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K Number
K023739
Device Name
GLUCOSE-SL-C ASSAY, MODEL 257-30
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
2003-01-17

(71 days)

Product Code
CFR
Regulation Number
862.1345
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the quantitative determination of glucose in serum and fluoride-oxalate plasma. For IN VITRO diagnostic use

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.

Device Description

Not Found

AI/ML Overview

This appears to be an FDA 510(k) clearance letter for the Glucose-SL-C Assay, not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.

The document only states:

  • Trade/Device Name: Glucose-SL-C Assay
  • Regulation Number: 21 CFR 862.1345
  • Regulation Name: Glucose Test System
  • Regulatory Class: Class II
  • Product Code: CFR
  • Indications for Use: For the quantitative determination of glucose in serum and fluoride-oxalate plasma. For IN VITRO diagnostic use. 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.

To provide the information you've requested, the actual study report or performance data for the Glucose-SL-C Assay would be needed. This document is merely the FDA's decision regarding substantial equivalence.

§ 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.