(227 days)
No
The summary describes a standard blood glucose monitoring system and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an in vitro diagnostic device used to monitor glucose levels, not to directly treat a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "This system is not for use in diagnosis or screening of diabetes mellitus".
No
The device description explicitly lists a "Accu-Chek Guide Me meter" and "Accu-Chek Guide test strips" as components of the system, indicating it includes hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes."
- Measurement: It is intended to "quantitatively measure glucose in fresh capillary whole blood". This is a measurement performed on a biological sample (blood) taken from the body, which is a key characteristic of an in vitro diagnostic device.
- Purpose: The purpose is "as an aid in monitoring the effectiveness of glucose control," which is a diagnostic purpose related to managing a medical condition (diabetes).
The definition of an In Vitro Diagnostic (IVD) device 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.
N/A
Intended Use / Indications for Use
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Product codes
NBW
Device Description
The Accu-Chek Guide Me Blood Glucose Monitoring System makes use of the Accu-Chek Guide Me meter, and the Accu-Chek Guide test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System consists of the following:
- Accu-Chek Guide Me meter
- Accu-Chek Guide test strips (previously cleared in K160944) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, and upper arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single-patient use by people with diabetes.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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December 13, 2018
Roche Diabetes Care Ginger Emrich Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250
Re: K181131
Trade/Device Name: Accu-Chek Guide Me Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 12, 2018 Received: November 13, 2018
Dear Ginger Emrich:
We have reviewed vour 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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181131
Device Name
Accu-Chek Guide Me Blood Glucose Monitoring System
Indications for Use (Describe)
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY: K181131
INTRODUCTION
According to the requirements of 21 CFR 807.92, the following information is intended to introduce the Accu-Chek Guide Me Blood Glucose Monitoring System, and provide sufficient detail to support a determination of substantial equivalence for K181131.
| Submission Number | K181131 |
|---|---|
| Submission Type | Special 510(k) |
| Submitter Name | Roche Diabetes Care |
| Address | 9115 Hague Road |
| Indianapolis, IN 46250 | |
| Contact | Primary: Ginger Emrich |
| Phone: (317) 521-4037 | |
| Email: ginger.emrich@roche.com |
Secondary: Susan Hollandbeck
Phone: (317) 521-3380
Email: susan.hollandbeck@roche.com |
| Date Prepared | November 12, 2018 |
| Proprietary Names | Accu-Chek Guide Me Blood Glucose Monitoring System |
| Common Names | Glucose test system |
| Classification Names /
Product Codes | Blood Glucose Test System, Over the Counter
(21 C.F.R. § 862.1345, Product Code NBW); Class II |
| Predicate Device | Accu-Chek Guide Blood Glucose Monitoring System
(K160944), clearance received on August 31, 2016. |
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Image /page/4/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in blue font, enclosed within a blue hexagon. The hexagon is horizontally oriented.
DEVICE DESCRIPTION
The Accu-Chek Guide Me Blood Glucose Monitoring System makes use of the Accu-Chek Guide Me meter, and the Accu-Chek Guide test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System consists of the following:
- Accu-Chek Guide Me meter
- Accu-Chek Guide test strips (previously cleared in K160944) ●
INTENDED USE
The Intended Use is identical to the predicate device with the exception of the device name. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
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Image /page/5/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in blue, enclosed within a blue hexagon. The hexagon is horizontally oriented, with the word "Roche" centered inside.
TECHNOLOGICAL CHARACTERISTICS
The Accu-Chek Guide test strip, measurement engine, and measurement principle used with the Accu-Chek Guide Me system have not been modified. System claims and performance have not changed.
The Accu-Chek Guide Me meter reflects the following modifications of the cleared Accu-Chek Guide meter:
- Updated user interface -
- -Fixed segment display
- -3 button interface
- -Modified meter housing - design / materials
- No strip eject, strip port light, target range indicator or beeper / reminders -
- -No pattern detection or meal indicator
- BLE pairing with fixed PIN (on meter backlabel); only supports one pairing at a time -
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Image /page/6/Picture/0 description: The image features the Roche logo, which consists of the word "Roche" in a blue, sans-serif font. The word is enclosed within a blue hexagon shape. The logo is simple and clean, with the blue color providing a sense of trust and reliability. The hexagon shape adds a modern and corporate feel to the overall design.
Similarities to Predicate Device
The following table shows the similarities of the modified device to the predicate device.
| | Accu-Chek Guide
Predicate (K160944) | Accu-Chek Guide Me
Modified Device |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Indications for Use | Quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control | Same |
| Alternative Site Testing | Palm and Upper arm | Same |
| Enzyme | FAD-GDH | Same |
| Test Principle | Amperometric Detection | Same |
| Primary Container (Vial) | Black, flip top oval vial, holds up to 50 strips
Closed vial height: 51 mm
Width at widest point: 18.3 mm
Width at narrowest point: 15.3 mm | Same |
| Sample Volume | 600 nanoliters | Same |
| Measurement Range | 20 - 600 mg/dL | Same |
| Hematocrit Range | 10 - 65% | Same |
| Operating Temperature
Range | 6 - 45 °C | Same |
| Operating Relative
Humidity Range | 10 - 90% | Same |
| Auto Control Solution
Identification | Yes | Same |
| Connectivity | USB for PC connectivity and BLE (Bluetooth Low Energy) for wireless connectivity | Same |
| Maximum Altitude | 10,150 feet | Same |
| Underdose Detection | Yes | Same |
| Coding | No | Same |
| Averages | 7, 14, 30, and 90 Day Average | Same |
| System Integrity Fail-safe
checks | Same | Same |
| Strip Handling / Dosing | Same | Same |
Table 1: Similarities to Predicate Device
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Differences to Predicate Device
The following table shows the differences of the modified device to the predicate device.
| Table 2: Differences to Predicate Device | ||
|---|---|---|
| Accu-Chek Guide | ||
| Predicate (K160944) | Accu-Chek Guide Me | |
| Modified Device | ||
| Target Range | ||
| Indication | Yes | No |
| Pattern Detection | Yes | No |
| Meal Indication | Yes | No |
| Beeper / Reminders | Yes | No |
| Strip Light | Yes | No |
| Strip Ejector | Yes | No |
| BLE Pairing | BLE pairing with variable | |
| PIN (new PIN generated | ||
| electronically at each pairing); | ||
| able to pair with 5 devices at a | ||
| time | BLE pairing with fixed PIN (on | |
| meter backlabel); only supports | ||
| one pairing at a time | ||
| Screen / Display | Dot Matrix LCD Display | |
| with Backlight | Fixed Segment LCD Display | |
| without Backlight | ||
| Meter Buttons | Hard cap front button |
4-way rocker design including
OK/Power, back, and
up/down functions | One Hard cap OK/Power button
on the side
2 soft buttons for memory
recall, and forwards /
backwards functions |
| Meter Housing
Materials | PET, IMD, PC,
TPF, and ABS/PC | PET, IMD, PC,
and Silicone Rubber |
Table 2: Differences to Predicate Device
SUBSTANTIAL EQUIVALENCE
The submitted information in this premarket notification supports a substantial equivalence decision. The differences between predicate and modified devices do not impact the indications for use or fundamental scientific technology.