(231 days)
The Randox Laboratories Ltd. Valproic Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. inthunotational with valproic acid which, in the presence of valproic acid antibody solution, rapidly agglutinate. When a sample containing valproic acid is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of valproic acid in the sample. By aggraination the change in scattered light as a change in absorbance, a concentration curve can montoning the onling in absorbance is inversely proportional to the concentration of valbroic acid in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of valproic acid wse or overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers r noo must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Valproic Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. inthunotational with valproic acid which, in the presence of valproic acid antibody solution, rapidly agglutinate. When a sample containing valproic acid is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of valproic acid in the sample. By aggraination the change in scattered light as a change in absorbance, a concentration curve can montoning the onling in absorbance is inversely proportional to the concentration of valbroic acid in the sample.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance in the format you've outlined.
The document is an FDA 510(k) clearance letter for the Randox Valproic Acid Test Kit. It confirms that the device has been found substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Here's what I can extract and why I cannot complete most of your request:
What can be extracted:
- Device Name: Valproic Acid Test Kit
- Intended Use: "An in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Measurements obtained by this device are used in the diagnosis and treatment of valproic acid use or overdose and in monitoring levels of valproic acid to ensure appropriate therapy."
- Mechanism of Action: Latex-enhanced immunoturbidimetric assay.
Why most of your request cannot be fulfilled from this document:
This 510(k) clearance letter does not include the actual study data, acceptance criteria, or performance data that were submitted by Randox Laboratories to the FDA. It is the FDA's response to that submission, stating that clearance has been granted.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics (e.g., accuracy, precision, linearity, limits of detection/quantification) or the acceptance criteria used for those metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: An MRMC study is typically for imaging devices or those requiring human interpretation. This is an in-vitro diagnostic assay for a chemical measurement, so an MRMC study is highly unlikely to have been performed or relevant. The document does not mention it.
- If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: As an in-vitro diagnostic kit, its performance is inherently standalone by the laboratory instrument, but the specific validation study details are not provided.
- The type of ground truth used: Not mentioned. For an assay quantifying a substance, the "ground truth" would typically be established by a reference method (e.g., GC-MS) or highly accurate known concentrations.
- The sample size for the training set: Not mentioned. (For an assay, "training set" might refer to data used during assay development and optimization, rather than a machine learning training set).
- How the ground truth for the training set was established: Not mentioned.
To obtain the information you are looking for, you would typically need to review the actual 510(k) submission document or a summary thereof, which often includes the detailed study reports and performance data. This FDA clearance letter is merely the official notification of market clearance.
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.