(86 days)
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.
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.
This document describes the Accu-Chek® Comfort Curve™ Test Strip and its substantial equivalence to a previously cleared device. However, it does not contain specific acceptance criteria (e.g., accuracy metrics, specific thresholds) or a detailed study section that proves the device meets such criteria.
The information provided primarily focuses on:
- Introduction and Device Identification: Submitter, device name, predicate device, and device description.
- Intended Use: How and by whom the test strips are to be used (diabetics, healthcare professionals, types of blood samples).
- Comparison to Predicate Device: The key change mentioned is a modification to the reference curve in the code key. This change allows the test strips to report results that reflect plasma glucose values instead of whole blood glucose values, aligning with common laboratory reporting practices. This is presented as a modification to an existing, cleared device, implying that the fundamental performance characteristics (accuracy, precision, etc.) of the strip itself are assumed to be similar, with the primary change being the conversion factor applied to the raw electrical signal.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is a summary of what can be inferred or stated based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. For a blood glucose meter, these would typically involve accuracy metrics compared to a laboratory reference method (e.g., ISO 15197 standards for bias, precision, and agreement within certain error bounds).
- Reported Device Performance: Not explicitly stated in terms of specific study results (e.g., mean bias, standard deviation of differences, percentage of values within +/-X% of reference). The document states that 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." This implies a recalibration rather than a new performance study to establish primary accuracy metrics for the device as a whole, given it's a modification to an already cleared device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no specific test set study is detailed. The ground truth would typically come from a laboratory reference method, not expert consensus in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device for measuring blood glucose, not an AI-powered diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a blood glucose test strip, not an algorithm in the traditional sense of AI. The device itself performs the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- While not explicitly stated, for a blood glucose test strip, the ground truth is universally established by a laboratory reference method (e.g., hexokinase method, glucose oxidase method) using a laboratory analyzer. The document mentions "laboratory plasma value," which strongly infers this type of ground truth.
8. The sample size for the training set
- Not applicable/Not mentioned. The "training set" concept (in the machine learning sense) doesn't directly apply here. The "reference curve" modification represents a recalibration, likely based on data comparing the strip's output to laboratory reference measurements. The size of that calibration data set is not specified.
9. How the ground truth for the training set was established
- As mentioned in point 7, the ground truth would have been established using laboratory reference methods to obtain plasma glucose values.
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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 informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Boehringer Mannheim Corporation9115 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 StripCommon name: Blood glucose test systemClassification name: glucose dehydrogenase, glucose |
| 3) Predicatedevice | We claim substantial equivalence to the unmodified Accu-Chek® ComfortCurve™ Test Strip. |
| 4) DeviceDescription | The Accu-Chek Comfort Curve Test Strips are to be used with the AccuChek® Advantage® and Accu-Chek® Complete™ Monitors. The AccuChek Comfort Curve test strips are designed for convenient, confident, andaccurate testing of blood glucose in whole blood samples. |
| Continued on next page |
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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 testingglucose in whole blood by persons with diabetes or by health careprofessionals in the home or in health care facilities.Professionals may use the test strips to test capillary, venous, arterial andneonate (including cord) blood samples; lay use is limited to capillary bloodtesting. |
|---|---|
| 6) Comparisonto predicatedevice | The modified Boehringer Mannheim Accu-Chek Comfort Curve Test Strip issubstantially equivalent to other products in commercial distribution intendedfor similar use. Most notably it is substantially equivalent to the previously510(k) cleared Accu-Chek Comfort Curve Test Strip (K980731).Blood glucose concentrations can be expressed two ways, as whole bloodglucose or as plasma (or serum) glucose. The concentration of glucose inwhole blood is lower (by about 8%) than the plasma glucose value for thissame blood sample because of the differences in distribution of water betweenthe two compartments (red blood cells and plasma). Test strips developed forthe measurement of whole blood samples were traditionally referenced toprovide a whole blood glucose value. However, many North Americanlaboratories have, for the last few decades, routinely measured and reportedonly the plasma glucose values. Recent advancements in the management ofpatients with diabetes have created a preference to have the results for bloodglucose test strips reflect the laboratory plasma value instead of the moretraditional whole blood value. For this reason Boehringer Mannheim hasmodified the reference curve employed within the code key used with theAccu-Chek Comfort Curve test strips to now provide results which reflect thehigher laboratory plasma glucose value. |
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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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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 …………
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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)
§ 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.