(175 days)
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No
The summary describes a standard blood glucose monitoring system using a reflectance photometer and test strips. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose, which is a diagnostic function, not a therapeutic one. It provides information about a patient's condition, but it does not treat or alleviate a disease or condition.
Yes
This device measures glucose levels in blood, which is a quantitative measurement used in the diagnosis and monitoring of conditions like diabetes.
No
The device description explicitly states it consists of a glucose reagent test strip and a reflectance photometer, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative measurement of glucose in a sample of whole blood." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (blood) outside of the body to diagnose or monitor a medical condition (blood glucose levels related to diabetes).
- Device Description: The description mentions a "glucose reagent test strip" and a "reflectance photometer." These are components used to perform a chemical reaction on the blood sample and then measure the result, which is the core principle of many in vitro diagnostic tests.
- Sample Type: The device uses "whole blood" samples, which are biological specimens analyzed in vitro.
The fact that it's used for "capillary blood glucose monitoring in the home" by "lay persons" and in a "clinical setting" by "healthcare professionals" further confirms its role in diagnosing or monitoring a medical condition using in vitro methods.
N/A
Intended Use / Indications for Use
The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.
Product codes
CGA
Device Description
The SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer and quality control materials and may include data transfer or management hardware and/or software tools.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults and neonates
Intended User / Care Setting
lay persons for capillary blood glucose monitoring in the home. It can also be used by healthcare professionals in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
MAY 2 1
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95037 |
|------------------|--------------------------------------------------------------|
| Contact | James Phelps/Roger Thies
Hyman, Phelps, and McNamara |
| Date | 11/25/98 |
| Proprietary Name | LifeScan SURESTEP® Blood Glucose
Monitoring System |
| Common Name | Blood Glucose Monitor |
| Classification | 75CGA: glucose oxidase, glucose
test system |
510(k) Summary Summary of Safety and Effectiveness
Device Description
The SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer and quality control materials and may include data transfer or management hardware and/or software tools.
Intended Use
The SURESTEP Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used by healthcare professionals in a clinical setting to measure glucose in arterial, venous and capillary samples in both adults and neonates.
Substantial Equivalence
The LifeScan SURESTEP Blood Glucose Monitoring System is substantially equivalent to the original SURESTEP Blood Glucose Monitoring System, K942455, and the SURESTEPPRO Blood Glucose Monitoring System, K970556.
1
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle image.
MAY 2 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LifeScan c/o James R. Phelps Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street. N.W. Suite 1200 Washington, D.C. 20005
Re: K984261
Trade Name: LifeScan SureStep® Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: May 14, 1999 Received: May 17, 1999
Dear Mr. Phelps:
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 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). 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 set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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.
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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 regulation (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Sutman
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
3
LifeScan, Inc. SureStep Blood Glucose Monitoring System 510(k) Submission
Statement of Intended Use
Device Name:
LifeScan SureStep® Blood Glucose Monitoring System
Indications for Use:
The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.
Sean Coogan
(Division Sign-Off) Division of Clinical Laboratory Devices a 2-510(k) Number
OR
Prescription Use (Per 21 CFR 801.109) Over-The Counter Use _ ▽
(Optional Format 1-2-96)