DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET

K123785 · Diazyme Laboratories · DDR · Jun 7, 2013 · Immunology

Device Facts

• Record ID: K123785
• Device Name: DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
• Applicant: Diazyme Laboratories
• Product Code: DDR · Immunology
• Decision Date: Jun 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only. The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only. The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

Device Story

Diazyme Myoglobin Assay is a latex-enhanced immunoturbidimetric assay; utilizes goat anti-human myoglobin-coated latex particles. Input: human serum or plasma samples. Principle: antigen-antibody reaction causes agglutination; detected via absorbance change at 570 nm on clinical chemistry analyzers (e.g., Hitachi 917). Output: quantitative myoglobin concentration determined by interpolation from a calibration curve. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing acute myocardial infarction. Benefits include rapid, automated quantification of myoglobin levels to support timely cardiac assessment.

Clinical Evidence

No clinical trials performed. Analytical performance established via bench testing: precision (total CV 3.58-5.3%), linearity (13.2-615.9 ng/mL, r²=0.9983), and method comparison against predicate (n=66, y=0.959x-5.141, r²=0.9855). Interference testing performed per CLSI EP7-A. Reference intervals established using 241 healthy adults.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: Tris-buffer, goat anti-human myoglobin-coated latex particles, sodium azide preservative. Form factor: ready-to-use liquid kit. Instrumentation: Hitachi 917 analyzer. Calibration: 6-point curve. Storage: 2-8°C.

Indications for Use

Indicated for quantitative determination of myoglobin in human serum and plasma to aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use.

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

• Roche Tina-Quant Myoglobin Gen. 2 Test System and C.f.a.s. (k061683)
• Myoglobin Control Set (k973358)

Submission Summary (Full Text)

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K123785

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### 510(k) Summary

## JUN 0 7 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's name: | Diazyme Laboratories |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's address: | 12889 Gregg Court<br>Poway, CA 92064<br>USA |
| Name of Contact Person: | Dr. Abhijit Datta<br>Diazyme Laboratories<br>12889 Gregg Court<br>Poway, CA 92064<br>Phone: [phone]<br>Fax: [phone] |
| Date the Summary was Prepared: | June 4, 2013 |
| Name of the Device | Diazyme Myoglobin Assay<br>Diazyme Myoglobin Calibrator Set<br>Diazyme Myoglobin Control Set |
| Trade Name: | Diazyme Myoglobin Assay<br>Diazyme Myoglobin Calibrator Set<br>Diazyme Myoglobin Control Set |
| Common/Usual Name | Diazyme Myoglobin Assay |
| Device Classification Name | Myoglobin Test System |
| Product code: | DDR (Myoglobin, Antigen, Antiserum, Control)<br>JIT - Calibrator, Secondary<br>JJX - Single (specified) Analyte Controls<br>(Assayed and Unassayed) |
| Panel: | Immunology (82) |
| Submission Type | 510k |
| Regulation Number | 21CFR 866.5680 |
| Device Class | Class II |

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Predicate Device:

Roche Tina-Quant Myoglobin Gen. 2 Test System and C.f.a.s. (Calibrators for automated systems) Myoglobin (K061683) Myoglobin Control Set (K973358)

Manufacturing Address

Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 USA

Establishment Registration 2032900

#### DESCRIPTION OF THE DEVICE

#### Clinical Significance

Myoglobin is a ~17kDa oxygen-binding protein whose concentration is elevated in response to a muscle injury. Characterized by x-ray crystallography in the 1950s, myoglobin has developed into an important marker for the diagnosis of a recent cardiac event. After a cardiac event or muscle injury occurs, its concentration rises and can be detected in vitro approximately 2 hours after the onset of symptoms and its measurement aids in the diagnosis of ST segment elevated myocardial infarction, which can ultimately lead to cardiac arrest. High concentrations of myoglobin also indicate extensive muscle damage (rhabodmyolysis) and can cause renal failure as high levels of the marker are toxic to the kidneys. The rapid increase in the concentration of myoglobin after muscular trauma makes it an important diagnostic indicator of cardiac stress and muscle damage, and provides early detection of necrosis in cardiac and skeletal muscle.

#### Assay Principle

The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.

#### Indications for Use:

The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.

The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

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| | | | | Table 1 Summarv of Assay Kit Components |
|--|--|--|--|-----------------------------------------|
|--|--|--|--|-----------------------------------------|

| Roche Tina-Quant Myoglobin Gen. 2,<br>C.f.a.s. Myoglobin (k061683), and<br>Myoglobin Control Set (k973358) | Diazyme Myoglobin Assay |
|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Reagent 1<br>buffer solution, ready to use | Reagent 1<br>100 mM Tris buffer solution with 0.09% sodium<br>azide, ready to use. |
| Reagent 2<br>Suspension of anti-human myoglobin<br>coated latex particles, ready to use | Reagent 2<br>Suspension of latex particles (< 0.5%) coated with<br>goat anti-human myoglobin with 0.09% sodium<br>azide, ready to use. |
| Calibrators<br>Ready to use liquid calibrators<br>containing myoglobin | Calibrators<br>Liquid stable calibrators prepared from human<br>serum, purified human myoglobin, and 0.09%<br>sodium azide. |
| Calibrator set | Calibrator set |
| 3 x 1.0 mL One-Level Calibrator | 1 x 1.0 mL Calibrator 1<br>1 x 1.0 mL Calibrator 2<br>1 x 1.0 mL Calibrator 3<br>1 x 1.0 mL Calibrator 4<br>1 x 1.0 mL Calibrator 5 |
| Control Set serum based | Control Set serum based |
| 1 x 3.0mL Control 1 | 1 x 1.0mL Control 1 |
| 1 x 3.0mL Control 2 | 1 x 1.0mL Control 2 |

## PERFORMANCE TESTING SUMMARIES

#### Method Comparison

Human plasma samples were tested with the Diazyme Myoglobin Assay and the obtained results were compared to the predicate method. A total of 66 samples (ranging from 16.9 to 615.9 ng/mL of myoglobin) were tested in both assays. The above described accuracy study showed that the Diazyme Myoglobin Assay results correlated well with predicate method with a correlation coefficient of R2 = 0.9855 with a slope of 0.9526 and -4.2228 y-intercept.

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| | Plasma Samples |
|----------------|----------------|
| n | 66 |
| Slope | 0.9526 |
| Intercept | -4.2228 |
| Correlation R2 | 0.9855 |

#### Precision .

The precision of the Diazyme Myoglobin Assay was evaluated according to Clinical and Laboratory Standards Institute EP5-A guideline. In the study, three levels of serum based controls containing approximately 66, 170, and 335 ng/mL of myoglobin, respectively, and three serum sample containing approximately 35, 150, and 400 ng/mL, of myoglobin, respectively, were tested with 2 runs per day in duplicates over 20 working days. Results were calculated using the EP Evaluator software precision statistic template and summarized in the following table:

#### Within-Run Precision

| | Control<br>Level 1 | Control<br>Level 2 | Control<br>Level 3 | Serum<br>Level 1 | Serum<br>Level 2 | Serum<br>Level 3 |
|------|--------------------|--------------------|--------------------|------------------|------------------|------------------|
| N | 80 | 80 | 80 | 80 | 80 | 80 |
| Mean | 65.97 | 172.8 | 337.0 | 37.78 | 148.6 | 414.3 |
| SD | 2.45 | 6.69 | 11.9 | 1.77 | 3.53 | 19.7 |
| CV% | 3.71% | 3.87% | 3.54% | 4.69% | 2.37% | 4.80% |

#### Total Precision

| | Control<br>Level 1 | Control<br>Level 2 | Control<br>Level 3 | Serum<br>Level 1 | Serum<br>Level 2 | Serum<br>Level 3 |
|------|--------------------|--------------------|--------------------|------------------|------------------|------------------|
| N | 80 | 80 | 80 | 80 | 80 | 80 |
| Mean | 65.97 | 172.8 | 337.0 | 37.78 | 148.6 | 414.3 |
| SD | 3.37 | 7.37 | 14.9 | 1.97 | 5.32 | 21.8 |
| CV% | 5.10% | 4.30% | 4.40% | 5.20% | 3.58% | 5.30% |

Conclusion: For the three levels of myoglobin control and three levels of serum specimens, 20day reproducibility data showed that the within-run precision was from 2.37% to 4.80% and total precision was from 3.58% to 5.3%. These results meet the acceptance criteria.

#### Linearity

A linearity set was prepared by mixing a low serum based sample of myoglobin containing 11 ng/mL and a high serum based sample of myoglobin containing 625 ng/mL, according to CLSI EP6-A. The assay was linear from 13.2 to 615.9 ng/mL.

#### Interference

The following substances normally present in the blood produced less than 10% deviation when tested at levels equal to the concentrations listed below:

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| Interferent | Concentration |
|----------------------------|---------------|
| Triglyceride | 1000 mg/dL |
| Intralipid | 125 mg/dL |
| Ascorbic Acid | 176 mg/dL |
| Bilirubin | 40 mg/dL |
| Bilirubin Conjugated | 40 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Rheumatoid Factor | 100 IU/mL |
| Heparin | 1.5 IU/mL |
| N-acetylcysteine | 11.04 mM |
| Acetylsalicylic Acid | 2.78 mM |
| Ampicillin | 152 µM |
| Carbamazepine | 0.13 mM |
| Na2-Cefoxitin | 1549 µM |
| Ibuprofen | 2425 µM |
| Ciclosporin | 0.125 µM |
| Levodopa | 30.4 mM |
| Methyldopa | 71 µM |
| Metronidazole | 701 µM |
| Rifampicin | 78.1 µM |
| Theophylline | 222 μM |
| Phenylbutazone | 650 µM |
| Valproic Acid, Sodium Salt | 3.5 mM |

The assay has no intralipid interference below 125 mg/dL. Specimens from patients undergoing Intralipid therapy may have interference with the Myoglobin Assay.

5

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 a stylized symbol that resembles a caduceus, with three wavy lines representing the staff and a single line representing the snake.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 7, 2013

Diazyme Laboratories C/O Abhijit Datta, Ph.D. 12889 Gregg Court POWAY CA 92064

Re: K123785

Trade/Device Name: Diazyme Myoglobin Assay Diazyme Myoglobin Calibrator Set Diazyme Myoglobin Control Set

Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: II Product Code: DDR, JIT, JJX Dated: April 26, 2013 Received: April 30, 2013

Dear Dr. Datta:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2-Dr. Datta

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Carol C. Benson -S for

Courtney H. Lias, Ph. D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: k123785

Device Name: Diazyme Myoglobin Assay, Diazyme Myoglobin Calibrator Set, Diazyme Myoglobin Control Set

Indications for Use:

The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.

The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

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 Diagnostics and Radiological Health (OIR)

Ruth A. Cheslêr -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k123785

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