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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

K974451

ONE TOUCH® II Hospital Blood Glucose Monitoring System 510(k) Submission

JAN 26 1998

510(k) Summary

Submitter

Contact Person

Date

Proprietary Name

Common Name

Classification Name

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035

Lori D. Conzen Regulatory Affairs Specialist Tel: (408) 942-5606 Fax: (408) 942-5906

November 13, 1997

ONE TOUCH® II Hospital Blood Glucose Monitoring System ONE TOUCH® II Test Strips (Hospital Products)

Blood Glucose Monitoring System

862.1345. Glucose test system 75CGA Glucose oxidase, glucose

Device Description

CONFIDENTIAL

{1}------------------------------------------------

Intended Use

Substantial Equivalence

The system manual for ONE TOUCH® II Hospital Blood Glucose Monitoring System and the package insert for the ONE TOUCH® Test Strips (Hospital Products) have been modified to identify arterial whole blood as a suitable sample and incorporate summaries of studies demonstrating arterial sample suitability in addition to necessary precautions. 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.

CONFIDENTIAL

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized depiction of four human profiles facing to the right, with flowing lines beneath them. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 26 1998

Lori D. Conzen Requlatory Affairs Specialist LifeScan, Inc. 1000 Gilbraltar Drive Milpitas, California 95035-6312

Re: K974451 ONE TOUCH® II Hospital Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: November 24, 1997 Received: November 25, 1997

Dear Ms. Conzen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements as setforth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

974451

Device Name:

ONE TOUCH® II Hospital Blood Glucose Monitoring System

Indications for Use:

The ONE TOUCH® II Hospital Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips (Hospital Products), control solutions, data management software 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 glucose levels in neonatal and non-neonatal whole blood samples. Non-neonatal glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use OR Over-the-Counter Use (per 21 CFR 801.109) - - -

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 974451

CONFIDENTIAL

Regulation Number and Section

§ 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.