(26 days)
K#031755
Not Found
No
The summary describes a standard glucose monitoring system and does not mention any AI or ML capabilities, image processing, or training/test sets typically associated with such technologies.
No.
This device is designed to measure glucose concentration for monitoring purposes, not to directly treat a condition.
Yes
The device measures glucose concentration, which is used to monitor glucose levels in persons with diabetes. This monitoring provides information about the patient's physiological state, which can be used to make decisions about their care, fitting the definition of a diagnostic device.
No
The device description explicitly mentions measuring glucose in capillary whole blood, which requires a physical glucose meter and test strips, indicating it is a hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to "quantitatively measure the concentration of glucose in capillary whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description reiterates the measurement of glucose in blood, confirming the in vitro nature of the test.
- Anatomical Site: While the blood is drawn from the body, the measurement itself is performed on the collected blood sample, not directly on the body.
- Performance Studies: The performance studies evaluate the accuracy and precision of the device in measuring glucose in blood samples, which is characteristic of IVD testing.
The core function of the device is to analyze a biological sample (blood) to provide diagnostic information (glucose concentration), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Accu-Chek Integra system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is I rotestinate illary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.
Product codes (comma separated list FDA assigned to the subject device)
LFR, NBW
Device Description
The Accu-Chek Integra system is designed to quantitatively measure the concentration of Accu 'Onck intogra oyets... illary whole blood by persons with diabetes use concentration of grassessionals for monitoring glucose in the home or in or by nounth ours proves is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood Professionals may aso the toot epillary whole blood testing. Capillary blood samples, luy doe is immed to off may . samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, upper arm, thigh, calf and palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities.
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)
Performance testing on the modified Accu-Chek Integra System demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Integra correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Integra is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#031755
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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MAY - 2 2005 510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------According to the requirements of 21 CFR 807.92, the following information Introduction According to the requirements in the basis for a determination of substantial equivalence. Roche Diagnostics 1) Submitter 9115 Hague Rd. name, Indianapolis, IN 46250 address, contact (317) 521-7688 Contact Person: Dimitris Demirtzoglou Date Prepared: April 1, 2005 and the same of the same of the same of the same of the same of the same of the same of the same and the seat and the seat and the seat and the seat of the seat of the seat o Proprietary name: Accu-Chek Integra System 2) Device Classification name: Glucose dehydrogenase, glucose test system name (21 C.F.R. § 862.1345)(75LFR) We claim substantial equivalence to the current legally marketed Accu-3) Predicate Chek Compact System (K#031755). device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Instrument Operating Principle -- photometry 4) Device Reagent Test Principle -- glucose dehydrogenase Description and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of th The Accu-Chek Integra system is designed to quantitatively measure the 5) Intended THC Accu 'Onck intogra oyets... illary whole blood by persons with diabetes use concentration of grassessionals for monitoring glucose in the home or in or by nounth ours proves is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood Professionals may aso the toot epillary whole blood testing. Capillary blood samples, luy doe is immed to off may .
samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.
Continued on next page
K 650877
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510(k) Summary, Continued
The Roche Diagnostics Accu-Chek Integra System is substantially 6) Similarities The Hoone Diagnoction Alegally marketed Accu-Chek Compact (predicate) System. The proposed modification is relatively modest in scope. The Oyoton: The proposes of the claims and features unaffected by the proposed modification.
| Feature/Claim | Detail |
|---|---|
| Intended use | The Accu-Chek Integra and Accu-Chek Compact systems are |
| designed to quantitatively measure the concentration of glucose in | |
| capillary whole blood for monitoring glucose. The devices are | |
| indicated for professional use and over-the-counter sale. Professionals | |
| may use the test strips to test capillary and venous blood samples; lay | |
| use is limited to capillary whole blood testing. Both systems are | |
| indicated for Alternate Site Testing use. | |
| Test principle | Glucose dye oxidoreductase mediator reaction. |
| Test strip storage | |
| conditions | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| Test strip operating | |
| conditions | Between +5° F (+10° C) and +104° F (+40° C). |
| Quality control | |
| testing frequency | Tests should be run with liquid quality control materials whenever a new vial |
| of test strips is opened or an unusual blood test result is obtained. | |
| Quality control | |
| acceptable range | The mean is strip lot specific and will be determined individually. The range |
| of the controls is within ± 15 mg/dL or ± 15% compared to the determined | |
| mean. | |
| Labeling instructions | |
| regarding expected | |
| results | The normal fasting adult blood glucose range for a non-diabetic is 65-95 |
| mg/dL (related to whole blood) mg/dL. One to two hours after meals, | |
| normal blood glucose levels should be less than 140 mg/dL. Doctors will | |
| determine the range that is appropriate for the patients. | |
| Labeling instructions | |
| regarding response | |
| to unusual results | Run a quality control test, if the result is outside the acceptable QC recovery |
| range contact Roche Diagnostics's Accu-Chek Customer Care center; if | |
| result is within the acceptable range, review proper testing procedure and | |
| repeat blood glucose test with a new test strip. |
Continued on next page
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510(k) Summary, Continued
6) Similarities (continued)
| Feature/Claim | Detail |
|---|---|
| Acceptable sample types | Capillary whole blood samples from a fingerstick or AST site. Venous blood may also be used only if drawn by health care professionals. |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 25 - 65% |
| Warnings and precautions | For in vitro diagnostic use only. |
Continued on next page
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510(k) Summary, Continued
- Data demonstrating substantial equivalence
Performance testing on the modified Accu-Chek Integra System demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Integra correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Integra is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 2 2005
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250
K050872 Re:
Trade/Device Name: Accu-Chek Integra Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: April 4, 2005 Received: April 6, 2005
Dear Mr. Demirtzoglou:
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 for associated in the Merce, 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 general obliable profice, 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 n may be oubject to data about 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 r lease be actious that I Driving that your device complies with other requirements of the Act that I Drivias Intact and regulations administered by other Federal agencies. You must or any I vith 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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This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper, MS, DVM
Jean M. Cooper, MS. 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
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Indications for Use
510(k) Number (if known):
Device Name: Accu-Chek Integra Test System
Indications For Use:
The Accu-Chek Integra system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.
Professionals may use the test strips to test capillary and venous blood samples; lay use is I rotestinate illary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.
Prescription Use X (Part 21 CFR 801 Subpart D) (AND/OR
Over-The-Counter Use __X (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)
Carol C Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and
510(k) K050872
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