(26 days)
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No
The description focuses on a chemical reagent set and standard analytical methods (Jaffe reaction, correlation coefficients, regression equations, precision, linearity) for measuring creatinine, with no mention of AI or ML.
No
The device is used to measure creatinine concentrations, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to measure creatinine concentrations in biological samples, which is a common diagnostic test to assess kidney function and detect related medical conditions.
No
The device description clearly states it is a "Creatinine Reagent Set," which is a chemical reagent, not software. It is used with a hardware system (SYNCHRON CX 3 System).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "used to measure creatinines concentrations in serum, plasma, or urine". These are biological samples taken from the human body.
- Device Description: It is described as a "Creatinine Reagent Set". Reagents used to analyze biological samples are a core component of IVD devices.
- Performance Studies: The document details performance studies involving "serum samples" and "urine samples", further confirming its use with biological specimens.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens taken from the body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Sigma Diagnostics Creatinine Reagent Set for the SYNCHRON CX 3 is formulated based on a modification of the Jaffe reagents described by Heinegard and Tiderstrom.
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
In comparison studies, a correlation coefficient of 0.999 and a regression equation of v = 1.03x - 0.01 was obtained with serum samples: and a correlation coefficient of 0.998 and a regression equation of y = 0.99x + 0.21 was obtained with urine samples. With-in run precision and total precision demonstrated %CV's of less than 4.5 % on serum samples and less than 2.1 % on urine samples. The Sigma Diagnostics Creatinine Reagent has been determined to be linear to 25 mg/dL with serum samples, and from 10 to 400 mg/dL with urine samples on the SYNCHRON CX 3 System.
Key Metrics
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Predicate Device(s)
Beckman Creatinine Reagent Kit, Part No. 443340
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
SEP 30 1998
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 Creatinine Reagent Set Procedure Number C7058 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Creatinine is synthesized in the kidney, the liver, and the pancreas.1 It is transported in the blood to other organs such as muscle and brain where it is phosphorylated to phosphocreatine. Some free creatine in muscle is converted to creatinine daily, and the amount of creatinine produced is proportional to muscle mass. In the absence of renal disease, the excretion rate of creatinine in an individual is relatively constant. Therefore, measurement of creatinine clearance is useful in detecting renal disease and estimating the extent of impairment of renal function.2
Most methods for creatinine measurement are based on the Jaffe reaction, where yellow/orange color forms when the metabolite is treated with alkaline picrate.3 The Sigma Diagnostics Creatinine Reagent Set for the SYNCHRON CX 3 is formulated based on a modification of the Jaffe reagents described by Heinegard and Tiderstrom. These modifications minimize the effect of interfering substances.4
The safety and effectiveness of Sigma Diagnostics Creatinine Reagent Set, Procedure Number C7058, is demonstrated by its substantial equivalency to Beckman Creatinine Reagent Kit, Part No. 443340. Both creatinine reagents are used to measure creatinines concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System, and the reaction principles for both reagents are identical. In comparison studies, a correlation coefficient of 0.999 and a regression equation of v = 1.03x - 0.01 was obtained with serum samples: and a correlation coefficient of 0.998 and a regression equation of y = 0.99x + 0.21 was obtained with urine samples. With-in run precision and total precision demonstrated %CV's of less than 4.5 % on serum samples and less than 2.1 % on urine samples. The Sigma Diagnostics Creatinine Reagent has been determined to be linear to 25 mg/dL with serum samples, and from 10 to 400 mg/dL with urine samples on the SYNCHRON CX 3 System.
REFERENCES:
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- Tietz NW: Textbook of clinical chemistry. WB Saunders, Philadelphia, 1986, pp 1271 -1281.
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- Bowers LD. Wong ET: Kinetic serum creatinine assays. Ill. An initial evaluation and review. Clin Chem 26:555, 1980
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- Jaffe M: Ueber den Niederschlag, welchen Picrinsaure in narmalen Harm eraeugt und uber eine neue Reaction des Kreatinins. Hoppe Seylers Z Physiol Chem 10:391, 1886
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- Tietz, NW, Clinical Guide to Laboratory Tests, WB Saunders, Co, Philadelphia, 1983