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.

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. It is a highly specific enzymatic method utilizing hexokinase (HK) and glucose-6-phosphate dehydrogens (G-6-PDH) combinationally.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Wako L-Type Glu 2" test, which is an in vitro assay for the quantitative determination of glucose. However, the document does not contain all the specific details requested for acceptance criteria and the study proving the device meets them.

Here's a breakdown of the available information based on the request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide a table of reported device performance values. It only states that "The safety and effectiveness of the Wako L-type Glu 2 is demonstrated by its substantial equivalency to Wako." This implies a comparison to a predicate device, but the specific performance metrics for either device are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. The device is an in vitro diagnostic for glucose, so expert review in the sense of image analysis by radiologists would not be applicable. For clinical chemistry devices, ground truth is typically established by reference methods or validated instruments, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text. Adjudication methods like "2+1" are typically used for subjectively interpreted data (e.g., medical imaging), which is not the case for a quantitative glucose assay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is an in vitro diagnostic for glucose measurement and not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is for in vitro diagnostic measurement. The device itself performs the measurement; it's not an algorithm that requires human-in-the-loop interaction in the context of interpretation. Standalone performance for this type of device would refer to its analytical performance characteristics (e.g., accuracy, precision, linearity), which are not detailed here beyond the claim of substantial equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

While not explicitly stated, for quantitative in vitro diagnostic assays like glucose, the ground truth is typically established using reference methods or validated comparator instruments. The document mentions a comparison to "Wako" (presumably an older Wako glucose test or an equivalent method), suggesting a comparative performance study against an established method.

8. The sample size for the training set

This information is not available in the provided text. The concept of a "training set" as understood in machine learning is not directly applicable here. For in vitro diagnostic devices, developmental testing involves analytical validation using various samples (e.g., spiked samples, patient samples spanning the measuring range), but these are usually referred to as validation or verification samples, not a "training set."

9. How the ground truth for the training set was established

This information is not available in the provided text due to the nature of the device and the lack of a "training set" in the machine learning sense.

Summary

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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:

Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 200 Ed., Saunders. Philadelphia, 1994.
Hengartner, H and Zuber, H .: FEBS LETTERS, 37, 212-216 (1973).
DG Klinische Chemie Mitteilungen 26 (1995) page 5.
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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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:

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)

Over-The-Counter Use (Optional Format 1-2-96)

Evelyn Cooper Ms. Dim

Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.