(345 days)
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.
1. Table of Acceptance Criteria and the Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Elecsys Myoglobin STAT assay K983176 Performance) | Reported Device Performance (Elecsys Myoglobin and Myoglobin STAT) |
|---|---|---|
| Measuring Range | 15-3000 ng/mL | 21-3000 ng/mL |
| Expected values (Men) | < 72 ng/ml | 28-72 ng/ml |
| Expected values (Women) | < 51 ng/ml | 25-58 ng/ml |
| Repeatability (Myoglobin assay) | ||
| @ 32.0 ng/mL | N/A (Predicate points are different) | 2.0% CV |
| @ 87.0 ng/mL | N/A (Predicate points are different) | 1.0% CV |
| @ 1020 ng/mL | N/A (Predicate points are different) | 1.8% CV |
| @ 1194 ng/mL | N/A (Predicate points are different) | 1.1% CV |
| @ 2474 ng/mL | N/A (Predicate points are different) | 1.8% CV |
| Repeatability (Myoglobin STAT assay) | ||
| @ 33.9 ng/mL | N/A (Predicate points are different) | 1.7% CV |
| @ 90.1 ng/mL | N/A (Predicate points are different) | 1.2% CV |
| @ 1016 ng/mL | N/A (Predicate points are different) | 1.8% CV |
| @ 1171 ng/mL | N/A (Predicate points are different) | 1.1% CV |
| @ 2468 ng/mL | N/A (Predicate points are different) | 2.2% CV |
| Repeatability (Predicate) | ||
| @ 43.0 ng/mL | 2.1% CV | N/A |
| @ 82.5 ng/mL | 1.3% CV | N/A |
| @ 237 ng/mL | 2.9% CV | N/A |
| @ 523 ng/mL | 2.9% CV | N/A |
| @ 672 ng/mL | 1.9% CV | N/A |
| @ 1147 ng/mL | 3.4% CV | N/A |
| @ 3056 ng/mL | 5.3% CV | N/A |
| Intermediate Precision (Total) (Myoglobin assay) | ||
| @ 32.0 ng/mL | N/A | 2.3% CV |
| @ 87.0 ng/mL | N/A | 1.5% CV |
| @ 1020 ng/mL | N/A | 2.5% CV |
| @ 1194 ng/mL | N/A | 1.8% CV |
| @ 2474 ng/mL | N/A | 2.2% CV |
| Intermediate Precision (Total) (Myoglobin STAT assay) | ||
| @ 33.9 ng/mL | N/A | 2.1% CV |
| @ 90.1 ng/mL | N/A | 1.3% CV |
| @ 1016 ng/mL | N/A | 2.2% CV |
| @ 1171 ng/mL | N/A | 1.3% CV |
| @ 2468 ng/mL | N/A | 2.6% CV |
| Intermediate Precision (Total) (Predicate) | ||
| @ 43.0 ng/mL | 2.6% CV | N/A |
| @ 82.5 ng/mL | 1.6% CV | N/A |
| @ 237 ng/mL | 3.6% CV | N/A |
| @ 523 ng/mL | 3.8% CV | N/A |
| @ 672 ng/mL | 2.3% CV | N/A |
| @ 1147 ng/mL | 4.0% CV | N/A |
| @ 3056 ng/mL | 6.7% CV | N/A |
| Method Comparison (Myoglobin assay vs. Predicate) | ||
| N | N/A | 129 |
| Range | N/A | 24 to 2945 |
| Passing/Bablok Slope | 1.01 (Predicate to its comparator) | 1.03 |
| Passing/Bablok Intercept | -0.135 (Predicate to its comparator) | 6.26 |
| Passing/Bablok r | 0.996 (Predicate to its comparator) | 0.987 |
| Linear Regression Slope | 0.997 (Predicate to its comparator) | 1.02 |
| Linear Regression Intercept | 1.284 (Predicate to its comparator) | 14.5 |
| Linear Regression r | 0.996 (Predicate to its comparator) | 0.999 |
| Deming Regression Slope | N/A | 1.00 |
| Deming Regression Intercept | N/A | 13.9 |
| Deming Regression r | N/A | 0.999 |
| Method Comparison (Myoglobin STAT assay vs. Predicate) | ||
| N | N/A | 139 |
| Range | N/A | 23 to 2523 |
| Passing/Bablok Slope | 1.01 (Predicate to its comparator) | 1.04 |
| Passing/Bablok Intercept | -0.135 (Predicate to its comparator) | -2.08 |
| Passing/Bablok r | 0.996 (Predicate to its comparator) | 0.955 |
| Linear Regression Slope | 0.997 (Predicate to its comparator) | 1.08 |
| Linear Regression Intercept | 1.284 (Predicate to its comparator) | -9.60 |
| Linear Regression r | 0.996 (Predicate to its comparator) | 0.988 |
| Deming Regression Slope | N/A | 1.09 |
| Deming Regression Intercept | N/A | -14.6 |
| Deming Regression r | N/A | 0.997 |
| Limit of Blank | Not Reported for predicate | 18 ng/mL |
| Limit of Detection | 21 ng/mL | 21 ng/mL |
| Limit of Quantitation | Not Reported for predicate | 25 ng/mL |
| Interferences (limitations) | Hemolytic: no effect up to 1.4 g/dL, Biotin: no effect up to 50 ng/mL, Lipemia: no effect up to 2200 mg/dL, Bilirubin: no effect up to 65 mg/dL, Rheumatoid factor: no effect up to 1500 IU/mL | Same as predicate |
Note: For the purpose of substantial equivalence, the reported device performance of the new assays is compared to the performance characteristics of the predicate device. Where specific acceptance criteria are not explicitly stated, the presented predicate device's performance often implicitly serves as the benchmark for demonstrating comparable characteristics.
2. Sample sizes used for the test set and the data provenance
- Method Comparison (Myoglobin assay): N = 129 samples were used for the test set.
- Method Comparison (Myoglobin STAT assay): N = 139 samples were used for the test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given it's a submission for an IVD device, the data for performance characteristics would typically be generated in controlled laboratory settings through prospective testing of manufactured lots and clinical sample comparisons.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For an in vitro diagnostic (IVD) immunoassay, "ground truth" is typically established by reference methods, comparison with a predicate device, or established scientific principles and accepted standards for analyte detection and quantification, rather than expert human interpretation of imaging or clinical data. The study primarily compares the performance of the new device to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology images) where human readers may disagree. For an immunoassay, the "ground truth" for comparison is based on quantitative measurements from established methods or the predicate device, not human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is an immunoassay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool for human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are for the standalone performance of the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay systems. The reported results (e.g., precision, method comparison, limit of detection) reflect the performance of the assay and analyzer without human interpretation of the final quantitative result. Humans are involved in operating the analyzer and interpreting the numerical output, but the "performance" described is the analytical performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance characteristics presented is primarily based on:
- Comparison to a predicate device: The Elecsys Myoglobin STAT assay (K983176) serves as the primary comparator.
- Internal reference preparations/standards: The Myoglobin STAT assay traceability is against an in-house reference preparation.
- Calibrated methods: The predicate device was calibrated against Tina-quant Myoglobin, which in turn was calibrated against a nephelometric method.
- Defined analytical methods: E.g., for precision, the coefficient of variation (CV) is calculated based on repeated measurements of control samples or patient samples. For method comparison, it refers to the correlation and agreement with the predicate device's quantitative measurements.
8. The sample size for the training set
This document does not specify a "training set" in the context of machine learning or AI algorithms. For an immunoassay, the development involves optimization of reagents, antibodies, and protocols, often using a large number of samples for validation and calibration curve generation. The provided sample sizes relate to the evaluation of performance characteristics (e.g., N=129 and N=139 for method comparison studies) and are equivalent to "test sets" for analytical validation.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML sense, this question is not directly applicable. For the development and calibration of the immunoassay, the "ground truth" for defining the calibration curve and ensuring accurate quantification would be established through a rigorous process involving:
- Certified reference materials or secondary reference materials traceable to international standards (if available).
- Serial dilutions of known concentrations of myoglobin.
- Comparison with established methodologies (e.g., gravimetric, spectrophotometric, or other widely accepted quantitative techniques).
- Manufacturer's in-house reference preparations that are carefully characterized and validated.
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11083260
OCT 1 6 2009
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
| SubmitterName, Address,Contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521 - 3225 | ||
|---|---|---|---|
| Contact person: | Jack Rogers, Regulatory Affairs Principal | ||
| Date prepared: | September 30, 2009 | ||
| Device Name | Proprietary name: | 1) Elecsys Myoglobin Immunoassay2) Elecsys Myoglobin STAT Immunoassay | |
| Common name: | 1) Myoglobin Immunoassay2) Myoglobin STAT Immunoassay | ||
| Classification name: | Myoglobin immunological test system | ||
| Classification | 21 CFR 866.5680; Class 2 | ||
| Device | The Elecsys Myoglobin Immunoassay includes two applications of the same |
reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
Page 1 of 6
Description
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Intended Use / Indications for Use
Elecsys Myoglobin Immunoassay
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Elecsys Myoglobin STAT Immunoassay
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Myoglobin and Elecsys Myoglobin STAT assays are Predicate substantially equivalent to the Elecsys Myoglobin STAT assay (K.983176). Device
Substantial Equivalence -Device Comparison
The following table compares the new Elecsys Myoglobin and Elecsys Myoglobin STAT assays with the predicate device Elecsys Myoglobin STAT Assay (K983176).
| Feature | Elecsys Myoglobin and MyoglobinSTAT | Elecsys Myoglobin STAT(K983176) Predicate |
|---|---|---|
| Intended Use /Indications forUse | Immunoassay for the in vitroquantitative determination ofmyoglobin in human serum andplasma. The assay is intended to aidin the rapid diagnosis of heart andrenal disease.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on the Elecsys and cobas eimmunoassay analyzers. | Immunoassay for the in vitroquantitative determination ofmyoglobin in human serum andplasma.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on the BoehringerMannheim Elecsys 1010 and 2010immunoassay analyzers. |
| Assay Protocol | Electrochemiluminescenceimmunoassay | Electrochemiluminescenceimmunoassay |
| Specimen Type | Human serum and plasma | Human serum and plasma |
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| Feature | Elecsys Myoglobin andMyoglobin STAT | Elecsys Myoglobin STAT(K983176) Predicate |
|---|---|---|
| Measuring Range | 21-3000 ng/ml. defined by thelower detection limit and themaximum of the master curve).Values below the detection limit arereported as <21 ng/ml. Valuesabove the measuring range arereported as >3000 ng/mL (or up to3000 ng/mL for 10-fold dilutedsamples) | 15-3000 ng/mL (defined by thelower detection limit and themaximum of the master curve).Values below the detection limit arereported as <15 ng/ml. Valuesabove the measuring range arereported as ≥ 3000 ng/mL (or up to3000 ng/mL for 10-fold dilutedsamples) |
| Expected values | Men 28-72 ng/mlWomen 25-58 ng/mlBased on a study with ElecsysMyoglobin STAT assay | Men < 72 ng/mlWomen < 51 ng/mlBased on a study with Tina-quantMyoglobin. |
| Traceability /Standardization | Myoglobin assayThe Elecsys Myoglobin assay hasbeen standardized against theElecsys Myoglobin STAT assay.Myoglobin STAT assayThis method has been standardizedagainst an in-house referencepreparation. | Calibrated against Tina-quantMyoglobin which was calibratedagainst a nephelometric method. |
| Dilution | Recommended dilution factor is1:10. The concentration of thediluted sample must be>50 ng/ml. | Recommended dilution factor is1:10. The concentration of thediluted sample must be>200 ng/mL. |
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Substantial Equivalence – Device Comparison (continued)
Roche
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| Feature | Elecsys Myoglobin andMyoglobin STAT | Elecsys Myoglobin STAT(K983176) Predicate |
|---|---|---|
| Performance Characteristics | ||
| Precision | Myoglobin assayRepeatability (within run)2.0% CV @ 32.0 ng/mL1.0% CV @ 87.0 ng/mL1.8% CV @ 1020 ng/mL1.1% CV @ 1194 ng/mL1.8% CV @ 2474 ng/mL | Repeatability (within run)2.1% CV @ 43.0 ng/mL1.3% CV @ 82.5 ng/mL2.9% CV @ 237 ng/mL2.9% CV @ 523 ng/mL1.9% CV @ 672 ng/mL3.4% CV @ 1147 ng/mL5.3% CV @ 3056 ng/mL |
| Intermediate Precision (Total)2.3% CV @ 32.0 ng/mL1.5% CV @ 87.0 ng/mL2.5% CV @ 1020 ng/mL1.8% CV @ 1194 ng/mL2.2% CV @ 2474 ng/mL | Intermediate Precision (Total)2.6% CV @ 43.0 ng/mL1.6% CV @ 82.5 ng/mL3.6% CV @ 237 ng/mL3.8% CV @ 523 ng/mL2.3% CV @ 672 ng/mL4.0% CV @ 1147 ng/mL6.7% CV @ 3056 ng/mL | |
| Myoglobin STAT assayRepeatability (within run)1.7% CV @ 33.9 ng/mL1.2% CV @ 90.1 ng/mL1.8% CV @ 1016 ng/mL1.1% CV @ 1171 ng/mL2.2% CV @ 2468 ng/mLIntermediate Precision (Total)2.1% CV @ 33.9 ng/mL1.3% CV @ 90.1 ng/mL2.2% CV @ 1016 ng/mL1.3% CV @ 1171 ng/mL2.6% CV @ 2468 ng/mL | ||
| Feature | Elecsys Myoglobin andMyoglobin STAT | Elecsys Myoglobin STAT(K983176) Predicate |
| Performance Characteristics (continued) | ||
| MethodComparison | Myoglobin assayN = 129Range: 24 to 2945Passing/BablokSlope = 1.03Intercept = 6.26r = 0.987Linear RegressionSlope = 1.02Intercept = 14.5r = 0.999Deming RegressionSlope = 1.00Intercept = 13.9r = 0.999Myoglobin STAT assayN = 139Range: 23 to 2523Passing/BablokSlope = 1.04Intercept = -2.08r = 0.955Linear RegressionSlope = 1.08Intercept = -9.60r = 0.988Deming RegressionSlope = 1.09Intercept = -14.6r = 0.997 | N = 398Range: 26 to 595Passing/BablokSlope = 1.01Intercept = -0.135r = 0.996Linear RegressionSlope = 0.997Intercept = 1.284r = 0.996 |
| Limit of Blank | 18 ng/mL | Not Reported |
| Limit ofDetection | 21 ng/mL | 21 ng/mL |
| Limit ofQuantitation | 25 ng/mL | Not Reported |
| Feature | Elecsys Myoglobin andMyoglobin STAT | Elecsys Myoglobin STAT(K983176) Predicate |
| Performance Characteristics (continued) | ||
| Interferences(limitations) | Hemolytic no effect up to 1.4 g/dLBiotin no effect up to 50 ng/mLLipemia no effect up to 2200 mg/dLBilirubin no effect up to 65 mg/dLRheumatoid factor no effect up to1500 IU/mL | Same |
Substantial Equivalence – Device Comparison (continued)
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Substantial Equivalence – Device Comparison (continued)
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Substantial Equivalence - Device Comparison (continued)
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved shapes.
Roche Diagnostics Centralized Diagnostics c/o Mr. Jack Rogers Regulatory Affairs Principal RPD Regulatory Submissions 9115 Hague Road Indianapolis, IN 46250
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
OCT 1 6 2009
Re: K083260
Trade Name: Elecsys® Myoglobin Immunoassay, Elecsys® Myoglobin STAT Immunoassay Regulation Number: 21 CFR §866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Codes: DDR Dated: September 30, 2009 Received: October 1, 2009
Dear Mr. Rogers:
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).
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K083260
Device Name: Elecsys Myoglobin Immunoassay
Indications For Use:
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Prescription Use X (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)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) |4083260
Page 1 of 2
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Indications for Use
510(k) Number: K083260
Device Name: Elecsys Myoglobin STAT Immunoassay
Indications For Use: -
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Prescription Use _ X (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 (OVD)
Signature
Division Sign-Off Affice of In Vitro Diagnostic Device Evaluation and Safety
510(k) 16083260
Page 2 of 2
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).