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K Number
K192730
Device Name
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
Manufacturer
BioSystems S.A.
Date Cleared
2020-09-09

(348 days)

Product Code
CHW,CDQ,CGA
Regulation Number
862.1145
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for three BioSystems S.A. reagents: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, and UREA/BUN-UV. As such, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML medical device.

The information typically provided in a 510(k) summary for in vitro diagnostic (IVD) reagents like these focuses on analytical performance characteristics (e.g., linearity, precision, accuracy, interference, stability) and correlation with a predicate device, rather than the AI/ML-specific criteria requested in the prompt.

Therefore, it is impossible to answer the questions based on the provided text. The document is about chemical reagents for laboratory testing, not an AI-powered diagnostic device.

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.