(50 days)
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No
The device description details a chemical reaction-based assay for glucose measurement, with no mention of AI or ML technologies.
No
The device is used for diagnostic determination of glucose, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro quantitative, diagnostic determination of glucose" and that its measurements "are used in the diagnosis and treatment of carbohydrate metabolism disorders".
No
The device description clearly indicates it is a chemical reagent used in a laboratory assay, not a software program.
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 reagent is intended for the "in vitro quantitative, diagnostic determination of glucose in human serum or urine". The phrase "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Diagnostic Purpose: The intended use also clearly states that the 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." This indicates the device is used for diagnostic purposes.
- Sample Type: The device analyzes human serum or urine, which are biological samples taken from the body.
- Device Description: The description details a chemical reaction used to measure glucose, which is a typical method for in vitro diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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:
-
- Hexokinase (HK) catalyses the phosphorylation of glucose by adenosine-5'-triphosphate (ATP) producing adenosine-5'-diphosphate (ADP) and glucose-6-phosphate (G-6-P).
-
- 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 is oxidized to 6-phosphogluconate (6-PG) with the reduction of nicotinamide adenine dinucleotide (NAD*) to reduced NAD (NADH) by glucose-6-phosphate dehydrogenase
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
Not Found
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).
Not Found
§ 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
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:
-
- 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 ________________________________________________________________________________________________________________________________________________________________
- Hexokinase (HK) catalyses the phosphorylation of glucose by adenosine-5'-triphosphate (ATP) producing adenosine-5'-diphosphate (ADP) and glucose-6-phosphate (G-6-P).
-
- 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 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-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
-
- Clinical Chemistry Theory, Analysis and Correlation. Kaplan LA, Pesce AJ (Eds.), CV Mosby Company, St. Louis, MO. 1257-61, 1984
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight.
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:
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) √
ﺳﮯ
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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