INFINITY GLUCOSE REAGENT

K984574 · Sigma Diagnostics, Inc. · CFR · Feb 11, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984574
• Device Name: INFINITY GLUCOSE REAGENT
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Feb 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

INFINITY™ Glucose Reagent is an in vitro diagnostic reagent for quantitative glucose determination in human serum or urine. It utilizes a hexokinase/glucose-6-phosphate dehydrogenase (G-6-PDH) enzymatic assay. The process involves two steps: 1) Hexokinase catalyzes glucose phosphorylation by ATP to produce glucose-6-phosphate (G-6-P); 2) G-6-PDH oxidizes G-6-P to 6-phosphogluconate, reducing NAD+ to NADH. The resulting NADH concentration is proportional to glucose concentration, measured via absorbance increase at 340 nm. The reagent is intended for use on automated or manual laboratory systems by clinical laboratory professionals. Results assist clinicians in diagnosing and managing hyperglycemia and hypoglycemia, aiding in the assessment of diabetes and other metabolic disorders.

Clinical Evidence

No clinical data provided; device relies on established hexokinase/G-6-PDH reference method performance.

Technological Characteristics

Enzymatic reagent system (hexokinase/G-6-PDH). Principle: UV spectrophotometric measurement of NADH at 340 nm. Compatible with automated and manual clinical chemistry analyzers.

Indications for Use

Indicated for quantitative measurement of glucose in human serum or urine for the diagnosis and management of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TRACE Scientific Glucose Reagents (K980026)

Submission Summary (Full Text)

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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 ________________________________________________________________________________________________________________________________________________________________

- 2. 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
- 2. 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

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) √

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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