(8 days)
No
The summary describes a reagent and enzymatic method for quantitative determination, with no mention of AI/ML terms or functionalities.
No
The device is described as being for "quantitative determination of Ammonia and Ammonia Blank in plasma," which indicates it is a diagnostic tool, not a therapeutic one. It analyzes a substance in the body rather than treating a condition.
No
The device is described as a quantitative determination of Ammonia and Ammonia Blank in plasma, which is an analytical measurement rather than a diagnostic interpretation used to identify a disease or condition. While the measurement of ammonia levels can be used in a diagnostic process, the device itself is performing the measurement, not the diagnosis.
No
The device description clearly states it is a "Reagent" and describes an "enzymatic method," indicating it is a chemical substance used in a laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of Ammonia and Ammonia Blank in plasma." This is a diagnostic test performed on a biological sample (plasma) outside of the body (in vitro) to provide information about a patient's health status.
- Device Description: The description mentions "GLDH enzymatic method," which is a common technique used in clinical chemistry for diagnostic testing.
- Performance Studies: The performance studies involve testing patient samples and comparing results to a predicate device, which is typical for demonstrating the performance of an IVD.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Paramax® Ammonia and Ammonia Blank Reagent is substantially equivalent to its predecessor, which was cleared to market on K770363. The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.
Product codes
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Device Description
The Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent are GLDH enzymatic method.
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
The correlation between the Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent was demonstrated by testing 197 samples on a Paramax® and DuPont aca Systems. The correlation coefficient was 0.986, and the regression equation was Paramax® value = (0.980X *aca value) -8.8. The data indicates that the results obtained by both reagents are substantially equivalent.
Key Metrics
correlation coefficient was 0.986
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1065 Ammonia test system.
(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.
0
Nov. 22, 1996
510(k) Summary of Safety and Effectiveness Information
The Paramax® Ammonia and Ammonia Blank Reagent is substantially equivalent to its predecessor, which was cleared to market on K770363. The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.
The Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent are GLDH enzymatic method.
The technological characteristics of the predicate device are similar to those previously described for the proposed device.
The correlation between the Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent was demonstrated by testing 197 samples on a Paramax® and DuPont aca Systems. The correlation coefficient was 0.986, and the regression equation was Paramax® value = (0.980X *aca value) -8.8. The data indicates that the results obtained by both reagents are substantially equivalent.
Image /page/0/Figure/6 description: The image shows the number 58 in bold font on the lower left side of the image. There is a partial drawing of a curved line on the right side of the image. The drawing is in black and white. The number 58 is also in black.