(27 days)
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Not Found
No
The device description details a standard reflectance photometer technology for measuring glucose, with no mention of AI or ML algorithms for data processing, interpretation, or prediction.
No
The device is described as a system for quantitative measurement of glucose in whole blood and an aid to monitor the effectiveness of diabetes control. It does not perform any therapeutic action.
Yes
The device measures glucose in whole blood to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
No
The device description explicitly details hardware components including a reflectance photometer, test strips, lancing device, lancets, and batteries. It is a physical blood glucose monitoring system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative measurement of glucose in whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Device Description: The description details the components and how they work together to analyze the blood sample. It involves a chemical reaction on a test strip and measurement by a photometer, all of which are characteristic of in vitro diagnostic procedures.
- Anatomical Site: The anatomical site is "whole blood," which is a biological specimen collected from the body for in vitro analysis.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description for monitoring blood glucose levels in individuals with diabetes.
N/A
Intended Use / Indications for Use
The SURESTEP System is for quantitative measurement of glucose in whole blood. It may be used by persons with diabetes in the home and by healthcare professionals in clinical settings as an aid to monitor effectiveness of diabetes control.
Product codes
NBW
Device Description
The LifeScan SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer, and a quality control solution. A lancing device and lancets are also included with the system. The user obtains a blood sample and applies it to the test strip before inserting the strip into the meter. The user obtains a blood sample and applies it to the test strip before inserting the strip into the meter. After inserting the strip into the meter, the glucose value displays on the meter's liquid crystal display (LCD). The test strip color can be compared visually to a color chart provided with the system to estimate if the glucose concentration is very high or very low as a backup to the meter.
When blood is placed on the test strip, glucose in the blood sample reacts with oxygen to yield gluconic acid and hydrogen peroxide. This reaction is catalyzed by the enzyme glucose oxidase present in the test strip. Hydrogen peroxide then reacts with the indicator dye, catalyzed by the presence of peroxidase in the test strip, creating a blue color proportional to the concentration of glucose present in the blood sample. An absorbent layer in the test strip acts as a reservoir for excess blood.
The blood glucose meter is a reflectance photometer that measures the light reflectance of the blue color that develops on the test strip. The meter electronically converts the reflectance data to a digital result that is displayed on a liquid crystal display (LCD). The meter is powered by two 1.5 V AAA alkaline batteries. The user calibrates the meter for each lot number of test strips in use by entering a calibration code specific to that lot number. A quality control solution is included in the system so that the user can check system performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
persons with diabetes in the home and by healthcare professionals in clinical settings
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
SURESTEP Blood Glucose Monitoring System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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
16022724
510(k) Summarv
SEP 1 2 2002
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Contact: John E. Hughes
Date Prepared: August 12, 2002 |
|------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device Name | SURESTEP® Blood Glucose Monitoring System
Common name: Glucose test system |
| Predicate Device | SURESTEP Blood Glucose Monitoring System |
Device Description
The LifeScan SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer, and a quality control solution. A lancing device and lancets are also included with the system. The user obtains a blood sample and applies it to the test strip before inserting the strip into the meter. The user obtains a blood sample and applies it to the test strip before inserting the strip into the meter. After inserting the strip into the meter, the glucose value displays on the meter's liquid crystal display (LCD). The test strip color can be compared visually to a color chart provided with the system to estimate if the glucose concentration is very high or very low as a backup to the meter.
When blood is placed on the test strip, glucose in the blood sample reacts with oxygen to yield gluconic acid and hydrogen peroxide. This reaction is catalyzed by the enzyme glucose oxidase present in the test strip. Hydrogen peroxide then reacts with the indicator dye, catalyzed by the presence of peroxidase in the test strip, creating a blue color proportional to the concentration of glucose present in the blood sample. An absorbent layer in the test strip acts as a reservoir for excess blood.
The blood glucose meter is a reflectance photometer that measures the light reflectance of the blue color that develops on the test strip. The meter electronically converts the reflectance data to a digital result that is displayed on a liquid crystal display (LCD). The meter is powered by two 1.5 V AAA alkaline batteries. The user calibrates the meter for each lot number of test strips in use by entering a calibration code specific to that lot number. A quality control solution is included in the system so that the user can check system performance.
Intended Use
The SURESTEP System is for quantitative measurement of glucose in whole blood. It may be used by persons with diabetes in the home and by healthcare professionals in clinical settings as an aid to monitor effectiveness of diabetes control.
1
Comparison to Predicate Device
The existing labeling of SURESTEP® Blood Glucose Monitoring System has been reformatted and simplified to increase understanding and provide clear explanations of the performance capabilities and the performance limitations of the system. In addition, the visual backup system has been modified by eliminating comparison colors equivalent to 100 mg glucose/dL and 180 mg glucose/dL.
Conclusion
The modified SURESTEP Blood Glucose Monitoring System is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 2 2002
Mr. John E. Hughes Manager, Regulatory Submissions LifeScan, Inc. 1000Gibraltar Drive Milpitas, CA 95035-6312
Re: K022724
Trade/Device Name: SureStep Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: August 15, 2002 Received: August 16, 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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 1 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" (21CFR 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/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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
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Indications for Use Statement
510(k) Number:
Device Name:
SURESTEP Blood Glucose Monitoring System
Indications for Use:
The SURESTEP System is for quantitative measurement of glucose in whole blood. It may be used by persons with diabetes in the home and by healthcare professionals in clinical settings as an aid to monitor effectiveness of diabetes control.
for Dr. Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devi 510(k) Number .
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use