WAKO AUTOKIT LP(A)

K981446 · Wako Chemicals USA, Inc. · DFC · Mar 9, 1999 · Immunology

Device Facts

• Record ID: K981446
• Device Name: WAKO AUTOKIT LP(A)
• Applicant: Wako Chemicals USA, Inc.
• Product Code: DFC · Immunology
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

The Wako Lp(a) assay is an in vitro turbidimetric immunoassay for the quantitative determination of lipoprotein(a) in serum or plasma to aid in the risk assessment of coronary heart disease (CAD).

Device Story

Wako Autokit Lp(a) is an in vitro diagnostic assay for quantitative measurement of lipoprotein (a) in serum or plasma. Principle of operation: turbidimetric immunoassay (TIA). Sample is mixed with buffer and anti-human lipoprotein (a) antibodies; specific binding creates insoluble aggregates causing turbidity. Turbidity is measured optically; signal intensity is proportional to Lp(a) concentration. Used in clinical laboratory settings by trained personnel. Output is a quantitative concentration value (mg/dL). Healthcare providers use this result in conjunction with other lipoprotein tests to assess coronary artery disease (CAD) risk. Benefit: provides objective data to assist in cardiovascular risk stratification.

Clinical Evidence

Bench testing only. Precision studies demonstrate acceptable day-to-day performance. Minimum detectable level is 0.3 mg/dL. Assay is linear up to 100 mg/dL.

Technological Characteristics

In vitro turbidimetric immunoassay (TIA). Reagents include buffer and anti-human lipoprotein (a) antibodies. Optical measurement of turbidity. Linear range: 0.3 mg/dL to 100 mg/dL.

Indications for Use

Indicated for the quantitative determination of lipoprotein(a) in serum or plasma to aid in the risk assessment of coronary heart disease (CAD) in patients.

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.

Predicate Devices

• Apo-tek Lp(a) assay
• Sigma's LDL

Submission Summary (Full Text)

{0}------------------------------------------------

3/9/90

Nako

Wako Chemicals USA Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.

## 510(k) Summary of Safety and Effectiveness

The Wako Autokit Lp(a) test is an in vitro diagnostic assay for the quantitative determination of lipoprotein (a) in serum or plasma to aid, in conjunction with other lipoprotein tests, with the risk assessment of coronary artery disease (CAD).

Components of Lp(a) have similarities to both LDL and plasminogen, suggesting that Lp(a) may represent a bridge between the fields of atherosclerosis and thrombosis. Numerous studies suggested an association of plasma Lp(a) concentrations with atherosclerotic vascular disease. There are numerous techniques for measuring Lp(a) such as radial immunodiffusion(RID), radio immunoassay (RIA), enzyme-linked immunoassay (ELISA), nephelometric immunoassay (NIA), and turbidimetric immunoassay (TIA). The Wako Lp(a) test kit is based on the TIA methodology.

When a sample is mixed with the Buffer and the Antibody, Lp(a) in the sample combines specifically with anti-human lipoprotein (a) antibodies in the reagent to vield an insoluble aggregate that causes turbidity. The degree of turbidity cab be measured optically and is proportional to the amount of Lp(a) in the sample.

The safety and effectiveness of the Wako Autokit Lp(a) assay is demonstrated by its substantial equivalency to the Apo-tek Lp(a) assay and Sigma's LDL, in its ability to determine cardiac risk. All of these systems are used to assess the risk of coronary artery disease (CAD).

Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 0.3 mg/dL. The Wako Autokit Lp(a) assay had determined to be linear to 100 mg/dL.

Tuka Wallin

February 22, 1999 Tonya Mallory Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

{1}------------------------------------------------

MAR - 9 1003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tonya Mallory Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237

Re: K981446 Trade Name: Wako Autokit Lp(a) Regulatory Class: II Product Code: DFC Dated: January 7, 1999 Received: January 11, 1999

### Dear Ms. Mallory:

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 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). 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 (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 requirements, 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 GMP 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.

{2}------------------------------------------------

#### Page 2

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 regulation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

{3}------------------------------------------------

Page 1 of 1

Wako Autokit Lp(a) 510(k) Number K981446

Jan Cooper
(Division Sign-Off)

( ( 510(k) Number_1981440

# Indications for Use:

The Wako Lp(a) assay is an in vitro turbidimetric immunoassay for the quantitative determination of lipoprotein(a) in serum or plasma to aid in the risk assessment of coronary heart disease (CAD).

Tonya Mallory

Wako Diagnostics

February 19, 1999

gr

机

Prescription Use