(25 days)
The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.
The SURESTEP Hospital Blood Glucose Monitoring System consists of a test strip (SURESTEPPRO Test Strips), a reflectance photometer, quality control solutions, and linearity solutions. Ancillary devices to aid in obtaining blood samples (e.g. lancing devices and lancets) are also provided.
A sample is placed on a test strip and inserted into the reflectance photometer. Glucose in the sample reacts with oxygen in a glucose oxidase-catalyzed reaction yielding gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, mediates transformation of indicator dyes into products with a blue color. The intensity of the resulting blue color is proportional to the concentration of glucose in the sample. The meter measures the amount of light reflected by this blue colored product and converts the reflectance data into a glucose concentration that is displayed on a liquid crystal display. The user adjusts the meter response for each lot of test strips by entering a calibration code specific to that lot of test strips.
The provided text is a 510(k) summary for the SURESTEP® Hospital Blood Glucose Monitoring System. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given input. The 510(k) summary does not include the performance data that would typically contain such details.
{0}------------------------------------------------
DEC 1 3 2002
510(k) Summary
| Submitter | LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035Contact: John E. HughesDate Prepared: November 12, 2002 |
|---|---|
| Device Name | SURESTEP® Hospital Blood Glucose Monitoring SystemCommon name: Glucose test system |
| Predicate Device | SURESTEP®PRO Blood Glucose Monitoring SystemSURESTEP® Blood Glucose Monitoring System |
Device Description
The SURESTEP Hospital Blood Glucose Monitoring System consists of a test strip (SURESTEPPRO Test Strips), a reflectance photometer, quality control solutions, and linearity solutions. Ancillary devices to aid in obtaining blood samples (e.g. lancing devices and lancets) are also provided.
A sample is placed on a test strip and inserted into the reflectance photometer. Glucose in the sample reacts with oxygen in a glucose oxidase-catalyzed reaction yielding gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, mediates transformation of indicator dyes into products with a blue color. The intensity of the resulting blue color is proportional to the concentration of glucose in the sample. The meter measures the amount of light reflected by this blue colored product and converts the reflectance data into a glucose concentration that is displayed on a liquid crystal display. The user adjusts the meter response for each lot of test strips by entering a calibration code specific to that lot of test strips.
Intended Use
The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.
Comparison to Predicate Device
The existing labeling for the SURESTEP Hospital Blood Glucose Monitoring System has been simplified to increase understanding and provide clear explanations of the performance capabilities and the performance limitations of the system.
{1}------------------------------------------------
Conclusion
.
The modified SURESTEP Hospital Blood Glucose Monitoring System is substantially equivalent to the predicate device.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is "2098 Gaither Road, Rockville MD 20850". The text is black and the background is white.
DEC 1 3 2002
Mr. John E. Hughes Manager, Regulatory Submissions LifeScan, Inc. 1000 Gibraltar Drive · Milpitas, CA 95035-6312
Re: K023832
Trade/Device Name: SureStep® Hospital Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: November 15, 2002 Received: November 18, 2002
Dear Mr. Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{3}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number:
Device Name:
SURESTEP® Hospital Blood Glucose Monitoring System
Indications for Use:
The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.
Lan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices 510(k) Number _ 1) 02
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109) __
OR
Over-the-Counter Use
§ 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.