(29 days)
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No
The description details a standard reflectance photometer system for glucose measurement based on enzymatic reactions and color intensity, with no mention of AI or ML algorithms for data processing, interpretation, or prediction.
No
The device is described as an in vitro diagnostic (IVD) device for quantitative measurement of glucose, which is used for diagnostic purposes rather than direct therapeutic intervention on the body.
Yes
The "Intended Use / Indications for Use" states that the systems are "for in vitro diagnostic use for the quantitative measurement of glucose".
No
The device description explicitly lists hardware components such as a reflectance photometer and test strips, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples."
- Device Description: The description details how the device measures glucose in a blood sample using chemical reactions on a test strip, which is a characteristic of in vitro diagnostic testing.
The fact that it can also be used by lay users at home doesn't change its classification as an IVD, as it is still performing a diagnostic test on a biological sample outside of the body.
N/A
Intended Use / Indications for Use
The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitanive measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.
Product codes
NBW, CGA
Device Description
The SURESTEPPRO and SURESTEPFLEXX Systems consist of a rest 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 external data management computer software designed to facilitate storage and retrieval of results 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 rest strips.
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
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Intended User / Care Setting
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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®PRO Blood Glucose Monitoring System
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.
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OCT 2 4 2002
510(k) Summary
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Contact: John E. Hughes
Date Prepared: October 23, 2002 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SURESTEP®PRO Professional Blood Glucose Management System
SURESTEP®FLEXX Professional Blood Glucose Management
System
Common name: Glucose test system |
| Predicate Device | SURESTEP®PRO Blood Glucose Monitoring System |
Device Description
The SURESTEPPRO and SURESTEPFLEXX Systems consist of a rest 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 external data management computer software designed to facilitate storage and retrieval of results 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 rest strips.
Intended Use
The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitanive measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.
Comparison to Predicate Device
The existing labeling for the SURESTEPPRO Professional Blood Glucose Management System and the SURESTEPFLEXX Protessional Blood Glucose Management System has
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been simplified to increase understanding and provide clear explanations of the performance capabilities and the performance limitations of the system.
Conclusion
The modified SURESTEPRO Professional Blood Glucose Management System and the SURESTEPFLEXX Professional Blood Glucose Management System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines representing the body.
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Mr. John E. Hughes Manager, Regulatory Submissions LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
Re: K023194
Trade/Device Name: SureStep®Pro Professional Blood Glucose Management System SureStep®Flexx Professional Blood Glucose Management System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; CGA Dated: September 24, 2002 Received: September 25, 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 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 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/dsma/dsmamain.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®PRO Professional Blood Glucose Management System SURESTEP®FLEXX Professional Blood Glucose Management System
Indications for Use:
The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in virro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.
ean
Cooper
(Division Sign-Off)
Division of Clinical Laborator
510(k) Number. K023194
Concurrence of CDRH, Office of Device Evaluation
Over-the-Counter Use__
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Prescription Use (Par 21 CFR 801.109) OR