Measurements obtained by this test are used in the diagnosis and treatment with diabetes mellitus, and in in one to be lister on with diabetes mellitus, newsload, some tabolism ther arseases of the disorders.

Device Description

The Wako L-Type Triglyceride test is an in vitro assay for the quantitative determination of triglyceride in serum. The Wako L-Type Triglyceride is an enzymatic method utilizing N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxyaniline sodium salt (DAOS) that produces blue pigment. Triglycerides in a sample are hydrolyzed to glycerol and free fatty acids in a reaction catalyzed by lipoprotein lipase (LPL). Glycerol is converted to glycerol-3-phosphate by glycerokinase (GK) in the presence of adenosine-5'-triphosphate(ATP). Glycerol-3-phosphate formed is oxidized by GPO in a reaction that produces hydrogen peroxide. The hydrogen peroxide produced causes DAOS and 4-aminoantipyrine to undergo a quantitative condensation catalyzed by peroxidase (POD), producing a blue pigment. The amount of triglycerides contained in the sample is determined by measuring the absorbance of the blue color.

AI/ML Overview

This Preamarket Notification (510(k)) for the Wako L-Type Triglyceride Test focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for novel diagnostic algorithms or devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation to Predicate Device (Wako Triglyceride 30R)	Correlation coefficient of 0.9995
Regression Equation (vs. Predicate)	y = 0.970x + 2.2
Precision	"Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific numerical criteria or performance provided beyond this qualitative statement)
Minimum Detectable Level	1.2 mg/dL
Clinical Use/Indications	"Measurements obtained by this test are used in the diagnosis and treatment of hyperlipidemia, hyperlipoproteinemia, and atherosclerosis, and in connection with diabetes mellitus, nephrosis, some metabolic diseases and other diseases of the liver and thyroid."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the comparison studies against the predicate assay.
The document does not specify the country of origin of the data.
The document does not explicitly state if the data was retrospective or prospective. However, typically, such comparison studies for 510(k) submissions would likely use retrospective samples or samples collected specifically for the comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of this 510(k) submission. For this type of in vitro diagnostic device (IVD), the "ground truth" for the comparison study is the performance of the legally marketed predicate device (Wako Triglyceride 30R). There are no human experts "establishing ground truth" in the way one would for image-based diagnostics requiring expert consensus. The predicate device itself serves as the reference standard.

4. Adjudication Method for the Test Set

This is not applicable as there is no "adjudication" in the sense of reconciling disagreements between multiple human readers or interpretations. The comparison is between the new device's measurements and the predicate device's measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in interpreting complex data (e.g., medical images). The Wako L-Type Triglyceride Test is an in vitro assay that provides a quantitative measurement, not an interpretative aid for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study presented is inherently a standalone performance study for an in vitro diagnostic device. The Wako L-Type Triglyceride test is an automated enzymatic assay. Its performance (correlation, regression, precision, minimum detectable level) is assessed directly without human input in the measurement process itself, only in the handling of samples and running the assay.

7. The Type of Ground Truth Used

The "ground truth" for the comparison study was the measurements obtained from the legally marketed predicate device, Wako Triglyceride 30R. This functions as a reference standard for establishing substantial equivalence.

8. The Sample Size for the Training Set

This document does not provide information on a "training set" sample size. For an IVD like this, there isn't a traditional "training set" in the machine learning sense. The device's formulation and assay parameters would have been developed/optimized by the manufacturer prior to these validation studies.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there's no explicit "training set" or "ground truth for training" described in the context of this 510(k) summary for an enzymatic assay. The development process for such an assay involves chemical and enzymatic optimization, calibration, and early-stage validation, but not a "ground truth" establishment in the data-driven sense of algorithm training.

Summary

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K993466

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

510(K) Summary of Safety and Effectiveness

The Wako L-Type Triglyceride test is an in vitro assay for the quantitative determination of triglyceride in serum.

Summary:

Waki

Lipids in serum consist of triglyceride, cholesterol, phospholipids, free fatty acid and slight amount of fat-soluble compounds such as amount of fat-soluble vitamins and carotene. Triglycerides are water-insoluble lipids, consisting of fatty acids linked to glycerol. Determination of triglyceride in serum is an important clinical test in diagnosis of arterial sclerosis, coronary heart diseases and diabetes. The clinical method using acetylacetone has been traditionally used to measure triglyceride. However, the method requires complicated procedure such as absorption or extraction. Therefore, the chemical method has been replaced with the specific methods employing enzymes. The enzymatic method employing glycerol-3-phosphate oxidase (GPO) has been used extensively with growing popularity since it is superior on specificity and simplicity, and the measurement can be done under ordinary conditions. The Wako L-Type Triglyceride is an enzymatic method utilizing N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxyaniline sodium salt (DAOS) that produces blue pigment. 14

Principle:

Triglycerides in a sample are hydrolyzed to glycerol and free fatty acids in a reaction catalyzed by lipoprotein lipase (LPL). Glycerol is converted to glycerol-3-phosphate by glycerokinase (GK) in the presence of adenosine-5'-triphosphate(ATP). Glycerol-3-phosphate formed is oxidized by GPO in a reaction that produces hydrogen peroxide. The hydrogen peroxide produced causes DAOS and 4-aminoantipyrine to undergo a quantitative condensation catalyzed by peroxidase (POD), producing a blue pigment. The amount of triglycerides contained in the sample is determined by measuring the absorbance of the blue color

The safety and effectiveness of the Wako L-Type Triglyceride is demonstrated by its substantial equivalency to Wako Triglyceride 30R product. Both test systems are used to measure triglyceride in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.9995 and a regression equation of y = 0.970 x + 2.2 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 1.2 mg/dL.

References:

Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
Spayd, R.W., Bruschi, B., et al .: Clin. Chem., 24, 1343-1350 (1978)
DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
AACC Press: Handbook of Lipoprotein Testing (1997).

Luiza Hallum

Tonya Mallory, Sr. Manager Wako Diagnostics September 22, 1999 1600 Bellwood Road Richmond, VA 23237

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 9 1999

Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond, Virginia 23237

Re: K993466

Trade Name: Wako L-Type Triglyceride Test Regulatory Class: I Product Code: CDT Dated: September 23, 1999 Received: October 13, 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 (OS) 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 Putman

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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Page !

510(k) Number (if known): _ K y 9 34b b Wako L-Type Triglycuide Test Device Name:

Indications For Use:

Mcasunments obfained by this test are used in the diagnosis and treatment With diabetes mellifus, and in in one to be lister on with diabetes melifras, newsload, some tabolism ther arseases of the disorders.

Sean Cooper

vision of Clinical Laboratory Device k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1705 Triglyceride test system.

(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.