(345 days)
K.983176
K.983176
No
The summary describes a standard immunoassay with electrochemiluminescence detection and calibration curves. There is no mention of AI, ML, or any related technologies in the device description or performance studies.
No
This device is an immunoassay for the in vitro quantitative determination of myoglobin, intended to aid in diagnosis, not to provide therapy.
Yes
The device is intended to "aid in the rapid diagnosis of heart and renal disease" by quantitatively determining myoglobin levels, which is a diagnostic purpose.
No
The device description clearly outlines a two-step sandwich immunoassay using reagents, streptavidin microparticles, and electrochemiluminescence detection, which are all hardware components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory test using reagents and an immunoassay analyzer to measure a substance (myoglobin) in a biological sample (serum and plasma). This is characteristic of an IVD.
- Performance Studies: The performance studies describe method comparisons and precision, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K983176; Elecsys Myoglobin STAT Assay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
N/A
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.
Product codes
DDR
Device Description
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.
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
- Myoglobin assay
- Repeatability (within run)
- 2.0% CV @ 32.0 ng/mL
- 1.0% CV @ 87.0 ng/mL
- 1.8% CV @ 1020 ng/mL
- 1.1% CV @ 1194 ng/mL
- 1.8% CV @ 2474 ng/mL
- Intermediate Precision (Total)
- 2.3% CV @ 32.0 ng/mL
- 1.5% CV @ 87.0 ng/mL
- 2.5% CV @ 1020 ng/mL
- 1.8% CV @ 1194 ng/mL
- 2.2% CV @ 2474 ng/mL
- Repeatability (within run)
- Myoglobin STAT assay
- Repeatability (within run)
- 1.7% CV @ 33.9 ng/mL
- 1.2% CV @ 90.1 ng/mL
- 1.8% CV @ 1016 ng/mL
- 1.1% CV @ 1171 ng/mL
- 2.2% CV @ 2468 ng/mL
- Intermediate Precision (Total)
- 2.1% CV @ 33.9 ng/mL
- 1.3% CV @ 90.1 ng/mL
- 2.2% CV @ 1016 ng/mL
- 1.3% CV @ 1171 ng/mL
- 2.6% CV @ 2468 ng/mL
- Repeatability (within run)
Method Comparison
- Myoglobin assay
- N = 129
- Range: 24 to 2945
- Passing/Bablok
- Slope = 1.03
- Intercept = 6.26
- r = 0.987
- Linear Regression
- Slope = 1.02
- Intercept = 14.5
- r = 0.999
- Deming Regression
- Slope = 1.00
- Intercept = 13.9
- r = 0.999
- Myoglobin STAT assay
- N = 139
- Range: 23 to 2523
- Passing/Bablok
- Slope = 1.04
- Intercept = -2.08
- r = 0.955
- Linear Regression
- Slope = 1.08
- Intercept = -9.60
- r = 0.988
- Deming Regression
- Slope = 1.09
- Intercept = -14.6
- r = 0.997
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Limit of Blank: 18 ng/mL
- Limit of Detection: 21 ng/mL
- Limit of Quantitation: 25 ng/mL
Predicate Device(s)
K.983176
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
| Submitter
Name, Address,
Contact | Roche Diagnostics
9115 Hague Rd
Indianapolis IN 46250
(317) 521 - 3225 | | |
|----------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|--|
| | Contact person: | Jack Rogers, Regulatory Affairs Principal | |
| | Date prepared: | September 30, 2009 | |
| Device Name | Proprietary name: | 1) Elecsys Myoglobin Immunoassay
2) Elecsys Myoglobin STAT Immunoassay | |
| | Common name: | 1) Myoglobin Immunoassay
2) 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.
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Description
Image /page/0/Picture/7 description: The image shows the word "Roche" inside of a hexagon. The word is written in a bold, sans-serif font. The hexagon is outlined in black. The image is simple and clear, with a focus on the company name.
1
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 Myoglobin
STAT | Elecsys Myoglobin STAT
(K983176) Predicate |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | Immunoassay for the in vitro
quantitative determination of
myoglobin in human serum and
plasma. The 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 electrochemiluminescence
immunoassay "ECLIA" is intended
for use on the Boehringer
Mannheim Elecsys 1010 and 2010
immunoassay analyzers. |
| Assay Protocol | Electrochemiluminescence
immunoassay | Electrochemiluminescence
immunoassay |
| Specimen Type | Human serum and plasma | Human serum and plasma |
Image /page/1/Picture/12 description: The image shows the logo for Roche, a healthcare company. The logo consists of the word "Roche" written in a bold, sans-serif font. The word is enclosed within a hexagon shape. The hexagon is outlined in black.
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| Feature | Elecsys Myoglobin and
Myoglobin STAT | Elecsys Myoglobin STAT
(K983176) Predicate |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring Range | 21-3000 ng/ml. defined by the
lower detection limit and the
maximum of the master curve).
Values below the detection limit are
reported as 3000 ng/mL (or up to
3000 ng/mL for 10-fold diluted
samples) | 15-3000 ng/mL (defined by the
lower detection limit and the
maximum of the master curve).
Values below the detection limit are
reported as 50 ng/ml. | Recommended dilution factor is
1:10. The concentration of the
diluted sample must be
200 ng/mL. |
・
.
Substantial Equivalence – Device Comparison (continued)
Roche
・
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| Feature | Elecsys Myoglobin and
Myoglobin STAT | Elecsys Myoglobin STAT
(K983176) Predicate |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Characteristics | | |
| Precision | Myoglobin assay
Repeatability (within run)
2.0% CV @ 32.0 ng/mL
1.0% CV @ 87.0 ng/mL
1.8% CV @ 1020 ng/mL
1.1% CV @ 1194 ng/mL
1.8% CV @ 2474 ng/mL | Repeatability (within run)
2.1% CV @ 43.0 ng/mL
1.3% CV @ 82.5 ng/mL
2.9% CV @ 237 ng/mL
2.9% CV @ 523 ng/mL
1.9% CV @ 672 ng/mL
3.4% CV @ 1147 ng/mL
5.3% CV @ 3056 ng/mL |
| | Intermediate Precision (Total)
2.3% CV @ 32.0 ng/mL
1.5% CV @ 87.0 ng/mL
2.5% CV @ 1020 ng/mL
1.8% CV @ 1194 ng/mL
2.2% CV @ 2474 ng/mL | Intermediate Precision (Total)
2.6% CV @ 43.0 ng/mL
1.6% CV @ 82.5 ng/mL
3.6% CV @ 237 ng/mL
3.8% CV @ 523 ng/mL
2.3% CV @ 672 ng/mL
4.0% CV @ 1147 ng/mL
6.7% CV @ 3056 ng/mL |
| | Myoglobin STAT assay
Repeatability (within run)
1.7% CV @ 33.9 ng/mL
1.2% CV @ 90.1 ng/mL
1.8% CV @ 1016 ng/mL
1.1% CV @ 1171 ng/mL
2.2% CV @ 2468 ng/mL
Intermediate Precision (Total)
2.1% CV @ 33.9 ng/mL
1.3% CV @ 90.1 ng/mL
2.2% CV @ 1016 ng/mL
1.3% CV @ 1171 ng/mL
2.6% CV @ 2468 ng/mL | |
| Feature | Elecsys Myoglobin and
Myoglobin STAT | Elecsys Myoglobin STAT
(K983176) Predicate |
| | Performance Characteristics (continued) | |
| Method
Comparison | Myoglobin assay
N = 129
Range: 24 to 2945
Passing/Bablok
Slope = 1.03
Intercept = 6.26
r = 0.987
Linear Regression
Slope = 1.02
Intercept = 14.5
r = 0.999
Deming Regression
Slope = 1.00
Intercept = 13.9
r = 0.999
Myoglobin STAT assay
N = 139
Range: 23 to 2523
Passing/Bablok
Slope = 1.04
Intercept = -2.08
r = 0.955
Linear Regression
Slope = 1.08
Intercept = -9.60
r = 0.988
Deming Regression
Slope = 1.09
Intercept = -14.6
r = 0.997 | N = 398
Range: 26 to 595
Passing/Bablok
Slope = 1.01
Intercept = -0.135
r = 0.996
Linear Regression
Slope = 0.997
Intercept = 1.284
r = 0.996 |
| Limit of Blank | 18 ng/mL | Not Reported |
| Limit of
Detection | 21 ng/mL | 21 ng/mL |
| Limit of
Quantitation | 25 ng/mL | Not Reported |
| Feature | Elecsys Myoglobin and
Myoglobin STAT | Elecsys Myoglobin STAT
(K983176) Predicate |
| | Performance Characteristics (continued) | |
| 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 |
Substantial Equivalence – Device Comparison (continued)
Image /page/3/Picture/3 description: The image shows the word "Roche" inside of a hexagon. The word is written in a simple, sans-serif font. The hexagon is outlined in black and appears to be a logo for the company Roche.
:
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Substantial Equivalence – Device Comparison (continued)
Image /page/4/Picture/3 description: The image shows the Roche logo. The logo consists of the word "Roche" written in black letters inside of a hexagon. The hexagon is also black and has a thick border.
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r
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: : : :
Substantial Equivalence - Device Comparison (continued)
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Image /page/5/Picture/5 description: The image shows the Roche company logo. The logo consists of the word "Roche" in bold, sans-serif font, enclosed within a hexagon. The hexagon is outlined in black.
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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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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/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
8
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
9
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
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