TINAQUANT MYOGLOBIN ASSAY

K972513 · Boehringer Mannheim Corp. · DDR · Jul 28, 1997 · Immunology

Device Facts

• Record ID: K972513
• Device Name: TINAQUANT MYOGLOBIN ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: DDR · Immunology
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Tina-quant® Myoglobin Assay is an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma using automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

Device Story

Tina-quant® Myoglobin Assay is an in-vitro diagnostic test for serum or plasma samples. Principle of operation: turbidimetric immunoinhibition (TINIA). Sample mixed with EDTA/glycine buffer (R1); then added to latex particles coated with polyclonal anti-human myoglobin antibodies (R2). Antibody-coated particles bind myoglobin to form aggregates; aggregate quantity proportional to myoglobin concentration. Turbidity measured via optical density increase at 570 nm on automated clinical chemistry analyzers (e.g., Hitachi 911). Used in clinical laboratory settings by trained technicians. Output is quantitative myoglobin concentration; assists healthcare providers in rapid diagnosis of heart and renal disease.

Clinical Evidence

Bench testing only. Performance evaluated via precision (intra-assay CV 0.3-2.6%; inter-assay CV 0.3-0.9%), linearity (3.0-560 ng/mL), and lower detection limit (3.0 ng/mL). Method comparison against predicate (N=41) showed correlation (r=0.989, y=1.06x+0.35). Interference testing confirmed no interference from bilirubin (60 mg/dL), hemoglobin (0.5 g/dL), lipemia (1500 mg/dL), or rheumatoid factor (100 IU/mL). Specificity testing showed high cross-reactivity for cardiac/skeletal myoglobin and negligible cross-reactivity for hemoglobin, IgG, and albumin.

Technological Characteristics

Immunoturbidometric assay using latex particles coated with polyclonal anti-human myoglobin antibodies. Reaction principle: turbidimetric immunoinhibition (TINIA). Detection: spectrophotometric at 570 nm. Requires automated clinical chemistry analyzer (e.g., Hitachi 911). Reagents: EDTA/glycine buffer and antibody-coated latex particles.

Indications for Use

Indicated for the quantitative determination of myoglobin in serum and plasma to aid in the diagnosis of heart and renal disease in patients requiring clinical chemistry analysis.

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

• Behring N Latex Myoglobin Assay (K902154)

Submission Summary (Full Text)

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JUL 2 8 1997

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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>2400 Bisso Lane<br>P.O. Box 4117<br>Concord, CA 94524-4117<br>(510) 674 - 0690, extension 8413<br>Fax: [phone]<br>Contact Person: Yvette Lloyd |
| | Date Prepared: July 2, 1997 |
| 2. Device name | Proprietary name: Tina-quant® Myoglobin Assay<br>Common name: Immunoturbidometric assay for the determination of Myoglobin.<br>Classification name: Myoglobin immunological test system |
| 3. Predicate device | The Boehringer Mannheim Tina-quant® Myoglobin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring N Latex Myoglobin Assay. |

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# 10(k) Summary, Continued

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The myoglobin determination is based upon turbidimetric immunoinhibition 4.Device (TINIA) using a serum or plasma blood sample. The sample containing f Description myoglobin is transferred into a EDTA/glycine buffer solution (R1 reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human myoglobin antibodies (R2 reagent) is added to mixture of the first step. The antibody-coated particles will bind to the myoglobin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of myoglobin present in the sample.

> The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of myoglobin in the sample is directly proportional to the amount of turbidity formed.

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## BOEHRING BO(k) Summary, Continued ORPORATION

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| 5.<br>Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of myoglobin. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.<br>Comparison<br>to predicate<br>device | The Boehringer Mannheim Tina-quant® Myoglobin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring N Latex Myoglobin Assay (K902154).<br><br>The following table compares the Tina-quant® Myoglobin with the predicate device, Behring Nephlometer 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.<br><br>Similarities:<br>•Intended Use: Immunoassay for the in vitro quantitative determination of Myoglobin<br><br>•Sample type: Serum and plasma |

•Product performance

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### 0(k) Summary, Continued સમાનિયા

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6. Comparison to predicate device cont.

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#### Differences:

| Feature | Tina-quant® Myoglobin | N Latex Myoglobin |
|----------------------------|------------------------------|-------------------|
| Reaction test<br>principle | Spectrophotometric<br>570 nm | Nephlometry |
| Instrument<br>required | Hitachi 911 | Nephlometer |

#### Performance Characteristics:

| Feature | Tina-quant® Myoglobin | N Latex Myoglobin |
|-----------|--------------------------------|-----------------------------------------------|
| Precision | Intra-Assay Precision (ng/mL): | Modified NCCLS:<br>Within run Precision(µg/L) |
| Level | Control 1 Control 2 Control3 | Low Mid High |
| N | 20 20 20 | 20 20 20 |
| Mean | 32.3 71.3 471.5 | 85 160 310 |
| SD | 0.8 0.6 1.6 | 2.0 2.4 2.9 |
| %CV | 2.6 0.9 0.3 | |
| | Inter-Assay Precision (ng/mL): | Day to Day Precision (µg/L): |
| | Sample 1 Sample 2 | |
| N | 20 20 | Low Mid High |
| Mean | 71.3 471.5 | 15 15 15 |
| SD | 0.6 1.6 | 85 160 310 |
| %CV | 0.9 0.3 | 4.8 4.2 5 |

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#### BOEHRING 90(k) Summary, Continued ANNHE CORPORATION

Image /page/4/Picture/1 description: The image shows the logo for Boehringer Mannheim. The logo consists of the word "boehringer" inside of a circle. To the left of the circle, the word "mannheim" is written vertically.

6. Comparison to predicate device, (cont.) Performance Characteristics:

| Feature | Tina-quant® Myoglobin | N Latex Myoglobin | |
|------------------------------------|-----------------------|-----------------------|-----------------------------------|
| Lower<br>Detection<br>Limit | 3.0 ng/mL | 25 µg/L | |
| | Linearity | 3.0 - 560 ng/mL | 25.0 - 400 µg/L |
| | Method<br>Comparison | Vs N Latex® Myoglobin | Vs Radioimmunnoassay<br>Myoglobin |
| | | Least Squares | Least Squares |
| $y=1.06x + 0.35$ | | $y =0.95x-4.33$ | |
| $r=0.989$ | | | |
| $SEE=19.61$ | | | |
| $N=41$ | | | |
| Passing/Bablok | | | |
| $y =1.07x + 3.6$ | | | |
| $r=0.989$<br>$SEE=13.61$<br>$N=41$ | | | |

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#### BOEHRINGER10(k) Summary, Continued MANNHEIM CORPORATION

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6.

Comparison
to predicate
device, (cont.)

#### Performance Characteristics:

| Feature | Tina-quant® Myoglobin | N Latex Myoglobin |
|-----------------------------|-----------------------|--------------------|
| Interfering<br>substances | No interference at: | |
| Bilirubin | 60 mg/dL | No interference |
| Hemoglobin | 0.5 g/dL | No interference |
| Lipemia | 1500 mg/dL | No interference |
| Rheumatoid<br>Factor | 100 IU/mL | <3000 IU/ml |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| Human cardiac<br>myoglobin | 102.4% | N/A |
| Human skeletal<br>myoglobin | 99.7% | N/A |
| Hemoglobin | 0.0 | N/A |
| Human IgG | 0.0 | N/A |
| Human Serum<br>Albumin | 0.0 | N/A |

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JUL 28 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Yvette R. Lloyd Requlatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, California 94524-4117

K972513 Re : Tina-quant® Myoglobin Assay Requlatory Class: II Product Code: DDR Dated: July 2, 1997 Received: July 7, 1997

Dear Ms. Lloyd:

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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 CMP regulation may result in regulatory 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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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 requlation (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 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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Page / of /

510(k) Number (if known): N/A

Device Name: Tina-quant® Myoglobin Assay

Indications For Use:

The Tina-quant® Myoglobin Assay is an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma using automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

Lions
Acting Branch Chief

(Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number K9725/7

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)