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K Number
K972473
Device Name
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
Manufacturer
LIFESCAN, INC.
Date Cleared
1997-12-16

(168 days)

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

The ONE TOUCH® II HOSPITAL Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips, control solutions, data management software, and the DataDock and other optional accessories is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings. It is intended for monitoring blood glucose levels in neonatal or non-neonatal whole blood samples. Non-neonatal blood glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.

Device Description

The DataDock is an optional accessory for the ONE TOUCH® II Hospital Meter. When the ONE TOUCH® II Hospital Meter is inserted into the DataDock, it provides features which improve ease-of-use and enhance data management capability.

AI/ML Overview

The provided text describes the 510(k) notification for the ONE TOUCH® II Hospital Blood Glucose Monitoring System DataDock. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets or their ground truth.

The document primarily focuses on:

  • Device Description: The DataDock is an optional accessory for the ONE TOUCH® II Hospital Meter.
  • Intended Use: For quantitative measurement of glucose in whole blood in hospital, clinic, and home settings, for neonatal or non-neonatal samples.
  • Substantial Equivalence: The DataDock is presented as an optional accessory that does not significantly change the safety, effectiveness, or intended use of the already-marketed ONE TOUCH® II Hospital Blood Glucose Monitoring System.
  • FDA Clearance: The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot provide the requested information based on the input text.

§ 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.