(338 days)
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 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.
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.
The provided 510(k) summary for K082699 describes the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays, along with their associated control and calibrator products. The submission aims to demonstrate substantial equivalence to predicate devices. However, it's important to note that this document does not describe acceptance criteria in the traditional sense of performance targets that trigger a pass/fail for a device. Instead, it presents performance data for the device and compares various features to a predicate device to establish substantial equivalence.
Here's an analysis of the provided information, framed to address your questions where applicable, and highlighting what's not explicitly stated in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document doesn't provide explicit "acceptance criteria" for the Elecsys Troponin I assays. It presents performance characteristics and compares them to a predicate device (Beckman Coulter Access AccuTnI Immunoassay, K021814) to establish substantial equivalence. The "reported device performance" columns below are the actual measured values from the studies. The "Acceptance Criteria" cells are left blank as they were not specified in the document.
Elecsys Troponin I STAT Assay (Main Assay)
| Feature | Acceptance Criteria | Reported Device Performance (Elecsys Troponin I STAT Assay) | Reported Predicate Device Performance (Beckman Coulter Access AccuTnI Assay, K021814) |
|---|---|---|---|
| Intended Use / Indication for Use | (Not specified) | Immunoassay for in vitro quantitative determination of cardiac troponin I in human serum and plasma; aids in diagnosis of myocardial infarction. For use on Elecsys analyzers. | Immunoassay for quantitative determination of cTnI in human serum and plasma; aids in diagnosis and treatment of myocardial infarction and cardiac muscle damage; aids in risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes. For use on Access Immunoassay Systems. |
| Assay Protocol | (Not specified) | Sandwich Principle | Sandwich Principle |
| Detection Protocol | (Not specified) | Electrochemiluminescence | Chemiluminescence |
| Traceability / Standardization | (Not specified) | Standardized against the Beckman Coulter Access AccuTnI assay. | Not stated. |
| Calibration Interval | (Not specified) | Once per reagent lot (renewed after 1 month/28 days, or 7 days on analyzer). | Every 56 days. |
| Sample Type | (Not specified) | Human serum and plasma | Human serum and plasma |
| Reagent Stability (Unopened) | (Not specified) | Up to stated expiration date (2-8°C) | Up to stated expiration date (2-8°C) |
| Reagent Stability (After Opening) | (Not specified) | 4 weeks (2-8°C), 2 weeks on analyzers | 56 days (2-10°C) |
| Calibrator | (Not specified) | Elecsys Troponin I STAT CalSet | Access AccuTnI Calibrators |
| Controls | (Not specified) | Elecsys PreciControl Troponin | Commercial control material |
| Expected values (Age 20-79) | (Not specified) | < 0.3 ng/mL (values < 0.3 ng/mL reported as "< 0.3 ng/mL") | 97.5th percentile: 0.03 ng/mL; 99th percentile: 0.04 ng/mL (Age 19-88) |
| Instrument | (Not specified) | Elecsys Analyzers | Access Immunoassay Systems |
| Measuring Range | (Not specified) | 0.30 – 25.00 µg/L (ng/mL) | 0.01 – 100.00 µg/L (ng/mL) |
| Precision (Repeatability) | (Not specified) | US Site 1: 4.8% CV @ 0.323; 3.3% CV @ 0.496; 2.2% CV @ 0.627; 1.7% CV @ 21.400; 4.2% CV @ 0.439; 2.9% CV @ 17.800 ng/mLUS Site 2: 3.0% CV @ 0.483; 3.9% CV @ 0.329; 1.8% CV @ 2.180; 2.1% CV @ 0.691; 4.0% CV @ 0.376; 2.3% CV @ 17.300 ng/mLEU Site 1: 2.5% CV @ 0.447; 4.1% CV @ 0.347; 0.7% CV @ 7.600; 3.1% CV @ 0.498; 2.6% CV @ 0.395; 0.6% CV @ 17.600 ng/mL | 4.03% CV @ 0.56; 3.06% CV @ 7.31; 3.29% CV @ 30.55; 4.42% CV @ 0.42; 3.42% CV @ 1.34 ng/mL |
| Precision (Intermediate) | (Not specified) | US Site 1: 8.9% CV @ 0.323; 5.9% CV @ 0.496; 5.3% CV @ 0.627; 3.2% CV @ 21.400; 6.7% CV @ 0.439; 3.6% CV @ 17.800 ng/mLUS Site 2: 4.0% CV @ 0.483; 5.7% CV @ 0.329; 2.4% CV @ 2.180; 2.9% CV @ 0.691; 5.3% CV @ 0.376; 2.6% CV @ 17.300 ng/mLEU Site 1: 6.1% CV @ 0.447; 8.0% CV @ 0.347; 4.3% CV @ 7.600; 5.4% CV @ 0.498; 4.8% CV @ 0.395; 1.9% CV @ 17.600 ng/mL | Between Run: 2.97% CV @ 0.56; 4.12% CV @ 7.31; 6.07% CV @ 30.55; 2.71% CV @ 0.42; 2.75% CV @ 1.34 ng/mL.Total Imprecision: 5.01% CV @ 0.56; 5.13% CV @ 7.31; 6.90% CV @ 30.55; 5.19% CV @ 0.42; 4.39% CV @ 1.34 ng/mL |
| Cut-off | (Not specified) | 0.3 ng/mL | 0.5 ng/mL |
| Hook Effect (max concentration w/o hook) | (Not specified) | 1,000 ng/mL | 1,920 ng/mL |
| Method Comparison (N, Range, Regression) | (Not specified) | N = 114; Range = 0.35 - 21.54 ng/mLPassing/Bablok: y = 0.7954x + 0.2187, tau = 0.8058Linear Regression: y = 0.7878x + 0.3204, r = 0.9519Deming: 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 (LoB) | (Not specified) | Studies done and LoB is less than LoQ (0.3 ng/mL) | Not given |
| Limit of Detection (LoD) | (Not specified) | Studies done and LoD is less than LoQ (0.3 ng/mL) | = 0.01 ng/mL (LDL) |
| Limit of Quantitation (LoQ) | (Not specified) | = 0.3 ng/mL at 10% CV | = 0.03 ng/mL at 20% CV; = 0.06 ng/mL at 10% CV |
| Limitations | (Not specified) | No interference from bilirubin (< 25 mg/dL), hemoglobin (< 400 mg/dL), Intralipid (< 1500 mg/dL), biotin (< 30 ng/mL), rheumatoid factor (up to 1500 IU/mL). High biotin doses (> 5 mg/day) require 8-hour wait. Rare anti-streptavidin and ruthenium interference. Use with clinical findings. | No interference from bilirubin (up to 40 mg/dL), fibrinogen (up to 1000 mg/dL), triglycerides (up to 1000 mg/dL), hemoglobin (up to 500 mg/dL), human serum albumin (up to 6000 mg/dL). |
Elecsys Troponin I Assay (18 Minute) - (Similar to STAT, but with slight differences in precision and method comparison)
| Feature | Acceptance Criteria | Reported Device Performance (Elecsys Troponin I Assay) | Reported Predicate Device Performance (Beckman Coulter Access AccuTnI Assay, K021814) |
|---|---|---|---|
| Precision (Repeatability) | (Not specified) | 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 | 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 |
| Precision (Intermediate) | (Not specified) | 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 | 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 |
| Method Comparison (N, Range, Regression) | (Not specified) | N = 115; Range = 0.34 - 24.62 ng/mLPassing/Bablok: y = 0.9743x - 0.00172, tau = 0.9616Linear Regression: y = 0.9934x - 0.0623, r = 0.9934Deming 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 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Method Comparison (Elecsys Troponin I STAT Assay): N = 114
- Method Comparison (Elecsys Troponin I Assay): N = 115
- Precision Studies: Not explicitly stated as a single "test set" sample size. The precision studies involved multiple samples at different concentration levels, tested repeatedly (within-run, between-run, between-day) across different sites (US Site 1, US Site 2, EU Site 1). The number of replicates for each sample at each site is not detailed.
- Data Provenance: The document explicitly mentions "US Site 1", "US Site 2", and "EU Site 1" for precision studies, indicating data from both the United States and Europe. The "Method Comparison" studies do not explicitly state the country of origin but are generally part of clinical trials or validation studies related to regulatory submissions. The studies are assumed to be prospective or generated specifically for the submission, but this is not explicitly stated as retrospective or prospective for all data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the 510(k) summary. These are in-vitro diagnostic immunoassays for quantitative determination of a biomarker; the "ground truth" for method comparison is typically the result from a well-established predicate device or a reference method, not established by human experts in the way it would be for an imaging AI device.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for this type of IVD immunoassay. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for quantifying a biomarker in a lab assay. The "gold standard" for comparison is often the predicate device itself or a recognized reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is an in-vitro diagnostic immunoassay, not an AI or imaging device that involves human readers.
6. Standalone Performance
Yes, the performance data presented (precision, linearity, method comparison, limits of detection/quantitation, interference) represents the standalone performance of the Elecsys Troponin I assays themselves. The comparison to the predicate device validates its performance relative to an already marketed and accepted device. Human interaction is limited to operating the analyzer and performing necessary calibration/quality control, not interpreting the results in a "human-in-the-loop" AI context.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Elecsys Troponin I immunoassays is established by:
- Comparison to a Predicate Device: The method comparison studies directly compare the results of the Elecsys assays to the Beckman Coulter Access AccuTnI assay (K021814). This predicate device serves as the de-facto "ground truth" for demonstrating substantial equivalence.
- Analytical Standards: The determination of Limits of Blank (LoB), Limits of Detection (LoD), Limits of Quantitation (LoQ), and precision are based on established statistical methods and analytical standards in laboratory medicine, often using spiked samples or reference materials.
- Clinical Significance: The "expected values" and cut-off levels are derived from population studies and clinical guidelines related to troponin levels in the diagnosis of myocardial infarction.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. For an in-vitro diagnostic immunoassay like the Elecsys Troponin I, the development process involves extensive analytical validation studies, but these are not typically referred to as "training sets" in the AI sense. The document does not specify a "training set" size. The samples used for initial development, optimization, and early validation are not detailed here.
9. How the Ground Truth for the Training Set Was Established
As discussed in point 8, the concept of a "training set" doesn't directly apply here in the AI context. For the analytical validation studies (e.g., precision, linearity), the "ground truth" (or target values) for samples would be established through:
- Gravimetric or Volumetric Preparations: For spiked samples, known concentrations of troponin I would be added to a matrix.
- Reference Methods: Comparison to established, highly accurate reference methods, if available, for specific analytical parameters.
- Predicate Device Results: For method comparison, the results from the predicate device are considered the comparative "truth."
The document does not detail how the "ground truth" for these various analytical studies was established beyond mentioning standardization against the predicate device.
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| 510(k) Summary | AUG 1 9 2009 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521-3338Contact Person: Jane Phillips |
| Date Prepared: 07/09/2009 | |
| Device Name | Proprietary name: 1.) Elecsys® Troponin I Immunoassay2.) Elecsys® Troponin I STAT Immunoassay3.) Elecsys® PreciControl Troponin4.) Elecsys® Troponin I CalSet5.) Elecsys® Troponin I STAT CalSet |
| Common name: 1.) Troponin I Immunoassay2.) Troponin I STAT Immunoassay3.) PreciControl Troponin4.) Troponin I CalSet5.) Troponin I STAT CalSet | |
| Classification name: 1.) Immunoassay Method, Troponin Subunit2.) Immunoassay Method, Troponin Subunit3.) Multi-Analyte Controls, All Kinds (assayed)4.) Calibrator, Secondary5.) Calibrator, Secondary | |
| Description | 1.) The Elecsys Troponin I immunoassay is a two step sandwichimmunoassay with streptavidin microparticles andelectrochemiluminescence detection. Results are determined using acalibration curve that is generated specifically on each instrument by a2 point calibration and a master curve provided with the reagent barcode. |
| 2.) The Elecsys Troponin I STAT immunoassay is a two step sandwichimmunoassay with streptavidin microparticles andelectrochemiluminescence detection. Results are determined using acalibration curve that is generated specifically on each instrument by a2 point calibration and a master curve provided with the reagent barcode. | |
| 3.) The Elecsys PreciControl Troponin is a lyophilized product consistingof human serum with added Troponin T and Troponin I in twoconcentration ranges. During manufacture, the analytes are spikedinto the matrix at the desired concentration levels. | |
| 4.) The Elecsys Troponin I CalSet is a lyophilized product consisting ofhuman serum with added Troponin I in two concentration ranges.During manufacture, the analyte is spiked into the matrix at thedesired concentration levels. | |
| 5.) The Elecsys Troponin I STAT CalSet is a lyophilized productconsisting of human serum with added Troponin I in twoconcentration ranges. During manufacture, the analyte is spiked intothe matrix at the desired concentration levels. | |
| Note: The reagent, calibrator, and quality control materials are all packagedseparately. |
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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.
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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).
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- 3.) Elecsys Troponin I CalSet and Troponin I STAT CalSet are equivalent to Elecsys proBNP II CalSet (K072437).
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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 vitroquantitative determination ofcardiac troponin I in human serumand plasma. The Elecsys TroponinI STAT assay is intended to aid inthe diagnosis of myocardialinfarction.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on the Elecsys analyzers. | The Access AccuTnI assay is aparamagnetic particle,chemiluminescent immunoassayfor the quantitative determinationof cardiac troponin I (cTnI) levelsin human serum and plasma usingthe Access Immunoassay Systemsto aid in the diagnosis andtreatment of myocardial infarctionand cardiac muscle damage.Cardiac troponin I determinationaids in the risk stratification ofpatients with unstable angina ornon-ST segment elevation acutecoronary syndromes with respect torelative risk of mortality,myocardial infarction, or increasedprobability of ischemic eventsrequiring urgent revascularizationprocedures. |
| Assay Protocol | Sandwich Principle | Sandwich Principle |
| Detection Protocol | Electrochemiluminescence | Chemiluminescence |
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
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| Immunoassay, continued | |||
|---|---|---|---|
| Feature | Elecsys Troponin I STAT Assay | Beckman Coulter AccessAccuTnI(K021814) Predicate | |
| Traceability /Standardization | Standardized against the BeckmanCoulter Access AccuTnI assay. | Not stated. | |
| Calibration Interval | Calibration must be performedonce per reagent lot using freshreagent. Renewed calibration:After 1 month (28 days)when using the samereagent lot After 7 days (when usingthe same reagent kit on theanalyzer) | An active calibration curve isrequired for all tests. For theAccess AccuTnI assay, calibrationis required every 56 days. | |
| Sample Type | Human serum and plasma | Human serum and plasma | |
| Reagent Stability | UnopenedUp to stated expiration datestored at 2-8°C After Opening4 weeks at 2-8°C 2 weeks on the analyzers | UnopenedUp to stated expiration datestored at 2-8°C After OpeningStable at 2 – 10°C for 56days 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 < 0.3ng/mL:Values less than 0.3 ng/mL will bereported as "< 0.3 ng/mL". | Age 19 – 88:97.5th percentile: 0.03 ng/mL99th 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 ISTAT Assay | Elecsys Troponin ISTAT Assay | Beckman CoulterAccess AccuTnI(K021814) Predicate |
| Precision | US Site 1Repeatability (within-run)4.8% CV @ 0.323 ng/mL3.3% CV @ 0.496 ng/mL2.2% CV @ 0.627 ng/mL1.7% CV @ 21.400 ng/mL4.2% CV @ 0.439 ng/mL2.9% CV @ 17.800 ng/mLIntermediate Precision(between-run andbetween-day)8.9% CV @ 0.323 ng/mL5.9% CV @ 0.496 ng/mL5.3% CV @ 0.627 ng/mL3.2% CV @ 21.400 ng/mL6.7% CV @ 0.439 ng/mL3.6% CV @ 17.800 ng/mLUS Site 2Repeatability3.0% CV @ 0.483 ng/mL3.9% CV @ 0.329 ng/mL1.8% CV @ 2.180 ng/mL2.1% CV @ 0.691 ng/mL4.0% CV @ 0.376 ng/mL2.3% CV @ 17.300 ng/mLIntermediate Precision4.0% CV @ 0.483 ng/mL5.7% CV @ 0.329 ng/mL2.4% CV @ 2.180 ng/mL2.9% CV @ 0.691 ng/mL5.3% CV @ 0.376 ng/mL2.6% CV @ 17.300 ng/mL | EU Site 1Repeatability2.5% CV @ 0.447 ng/mL4.1% CV @ 0.347 ng/mL0.7% CV @ 7.600 ng/mL3.1% CV @ 0.498 ng/mL2.6% CV @ 0.395 ng/mL0.6% CV @ 17.600 ng/mLIntermediate Precision6.1% CV @ 0.447 ng/mL8.0% CV @ 0.347 ng/mL4.3% CV @ 7.600 ng/mL5.4% CV @ 0.498 ng/mL4.8% CV @ 0.395 ng/mL1.9% CV @ 17.600 ng/mL | Within Run:4.03% CV @ 0.56 ng/mL3.06% CV @ 7.31 ng/mL3.29% CV @ 30.55 ng/mL4.42% CV @ 0.42 ng/mL3.42% CV @ 1.34 ng/mLBetween Run:2.97% CV @ 0.56 ng/mL4.12% CV @ 7.31 ng/mL6.07% CV @ 30.55 ng/mL2.71% CV @ 0.42 ng/mL2.75% CV @ 1.34 ng/mLTotal Imprecision:5.01% CV @ 0.56 ng/mL5.13% CV @ 7.31 ng/mL6.90% CV @ 30.55 ng/mL5.19% CV @ 0.42 ng/mL4.39% CV @ 1.34 ng/mL |
| Immunoassay, continued | |||
| Feature | Elecsys Troponin I STAT Assay | Beckman Coulter AccessAccuTnI(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 = 114Range = 0.35 - 21.54 ng/mLPassing/Bablok:y = 0.7954x + 0.2187tau = 0.8058Linear Regression:y = 0.7878x + 0.3204r = 0.9519Deming:y = 0.8198x + 0.2168r = 0.9465 | N = 157Range = 0.03 - 44.89Intercept = -1.039 ng/mLSlope = 0.932r = 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 |
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| Feature | Elecsys Troponin I STAT Assay | Beckman Coulter AccessAccuTnI(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 |
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Device Comparison -Control
The following table compares the Elecsys Troponin I Assay (18 Minute) with the predicate device (K021814).
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Substantial equivalence – comparison to the predicate device
| Immunoassay | |||
|---|---|---|---|
| Feature | Elecsys Troponin I Assay | Beckman Coulter AccessAccuTnI(K021814) Predicate | |
| Intended Use /Indication for Use | Immunoassay for the in vitroquantitative determination ofcardiac troponin I in human serumand plasma. The Elecsys TroponinI assay is intended to aid in thediagnosis of myocardial infarction.The electrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on the Elecsys andMODULAR Analytics E170immunoassay analyzers. | The Access AccuTnI assay is aparamagnetic particle,chemiluminescent immunoassayfor the quantitative determinationof cardiac troponin I (cTnI) levelsin human serum and plasma usingthe Access Immunoassay Systemsto aid in the diagnosis andtreatment of myocardial infarctionand cardiac muscle damage.Cardiac troponin I determinationaids in the risk stratification ofpatients with unstable angina ornon-ST segment elevation acutecoronary syndromes with respect torelative risk of mortality,myocardial infarction, or increasedprobability of ischemic eventsrequiring urgent revascularizationprocedures. | |
| 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 AccessAccuTnI(K021814) Predicate |
| Traceability /Standardization | Standardized against the BeckmanCoulter Access AccuTnI assay. | Not stated. |
| Calibration Interval | Calibration must be performedonce per reagent lot using freshreagent. Renewed calibration:After 1 month (28 days)when using the samereagent lot After 7 days (when usingthe same reagent kit on theanalyzer) | An active calibration curve isrequired for all tests. For theAccess AccuTnI assay, calibrationis required every 56 days. |
| Sample Type | Human serum and plasma | Human serum and plasma |
| Reagent Stability | UnopenedUp to stated expiration datestored at 2-8°C After Opening 4 weeks at 2-8°C 2 weeks on the analyzers | Unopened Up to stated expiration datestored at 2-8°C After Opening Stable at 2 – 10°C for 56days 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 < 0.3ng/mL: | Age 19 – 88:97.5th percentile: 0.03 ng/mL99th percentile: 0.04 ng/mL |
| Values less than 0.3 ng/mL will bereported as "< 0.3 ng/mL". | ||
| Instrument | Elecsys and MODULAR AnalyticsE170 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 AccessAccuTnI(K021814) Predicate |
| Precision | Repeatability (within run)5.3% CV @ 0.322 ng/mL5.2% CV @ 0.425 ng/mL2.7% CV @ 17.6 ng/mL7.0% CV @ 0.340 ng/mL2.6% CV @ 18.0 ng/mLIntermediate Precision (between-run andbetween-day)8.7% CV @ 0.322 ng/mL7.3% CV @ 0.425 ng/mL4.7% CV @ 17.6 ng/mL8.0% CV @ 0.340 ng/mL4.4% CV @ 18.0 ng/mL | Within Run:4.03% CV @ 0.56 ng/mL3.06% CV @ 7.31 ng/mL3.29% CV @ 30.55 ng/mL4.42% CV @ 0.42 ng/mL3.42% CV @ 1.34 ng/mLBetween Run:2.97% CV @ 0.56 ng/mL4.12% CV @ 7.31 ng/mL6.07% CV @ 30.55 ng/mL2.71% CV @ 0.42 ng/mL2.75% CV @ 1.34 ng/mLTotal Imprecision:5.01% CV @ 0.56 ng/mL5.13% CV @ 7.31 ng/mL6.90% CV @ 30.55 ng/mL5.19% CV @ 0.42 ng/mL4.39% 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 AccessAccuTnI(K021814) Predicate |
| Hook Effect | 1000 ng/mL | 1,920 ng/mL |
| Method Comparison | N = 115Range = 0.34 - 24.62 ng/mLPassing/Bablok:y = 0.9743x - 0.00172tau = 0.9616Linear Regression:y = 0.9934x - 0.0623r = 0.9934Deming Regressiony = 1x - 0.1080r = 0.9971 | N = 157Range = 0.03 - 44.89Intercept = - 1.039 ng/mLSlope = 0.932r = 0.980 |
| Limit of Blank | Studies done and LoB is less thanLoQ (0.3 ng/mL) | Not given |
| Limit of Detection /Analytical Sensitivity | Studies done and LoD is less thanLoQ (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% CV0.06 ng/mL at 10% CV |
.
සිට පිහිටා මෙය සිට ප
{13}------------------------------------------------
| Immunoassay, continued | ||
|---|---|---|
| Feature | Elecsys Troponin I Assay | Beckman Coulter AccessAccuTnI(K021814) Predicate |
| Limitations | • No interference from bilirubinif less than 25 mg/dL• No interference fromhemoglobin if less than 400mg/dL• No interference from Intralipidif less than 1500 mg/dL• No interference from biotin ifless than 30 ng/mL• No interference fromrheumatoid factor up to 1500IU/mL• In patients receiving high biotindoses > 5 mg/day, sampleshould not be taken until 8hours after administration.• Rare occurrence of interferencefrom high titers of anti-streptavidin and ruthenium• Use in conjunction with patientmedical history, clinical examand other findings | • No interference from bilirubinup to 40 mg/dL• No interference from fibrinogenup to 1000 mg/dL• No interference fromtriglycerides up to 1000 mg/dL• No interference fromhemoglobin up to 500 mg/dL• No interference from humanserum albumin up to 6000mg/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 Comparison predicate device (K072437). Control
| PreciControl Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Troponin I | Elecsys PreciControl Cardiac II(K072437) Predicate |
| Intended Use | Used for quality control of theElecsys Troponin I and ElecsysTroponin I STAT immunoassayson the Elecsys and MODULARAnalytics E170 Analyzers. | Used for quality control ofspecified immunoassays on theElecsys and cobas e immunoassayanalyzers. |
| Levels | Two | Two |
| Format | Lyophilized, human serum | Lyophilized, human serum |
| Analyte Concentration | Troponin T: approx. 0.03 ng/mLand 2.5 ng/mLTroponin I: 0.4 ng/mL and 18ng/mL | CK-MB: approx. 5 and 50 ng/mlDigitoxin: approx 17 and 38ng/mL (not for use in U.S.)Digoxin: approx. 1.2 and 3 ng/mlMyoglobin: approx. 80 and 1000ng/mlNT-proBNP: approx. 0.15 and 5ng/ml |
| Stability | Unopened: store at 2 - 8°C up toexpiration dateReconstituted:5 hrs at 20 - 25°C (on analyzer)4 days at 2 - 8°C3 months at -20°C (freeze onlyonce)After thawing - use only once | Unopened: store at 2 - 8°C up toexpiration dateReconstituted:3 hrs at 20 - 25°C (on analyzer)3 days at 2 - 8°C3 months at -20°C (freeze onlyonce)After thawing - use only once |
| Handling | Dissolve carefully the contents ofone bottle by adding exactly 2.0mL of distilled water and allowstand closed for 60 minutes toreconstitute. Mix carefully,avoiding the formation of foam | Dissolve carefully the contents ofone bottle by adding exactly 2.0mL of distilled water and allowstand closed for 15 minutes toreconstitute. Mix carefully,avoiding the formation of foam. |
23
..............
ﺔ
·
{15}------------------------------------------------
The following table compares the Elecsys Troponin I CalSet with the Device Comparison predicate device (K072437). CalSet
| CalSet Comparison | ||
|---|---|---|
| Characteristic | Elecsys Troponin I CalSet | Elecsys proBNP II CalSet(K072437) Predicate |
| Intended Use | The Elecsys Troponin I CalSet isused for calibrating the quantitativeElecsys Troponin I assay on theElecsys and MODULAR AnalyticsE170 analyzers. | Used for calibrating thequantitative Elecsys proBNP IIassay on Elecsys and cobas eimmunoassay analyzers. |
| Levels | Two | Two |
| Format | Lyophilized, human serum | Lyophilized, equine serum |
| Analyte Concentration | Troponin I: 0.4 ng/mL and 30ng/mL | proBNP: 16.6 pmol/L and 320pmol/L |
| Stability | Unopened:• Store at 2 – 8°C until expirationdate.Reconstituted:• 2 – 8°C: 4 days• -20°C: 3 months (freeze onlyonce)• On the Elecsys andMODULAR Analytics E170analyzers: use only once | Unopened:• Store at 2 – 8°C until expirationdate.Reconstituted:• 2 – 8°C: 2 weeks• -20°C: 3 months (freeze onlyonce)• On Elecsys 1010/2010 andcobas e411 analyzers at 20 –25°C: up to 5 hours• On MODULAR ANALYTICSE170 and cobas e601analyzers: use only once |
| Handling | Dissolve contents of one bottle byadding exactly 1.0 mL of distilledwater and allow to stand closed for60 minutes to reconstitute. Mixcarefully, avoiding the formation offoam. | Dissolve contents of one bottle byadding exactly 1.0 mL of distilledwater and allow to stand closed for15 minutes to reconstitute. Mixcarefully, avoiding the formation offoam. |
| CalSet Comparison | ||
| Characteristic | Elecsys Troponin I STAT CalSet | Elecsys proBNP II CalSet(K072437) Predicate |
| Intended Use | The Elecsys Troponin I STATCalSet is used for calibrating thequantitative Elecsys Troponin ISTAT assay on the Elecsysanalyzers. | Used for calibrating thequantitative Elecsys proBNP IIassay on Elecsys and cobas eimmunoassay analyzers. |
| Levels | Two | Two |
| Analyte Concentration | Troponin I: 0.4 ng/mL and 30ng/mL | CK-MB: approx. 5 and 50 ng/mlDigitoxin: approx 17 and 38ng/mL (not for use in U.S.)Digoxin: approx. 1.2 and 3 ng/mlMyoglobin: approx. 80 and 1000ng/mlNT-proBNP: approx. 0.15 and 5ng/ml |
| Format | Lyophilized, human serum | Lyophilized, equine serum |
| Stability | Unopened:• Store at 2 - 8°C until expirationdate.Reconstituted:• 2 - 8°C: 4 days• -20°C: 3 months (freeze onlyonce)• On Elecsys analyzers: up to 5hours | Unopened:• Store at 2 - 8°C until expirationdate.Reconstituted:• 2 - 8°C: 2 weeks• -20°C: 3 months (freeze onlyonce)• On Elecsys 1010/2010 andcobas e411 analyzers at 20 –25°C: up to 5 hours• On MODULAR ANALYTICSE170 and cobas e601analyzers: use only once |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
{16}------------------------------------------------
The following table compares the Elecsys Troponin I STAT CalSet with Device Comparison STAT CalSet the predicate device (K072437).
{17}------------------------------------------------
0
The following table compares the Elecsys Troponin I STAT CalSet with Device Comparison the predicate device (K072437). STAT CalSet
.
| CalSet Comparison, continued | ||
|---|---|---|
| Characteristic | Elecsys Troponin I STAT CalSet | Elecsys proBNP II CalSet(K072437) Predicate |
| Handling | Dissolve contents of one bottle byadding exactly 1.0 mL of distilledwater and allow to stand closed for60 minutes to reconstitute. Mixcarefully, avoiding the formation offoam. | Dissolve contents of one bottle byadding exactly 1.0 mL of distilledwater and allow to stand closed for15 minutes to reconstitute. Mixcarefully, avoiding the formation offoam. |
1 - 1992 2017
{18}------------------------------------------------
Public Health Service
Image /page/18/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is smaller than the central symbol.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 1 9 2009
Re: K082699
Roche Diagnostics
c/o Dr. Jane Phillips
9115 Hague Road Indianapolis, IN 46250
Centralized Diagnostics
Regulatory Affairs Principal
Trade Name: Roche Elecsys® Troponin I Immunoassay, Roche Elecsys® Troponin I STAT Immunoassay, Roche Elecsys® PreciControl Troponin. Roche Elecsys® Troponin I CalSet, Roche Elecsys® Troponin I STAT CalSet Regulation Number: 21 CFR $862.1215
Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test Regulatory Class: Class II
Product Codes: MMI, JJY, JIT
Dated: June 17, 2009
Received: June 18, 2009
Dear Dr. Phillips:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{19}------------------------------------------------
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{20}------------------------------------------------
Indications for Use - Elecsys Troponin I Immunoassay
510(k) Number: 082699
Device Name: Elecsys Troponin I Immunoassay
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.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Bowen
510(k) K082699
Page 1 of 5
{21}------------------------------------------------
Indications for Use - Elecsys Troponin I STAT Immunoassay
510(k) Number: 082699
Device Name: Elecsys Troponin I STAT Immunoassay
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.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
510(k) K082699
Page 2 of 5
{22}------------------------------------------------
Indications for Use - Elecsys PreciControl Troponin
510(k) Number: 082699
Device Name: Elecsys PreciControl Troponin
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.
Prescription Use ____XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
510(k) K082699
Page 3 of 5
{23}------------------------------------------------
Indications for Use - Elecsys Troponin I CalSet
510(k) Number: 082699
Device Name: Elecsys Troponin I CalSet
Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the Elecsys and MODULAR Analytics E170 analyzers.
Prescription Use __ XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use . (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
510(k) K082699
Page 4 of 5
{24}------------------------------------------------
Indications for Use – Elecsys Troponin I STAT CalSet
510(k) Number: 082699
Device Name: Elecsys Troponin I STAT CalSet
Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
510(k) K082699
Page 5 of 5
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.