(434 days)
No
The description focuses on the electrochemical detection method and enzyme modification, with no mention of AI or ML.
No.
This device is an in vitro diagnostic device used to measure blood glucose levels, aiding in monitoring the effectiveness of diabetes control. It does not provide therapy or treatment for diabetes.
Yes
The Intended Use / Indications for Use section explicitly states that the system is for "quantitative measurement of glucose (sugar)" and "is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control." This aligns with the definition of a diagnostic device, even though it explicitly states it should not be used for initial diagnosis or screening. It monitors a physiological state.
No
The device description explicitly details a "modified test strip" and a "blood glucose testing product" used with a "meter." These are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self- testing outside the body (in vitro diagnostic use)..."
- Definition of IVD: An in vitro diagnostic device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device fits this definition as it measures glucose in blood samples outside the body.
- Method of Operation: The "Device Description" details the electrochemical detection technique and the use of a dry reagent based on the Mut. Q-GDH method for glucose determination, which are typical components and processes of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Product codes
NBW, LFR
Device Description
The modified test strip is a blood glucose testing product used in conjunction with the ACCU-CHEK® Compact Plus meter.
Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.
The newly advanced test strip measures blood glucose rapidly and reliably via an electrochemical detection technique. The new version of the test strip employs a disposable dry reagent based on the Mut. Q-GDH method for glucose determination.
When a drop of blood is applied to the test strip first Glucose is oxidized by the enzyme Mut. Q-GDH with simultaneous reduction of the coenzyme. In a second step the coenzyme is reoxidized by the enzyme Mut. Q-GDH with simultaneous reduction of the mediator which finally reduces the indicator chemically to produce the color of heteropolyblue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self- testing outside the body (in vitro diagnostic use) by people with diabetes at home
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
Performance testing on the ACCU-CHEK Compact Plus System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.
Key Metrics
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.
0
FEB 1 2 2013
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Submitter name, address, contact
Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-4793 Contact Person: Nate Carrington Date Prepared: February 12, 2013
- Device name
Proprietary names: ACCU-CHEK Compact Plus System ACCU-CHEK Compact Plus Test Strip ACCU-CHEK Compact Plus Meter
Classification name: Glucose dehydrogenase, glucose test system (21 C.F.R. § 862.1345)
NBW, Blood Glucose Test System, Over-the-Counter LFR, Glucose Dehydrogenase
- Predicate device
ACCU-CHEK Compact System, #K031755
The ACCU-CHEK Compact System is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The ACCU-CHEK Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
Continued on next page
1
510(k) Summary, Continued
4) Device Description
The modified test strip is a blood glucose testing product used in conjunction with the ACCU-CHEK® Compact Plus meter.
Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.
The newly advanced test strip measures blood glucose rapidly and reliably via an electrochemical detection technique. The new version of the test strip employs a disposable dry reagent based on the Mut. Q-GDH method for glucose determination.
When a drop of blood is applied to the test strip first Glucose is oxidized by the enzyme Mut. Q-GDH with simultaneous reduction of the coenzyme. In a second step the coenzyme is reoxidized by the enzyme Mut. Q-GDH with simultaneous reduction of the mediator which finally reduces the indicator chemically to produce the color of heteropolyblue.
5) Intended use
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Continued on next page
2
510(k) Summary, Continued
The ACCU-CHEK Compact Plus Test System is substantially equivalent to 6) Substantial equivalence the ACCU-CHEK Compact System. 7) Data
demonstrating substantial equivalence
Performance testing on the ACCU-CHEK Compact Plus System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2013
Roche Diagnostics c/o Michael Flis 9115 Hague Road Indianapolis, IN 46250-0457
Re: K113614
Trade/Device Name: ACCU-CHECK Compact Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: February 05, 2013 Received: February 06, 2013
Dear Mr. Flis:
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. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
Page 2-Mr. Flis
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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) 796-7100 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 Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K113614
Device Name: ACCU-CHEK Compact Plus Blood Glucose Monitoring System
Indications for Use:
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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 Devices and Radiologic Health (OIR)
Kathering & Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)_k113614