(338 days)
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an immunoassay intended to aid in the diagnosis of myocardial infarction by measuring cardiac troponin I, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Elecsys Troponin I and Elecsys Troponin I STAT assays are "intended to aid in the diagnosis of myocardial infarction." This directly indicates a diagnostic purpose.
No
The device description explicitly details physical components like immunoassays, microparticles, lyophilized products (reagents, calibrators, quality controls), and mentions use on specific hardware analyzers (Elecsys and MODULAR Analytics E170). This indicates it is a system involving both hardware and reagents, not solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The text explicitly states "Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD. It also states the assay is "intended to aid in the diagnosis of myocardial infarction," which is a diagnostic purpose.
- Device Description: The description details the components and methodology of an immunoassay designed to analyze biological samples (serum and plasma) outside of the body.
- Calibrators and Controls: The inclusion of calibrators (Elecsys Troponin I CalSet, Elecsys Troponin I STAT CalSet) and quality controls (Elecsys PreciControl Troponin) are standard components of IVD systems used to ensure the accuracy and reliability of the test results.
Therefore, the information provided strongly indicates that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Elecsys Troponin I Immunoassay: Immunoassay for the in vitro 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.
Product codes
MMI, JJY, JIT
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (Elecsys Troponin I STAT Assay):
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
Method Comparison (Elecsys Troponin I STAT Assay):
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
Precision (Elecsys Troponin I Assay):
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
Method Comparison (Elecsys Troponin I Assay):
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Quantitation / Functional Sensitivity:
Elecsys Troponin I STAT Assay: = 0.3 ng/mL at 10% CV
Elecsys Troponin I Assay: 0.3 ng/mL at 10% CV
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| 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. |
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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.
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
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・
| 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 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).
.
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
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| 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 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 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 the | |
| Elecsys Troponin I and Elecsys | ||
| Troponin I STAT immunoassays | ||
| on the Elecsys and MODULAR | ||
| Analytics E170 Analyzers. | Used for quality control of | |
| specified immunoassays on the | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Levels | Two | Two |
| Format | Lyophilized, human serum | Lyophilized, human serum |
| Analyte Concentration | Troponin T: approx. 0.03 ng/mL | |
| and 2.5 ng/mL | ||
| Troponin I: 0.4 ng/mL and 18 | ||
| ng/mL | CK-MB: approx. 5 and 50 ng/ml | |
| Digitoxin: approx 17 and 38 | ||
| ng/mL (not for use in U.S.) | ||
| Digoxin: approx. 1.2 and 3 ng/ml | ||
| Myoglobin: approx. 80 and 1000 | ||
| ng/ml | ||
| NT-proBNP: approx. 0.15 and 5 | ||
| ng/ml | ||
| Stability | Unopened: store at 2 - 8°C up to | |
| expiration date |
Reconstituted:
5 hrs at 20 - 25°C (on analyzer)
4 days at 2 - 8°C
3 months at -20°C (freeze only
once)
After thawing - use only once | Unopened: store at 2 - 8°C up to
expiration date
Reconstituted:
3 hrs at 20 - 25°C (on analyzer)
3 days at 2 - 8°C
3 months at -20°C (freeze only
once)
After thawing - use only once |
| Handling | Dissolve carefully the contents of
one bottle by adding exactly 2.0
mL of distilled water and allow
stand closed for 60 minutes to
reconstitute. Mix carefully,
avoiding the formation of foam | Dissolve carefully the contents of
one bottle by adding exactly 2.0
mL of distilled water and allow
stand closed for 15 minutes to
reconstitute. Mix carefully,
avoiding the formation of foam. |
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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 is | |
| used for calibrating the quantitative | ||
| Elecsys Troponin I assay on the | ||
| Elecsys and MODULAR Analytics | ||
| E170 analyzers. | Used for calibrating the | |
| quantitative Elecsys proBNP II | ||
| assay on Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Levels | Two | Two |
| Format | Lyophilized, human serum | Lyophilized, equine serum |
| Analyte Concentration | Troponin I: 0.4 ng/mL and 30 | |
| ng/mL | proBNP: 16.6 pmol/L and 320 | |
| pmol/L | ||
| Stability | Unopened: | |
| • Store at 2 – 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • 2 – 8°C: 4 days | ||
| • -20°C: 3 months (freeze only | ||
| once) | ||
| • On the Elecsys and | ||
| MODULAR Analytics E170 | ||
| analyzers: use only once | Unopened: | |
| • Store at 2 – 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • 2 – 8°C: 2 weeks | ||
| • -20°C: 3 months (freeze only | ||
| once) | ||
| • On Elecsys 1010/2010 and | ||
| cobas e411 analyzers at 20 – | ||
| 25°C: up to 5 hours | ||
| • On MODULAR ANALYTICS | ||
| E170 and cobas e601 | ||
| analyzers: use only once | ||
| Handling | Dissolve contents of one bottle by | |
| adding exactly 1.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 60 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. | Dissolve contents of one bottle by | |
| adding exactly 1.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 15 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. | ||
| CalSet Comparison | ||
| Characteristic | Elecsys Troponin I STAT CalSet | Elecsys proBNP II CalSet |
| (K072437) Predicate | ||
| Intended Use | The Elecsys Troponin I STAT | |
| CalSet is used for calibrating the | ||
| quantitative Elecsys Troponin I | ||
| STAT assay on the Elecsys | ||
| analyzers. | Used for calibrating the | |
| quantitative Elecsys proBNP II | ||
| assay on Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Levels | Two | Two |
| Analyte Concentration | Troponin I: 0.4 ng/mL and 30 | |
| ng/mL | CK-MB: approx. 5 and 50 ng/ml | |
| Digitoxin: approx 17 and 38 | ||
| ng/mL (not for use in U.S.) | ||
| Digoxin: approx. 1.2 and 3 ng/ml | ||
| Myoglobin: approx. 80 and 1000 | ||
| ng/ml | ||
| NT-proBNP: approx. 0.15 and 5 | ||
| ng/ml | ||
| Format | Lyophilized, human serum | Lyophilized, equine serum |
| Stability | Unopened: | |
| • Store at 2 - 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • 2 - 8°C: 4 days | ||
| • -20°C: 3 months (freeze only | ||
| once) | ||
| • On Elecsys analyzers: up to 5 | ||
| hours | Unopened: | |
| • Store at 2 - 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • 2 - 8°C: 2 weeks | ||
| • -20°C: 3 months (freeze only | ||
| once) | ||
| • On Elecsys 1010/2010 and | ||
| cobas e411 analyzers at 20 – | ||
| 25°C: up to 5 hours | ||
| • On MODULAR ANALYTICS | ||
| E170 and cobas e601 | ||
| analyzers: 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 by | |
| adding exactly 1.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 60 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. | Dissolve contents of one bottle by | |
| adding exactly 1.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 15 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. |
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