytics E170. Connectivity: Automated analyzer-based. Calibration: 2-point calibration with master curve via barcode.

Indications for Use

Indicated for in vitro quantitative determination of cardiac troponin I in human serum and plasma to aid in the diagnosis of myocardial infarction. For use by clinicians in prescription settings.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

Beckman Coulter Access AccuTnI Immunoassay (K021814)
Elecsys PreciControl Cardiac II (K072437)
Elecsys proBNP II CalSet (K072437)

Related Devices

K984105 — ELECSYS TROPONIN T STAT TEST · Boehringer Mannheim Corp. · Dec 8, 1998
K202525 — Alinity i STAT High Sensitivity Troponin-I · Abbott Laboratories Diagnostics Division · May 19, 2022
K162895 — Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 · Roche Diagnostics · Jan 18, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ K082699 | 510(k) Summary | AUG 1 9 2009 | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 (317) 521-3338 Contact Person: Jane Phillips | | | Date Prepared: 07/09/2009 | | Device Name | Proprietary name: 1.) Elecsys® Troponin I Immunoassay 2.) Elecsys® Troponin I STAT Immunoassay 3.) Elecsys® PreciControl Troponin 4.) Elecsys® Troponin I CalSet 5.) Elecsys® Troponin I STAT CalSet | | | Common name: 1.) Troponin I Immunoassay 2.) Troponin I STAT Immunoassay 3.) PreciControl Troponin 4.) Troponin I CalSet 5.) Troponin I STAT CalSet | | | Classification name: 1.) Immunoassay Method, Troponin Subunit 2.) Immunoassay Method, Troponin Subunit 3.) Multi-Analyte Controls, All Kinds (assayed) 4.) Calibrator, Secondary 5.) Calibrator, Secondary | | Description | 1.) The Elecsys Troponin I immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. | | | 2.) The Elecsys Troponin I STAT immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. | | | 3.) The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added Troponin T and Troponin I in two concentration ranges. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. | | | 4.) The Elecsys Troponin I CalSet is a lyophilized product consisting of human serum with added Troponin I in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | | | 5.) The Elecsys Troponin I STAT CalSet is a lyophilized product consisting of human serum with added Troponin I in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | | | Note: The reagent, calibrator, and quality control materials are all packaged separately. | のお気になる。・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ {1}------------------------------------------------ i - . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ · . , . . . . : 上一篇: . . {2}------------------------------------------------ Intended Use / Elecsys Troponin I Immunoassay: Immunoassay for the in vitro Indications for quantitative determination of cardiac troponin I in human serum and plasma. Use The Elecsys Troponin I assay is intended to aid in the diagnosis of myocardial infarction. > The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers. Elecsys Troponin I STAT Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers. Elecsys PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and MODULAR Analytics E170 Analyzers. The Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the Elecsys and MODULAR Analytics E170 analyzers. The Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers. {3}------------------------------------------------ Substantial equivalence The Elecsys Troponin I and Troponin I STAT Test Systems are substantially equivalent to other devices legally marketed in the United States. - 1.). Elecsys Troponin I and Troponin I STAT Immunoassays are equivalent to the Beckman Coulter Access AccuTnI Immunoassay (K021814). - 2.) Elecsys PreciControl Troponin is equivalent to Elecsys PreciControl Cardiac II (K072437). 42 - 3.) Elecsys Troponin I CalSet and Troponin I STAT CalSet are equivalent to Elecsys proBNP II CalSet (K072437). {4}------------------------------------------------ Device Comparison -Immunoassay The following table compares the Elecsys Troponin I STAT test system with the predicate device (K021814). #### Substantial equivalence – comparison to the predicate device | Feature | Immunoassay | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Elecsys Troponin I STAT Assay | Beckman Coulter Access | | | | AccuTnI | | | | (K021814) Predicate | | Intended Use / Indication for Use | Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers. | The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures. | | Assay Protocol | Sandwich Principle | Sandwich Principle | | Detection Protocol | Electrochemiluminescence | Chemiluminescence | • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • {5}------------------------------------------------ . ・ | Immunoassay, continued | | | | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Troponin I STAT Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | | Traceability / Standardization | Standardized against the Beckman Coulter Access AccuTnI assay. | Not stated. | | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent. Renewed calibration: After 1 month (28 days) when using the same reagent lot After 7 days (when using the same reagent kit on the analyzer) | An active calibration curve is required for all tests. For the Access AccuTnI assay, calibration is required every 56 days. | | | Sample Type | Human serum and plasma | Human serum and plasma | | | Reagent Stability | Unopened Up to stated expiration date stored at 2-8°C After Opening 4 weeks at 2-8°C 2 weeks on the analyzers | Unopened Up to stated expiration date stored at 2-8°C After Opening Stable at 2 – 10°C for 56 days after initial use | | | Calibrator | Elecsys Troponin I STAT CalSet | Access AccuTnI Calibrators | | | Controls | Elecsys PreciControl Troponin | Commercial control material | | | Expected values | Age 20 – 79, expected value < 0.3 ng/mL: Values less than 0.3 ng/mL will be reported as "< 0.3 ng/mL". | Age 19 – 88: 97.5th percentile: 0.03 ng/mL 99th percentile: 0.04 ng/mL | | | Instrument | Elecsys Analyzers | Access Immunoassay Systems | | | Measuring Range | 0.30 – 25.00 µg/L (ng/mL) | 0.01 – 100.00 µg/L (ng/mL) | | | Feature | Elecsys Troponin I STAT Assay | Elecsys Troponin I STAT Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | Precision | US Site 1 Repeatability (within-run) 4.8% CV @ 0.323 ng/mL 3.3% CV @ 0.496 ng/mL 2.2% CV @ 0.627 ng/mL 1.7% CV @ 21.400 ng/mL 4.2% CV @ 0.439 ng/mL 2.9% CV @ 17.800 ng/mL Intermediate Precision (between-run and between-day) 8.9% CV @ 0.323 ng/mL 5.9% CV @ 0.496 ng/mL 5.3% CV @ 0.627 ng/mL 3.2% CV @ 21.400 ng/mL 6.7% CV @ 0.439 ng/mL 3.6% CV @ 17.800 ng/mL US Site 2 Repeatability 3.0% CV @ 0.483 ng/mL 3.9% CV @ 0.329 ng/mL 1.8% CV @ 2.180 ng/mL 2.1% CV @ 0.691 ng/mL 4.0% CV @ 0.376 ng/mL 2.3% CV @ 17.300 ng/mL Intermediate Precision 4.0% CV @ 0.483 ng/mL 5.7% CV @ 0.329 ng/mL 2.4% CV @ 2.180 ng/mL 2.9% CV @ 0.691 ng/mL 5.3% CV @ 0.376 ng/mL 2.6% CV @ 17.300 ng/mL | EU Site 1 Repeatability 2.5% CV @ 0.447 ng/mL 4.1% CV @ 0.347 ng/mL 0.7% CV @ 7.600 ng/mL 3.1% CV @ 0.498 ng/mL 2.6% CV @ 0.395 ng/mL 0.6% CV @ 17.600 ng/mL Intermediate Precision 6.1% CV @ 0.447 ng/mL 8.0% CV @ 0.347 ng/mL 4.3% CV @ 7.600 ng/mL 5.4% CV @ 0.498 ng/mL 4.8% CV @ 0.395 ng/mL 1.9% CV @ 17.600 ng/mL | Within Run: 4.03% CV @ 0.56 ng/mL 3.06% CV @ 7.31 ng/mL 3.29% CV @ 30.55 ng/mL 4.42% CV @ 0.42 ng/mL 3.42% CV @ 1.34 ng/mL Between Run: 2.97% CV @ 0.56 ng/mL 4.12% CV @ 7.31 ng/mL 6.07% CV @ 30.55 ng/mL 2.71% CV @ 0.42 ng/mL 2.75% CV @ 1.34 ng/mL Total Imprecision: 5.01% CV @ 0.56 ng/mL 5.13% CV @ 7.31 ng/mL 6.90% CV @ 30.55 ng/mL 5.19% CV @ 0.42 ng/mL 4.39% CV @ 1.34 ng/mL | | Immunoassay, continued | | | | | Feature | Elecsys Troponin I STAT Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | | Cut-off | 0.3 ng/mL | 0.5 ng/mL | | | Hook Effect | 1,000 ng/mL | 1,920 ng/mL | | | Method Comparison | N = 114 Range = 0.35 - 21.54 ng/mL Passing/Bablok: y = 0.7954x + 0.2187 tau = 0.8058 Linear Regression: y = 0.7878x + 0.3204 r = 0.9519 Deming: y = 0.8198x + 0.2168 r = 0.9465 | N = 157 Range = 0.03 - 44.89 Intercept = -1.039 ng/mL Slope = 0.932 r = 0.980 | | | Limit of Blank | Studies done and LoB is less than LoQ (0.3 ng/mL) | Not given | | | Limit of Detection / Analytical Sensitivity | Studies done and LoB is less than LoQ (0.3 ng/mL) | = 0.01 ng/mL (LDL) | | | Limit of Quantitation / Functional Sensitivity | = 0.3 ng/mL at 10% CV | = 0.03 ng/mL at 20% CV = 0.06 ng/mL at 10% CV | | and the state of the state of the states of the states 44 ୍ର ପ୍ରଦାନ . {6}------------------------------------------------ : . : 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 and the control control control of the control of ・ {7}------------------------------------------------ The state to the trade to the states in the series {8}------------------------------------------------ , . | Feature | Elecsys Troponin I STAT Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | |-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Limitations | No interference from bilirubin if less than 25 mg/dL No interference from hemoglobin if less than 400 mg/dL No interference from Intralipid if less than 1500 mg/dL No interference from biotin if less than 30 ng/mL No interference from rheumatoid factor up to 1500 IU/mL In patients receiving high biotin doses > 5 mg/day, sample should not be taken until 8 hours after administration. Rare occurrence of interference from high titers of anti-streptavidin and ruthenium Use in conjunction with patient medical history, clinical exam and other findings | No interference from bilirubin up to 40 mg/dL No interference from fibrinogen up to 1000 mg/dL No interference from triglycerides up to 1000 mg/dL No interference from hemoglobin up to 500 mg/dL No interference from human serum albumin up to 6000 mg/dL | . and the same of the same of the same of the same of the same of the same of the same of the same of the seat of the seat of the seat of the seat of the seat of the seat of th 47 ート・・・・・ . {9}------------------------------------------------ Device Comparison -Control The following table compares the Elecsys Troponin I Assay (18 Minute) with the predicate device (K021814). . #### Substantial equivalence – comparison to the predicate device | | Immunoassay | | | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Feature | Elecsys Troponin I Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | | Intended Use / Indication for Use | Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers. | The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures. | | | Assay Protocol | Sandwich Principle | Sandwich Principle | | | Detection Protocol | Electrochemiluminescence | Chemiluminescence | | 48 … "はなかな {10}------------------------------------------------ · | | Immunoassay, continued | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Troponin I Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | Traceability / Standardization | Standardized against the Beckman Coulter Access AccuTnI assay. | Not stated. | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent. Renewed calibration: After 1 month (28 days) when using the same reagent lot After 7 days (when using the same reagent kit on the analyzer) | An active calibration curve is required for all tests. For the Access AccuTnI assay, calibration is required every 56 days. | | Sample Type | Human serum and plasma | Human serum and plasma | | Reagent Stability | Unopened Up to stated expiration date stored at 2-8°C After Opening 4 weeks at 2-8°C 2 weeks on the analyzers | Unopened Up to stated expiration date stored at 2-8°C After Opening Stable at 2 – 10°C for 56 days after initial use | | Calibrator | Elecsys Troponin I CalSet | Access AccuTnI Calibrators | | Controls | Elecsys PreciControl Troponin | Commercial control material | | Expected values | Age 20 – 79 expected value < 0.3 ng/mL: | Age 19 – 88: 97.5th percentile: 0.03 ng/mL 99th percentile: 0.04 ng/mL | | | Values less than 0.3 ng/mL will be reported as "< 0.3 ng/mL". | | | Instrument | Elecsys and MODULAR Analytics E170 Analyzers | Access Immunoassay Systems | | Measuring Range | 0.30 – 25.00 µg/L (ng/mL) | 0.01 – 100 µg/L (ng/mL) | and the comments of the comments of the comments of : : 49 . ਵਿੱਚ ਇੱਕ ਸਾਹਿਤ ਕਾਲ ਵਿੱਚ ਸੰਗ੍ਰਾਨ ਵਿੱਚ ਇੱਕ ਸਿੰਘ ਸੀ। ਉਹ ਸੀ। ਉਹ ਇੱਕ ਸਿੰਘ ਸੀ। ਉਹ ਸੀ। ਉਹ ਸਾਲ ਵਿੱਚ ਇੱਕ ਸਿੰਘ ਸੀ। ਉਸ ਦੀ ਸਾਲ ਵਿੱਚ ਇੱਕ ਸਿੰਘ ਸੀ। ਉਸ ਦੀ ਸਾਲ ਵਿੱਚ ਇੱਕ ਸਿੰਘ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ . : 上一篇: 上一篇: {11}------------------------------------------------ 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - | Immunoassay, continued | | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Troponin I Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | Precision | Repeatability (within run) 5.3% CV @ 0.322 ng/mL 5.2% CV @ 0.425 ng/mL 2.7% CV @ 17.6 ng/mL 7.0% CV @ 0.340 ng/mL 2.6% CV @ 18.0 ng/mL Intermediate Precision (between-run and between-day) 8.7% CV @ 0.322 ng/mL 7.3% CV @ 0.425 ng/mL 4.7% CV @ 17.6 ng/mL 8.0% CV @ 0.340 ng/mL 4.4% CV @ 18.0 ng/mL | Within Run: 4.03% CV @ 0.56 ng/mL 3.06% CV @ 7.31 ng/mL 3.29% CV @ 30.55 ng/mL 4.42% CV @ 0.42 ng/mL 3.42% CV @ 1.34 ng/mL Between Run: 2.97% CV @ 0.56 ng/mL 4.12% CV @ 7.31 ng/mL 6.07% CV @ 30.55 ng/mL 2.71% CV @ 0.42 ng/mL 2.75% CV @ 1.34 ng/mL Total Imprecision: 5.01% CV @ 0.56 ng/mL 5.13% CV @ 7.31 ng/mL 6.90% CV @ 30.55 ng/mL 5.19% CV @ 0.42 ng/mL 4.39% CV @ 1.34 ng/mL | | Cut-off | 0.3 ng/mL | 0.5 ng/mL | · . . . ・ : a produktion and the second secondo 11 - 11 - 11 {12}------------------------------------------------ 100 - 100 - | Immunoassay, continued | | | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Feature | Elecsys Troponin I Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | Hook Effect | 1000 ng/mL | 1,920 ng/mL | | Method Comparison | N = 115 Range = 0.34 - 24.62 ng/mL Passing/Bablok: y = 0.9743x - 0.00172 tau = 0.9616 Linear Regression: y = 0.9934x - 0.0623 r = 0.9934 Deming Regression y = 1x - 0.1080 r = 0.9971 | N = 157 Range = 0.03 - 44.89 Intercept = - 1.039 ng/mL Slope = 0.932 r = 0.980 | | Limit of Blank | Studies done and LoB is less than LoQ (0.3 ng/mL) | Not given | | Limit of Detection / Analytical Sensitivity | Studies done and LoD is less than LoQ (0.3 ng/mL) | 0.01 ng/mL (LDL) | | Limit of Quantitation / Functional Sensitivity | 0.3 ng/mL at 10% CV | 0.03 ng/mL at 20% CV 0.06 ng/mL at 10% CV | . සිට පිහිටා මෙය සිට ප {13}------------------------------------------------ | Immunoassay, continued | | | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Troponin I Assay | Beckman Coulter Access AccuTnI (K021814) Predicate | | Limitations | • No interference from bilirubin if less than 25 mg/dL • No interference from hemoglobin if less than 400 mg/dL • No interference from Intralipid if less than 1500 mg/dL • No interference from biotin if less than 30 ng/mL • No interference from rheumatoid factor up to 1500 IU/mL • In patients receiving high biotin doses > 5 mg/day, sample should not be taken until 8 hours after administration. • Rare occurrence of interference from high titers of anti- streptavidin and ruthenium • Use in conjunction with patient medical history, clinical exam and other findings | • No interference from bilirubin up to 40 mg/dL • No interference from fibrinogen up to 1000 mg/dL • No interference from triglycerides up to 1000 mg/dL • No interference from hemoglobin up to 500 mg/dL • No interference from human serum albumin up to 6000 mg/dL | 52 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 100 million and the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the . . . . 1000 - 1000 {14}------------------------------------------------ The following table compares the Elecsys PreciControl Troponin with the Device…

ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

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Device Story

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Technological Characteristics

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ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

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Device Story

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