Diazyme Lipoprotein (a) Assay

K180074 · Diazyme Laboratories, Inc. · DFC · Mar 22, 2018 · Immunology

Device Facts

• Record ID: K180074
• Device Name: Diazyme Lipoprotein (a) Assay
• Applicant: Diazyme Laboratories, Inc.
• Product Code: DFC · Immunology
• Decision Date: Mar 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma on Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only

Device Story

The Diazyme Lipoprotein(a) Assay is an in vitro diagnostic reagent kit used on clinical chemistry analyzers (e.g., Beckman Coulter AU400) to quantify Lp(a) in human serum or plasma. The assay utilizes latex particles coated with anti-Lp(a) antibodies; when mixed with a patient sample, the antibodies bind to Lp(a), causing agglutination. This agglutination increases sample turbidity, which is measured optically by the analyzer. The degree of turbidity is directly proportional to the Lp(a) concentration. The assay is intended for use by laboratory professionals to assist clinicians in evaluating lipid metabolism and atherosclerotic cardiovascular disease risk. Results are interpreted alongside patient history and other clinical findings.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (N=80 per sample, total CV 1.4-8.9%). Linearity confirmed from 0.2 to 102.6 mg/dL (r²=0.9975). LoB/LoD/LoQ determined per CLSI EP17-A2 (LoQ 3.2 mg/dL). Interference testing per CLSI EP07-A2 showed no significant interference from triglycerides, ascorbic acid, bilirubin, or hemoglobin. Method comparison against an existing commercial method (N=99) showed high correlation (r²=0.9868, slope 0.9828). Matrix comparison confirmed performance in K₂EDTA and lithium heparin plasma.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents: Tris buffer and latex particles coated with anti-Lp(a) antibodies. Measuring range: 5.4–100 mg/dL. Optical measurement of agglutination-induced turbidity. Validated on Beckman Coulter AU400 chemistry analyzer. No specific software algorithm class or connectivity features described beyond standard clinical chemistry analyzer integration.

Indications for Use

Indicated for the quantitative determination of Lp(a) in human serum or plasma to evaluate lipid metabolism disorders and assess atherosclerotic cardiovascular disease risk in adult populations. Contraindications: None stated; however, Apo A size heterogeneity may impact measurement accuracy.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2018

DIAZYME LABORATORIES, INC. ABHIJIT DATTA VP OPERATIONS 12889 GREGG COURT POWAY, CA 92064

Re: K180074

Trade/Device Name: Diazyme Lipoprotein (a) Assay Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: January 9, 2018 Received: January 10, 2018

Dear Abhijit 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Kellie B. Kelm -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 (if known) k180074

Device Name Diazyme Lipoprotein (a) Assay

#### Indications for Use (Describe)

The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> </span> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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