(135 days)
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.
The Sigma Diagnostics Glucose Reagent is formulated to use this methodology on the SYNCHRON CX®3 System.
The provided text describes a glucose reagent (Sigma Diagnostics Glucose Reagent), not a device in the AI/ML sense that would have specific acceptance criteria for diagnostic performance metrics like sensitivity, specificity, or AUC. This is a chemical reagent used in a laboratory setting on an existing automated system (SYNCHRON CX®3 System).
Therefore, many of the requested points are not applicable. However, I can interpret the "acceptance criteria" and "study" in the context of demonstrating substantial equivalence for a medical device (reagent) as outlined in a 510(k) submission.
Here's an attempt to answer based on the provided information, noting where sections are not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Correlation to Predicate Device | |
| Serum Samples: R > 0.95 (implied) | R = 0.997 |
| Urine Samples: R > 0.95 (implied) | R = 0.976 |
| CSF Samples: R > 0.95 (implied) | R = 0.981 |
| Regression Slope (Predicate vs. Device) | |
| Serum Samples: Slope ≈ 1 (implied) | y = 1.01x - 1.73 |
| Urine Samples: Slope ≈ 1 (implied) | y = 0.97x - 2.68 |
| CSF Samples: Slope ≈ 1 (implied) | y = 1.02x - 2.95 |
| Precision (%CV) | |
| Serum Samples: %CV < 5% (implied) | Within-run & Total %CV < 2.0% |
| Urine Samples: %CV < 5% (implied) | Within-run & Total %CV < 3.8% |
| CSF Samples: %CV < 5% (implied) | Within-run & Total %CV < 2.3% |
| Linearity Range | |
| Adequate for clinical use (implied) | Linear to 900 mg/dL |
Note: The specific numerical acceptance criteria (e.g., R > 0.95, %CV < 5%) are implied benchmarks for demonstrating substantial equivalence for in-vitro diagnostic assays, as they are not explicitly stated in the provided text. The reported performance clearly meets these implied standards.
2. Sample size used for the test set and the data provenance
- Sample Size: The exact number of samples used for the correlation and precision studies is not specified in the provided text.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "comparison studies" conducted to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a chemical reagent for quantitative measurement of glucose, not an AI/ML diagnostic device requiring expert review for ground truth. The "ground truth" here is the measurement obtained by the predicate device and the analyte concentration itself.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not Applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a chemical reagent. The "standalone performance" is its ability to accurately measure glucose on the SYNCHRON CX®3 System, which is what the correlation, precision, and linearity studies evaluate.
7. The type of ground truth used
- For the correlation studies, the "ground truth" was the measurements obtained from the predicate device (Beckman Glucose Reagent Kit, Part No. 443355). The performance of the new reagent was compared against this established method.
- For precision and linearity, the ground truth is the true concentration of glucose in the control materials or spiked samples.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The "development" of the reagent involves chemical formulation and optimization.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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:
-
- Searcy RL: Diagnostic Biochemistry, McGraw Hill, New York, 1969, pp 460-464
- Kadish A, et al: J Clin Chem 14(2):16, 1968 2.
§ 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.