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).
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 Description

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.

AI/ML Overview

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Aid in risk assessment of coronary artery disease (CAD)	Demonstrated substantial equivalency to the Apo-tek Lp(a) assay and Sigma's LDL in assessing cardiac risk.
Precision	Precision studies indicate acceptable values can be obtained on a day-to-day basis.
Minimum detectable level	Estimated to be 0.3 mg/dL.
Linearity	Determined to be linear to 100 mg/dL.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set during the substantial equivalence study.
The data provenance is not specified, but typically, these studies for diagnostic devices involve clinical samples. It is not stated whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish ground truth for a test set, nor their qualifications. Given that the device is compared to other assays (Apo-tek Lp(a) and Sigma's LDL), the ground truth for CAD risk assessment would likely rely on the established clinical utility and accuracy of these predicate devices and broader clinical diagnostic standards for CAD.

4. Adjudication Method

The document does not specify an adjudication method. The study primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a direct expert-adjudicated clinical outcome study for diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This type of study is more common for imaging-based diagnostics where human interpretation is a primary component. The Wako Autokit Lp(a) is an in vitro turbidimetric immunoassay, which is an automated or semi-automated laboratory test.

6. Standalone (Algorithm Only) Performance Study

The information provided describes the performance of the Wako Autokit Lp(a) assay itself, which is a standalone in vitro diagnostic device (an "algorithm" in the context of a lab test). The reported precision, minimum detectable level, and linearity are all measures of its standalone performance. The "substantial equivalence" claim is a comparison of this standalone performance to other predicate devices.

7. Type of Ground Truth Used

The primary "ground truth" used for demonstrating effectiveness appears to be:

Established performance of predicate devices: The Wako Autokit Lp(a) assay's ability to determine cardiac risk is proven by its substantial equivalency to the Apo-tek Lp(a) assay and Sigma's LDL, which are presumably already established as effective in assessing CAD risk.
Analytical performance characteristics: Precision, minimum detectable level, and linearity are inherent analytical characteristics that define the assay's performance.

There is no mention of pathology, direct outcomes data, or expert consensus specific to a test set in the context of a new diagnostic accuracy study for clinical utility.

8. Sample Size for the Training Set

The document does not specify a training set or its sample size. For an in vitro diagnostic assay like this, "training" might refer to the internal development and calibration of the assay, which would involve numerous samples, but these are not explicitly detailed as a "training set" in the context of a validation study for regulatory submission.

9. How Ground Truth for the Training Set Was Established

As no specific training set is outlined, the method for establishing its ground truth is not described. The assay's development would involve using reference materials and samples with known Lp(a) concentrations for calibration and optimization, but this process is not detailed in the summary.

Summary

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3/9/90

Nako

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

510(k) Summary of Safety and Effectiveness

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

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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.

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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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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

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Prescription Use

Regulation Number and Section

§ 866.5600 Low-density lipoprotein immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).