ELECSYS MYOGLOBIN STAT ASSAY

K983176 · Boehringer Mannheim Corp. · DDR · Sep 24, 1998 · Immunology

Device Facts

• Record ID: K983176
• Device Name: ELECSYS MYOGLOBIN STAT ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: DDR · Immunology
• Decision Date: Sep 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

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.

Device Story

Elecsys Myoglobin STAT Assay is an in vitro diagnostic immunoassay for quantitative myoglobin measurement in human serum/plasma. Used on Boehringer Mannheim Elecsys 1010/2010 analyzers by laboratory professionals. Principle: sandwich electrochemiluminescence immunoassay (ECLIA). Sample (15 uL) incubated with biotinylated monoclonal anti-myoglobin antibody and ruthenium-labeled monoclonal anti-myoglobin antibody; complex binds to streptavidin-coated microparticles. Microparticles magnetically captured on electrode surface; voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve and reagent bar code master curve. Provides rapid myoglobin levels to assist clinicians in diagnosing heart and renal disease.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=60 per level), linearity (15-3,000 ng/mL), and method comparison against predicate (N=398, Passing/Bablok y=1.01x-0.13, r=1.0). Interference testing showed no interference for bilirubin (65 mg/dL), hemoglobin (1.4 g/dL), lipemia (2200 mg/dL), and biotin (50 ng/mL).

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Reagents: biotinylated monoclonal antibody, ruthenium-complex labeled monoclonal antibody, streptavidin-coated microparticles. Detection: photomultiplier measurement of chemiluminescent emission upon voltage application. Analyzers: Elecsys 1010/2010. Linearity: 15-3,000 ng/mL. Lower detection limit: 15 ng/mL.

Indications for Use

Indicated for the in vitro quantitative determination of myoglobin in human serum and plasma to aid in the rapid diagnosis of heart and renal disease.

Regulatory Classification

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.

Predicate Devices

• Tina-quant Myoglobin Assay (K972513)

Submission Summary (Full Text)

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KG83176

ੋਕੇ ਮ SEP 2 4 1998

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# 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(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. |

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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)

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ﻣﻴﺪ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ

| 5.<br>Intended use | Immunoassay for the in vitro quantitative determination of myoglobin in<br>human serum and plasma.<br>The electrochemiluminescence immunoassay "ECLIA" is intended for use on<br>the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.<br>Comparison to<br>predicate<br>device | The Boehringer Mannheim Elecsys® Myoglobin is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably it is substantially equivalent to the currently marketed Tina-quant®<br>Myoglobin Assay (K972513).<br><br>The following table compares the Elecsys® Myoglobin with the predicate<br>device, Tina-quant® Myoglobin Assay. Specific data on the performance of<br>the test have been incorporated into the draft labeling in attachment 5.<br>Labeling for the predicate device in provided in attachment 6.<br><br><b>Similarities:</b><br>•Intended Use: Immunoassay for the in vitro quantitative determination<br>of Myoglobin<br>•Sample type: Serum and plasma |

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6.
Comparison to predicate
device cont.

#### Differences:

| Feature | Elecsys® Myoglobin STAT | Tina-quant® Myoglobin |
|----------------------------|--------------------------|-----------------------|
| Reaction test<br>principle | Electrochemiluminescence | Immunoturbidity |
| Instrument<br>required | Elecsys analyzer | Hitachi analyzer |

#### Performance Characteristics:

| Feature | Elecsys® Myoglobin STAT | Tina-quant® Myoglobin |
|-----------------------------|---------------------------------------|-------------------------------------------|
| Precision<br>Level | Modified NCCLS (ng/mL)<br>HS1 HS4 HS5 | Modified NCCLS (ng/mL)<br>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<br>Level | Modified NCCLS (ng/mL)<br>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<br>Detection<br>Limit | 15 ng/mL | 3 ng/mL |

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6.

Performance Characteristics:

6.
Comparison to predicate
device, (cont.)

| Feature | Elecsys® Myoglobin STAT | Tina-quant® Myoglobin |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Lower<br>Detection<br>Limit | 15 ng/mL | 3.0 ng/mL |
| Linearity | 15 - 3,000 ng/mL | 3.0 - 560 ng/mL |
| Method<br>Comparison | Vs Tina-quant Myoglobin<br>Passing/Bablok<br>$y =1.01x - 0.13$<br>$r = 1.0$<br>$SEE = 4.54$<br>$N=398$<br><br>Least Squares<br>$y =1.0x + 1.28$<br>$r = 1.0$<br>$SEE = 7.58$<br>$N=398$ | |
| Interfering<br>substances | No interference at:<br>Bilirubin 65 mg/dL<br>Hemoglobin 1.4 g/dL<br>Lipemia 2200 mg/dL<br>Biotin 50 ng/mL | No interference at:<br>60 mg/dL<br>0.5 g/dL<br>1500 mg/dL |

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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.

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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#### 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)