(27 days)
Wako Triglyceride 30R product.
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No
The device description details a purely enzymatic and colorimetric assay for triglyceride measurement, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic assay used for the quantitative determination of triglyceride in serum, aiding in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this test are used in the diagnosis and treatment with diabetes mellitus." This directly indicates its role as a diagnostic device.
No
The device description clearly describes an in vitro diagnostic assay that utilizes chemical reactions and enzymatic methods to measure triglyceride levels in serum, indicating it is a physical test kit and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the 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." This clearly indicates the test is used for diagnostic purposes.
- Device Description: The "Device Description" details an "in vitro assay for the quantitative determination of triglyceride in serum." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. The description also outlines the chemical reactions used to measure a substance (triglyceride) in a biological sample (serum).
These points strongly align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Measurements obtained 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.
Product codes (comma separated list FDA assigned to the subject device)
CDT
Device Description
The Wako L-Type Triglyceride test is an in vitro assay for the quantitative determination of triglyceride in serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.9995; regression equation of y = 0.970 x + 2.2; minimum detectable level of 1.2 mg/dL.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Wako Triglyceride 30R product.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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:
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Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
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Spayd, R.W., Bruschi, B., et al .: Clin. Chem., 24, 1343-1350 (1978)
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DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
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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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles forming a wing-like shape, which is a common symbol associated with health and human services.
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)