ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K121679 |
|---|---|
| Device Name | ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | Roche Diagnostics |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Oct 11, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips. The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
Device Story
System measures blood glucose via electrochemical biosensor technology; utilizes mutant quinoprotein glucose dehydrogenase (Mut. Q-GDH) enzyme on single-use test strips. Input: 0.6 μL whole blood sample (capillary, venous, arterial, or neonatal heelstick). Operation: capillary action draws blood into strip; meter measures electrical current proportional to glucose concentration. Used in professional healthcare settings; operated by clinicians/technicians. Includes code key reader for lot-specific calibration. Output: quantitative glucose value displayed on meter. Data management: stores 2,000 patient results; supports barcode scanning for patient/operator ID; transmits data via infrared/wireless to hospital systems. Benefits: rapid, point-of-care glucose monitoring for multiple-patient environments; aids in glycemic control management.
Clinical Evidence
Bench testing and performance evaluation. Accuracy assessed against laboratory methods using arterial (N=214), capillary (N=200), neonatal capillary (N=191), and venous (N=439) samples. Results showed high correlation (r=0.976-0.995) and compliance with ISO 15197:2003 accuracy limits. Precision studies showed strip-to-strip variation ≤ 3.4%. Consumer user performance evaluation (N=174) showed 98.9% of results within accuracy limits.
Technological Characteristics
Glucose dehydrogenase-based electrochemical biosensor. System includes meter, test strips, control solutions, and linearity kit. Features wireless WLAN connectivity. Measuring range 10-600 mg/dL; measuring time 5 seconds; sample volume 0.6 µL. Hematocrit range 10-65%.
Indications for Use
Indicated for professional healthcare settings to monitor glucose control in patients using venous, arterial, neonatal heelstick, or capillary whole blood. Not for diabetes diagnosis/screening or neonate cord blood testing. Contraindicated for patients with severe dehydration (DKA, HHS), hypotension, shock, decompensated heart failure (NYHA Class IV), or peripheral arterial occlusive disease.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ACCU-CHEK Inform System (k003846)
- ACCU-CHEK Aviva Control Solutions (k043474)
- Nova StatStrip Glucose Linearity Kit (k060345)
Related Devices
- K232075 — StatStrip Glucose Hospital Meter System · Nova Biomedical Corporation · Feb 23, 2024
- K181043 — StatStrip Glucose Hospital Meter System · Nova Biomedical Corporation · Jul 12, 2018
- K130094 — FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM · Abbott Diabetes Care · Jun 27, 2013
Submission Summary (Full Text)
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## 510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 1) Submitter<br>name.<br>address.<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>Contact Person: Mike Flis<br>Date Prepared: 11 October 2012 | | |
| 2) Device<br>name | ACCU-CHEK Inform II Blood Glucose Monitoring System consisting of:<br>Meter: ACCU-CHEK Inform II Meter<br>●<br>Test Strip: ACCU-CHEK Inform II Test Strip<br>Controls: ACCU-CHEK Inform II Control Solutions<br>●<br>Linearity Kit: ACCU-CHEK Inform II Linearity Test Kit<br>whole blood glucose test system<br>Common name:<br>Classification name: Glucose dehydrogenase, glucose (21 C.F.R. § 862.1345)<br>LFR, Glucose Dehydrogenase<br>Product Codes:<br>JJX, Single (specified) analyte controls (assayed and<br>unassayed) | | |
| 3) Predicate<br>device | The ACCU-CHEK Inform System presented in k003846 is the predicate for<br>the ACCU-CHEK Inform II system.<br>The controls solutions presented in the ACCU-CHEK Aviva 510(k)<br>submission (k043474) are the predicate for the ACCU-CHEK Inform II<br>control solutions.<br>The Nova StatStrip Glucose Linearity Kit (receiving clearance in k060345) is<br>the predicate for the ACCU-CHEK Inform II Linearity Kit. | | |
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K121679
OCT 1 1 2012
Roche
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## 510(k) Summary, Continued
The ACCU-CHEK Inform II System includes the following components and 4) Device Description accessories: Meter, Code Key Reader, Base Unit (with power supply) test strips, and controls.
> When an ACCU-CHEK Inform II test-strip is inserted into the ACCU-CHEK Inform II meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes - both are used to assure an adequate sample has been applied.
The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.
After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.
ACCU-CHEK Inform II System is the first point-of-care glucose meter featuring wireless connectivity functionality. Unlike the predicate device, ACCU-CHEK Inform II meter has the capability of direct data transfer right after each measurement, thus ensuring actual patient data to appear on the doctor's desk shortly after these data have been created at the bedside. It is understood that a transfer of data can only occur, when a stable communication with the Data Management System has been built up by the devices before transfer of data.
The glucose meter system has been designed in a way that its connectivity feature is virtually invisible to the operator. Only the appearance of an icon at the lower edge of the touch screen display indicates potential radio frequency activity to allow new information on control material or strip code files to be downloaded.
Even when there is no wireless WLAN available, the ACCU-CHEK Inform II meters work fine as long as the necessary information like operator list, strip code, and control lot is available. The device can store as many as 2000 measurement results in its memory which will be transferred as soon as there is a stable connection to the WLAN and no measurement operation pending.
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## 510(k) Summary, Continued
5) Intended use
#### ACCU-CHEK Inform II System
The ACCU-CHEK Inform II Test strip are for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The multiple-patient use ACCU-CHEK Inform II Blood Glucose Monitoring System will consist of:
- . Meter: ACCU-CHEK Inform II Meter
- Test Strip: ACCU-CHEK Inform II Test Strip .
- . Controls: ACCU-CHEK Inform II Control Solutions
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
6) Substantial equivalence The ACCU-CHEK Inform II Test System is substantially equivalent to the ACCU-CHEK Inform Test System.
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## 510(k) Summary, Continued
Performance testing on the ACCU-CHEK Inform II System demonstrated 7) Data demonstrati that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate ng substantial device. equivalence
| | ACCU-CHEK<br>Inform II<br>System | ACCU-CHEK<br>Inform II System<br>ISO 15197:2003 | ACCU-CHEK Inform<br>(predicate) |
|--------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Arterial Blood<br>Samples | N = 214<br>y = 1.038x - 3.5<br>r = 0.990<br>Range = 58 to 322 mg/dL<br>HCT range = 19 to 54% | 100% of glucose results fit<br>within accuracy<br>requirement limits | N = 143<br>y = 1.045x - 1.3<br>r = 0.984<br>Range = 75 to 388 mg/dL |
| Capillary Blood<br>Samples | N = 200<br>y = 1.018x - 3.4<br>r = 0.980<br>Range = 22 to 572 mg/dL | 100% of glucose results fit<br>within accuracy<br>requirement limits | N = 187<br>y = 0.991x + 8.4<br>r = 0.980<br>Range = 41 to 503 mg/dL |
| Neonate<br>Capillary Blood<br>Samples | N = 191<br>y = 1.011x + 1.5<br>r = 0.976<br>Range = 28 to 152 mg/dL<br>HCT range = 23 to 58% | 99.4% of glucose results<br>fit within accuracy<br>requirement limits | N = 105<br>y = 0.999x - 4.4<br>r = 0.981<br>Range = 33 to 153 mg/dL<br>HCT Range = 30 to 64% |
| Neonate Cord<br>Blood Samples | Not claimed | Not claimed | Same as above |
| Venous Blood<br>Samples | N = 439<br>y = 1.01x -2.2<br>r = 0.995<br>Range = 38-546 mg/dL<br>HCT range = 20-63% | 100% of glucose results fit<br>within accuracy<br>requirement limits | N = 218<br>y = 0.975x + 3.0<br>r = 0.987<br>Range = 41 to 503 mg/dL |
| Precision | Repeatability and<br>reproducibility studies<br>show a variation from<br>strip to strip ≤ 3.4% | Not applicable | Repeatability and reproducibility<br>studies show a variation from strip<br>to strip ≤ 3.2% |
| Consumer User<br>Performance<br>Evaluation | N = 174<br>y = 0.933x + 6.6<br>r = 0.990<br>Range = 56-579 mg/dL | 98.9% of glucose results<br>fit within accuracy<br>requirement limits | N = 187<br>y = 0.985x + 7.5<br>r = 0.977<br>Range = 41 to 503 mg/dL |
| Measuring Range | 10-600 mg/dL | --- | 10- 600 mg/dL |
| Measuring Time | 5 seconds | --- | 5 seconds |
| Sample Volume | 0.6 µL | --- | 0.6 µL |
| Hematocrit<br>Range | 10-65% | --- | 20-65% for glucose <200 mg/dL<br>20-55% for glucose >200 mg/dL |
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The ACCU-CHEK Aviva control solutions (receiving clearance in k043474) 7) Data are the predicate control solutions for the ACCU-CHEK Inform II control demonstrati ng solutions. Below is a comparison of the ACCU-CHEK Inform II control substantial solutions to the predicate, and the regulation numbers and product codes have equivalence, been included. continued
| | ACCU-CHEK Inform II<br>Control Solutions (k121679) | ACCU-CHEK Aviva Control<br>Solutions (k043474) |
|------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | For performance checks on the<br>ACCU-CHEK Inform II system<br>with ACCU-CHEK Inform II test<br>strips. | For performance checks on the ACCU-<br>CHEK Aviva system with ACCU-<br>CHEK Aviva test strips |
| Classification<br>Regulation | 862. 1660 | 862. 1660 |
| Product Code | JJX | JJX |
| Analyte | Glucose | Glucose |
| Number of<br>Solutions | 2 Levels | 2 Levels |
| Low Level<br>Target | 45 mg/dL | 45 mg/dL |
| High Level<br>Target | 307 mg/dL | 307 mg/dL |
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The Nova StatStrip Glucose Linearity Kit (receiving clearance in k060345) is 7) Data the predicate for the ACCU-CHEK Inform II Linearity Kit. Below is a demonstrati ng
substantial comparison of the ACCU-CHEK Inform II Linearity Kit to its predicate, and the regulation numbers and product codes have been included. equivalence, continued
| | ACCU-CHEK Inform II Linearity<br>Kit (k121679) | Nova StatStrip Glucose Linearity<br>Kit (k060345) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | For periodic verification of linearity<br>of the ACCU-CHEK Inform II<br>system using ACCU-CHEK Inform<br>II test strips. | Nova StatStrip Glucose Linearity<br>Kit solutions are used to check the<br>linearity of the Nova StatStrip<br>Glucose Hospital System. |
| Classification<br>Regulation | 862. 1660 | 862. 1660 |
| Product Code | JJX | JJX |
| Analyte | Glucose | Glucose |
| Number of<br>Solutions | 6 Levels | 5 Levels |
| Low Level Target | 28 mg/dL | 31 mg/dL |
| High Level Target | 559 mg/dL | 514 mg/dL |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2012
Roche Diagnostics c/o Mike Flis 9115 Hague Road Indianapolis, Indiana 46250
Re: k121679 Trade Name: Accu-chek Inform II blood glucose monitoring system Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. LFR, JJX Dated: September 19, 2012 Received: September 21, 2012
Dear Mr. Flis:
This letter corrects our substantially equivalent letter of October 11, 2012.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Carol C. Benson
for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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## Indications for Use Statement
510(k) Number (if known): k121679 Device Name: ACCU-CHEK Inform II Blood Glucose Monitoring System
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
Prescription Use __ XX (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ XX AND/OR (21 CFR 801 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): k121679
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