(86 days)
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No
The document describes a glucose test strip and monitor system, which is a chemical and electrochemical measurement technology. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is a test strip used for measuring glucose levels, not for treating a condition.
Yes
The device is intended for testing glucose in whole blood by persons with diabetes or healthcare professionals, which is a diagnostic purpose to monitor a health condition.
No
The device described is a physical test strip, which is a hardware component used in conjunction with glucose monitors. It is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "testing glucose in whole blood". This is a diagnostic test performed on a biological sample (blood) outside of the body (in vitro).
- Device Description: The description reinforces that the test strips are for "testing of blood glucose in whole blood samples".
- Anatomical Site: While not directly applicable to the test strip itself, the description of the blood samples (capillary, venous, arterial, neonate) further indicates that it's used for analyzing biological material.
The core function of the Accu-Chek Comfort Curve Test Strips is to perform a diagnostic test on a biological sample to determine a health parameter (blood glucose level). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
Product codes (comma separated list FDA assigned to the subject device)
LFR
Device Description
The Accu-Chek Comfort Curve Test Strips are to be used with the Accu Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu Chek Comfort Curve test strips are designed for convenient, confident, and accurate testing of blood glucose in whole blood samples.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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.
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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).
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§ 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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Accu-Chek® Comfort Curve™ Test Strip
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. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000 |
| | Contact Person:
Mike Flis |
| | Date Prepared:
June 5, 1998 |
| 2) Device name | Proprietary name: Accu-Chek® Comfort Curve™ Test Strip
Common name: Blood glucose test system
Classification name: glucose dehydrogenase, glucose |
| 3) Predicate
device | We claim substantial equivalence to the unmodified Accu-Chek® Comfort
Curve™ Test Strip. |
| 4) Device
Description | The Accu-Chek Comfort Curve Test Strips are to be used with the Accu
Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu
Chek Comfort Curve test strips are designed for convenient, confident, and
accurate testing of blood glucose in whole blood samples. |
| | Continued on next page |
1
510(k) Summary, Continued
| 5) Intended use | The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-
Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-
Chek Advantage and Accu-Chek Complete systems are designed for testing
glucose in whole blood by persons with diabetes or by health care
professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and
neonate (including cord) blood samples; lay use is limited to capillary blood
testing. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison
to predicate
device | The modified Boehringer Mannheim Accu-Chek Comfort Curve Test Strip is
substantially equivalent to other products in commercial distribution intended
for similar use. Most notably it is substantially equivalent to the previously
510(k) cleared Accu-Chek Comfort Curve Test Strip (K980731).
Blood glucose concentrations can be expressed two ways, as whole blood
glucose or as plasma (or serum) glucose. The concentration of glucose in
whole blood is lower (by about 8%) than the plasma glucose value for this
same blood sample because of the differences in distribution of water between
the two compartments (red blood cells and plasma). Test strips developed for
the measurement of whole blood samples were traditionally referenced to
provide a whole blood glucose value. However, many North American
laboratories have, for the last few decades, routinely measured and reported
only the plasma glucose values. Recent advancements in the management of
patients with diabetes have created a preference to have the results for blood
glucose test strips reflect the laboratory plasma value instead of the more
traditional whole blood value. For this reason Boehringer Mannheim has
modified the reference curve employed within the code key used with the
Accu-Chek Comfort Curve test strips to now provide results which reflect the
higher laboratory plasma glucose value. |
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2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 1098 SEP
Mike Flis Regulatory Affairs Specialist Boehringer Mannheim 9115 Haque Road P.O. Box 50457 46250-0457 Indianapolis, Indiana
Re : K982002 Accu-Chek® Comfort Curve™ Test Strip Requlatory Class: II Product Code: LFR Dated: June 5, 1998 Received: June 8, 1998
Dear Mr. Flis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling; and mann prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set --forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure …………
4
510(k) Number (if known): Device Name: Accu-Chek® Comfort Curve™ Test Strip Indications for Use:
The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number_k
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)