(63 days)
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No
The description focuses on a traditional enzymatic assay for glucose measurement and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for measuring glucose, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "diagnosis... of carbohydrate metabolism disorders".
No
The device description clearly states it is an "in vitro assay" utilizing enzymatic methods, which are chemical reagents and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "measure glucose quantitatively in blood and other body fluids" and that these measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders." This aligns perfectly with the definition of an IVD, which is a device used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device description confirms it is an "in vitro assay for the quantitative determination of glucose in serum, plasma or urine." This further reinforces its use in examining body fluids outside of the body.
- Method: The description of the enzymatic method (hexokinase and glucose-6-phosphate dehydrogenase) is a common technique used in in vitro diagnostic tests for glucose.
The information provided clearly indicates that this device is designed to be used in vitro (outside the living body) to analyze biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
A Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Product codes
CFR
Device Description
The Wako L-Type Glu 2 test is an in vitro assay for the quantitative determination of glucose in serum, plasma or urine. The Wako L-Type Glu 2 is a highly specific enzymatic method utilizing hexokinase (HK) and glucose-6-phosphate dehydrogens (G-6-PDH) combinationally.
When a sample is mixed with Enzyme and ATP, the glucose in the sample yields glucose-6-phosphate (G-6-P) and adenosine-5' -diphosphate (ADP) by HK. G-6-P is conversed to 6-phosphogluconic acid by G-6-PDH in the presence of NAD and at the same time. NAD is reduced to NADH. By measuring the increase in the absorbance at 340 nm due to the reduction of NAD, glucose concentration in the sample is determined.
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)
The safety and effectiveness of the Wako L-type Glu 2 is demonstrated by its substantial equivalency to Wako.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
KC024281
FEB 2 4 2003
Wako Diagnostics 1600 Bellwood Road, Richmond, VA 23237 U.S.A.
510(K) Summary of Safety and Effectiveness
The Wako L-Type Glu 2 test is an in vitro assay for the quantitative determination of glucose in serum, plasma or urine.
Summarv:
Wako
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus. There are several methods used for the determination of glucose level. In the past, colorimetric or oxidation-reduction methods were used. The Wako L-Type Glu 2 is a highly specific enzymatic method utilizing hexokinase (HK) and glucose-6-phosphate dehydrogens (G-6-PDH) combinationally.
Principle:
When a sample is mixed with Enzyme and ATP, the glucose in the sample yields glucose-6-phosphate (G-6-P) and adenosine-5' -diphosphate (ADP) by HK. G-6-P is conversed to 6-phosphogluconic acid by G-6-PDH in the presence of NAD and at the same time. NAD is reduced to NADH. By measuring the increase in the absorbance at 340 nm due to the reduction of NAD, glucose concentration in the sample is determined.
The safety and effectiveness of the Wako L-type Glu 2 is demonstrated by its substantial equivalency to Wako
Both test systems are used to measure glucose in serum, plasma or urine.
References:
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Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 200 Ed., Saunders. Philadelphia, 1994.
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Hengartner, H and Zuber, H .: FEBS LETTERS, 37, 212-216 (1973).
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DG Klinische Chemie Mitteilungen 26 (1995) page 5.
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Ghan, A. Y. W., Swaminathan, R., Cockram, C.S .: Clin.Chem.,35:315-317,1989.
Anna Hallum
Sr. Manager Wako Diagnostics Tonva Mattory. September 22, 1999 1600 Bellwood Road Richmond, VA 23237
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 4 2003
Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond. VA 23237
Re: K024281 Trade/Device Name: Wako L-Type Glucose 2 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: December 20, 2002 Received: December 23, 2002
Dear Ms. Mallory:
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. Ilisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use:
A Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Proprietary Name: Wako L-Type Glucose 2
Established Registration Number: 1627434
Ko2428 Premarket Notification 510 (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 V (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Evelyn Cooper Ms. Dim
Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________