CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN

K974325 · Chiron Diagnostics Corp. · DDR · Dec 8, 1997 · Immunology

Device Facts

• Record ID: K974325
• Device Name: CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
• Applicant: Chiron Diagnostics Corp.
• Product Code: DDR · Immunology
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The intended use of Chiron Diagnostics ACS:180 Myoglobin Assay is for the quantitative determination of Myoglobin in serum or plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS Automated Chemiluminescence Systems.

Device Story

The Chiron Diagnostics ACS:180 Myoglobin assay is an in vitro diagnostic test for measuring myoglobin levels in serum or plasma. It utilizes a two-site sandwich immunoassay format based on direct chemiluminometric technology. The system employs a Lite Reagent containing polyclonal goat anti-myoglobin antibodies labeled with acridinium ester and a Solid Phase containing monoclonal mouse anti-myoglobin antibodies coupled to paramagnetic particles. The assay is performed on the Chiron Diagnostics ACS Automated Chemiluminescence Systems. By quantifying myoglobin, which is released into circulation following cardiac muscle injury, the device serves as an aid in the early diagnosis of acute myocardial infarction and as a rule-out indicator in emergency department settings. Healthcare providers use the quantitative results to evaluate patients presenting with symptoms of potential myocardial infarction, often in conjunction with other cardiac markers like CK-MB or cTnI, to improve diagnostic accuracy and reduce unnecessary admissions to Coronary Care Units.

Clinical Evidence

Bench testing only. Performance evaluated using 703 samples from healthy individuals to establish reference ranges (Male: 5.1–90.7 ng/mL; Female: 10–65.3 ng/mL). Analytical sensitivity is ≤10 ng/mL. Method comparison with an alternate EIA method (n=123) yielded a correlation coefficient of 0.99. Precision testing (n=144 per sample) demonstrated total CVs between 4.2% and 5.3%.

Technological Characteristics

Two-site sandwich immunoassay using direct chemiluminometric technology. Reagents: polyclonal goat anti-myoglobin (acridinium ester labeled) and monoclonal mouse anti-myoglobin (paramagnetic particle coupled). Measures concentrations up to 1000 ng/mL. Automated system operation.

Indications for Use

Indicated for the quantitative determination of myoglobin in serum or plasma as an aid in the diagnosis of acute myocardial infarction. Intended for use in clinical laboratory settings by professional personnel.

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

• Stratus Myoglobin Fluorometric Enzyme Immunoassay (Dade International Inc.)

Submission Summary (Full Text)

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KCN4325

Company Confidential

# DEC = 8 1997

# Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

# 1. Submitters Information

| Contact person: | William J. Pignato<br>Director of Regulatory Affairs |
|------------------------|-------------------------------------------------------------------------|
| Address: | Chiron Diagnostics Corporation<br>63 North Street<br>Medfield, MA 02052 |
| Phone:<br>Fax | [phone]<br>[phone] |
| Date Summary Prepared: | November 14, 1997 |

#### 2. Device Information

| Proprietary Name: | Chiron Diagnostics ACS:180 Myoglobin |
|------------------------|--------------------------------------|
| Common Name: | Myoglobin Immunological test system |
| Device Classification: | Class II, 21 CFR 866.5680 |

## 3. Predicate Device Information

| Name: | Stratus Myoglobin Fluorometric Enzyme |
|---------------|---------------------------------------|
| | Immunoassay |
| Manufacturer: | Dade International Inc. |

## 4. Device Description

Myoglobin is a oxygen-binding, heme protein, found in cardiac and skeletal muscle. Myoglobin is noted for its rapid release into the circulation following tissue injury. Elevated levels of myoglobin can be found in conditions of muscle damage, such as acute and chronic skeletal muscle disease, renal failure, myocarditis, open-heart surgery, and after heavy exercise.

Myoglobin releases into the circulation as early as 2 to 4 hours after cell damage, peaks at between 9 and 12 hours, and returns to normal within 24 to 36 hours. In the absence of skeletal muscle trauma, myoglobin has been used as an early indicator of myocardial infarction, and therefore as a rule out indicator. Myoglobin has a negative predictive value of 99%, which improves the rule out capabilities of the emergency department and helps reduce the number of patients inappropriately admitted to the Coronary Care Units with symptoms atypical of acute

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myocardial infarction. When used in combination with other cardiac markers such as CK-MB or cTnl, the ACS myoglobin assay is a valuable diagnostic tool to be used in the early evaluation of the potential acute myocardial infarction patient.

#### 5. Statement of Intended Use

The intended use of Chiron Diagnostics ACS:180 Myoglobin Assay is for the quantitative determination of Myoglobin in serum or plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS Automated Chemiluminescence Systems.

## 6. Summary of Technological Characteristics

The Chiron Diagnostics ACS:180 Myoglobin assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a polyclonal goat anti-myoglobin antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-myoglobin antibody covalently coupled to paramagnetic particles.

#### 6. Performance Characteristics

## Expected Results

To confirm the ACS:180 Myoglobin reference range 703 serum and plasma samples from apparently healthy individuals were analyzed. Based on a central 95% interval, the following reference ranges were established:

| Sample<br>Category | N | Average<br>(ng/mL)<br>(µg/L) | Range<br>(ng/mL)<br>(µg/L) |
|--------------------|-----|------------------------------|----------------------------|
| Male | 353 | 47.9 | 5.1–90.7 |
| Female | 350 | 32.7 | 10–65.3 |

As with all in vitro diagnostic asavs, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results.

## Sensitivity and Assay Reportable Range

The ACS:180 Myoglobin assay measures myoglobin concentrations up to 1000 ng/mL(ug/L) with a minimum detectable concentration (analytical sensitivity) of ≤10

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ng/mL(ug/L). Analytical sensitivity is defined as the concentration of myoglobin that corresponds to the RLUs that are two standard deviations greater than the mean RLUs of 20 replicate determinations of the Myoglobin zero standard.

## Method Comparison

For 123 samples in the range of 27 to 957 ng/mL(μg/L) the relationship between the ACS:180 Myoglobin assay and an alternate myoglobin EIA method is described by the equation:

ACS:180 Myoglobin = 1.06 x (alternate ElA method) - 4.6 ng/mL(µg/L) Correlation coefficient (r) = 0.99

## Precision

Eight samples were assayed 6 times in 6 assays, on each of 4 systems (n =144 for each sample), over a period of 3 days. Total precision (% CV) range between 4.2 to 5.3.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 8 1997

William J. Pignato Director of Regulatory Affairs Chiron Diagnostics 63 North Street 02052-1688 Medfield, Massachusetts

K974325 Re : Chiron Diagnostics ACS:180® Myoglobin Assay Product Code: DDR Requlatory Class: II Dated: November 14, 1997 Received: November 18, 1997

Dear Mr. Pignato:

requlations.

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 The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CDIA-667, Chita device may require at it does, you should contact a 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 described in four in four alence of your device to a legally Finding or bubbeansaaries in a classification for your marketed produce acits 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 Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to che regaration Cherchon" (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 Litman

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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Company Confidential

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R 9743 85 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Chiron Diagnostics ACS:180 Myoglobin Assay

Indications for Use:

The Chiron Diagnostics ACS:180 Myoglobin Assay is used for the quantitative rric Onliner Blaghoodies in serum or plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS Automated Chemiluminescence Systems.

(PLEASE DO NOT WRITE BELOW THIS LINE---CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
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OR

| Over-The-Counter Use<br>(Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
|-----------------------------------------|--------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 974328 |