(85 days)
Not Found
Not Found
No
The description focuses on electrochemical measurement of blood glucose and does not mention any AI/ML components or algorithms.
No.
The device is a diagnostic tool used to measure blood glucose levels, not to provide therapy or treatment.
Yes
The device quantitatively measures concentration (blood glucose), which is used for diagnostic purposes, specifically for monitoring blood glucose levels in individuals, including those with diabetes.
No
The device description explicitly lists hardware components: "The ACCU-CHEK Performa blood glucose monitor, The ACCU-CHEK Performa blood glucose test strip, The ACCU-CHEK Performa Control Solutions."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "quantitatively measure the concentration of [substance] in the home or in health care facilities." This involves analyzing a biological sample (blood) outside of the body to provide diagnostic information (blood glucose levels).
- Device Description: It explicitly describes a "blood glucose testing product" that uses a test strip and a meter to analyze a blood sample. This is a classic example of an in vitro diagnostic device.
- Test Principle: The description of how the device works ("Blood from the test site works with the chemicals in the test strip to make a small electric current in the test strip. The meter reads the current and gives a blood glucose result.") clearly indicates an in vitro chemical reaction and analysis.
- Sample Type: It uses blood (capillary, venous, arterial, and neonatal blood), which is a biological sample analyzed outside the body.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ACCU-CHEK Performa system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
Product codes
NBW, LFR
Device Description
The ACCU-CHEK Performa is a blood glucose testing product and based on the ACCU-CHEK Aviva System. The ACCU-CHEK Performa system maintains performance characteristics with ACCU-CHEK Aviva.
The ACCU-CHEK Performa system is comprised of:
- The ACCU-CHEK Performa blood glucose monitor
- The ACCU-CHEK Performa blood glucose test strip
- The ACCU-CHEK Performa Control Solutions
The test principle is:
Blood from the test site works with the chemicals in the test strip to make a small electric current in the test strip. The meter reads the current and gives a blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Traditional fingertip site, palm, forearm, upper arm, thigh, and calf.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or in health care facilities. Professionals or home users.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing on the ACCU-CHEK Performa System demonstrated that the device meets the performance requirements for its intended use. All predetermined acceptance criteria were satisfied. The data demonstrates that the ACCU-CHEK Performa is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACCU-CHEK Aviva System
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
| 510(k) Summary | MAY 2 5 2007 |
|---|---|
| ---------------- | -------------- |
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.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000
Contact Person: Scott Thiel
Date Prepared: February 27, 2007 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: ACCU-CHEK Performa System
Classification name: Glucose dehydrogenase, glucose test system
(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicate device | ACCU-CHEK Aviva System |
| 4) Device Description | The ACCU-CHEK Performa is a blood glucose testing product and based on the ACCU-CHEK Aviva System. The ACCU-CHEK Performa system maintains performance characteristics with ACCU-CHEK Aviva.
The ACCU-CHEK Performa system is comprised of:
The ACCU-CHEK Performa blood glucose monitorThe ACCU-CHEK Performa blood glucose test stripThe ACCU-CHEK Performa Control Solutions |
The test principle is:
Blood from the test site works with the chemicals in the test strip to make
a small electric current in the test strip. The meter reads the current and
gives a blood glucose result.
Continued on next page
510(k) Summary
1
510(k) Summary, Continued
| 5) Intended
use | The ACCU-CHEK Performa system is designed to quantitatively measure
the concentration of glucose for monitoring glucose in the home or in
health care facilities. Testing sites include traditional fingertip site along
with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and
neonatal blood; home use is limited to capillary whole blood testing. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Substantial
equivalence | The Roche Diagnostics ACCU-CHEK Performa System is substantially
equivalent to the current legally marketed ACCU-CHEK Aviva System. |
| 7) Data
demonstrating
substantial
equivalence | Performance testing on the ACCU-CHEK Performa System demonstrated
that the device meets the performance requirements for its intended use.
All predetermined acceptance criteria were satisfied. The data
demonstrates that the ACCU-CHEK Performa is substantially equivalent to
the predicate device. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings and tail feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2007
Mr. Scott Thiel, MBA, MT(ASCP) Regulatory Affairs Program Manager Regulatory Affairs Diabetes Care Indianapolis Office Roche Diagnostic Corp. 9115 Hague Rd. Indianapolis, IN 46256
K070585 Re:
Trade/Device Name: ACCU-CHEK® Performa System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: February 27, 2007 Received: March 1, 2007
Dear Mr. Thiel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your becamined the device is substantially equivalent (for the indications forcronous above and normal to legally marketed predicate devices marketed in interstate for use build in the energency of 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
K070585 Attachment 3
Indications for Use
K070585 510(k) Number (if known):
ACCU-CHEK® Performa System Device Name:
Indications For Use:
The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of The recor crimites I visual in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
Prescription Use XX (Part 21 CFR 801 Subpart D)
Image /page/4/Picture/8 description: The image shows a circle with the text "AND/OR" inside. The text is written in a simple, sans-serif font. The circle is drawn with a thin, black line. The text is centered within the circle.
Over-The-Counter Use ___ XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.C.H
Division Sign-Off
Division Sign-Off
.
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Office of In Vitro Diagnostic Device
Evaluation and Safety
K070585