(14 days)
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No
The description details a standard immunoassay based on chemical reactions and optical detection, with results determined via a calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making.
No
This device is for in vitro diagnostic (IVD) use, specifically for the quantitative determination of myoglobin in human serum and plasma to aid in the diagnosis of heart and renal disease. It measures a biomarker and does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease." This indicates the device's role in diagnosing medical conditions.
No
The device description details a complex immunoassay system involving reagents, incubation steps, microparticles, magnetic capture, and chemiluminescent emission measurement. This clearly indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "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-based assay ("electrochemiluminescence immunoassay") that analyzes biological samples (serum and plasma) outside of the body.
- Regulatory Context: The mention of a "Predicate Device(s)" with a K number (K972513) indicates that this device has gone through a regulatory submission process, which is typical for IVDs. The predicate device is also an "immunological test system," further confirming the IVD nature.
- Purpose: The purpose of measuring myoglobin in serum and plasma is to aid in the diagnosis of heart and renal disease, which is a diagnostic purpose performed on samples taken from the body.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 immunoassay analyzers.
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 and renal disease.
Product codes (comma separated list FDA assigned to the subject device)
DDR
Device Description
The Elecsys ® Myoglobin test principle is based on the sandwich principal. Total duration of assay: 9 minutes, 37 ℃. •1st incubation (4.5 minutes): By incubating the sample (15 uL) with a biotinylated monoclonal myoglobin-specific antibody (75 ul) and a monoclonal myoglobin -specific antibody labeled with a ruthenium-complex** (75 uL), a sandwich immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample. •2nd incubation (4.5 minutes): After addition of streptavidin-coated microparticles (35 uL) the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). •Results are determined via a calibration curve that is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+22)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Level (Modified NCCLS (ng/mL)):
HS1: Intra-assay SD 0.89, %CV 2.1; Total SD 1.11, %CV 2.6 (N=60, 43.0)
HS4: Intra-assay SD 39.5, %CV 3.4; Total SD 46.3, %CV 4.0 (N=60, 1147)
HS5: Intra-assay SD 161, %CV 5.3; Total SD 204, %CV 6.7 (N=60, 3056)
PCC1: Intra-assay SD 1.03, %CV 1.3; Total SD 1.31, %CV 1.6 (N=60, 82.5)
PCC2: Intra-assay SD 12.5, %CV 1.9; Total SD 15.6, %CV 2.3 (N=60, 672)
Lower Detection Limit: 15 ng/mL
Linearity: 15 - 3,000 ng/mL
Method Comparison vs Tina-quant Myoglobin (N=398):
Passing/Bablok: y = 1.01x - 0.13, r = 1.0, SEE = 4.54
Least Squares: y = 1.0x + 1.28, r = 1.0, SEE = 7.58
Interfering substances: No interference at Bilirubin 65 mg/dL, Hemoglobin 1.4 g/dL, Lipemia 2200 mg/dL, Biotin 50 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KG83176
ੋਕੇ ਮ SEP 2 4 1998
and and the state state and and and
510(k) Summary
| 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. |
|---|---|
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 845 - 3723 | |
| Contact Person: Priscilla A. Hamill | |
| Date Prepared: September 08, 1998 | |
| 2. Device name | Proprietary name: Elecsys® Myoglobin STAT Assay |
| Common name: Electrochemiluminescence assay for the determination of Myoglobin. | |
| Classification name: Myoglobin immunological test system | |
| 3. Predicate device | The Boehringer Mannheim Elecsys Myoglobin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Boehringer Mannheim Tina-quant Myoglobin Assay. |
continued on next page
1
The Elecsys ® Myoglobin test principle is based on the sandwich principal. 4.Device Description Total duration of assay: 9 minutes, 37 ℃. ·1st incubation (4.5 minutes): By incubating the sample (15 uL) with a biotinylated monoclonal myoglobin-specific antibody (75 ul) and a monoclonal myoglobin -specific antibody labeled with a ruthenium-complex** (75 uL), a sandwich immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample. ·2nd incubation (4.5 minutes): After addition of streptavidin-coated microparticles (35 uL) the complex becomes bound to the solid phase via interaction of biotin and streptavidin. · The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). ·Results are determined via a calibration curve that is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+22)
Continued on next page
2
ﻣﻴﺪ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ
| 5.
Intended use | 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. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.
Comparison to
predicate
device | The Boehringer Mannheim Elecsys® Myoglobin is substantially equivalent to
other products in commercial distribution intended for similar use. Most
notably it is substantially equivalent to the currently marketed Tina-quant®
Myoglobin Assay (K972513).
The following table compares the Elecsys® Myoglobin with the predicate
device, Tina-quant® Myoglobin Assay. Specific data on the performance of
the test have been incorporated into the draft labeling in attachment 5.
Labeling for the predicate device in provided in attachment 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination
of Myoglobin
•Sample type: Serum and plasma |
Continued on next page
3
Comparison to predicate
device cont.
Differences:
| Feature | Elecsys® Myoglobin STAT | Tina-quant® Myoglobin |
|---|---|---|
| Reaction test | ||
| principle | Electrochemiluminescence | Immunoturbidity |
| Instrument | ||
| required | Elecsys analyzer | Hitachi analyzer |
Performance Characteristics:
| Feature | Elecsys® Myoglobin STAT | Tina-quant® Myoglobin |
|---|---|---|
| Precision | ||
| Level | Modified NCCLS (ng/mL) | |
| HS1 HS4 HS5 | Modified NCCLS (ng/mL) | |
| HS1 HS2 Control | ||
| N | 60 60 60 | 21 21 21 |
| Intra-assay | 43.0 1147 3056 | 73.3 536.7 53.1 |
| SD | 0.89 39.5 161 | 0.9 1.6 1.1 |
| %CV | 2.1 3.4 5.3 | 1.2 0.3 2.1 |
| Total | 43.0 1147 3056 | 70.8 528.2 51.8 |
| SD | 1.11 46.3 204 | 1.6 7.7 1.9 |
| %CV | 2.6 4.0 6.7 | 2.3 1.5 3.7 |
| Precision | ||
| Level | Modified NCCLS (ng/mL) | |
| PCC1 PCC2 | ||
| N | 60 60 | |
| Intra-assay | 82.5 672 | |
| SD | 1.03 12.5 | |
| %CV | 1.3 1.9 | |
| Total | 82.5 672 | |
| SD | 1.31 15.6 | |
| %CV | 1.6 2.3 | |
| Lower | ||
| Detection | ||
| Limit | 15 ng/mL | 3 ng/mL |
Continued on next page
4
Performance Characteristics:
Comparison to predicate
device, (cont.)
| Feature | Elecsys® Myoglobin STAT | Tina-quant® Myoglobin |
|---|---|---|
| Lower | ||
| Detection | ||
| Limit | 15 ng/mL | 3.0 ng/mL |
| Linearity | 15 - 3,000 ng/mL | 3.0 - 560 ng/mL |
| Method | ||
| Comparison | Vs Tina-quant Myoglobin | |
| Passing/Bablok | ||
| $y =1.01x - 0.13$ | ||
| $r = 1.0$ | ||
| $SEE = 4.54$ | ||
| $N=398$ |
Least Squares
$y =1.0x + 1.28$
$r = 1.0$
$SEE = 7.58$
$N=398$ | |
| Interfering
substances | No interference at:
Bilirubin 65 mg/dL
Hemoglobin 1.4 g/dL
Lipemia 2200 mg/dL
Biotin 50 ng/mL | No interference at:
60 mg/dL
0.5 g/dL
1500 mg/dL |
5
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
SEP 2 4 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Priscilla A. Hamill Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K983176 Elecsys® Myoglobin STAT Regulatory Class: II Product Code: DDR September 8, 1998 Dated: Received: September 10, 1998
Dear Ms. Hamill:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
6
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
14983176 510(k) Number (if known): N/A
Device Name: Elecsys® Myoglobin STAT Assay
Indications For Use:
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 immunoassay analyzers.
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 and renal disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983176
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)