INFINITY GLUCOSE REAGENT by SIGMA DIAGNOSTICS, INC.

The Sigma Diagnostics INFINITY™ Glucose Reagent is intended for the in vitro quantitative, diagnostic determination of glucose in human serum or urine on both automated and manual systems.

The Sigma Diagnostics INFINITY™ Glucose Reagent is a device intended to measure glucose quantitatively in serum or urine. Measurements obtained by the device 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 Sigma Diagnostics INFINITY™ Glucose Reagent is based on the hexokinase/glucose-6-phosphate dehydrogenase method. The series of reactions involved in the assay system is as follows:

Hexokinase (HK) catalyses the phosphorylation of glucose by adenosine-5'-triphosphate (ATP) producing adenosine-5'-diphosphate (ADP) and glucose-6-phosphate (G-6-P).
Glucose + ATP ________________________________________________________________________________________________________________________________________________________________
G-6-P is oxidized to 6-phosphogluconate (6-PG) with the reduction of nicotinamide adenine dinucleotide (NAD*) to reduced NAD (NADH) by glucose-6-phosphate dehydrogenase (G-6-PDH). The amount of NADH formed is proportional to the concentration of glucose in the sample and can be measured by the increase in absorbance at 340 nm.
G-6-P + NAD*

AI/ML Overview

The provided text is a 510(k) summary for the INFINITY™ Glucose Reagent. It describes the intended use and the method of glucose determination, and states that it is substantially equivalent to a previously cleared device. However, this document does not contain the specific acceptance criteria for performance, nor does it detail a study proving the device meets said criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (TRACE Scientific Glucose Reagents cleared as K980026) rather than presenting a detailed performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

A table of acceptance criteria and the reported device performance:
- Cannot be provided as this information is not in the document. The document states that the device is "substantially equivalent to" the predicate device, implying its performance is comparable, but does not list specific criteria or performance metrics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided as no specific performance studies are detailed in this 510(k) summary.
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):
- Cannot be provided as no specific performance studies are detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided as no specific performance studies are detailed.
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:
- Not applicable. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. This is a chemical reagent for quantitative measurement of glucose. The "standalone performance" would relate to its analytical performance (accuracy, precision, linearity, etc.), which is implied to be equivalent to the predicate but not explicitly detailed or quantified with acceptance criteria in this document.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a glucose reagent, the "ground truth" would typically be established by a reference method. The document states: "The hexokinase/glucose-6-phosphate dehydrogenase method developed by the American Association of Clinical Chemistry and Centers for Disease Control has been accepted as the reference method for glucose determination." It also states, "The Sigma Diagnostics INFINITY Glucose Reagent is based on the reference method." Therefore, the ground truth for validation would likely be measurements obtained using the hexokinase/glucose-6-phosphate dehydrogenase reference method.
The sample size for the training set:
- Not applicable. This device is a chemical reagent, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. (See point 8).

Summary of available information:

The 510(k) summary for the INFINITY™ Glucose Reagent does not include detailed acceptance criteria or the specifics of a study proving the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (TRACE Scientific Glucose Reagents cleared as K980026). The "ground truth" for glucose determination is based on the established hexokinase/glucose-6-phosphate dehydrogenase reference method.

To obtain the detailed performance data, acceptance criteria, and study methods, one would typically need to review the full 510(k) submission or the predicate device's documentation if the substantial equivalence argument relies on prior clearance. This summary document is a high-level overview.

Summary

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K9F45K74

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

INFINITY™ Glucose Reagent, Procedures 17/18

Sigma Diagnostics INFINITY™ Glucose Reagent is intended for the in vitro quantitative, diagnostic determination of glucose in human serum or urine on both automated and manual systems.

The accurate estimation of glucose is important in the diagnosis and management of hyperqlycemia and hypodlycemia. Hyperglycemia may occur as a result of diabetes mellitus, in patients receiving glucose containing fluids intravenously, during severe stress and cerebrovascullar accidents. Hypodvcemia may be the result of an insulinoma, insulin administration, inborn errors of carbohydrate metabolism or fasting. 1 Often in the investigation of these disorders glucose determinations are performed in conjunction with various tolerance tests or simulation tests. For a more detailed discussion of glucose metabolism the user should refer to a standard textbook such as Kaplan.2

The hexokinase/glucose-6-phosphate dehydrogenase method developed by the American Association of Clinical Chemistry and Centers for Disease Control has been accepted as the reference method for glucose determination. In that procedure protein free filtrates prepared by the Somogyi technique using ZnSO4 / BaSO4 precipitation are used. For routine laboratory use however, serum or plasma without protein removal is the preferred method. The Sigma Diagnostics INFINITY Glucose Reagent is based on the reference method.

The series of reactions involved in the assay system is as follows:

1. Hexokinase (HK) catalyses the phosphorylation of glucose by adenosine-5'-triphosphate (ATP) producing adenosine-5'-diphosphate (ADP) and glucose-6-phosphate (G-6-P).
  Glucose + ATP ________________________________________________________________________________________________________________________________________________________________
1. G-6-P is oxidized to 6-phosphogluconate (6-PG) with the reduction of nicotinamide adenine dinucleotide (NAD*) to reduced NAD (NADH) by glucose-6-phosphate dehydrogenase
  (G-6-PDH). The amount of NADH formed is proportional to the concentration of glucose in the sample and can be measured by the increase in absorbance at 340 nm.

G-6-P + NAD*

The Sigma Diagnostics INFINITY™ Glucose Reagents (Procedure No. 17/18) are substantially equivalent to, and are the same products as the TRACE Scientific Glucose Reagents cleared by the FDA as K980026.

References

Zilva JF. Pannall PR: Carbohydrate Metabolism in "Clinical Chemistry in Diagnosis and 1. Treatment". Lloyd-Luke, London 1979, Chap 9: 174-214
1. Clinical Chemistry Theory, Analysis and Correlation. Kaplan LA, Pesce AJ (Eds.), CV Mosby Company, St. Louis, MO. 1257-61, 1984

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Public Health Service

FEB 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Clinical Technical Services 545 South Ewing Avenue St. Louis, Missouri 63103

Re: K984574

Trade Name: INFINITY™ Glucose Reagent Regulatory Class: II Product Code: CFR Dated: December 21, 1998 Received: December 23, 1998

Dear Dr. Gilbert:

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 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 1 of 1

510(k) Number (if known): __

Device Name: INFINITY™ Glucose Reagent

Indications For Use:

Dean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number _ 12 984574

(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) √

ﺳﮯ

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.