(62 days)
The ONE TOUCH® II Hospital Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in whole blood when monitoring blood glucose levels in hospitals, clinics, and in home settings. ONE TOUCH® Test Strips may be used with the ONE TOUCH® II Hospital Meter to monitor neonates for hypoglycemia in hospital, clinic and home settings. Non-neonatal whole blood glucose measurements may also be reported in terms of approximate plasma/serum equivalents.
The ONE TOUCH® II Hospital Blood Glucose Monitoring System consists of a reagent test strip, a portable, hand-held, battery operated, electronic reflectance photometer (meter) and ancillary devices. The test method employs a dry reagent technology based on the glucose oxidase method and is specific to D-glucose. The intensity of the blue color produced on the strip after applying a drop of whole blood to the ONE TOUCH® Test Strip correlates with the level of glucose in the whole blood sample. The meter measures the reflectance of the reacted test strip at specific wavelengths and displays the corresponding whole blood glucose value or converts the reading to an approximate plasma/serum glucose equivalent.
The provided text for K974451, "ONE TOUCH® II Hospital Blood Glucose Monitoring System 510(k) Submission," does not contain detailed information regarding the specific acceptance criteria for device performance or the study design and results. The document primarily focuses on the device description, intended use, and substantial equivalence to previously marketed devices.
Therefore, I cannot fully answer all the questions as the required details are not present in the provided text.
Based on the available information, here's what can be extracted:
- Device Name: ONE TOUCH® II Hospital Blood Glucose Monitoring System
- Submission Date: November 13, 1997
- Approval Date: January 26, 1998
Missing Information:
The document does not contain critical information needed to answer most of your questions, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, if done, and its effect size.
- Information about a standalone performance study.
- The specific type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set.
- How the ground truth for the training set was established.
General Observations from the Text:
- Substantial Equivalence Claim: The submission states that "No changes to existing technology were required for implementation, so the 'substantial equivalence' of the ONE TOUCH® II Hospital Blood Glucose Monitoring System is unaffected." This implies that the device's performance characteristics were considered substantially equivalent to a predicate device, and thus, detailed new performance studies to establish novel acceptance criteria might not have been a primary focus of this specific summary, but rather referenced existing data or predicate device performance.
- Study Mentioned: The document mentions "summaries of studies demonstrating arterial sample suitability." This indicates that some studies were conducted, but their details (acceptance criteria, sample size, methodology, results) are not provided in this 510(k) summary.
- Intended Use: The device is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings, and can monitor neonates. Non-neonatal results can be reported in whole blood or plasma/serum equivalents.
To answer your questions thoroughly, more detailed performance study reports, which are often part of a 510(k) submission but not always fully summarized in the public-facing 510(k) Summary, would be required.
§ 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.