DIAZYME APOLIPOPROTEIN A-1 ASSAY

K072977 · General Atomics · MSJ · Jul 16, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072977
• Device Name: DIAZYME APOLIPOPROTEIN A-1 ASSAY
• Applicant: General Atomics
• Product Code: MSJ · Clinical Chemistry
• Decision Date: Jul 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) 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 A-I Assay in serum. For in vitro Diagnostic Use. Controls: To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.

Device Story

The Diazyme Apolipoprotein A-I Assay is an in vitro diagnostic test used to measure Apo A-I levels in human serum samples. The device utilizes an immunoturbidimetric principle; patient serum is mixed with specific antiserum to form insoluble immune complexes. The resulting turbidity, which is proportional to the concentration of Apo A-I in the sample, is measured spectrophotometrically at 340 nm. The concentration is determined by comparing the sample absorbance against a standard curve. The assay is intended for use in clinical laboratory settings by trained personnel. Results are provided to healthcare providers to assist in the assessment of coronary artery disease risk. The device includes reagents, calibrators, and controls to ensure measurement accuracy and performance monitoring.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A (n=40 per level, CV% 0.6-3.3%). Linearity evaluated per CLSI EP6-A (R^2=0.999, range 20-228 mg/dL). Analytical specificity confirmed no interference from ascorbic acid, bilirubin, hemoglobin, triglycerides, or Apo A-II. Method comparison with predicate (n=65) yielded y = 0.908x + 2.813, R^2 = 0.979. No clinical sensitivity or specificity studies performed.

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-human-apo A-I antibody. Measures absorbance at 340 nm. Requires instrument with 37°C temperature control. Calibrators and controls are lyophilized human serum. Traceable to WHO/IFCC SP-101. Reagents stable for 1 year; on-board stability 60 days on Hitachi 917. No specific ASTM standards cited.

Indications for Use

Indicated for the in vitro quantitative determination of apolipoprotein A-I in human serum to aid in assessing coronary artery disease risk. For prescription 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 AI Assay (k993345)
• K-Assay Apo A1/B calibrator set (k993606)
• Cliniqa Lipid Control (k061182)

Submission Summary (Full Text)

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K072977

# JUL 1 6 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: | 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: | September 24, 2007, June 5, 2008, and July 8, 2008 |
| Name of the Device | Diazyme Apolipoprotein A-I Assay |
| Trade Name: | Diazyme Apolipoprotein A-I Assay |
| Common/Usual Name | Apolipoprotein A-I Test System |
| Device Classification Name | Lipoprotein test system |
| Product code: | MSJ (reagent), JIT (calibrator), JJX (control) |
| Submission Type<br>============================================================================================================================================================================== | 510k |
| Regulation Number | 862.1475(reagent), 862.1150(calibrator), 862.1660(control) |
| Device Class | II (reagent), II (calibrator), I Reserved (control) |
| 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 AI ASSAY (k993345)<br>manufactured by Kamiya Biomedical Company |

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### Substantial Equivalence Information

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

K-Assay Apo AI Assay

#### 2. Predicate 510(k) number(s): K993345

#### 3. Comparison with predicate:

### Indications for Use

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

#### Principle

| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| This method is based on the reaction of a sam-<br>ple containing human Apo A-I and specific<br>antiserum to form an insoluble complex which<br>can be measured turbidimetrically at 340nm.<br>By constructing a standard curve from the ab-<br>sorbance of standards the concentration of Apo<br>A-1 can be determined. | This method quantifies Apolipoprotein AI<br>based on immunoturbidimetric assay. The re-<br>agent uses a goat polyclonal antibody specific<br>for human Apolipoprotein AI. The antibody<br>binds to the Apo AI in the serum forming<br>light scattering immune complexes, which<br>increase the turbidity of the sample. Since the<br>turbidity is proportional to the amount of Apo<br>AI in the sample, the Apolipoprotein AI con-<br>centration can be determined by measuring<br>this increase in turbidity. The increase in tur-<br>bidity is measured at 800 nm. Apolipoprotein<br>AI in the sample is quantitatively determined. | Similar |

#### Test Objective

| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------|
| The Diazyme LDL-Cholesterol Assay is in-<br>tended for the in vitro quantitative determina-<br>tion of Low Density Lipoprotein Cholesterol<br>in human serum or plasma. | For the quantitative determination of human<br>Apolipoprotein AI (Apo AI) in serum by im-<br>munoturbidimetric assay. | Same |
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
| Quantitative | Quantitative | Same |

:

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#### Specimen Type

| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|----------------------------------|----------------------|-------------|
| Human serum | Human serum | Same |

### Product Type

| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|----------------------------------|---------------------------------|-------------|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |

#### Performance

| Performance | |
|----------------------------------|--------------------------------|
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay |
| Reportable Range: | Reportable Range: |
| Serum: 20- 228 mg/dL | Serum: 20 – 300 mg/dL |
| Precision/Serum: | Precision/Serum: |
| Within Run: 0.6% -0.9% | Within Run: 1.51% -1.87% |
| Total: 1.8%-3.3% | Total: 1.05%-1.57% |
| Accuracy/Serum: | Accuracy/Serum: |
| Correlation Coefficient: 0.9789 | Correlation Coefficient: 0.970 |
| Slope/Intercept: | Slope/Intercept: |
| $y = 0.91x + 2.813$ | $y = 0.980x + 4.776$ mg/dL |

### Calibrator Comparison

| Calibrator Comparison | | |
|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------|
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
| Lyophilized form | Lyophilized form | Same |
| Diazyme Apolipoprotein A-I calibrator value is<br>traceable to the WHO International Reference<br>Material for Apo AI, Sp1-01. | K-Assay Apo AI calibrator value is traceable<br>to the WHO International Reference<br>Material for Apo AI, Sp1-01. | Same |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

General Atomics Diazyme Laboratories c/o Mr. Charles Yu. Quality System Manager 12889 Gregg Court Poway, California 92064

> k072977 Trade Name: Diazyme Apolipoprotein A-I Assay; Diazyme Apolipoprotein A-I Calibrator, and Diazyme Apolipoprotein A-I Control, Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, meets the limitation to exemption in 862.9(c)(4) Product Code: MSJ, JIT, JJX Dated: June 5, 2008 Received: June 17, 2008

JUL 1 6 2008

#### Dear Mr. Yur.

Re:

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 you 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.

Yéan 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: | K072977 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Diazyme Apolipoprotein A-I Assay |
| Indications for Use: | The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative<br>determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an<br>aid for assessing the risk of coronary artery disease. For in vitro Diagnostic<br>use. |
| Calibrator: | For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro<br>Diagnostic Use. |
| Controls: | To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum.<br>For in vitro Diagnostic Use. |

7

Division/Sign-Off

Office of In Vir o Dingnostic Device Evaluation and Unitedy

510(k) k072977

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)