DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX

K073488 · Diazyme Laboratories · MSJ · Mar 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073488
• Device Name: DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
• Applicant: Diazyme Laboratories
• Product Code: MSJ · Clinical Chemistry
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use. Calibrator: For calibration of the Diazyme Apolipoprotein B Assay in serum. For in vitro Diagnostic Use. Controls: To monitor the performance of Diazyme Apolipoprotein B Assay in serum. For in vitro Diagnostic Use.

Device Story

Diazyme Apolipoprotein B Assay is an in vitro diagnostic immunoassay for serum samples. It utilizes a turbidimetric principle where sample apo B reacts with specific anti-human-apoB antiserum to form an insoluble complex. The resulting turbidity is measured at 340 nm on clinical chemistry analyzers (e.g., Hitachi 917). The device is intended for use by laboratory professionals in clinical settings. Output is a quantitative concentration value (mg/dL) derived from a standard curve. This value assists clinicians in evaluating coronary artery disease risk. The assay includes reagents, calibrators, and controls.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical bench testing. Method comparison study (n=62) against the predicate device showed a correlation coefficient of 0.9864, slope of 1.0143, and y-intercept of -4.3806. Precision studies (CLSI EP5-A) showed total CVs ranging from 2.1% to 4.8%. Linearity (CLSI EP6-A) demonstrated R²=0.9992. Analytical specificity testing confirmed no significant interference from ascorbic acid, bilirubin, hemoglobin, triglycerides, or Apo A-1.

Technological Characteristics

Turbidimetric immunoassay. Reagents: buffer (polyethylene glycol, Tris/HCl, NaCl) and anti-human-apoB antibody. Requires clinical chemistry analyzer with 340 nm absorbance capability and 37°C temperature control. Calibrators are human serum-derived and traceable to WHO/IFCC standards. Performance validated per CLSI guidelines (EP5-A, EP6-A, EP7-A, EP9-A, EP17-A).

Indications for Use

Indicated for quantitative determination of human Apolipoprotein B in serum to aid in assessing coronary artery disease risk. For in vitro diagnostic use.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• K-Assay Apo B Assay (k993354)

Submission Summary (Full Text)

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Ko73488

MAR - 7 2008

### 510(k) Summary

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: | Charles Yu<br>Diazyme Laboratories<br>12889 Gregg Court<br>Poway, CA 92064<br>Phone: [phone]<br>Fax: [phone] |
| Date the Summary was Prepared: | September 24, 2007 |
| Name of the Device | Diazyme Apolipoprotein B Assay |
| Trade Name: | Diazyme Apolipoprotein B Assay |
| Common/Usual Name | Apolipoprotein B Test System |
| Device Classification Name | Alpha-1-lipoprotein Immunological Test System |
| Reagents | |
| Product code: | MSJ |
| Submission Type | 510k |
| Regulation Number | 862.1475 |
| Device Class | II |

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# Calibrator

| Product code: | JIT |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Type | 510k |
| Regulation Number | 862.1150 |
| Device Class | II |
| Control | |
| Product code: | JJX |
| Submission Type | 510k |
| Regulation Number | 862.1660 |
| Device Class | I Reserved |
| Predicate Device: | For the Alpha-1-lipoprotein Immunological Test System<br>Lipoprotein test system, we are claiming equivalence<br>[807.92(a) (3) to K-ASSAY APO B ASSAY (k993354)<br>manufactured by Kamiya Biomedical Company |

.

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## Substantial Equivalence Information

#### 1. Predicate device name(s):

K-Assay Apo B Assay

- 2. Predicate 510(k) number(s): K993354
#### 3. Comparison with predicate:

## Indications for Use

| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------|
| The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. | For the quantitative determination of human Apolipoprotein B (Apo B) in serum by immunoturbidimetric assay. | Same |

## Principle

| Diazyme Apolipoprotein B Assay | K-Assay Assay | Equivalency |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| This method is based on the reaction of a<br>sample containing human Apo B and a spe-<br>cific antiserum to form an insoluble complex<br>which can be measured turbidimetrically at<br>340nm. By constructing a standard curve<br>from the absorbance of standards the concen-<br>tration of Apo B can be determined. | This method quantifies Apolipoprotein AI<br>based on immunoturbidimetric assay. The<br>reagent uses a goat polyclonal antibody<br>specific for human Apolipoprotein B. The<br>antibody binds to the Apo B in the serum<br>forming light scattering immune com-<br>plexes, which increase the turbidity of the<br>sample. Since the turbidity is proportional<br>to the amount of Apo B in the sample, the<br>Apolipoprotein B concentration can be de-<br>termined by measuring this increase in tur-<br>bidity. The increase in turbidity is meas-<br>ured at 600 nm. Apolipoprotein B in the<br>sample is quantitatively determined. | Similar |

### Test Objective

| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------|
| The Diazyme Apolipoprotein B Assay is<br>intended for the quantitative<br>determination of apolipoprotein B (apo<br>B) in serum. It can be used as an aid for<br>assessing the risk of coronary artery<br>disease. | For the quantitative determination of hu-<br>man Apolipoprotein B (Apo B) in serum by<br>immunoturbidimetric assay. | Same |

| Diazyme Apolipoprotein B Assay | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|
| a verse some and a video a video a management - from the management of the responsible of the same of the same of | Apo B Assay | 1 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | IK-Assav | Equivalency |
| | | |

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| Quantitative | Quantitative | Same |
|--------------|--------------|------|
|--------------|--------------|------|

# Specimen Type

| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|--------------------------------|---------------------|-------------|
| Human serum | Human serum | Same |

# Product Type

'

| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|---------------------------------|---------------------------------|-------------|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |

# Performance

| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay |
|---------------------------------|--------------------------------|
| Reportable Range: | Reportable Range: |
| Serum: 25.0 – 160 mg/dL | Serum: 25 – 250 mg/dL |
| Precision/Serum: | Precision/Serum: |
| Within Run: 1.2% -1.4% | Within Run: 1.44% -2.12% |
| Total: 2.1%–4.8% | Total: 1.09%–2.33% |
| Accuracy/Serum: | Accuracy/Serum: |
| Correlation Coefficient: 0.9864 | Correlation Coefficient: 0.885 |
| Slope/Intercept: | Slope/Intercept: |
| $y = 1.0143x - 4.3806$ mg/dL | $y = 1.442x + 0.00$ mg/dL |

# Calibrator Comparison

| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------|
| Lyophilized form | Lyophilized form | Same |
| Diazyme Apolipoprotein B calibrator value is<br>traceable to the WHO/IFCC Reference Stan-<br>dard. | K-Assay Apo B calibrator value is traceable<br>to the WHO International Reference<br>Material for Apo B, SP3-07. | Same |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

General Atomics Diazyme Laboratories Division, c/o Mr. Charles Yu

MAR - 7 2008

Quality System Manager 12889 Gregg Court Poway, CA 92064

Re: k073488

Trade Name: Diazyme Apolipoprotein B Assay Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class II Product Codes: MSJ, JIT, JJX Dated: February 21, 2008 Received: February 22, 2008

Dear Mr. Yu:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 vou desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.v.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number: | K073488 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Diazyme Apolipoprotein B Assay |
| Indications for Use: | The Diazyme Apolipoprotein B Assay is intended for the quantitative<br>determination of apolipoprotein B (apo B) in serum. It can be used as an aid<br>for assessing the risk of coronary artery disease. For in vitro Diagnostic use. |
| Calibrator: | For calibration of the Diazyme Apolipoprotein B Assay in serum. For in vitro<br>Diagnostic Use. |
| Controls: | To monitor the performance of Diazyme Apolipoprotein B Assay in serum. For<br>in vitro Diagnostic Use. |

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

A

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073488