(135 days)
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No
The summary describes a chemical reagent for glucose measurement and does not mention any AI/ML components or methodologies.
No.
Explanation: The device is a "Glucose Reagent" used for diagnosing disorders related to carbohydrate metabolism by measuring glucose levels, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Glucose determinations... are useful for detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions," which are diagnostic purposes.
No
The device description explicitly states it is a "Glucose Reagent" and is formulated for use on a "SYNCHRON CX®3 System," indicating it is a chemical reagent and associated hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "The diagnosis of disorders associated with abnormal carbohydrate metabolisms depends in part on the measurement of glucose." It also mentions the use of glucose determinations for "detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions." These are all diagnostic purposes.
- Device Description: The device is a "Glucose Reagent," which is a chemical substance used in a laboratory setting to perform a test on a biological sample (serum, urine, CSF). This is characteristic of an in vitro diagnostic device.
- Methodology: The description mentions using this methodology on the "SYNCHRON CX®3 System," which is a clinical analyzer used for in vitro diagnostic testing.
- Performance Studies: The performance studies describe the evaluation of the reagent's performance in measuring glucose in biological samples (serum, urine, CSF), which is typical for an IVD.
- Predicate Device: The mention of a predicate device (Beckman Glucose Reagent Kit) further confirms that this device is intended for the same diagnostic purpose as a previously cleared IVD.
Therefore, based on the provided information, the Sigma Diagnostics Glucose Reagent is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The diagnosis of disorders associated with abnormal carbohydrate metabolisms depends in part on the measurement of glucose. The most significant of these diseases is diabetes mellitus, which is characterized by abnormally high concentrations of glucose in physiological fluids. Increased glucose concentration also occurs during hyperactivity of endocrine glands such as the theroid and the adrenal. Hypoglycemia is a condition characterized by low glucose levels that can result from a variety of conditions such as insulin overdose, liver diseases, and hypopituitarism. Glucose determinations, therefore, are useful for detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions.
Product codes
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Device Description
Quantitative measurement of glucose by means of a modified polarographic oxygen sensor for recording oxygen consumption was introduced in 1969 by A. Kadish, et al.2 The Sigma Diagnostics Glucose Reagent is formulated to use this methodology on the SYNCHRON CX®3 System.
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)
In comparison studies, a correlation coefficient of 0.997 and a regression equation of v = 1.01x - 1.73 was obtained with serum samples: a correlation coefficient of 0.976 and a regression equation of y = 0.97x - 2.68 was obtained with urine samples: and a correlation coefficient of 0.981 and a regression equation of y = 1.02x - 2.95 was obtained with CSF samples. With-in run precision and total precision demonstrated % CV's of less than 2.0 % on serum samples; less than 3.8 % on urine samples; and less than 2.3 % on CSF samples. The Sigma Diagnostics Glucose Reagent has been determined to be linear to 900 mg/dL using the ORDAC function on the SYNCHRON CX 3 System.
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.
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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.
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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
JAN 17 1997
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 Glucose Reagent Procedure Number G4903 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
The diagnosis of disorders associated with abnormal carbohydrate metabolisms depends in part on the measurement of glucose. The most significant of these diseases is diabetes mellitus, which is characterized by abnormally high concentrations of glucose in physiological fluids. Increased glucose concentration also occurs during hyperactivity of endocrine glands such as the theroid and the adrenal. Hypoglycemia is a condition characterized by low glucose levels that can result from a variety of conditions such as insulin overdose, liver diseases, and hypopituitarism. Glucose determinations, therefore, are useful for detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions.
Quantitative measurement of glucose by means of a modified polarographic oxygen sensor for recording oxygen consumption was introduced in 1969 by A. Kadish, et al.2 The Sigma Diagnostics Glucose Reagent is formulated to use this methodology on the SYNCHRON CX®3 System.
The safety and effectiveness of Sigma Diagnostics Glucose Reagent, Procedure Number G4903, are demonstrated by its substantial equivalency to Beckman Glucose Reagent Kit, Part No. 443355. Both glucose reagents are used to measure glucose concentrations in serum, plasma, urine, or CSF on the SYNCHRON CX 3 System, and the reaction principles for both reagents are identical. In comparison studies, a correlation coefficient of 0.997 and a regression equation of v = 1.01x - 1.73 was obtained with serum samples: a correlation coefficient of 0.976 and a regression equation of y = 0.97x - 2.68 was obtained with urine samples: and a correlation coefficient of 0.981 and a regression equation of y = 1.02x - 2.95 was obtained with CSF samples. With-in run precision and total precision demonstrated % CV's of less than 2.0 % on serum samples; less than 3.8 % on urine samples; and less than 2.3 % on CSF samples. The Sigma Diagnostics Glucose Reagent has been determined to be linear to 900 mg/dL using the ORDAC function on the SYNCHRON CX 3 System.
REFERENCES:
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- Searcy RL: Diagnostic Biochemistry, McGraw Hill, New York, 1969, pp 460-464
- Kadish A, et al: J Clin Chem 14(2):16, 1968 2.