(166 days)
The Accu-Chek A1c Hemoglobin Test is designed for use with BMC Hitachi reagents that measure glycosylated hemoglobin. The test has not been evaluated using any other methodology. The device is intended for at-home or in-office use to collect a whole blood sample. The product will be marketed over-the-counter. Test results should be evaluated together with a personal doctor.
Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. This product is not indicated for the diagnosis of diabetes mellitus.
The device is a kit containing the materials required to collect a whole blood sample on a test strip and mail it to a laboratory for determination of Hemoglobin A1c. The kit contains test strips, disposable lancets, instructions booklet, other related labeling, a return envelope, and a patient identification card for returning a result to the patient and/or his/her doctor.
The provided text describes a 510(k) premarket notification for the Accu-Chek A1c™ Hemoglobin Test. This device is a kit for collecting a whole blood sample for Hemoglobin A1c testing, intended for at-home or in-office use.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria for the Accu-Chek A1c™ Hemoglobin Test itself. Instead, it focuses on demonstrating that the accessory device's sample collection method does not negatively impact the performance of the analytical assay (Tina Quant Hemoglobin A1c Assay) and provides acceptable user experience.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with professional sample collection: Samples collected using the accessory device by untrained laypersons should correlate well with whole blood samples collected and handled directly by healthcare professionals. | "evaluation studies provide evidence that results produced using samples collected by untrained lay persons using the accessory device correlate well with whole blood samples collected and handled directly by health care professionals" |
| Ease of Use/User Acceptance: The kit should be easy for users to understand and operate. | "Study participants indicated that the kit is acceptable as designed." "Study participants filled out questionnaires regarding the ease of use." |
| Reagent and Sample Stability: The collected samples and reagents should remain stable under expected environmental conditions. | "the Accu-Chek A1c Hemoglobin Test was evaluated for reagent and sample stability when exposed to abusive environmental conditions." (No specific results provided, but implies satisfactory stability was met). |
| Unaffected analytical and post-analytical stages: The use of the accessory device should not alter the performance characteristics of the Tina Quant Hemoglobin A1c assay beyond the pre-analytical stage. | "All procedural steps and performance specifications associated with the analytical and post analytical stages of the assay are unaffected by the introduction of this accessory device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only mentions "user studies" and "study participants." The specific number of participants in these studies is not provided.
- Data Provenance: The studies were described as "actual use situations (user studies)." This implies the data was collected prospectively from participants following the instructions for the device's intended use. The country of origin is not specified, but given the submitter is "Boehringer Mannheim Corporation" in "Indianapolis, IN," it is reasonable to infer the studies were conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those experts
- For evaluating the correlation, samples collected by "health care professionals" are used as the reference. The number of such professionals or their specific qualifications (e.g., radiologist with 10 years of experience) is not specified.
- For the 'ease of use' aspect, the ground truth is "user indications" from "study participants" via "questionnaires." These participants are described as "untrained lay persons."
4. Adjudication Method for the Test Set
- The document does not describe any formal adjudication method (e.g., 2+1, 3+1). The evaluation seems to rely on direct comparison of results and participant feedback.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sample collection kit, not an AI-assisted diagnostic tool that would involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a sample collection kit, not an algorithm. The core analytical performance is tied to the Tina Quant Hemoglobin A1c Assay, which is a chemical assay, not an algorithm. The device itself is an accessory that facilitates sample collection for that assay.
7. The Type of Ground Truth Used
- The ground truth for the correlation study appears to be measurements from whole blood samples collected and handled directly by health care professionals using the established Tina Quant Hemoglobin A1c Assay procedure.
- The ground truth for the ease of use study is user feedback/responses from questionnaires.
8. The Sample Size for the Training Set
- The document does not mention a training set. This is expected as the device is a sample collection kit and not a machine learning or AI-based system that would typically require a training set. The "evaluation studies" describe validation, not training.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable as there is no mention of a training set.
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MAY | 3 1998
.
510(k) Summary
ﯾﺎ ﮐﮧ ﺍﯾﮏ ﺳﯿ
| 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: November 14, 1997 | |
| 2) Device name | Proprietary name: Accu-Chek A1cTM Hemoglobin Test |
| Common name: Hemoglobin A1c Test | |
| Classification name: Glycosylated Hemoglobin Assay | |
| 3) Predicatedevice | The device is an accessory to our Tina Quant Hemoglobin A1c Assay. Weclaim our own device as the predicate device (#K934070). |
| In addition, a secondary predicate device may be considered. The role of theAccu-Chek A1c Hemoglobin TestTM in the overall process is substantiallyequivalent to the intended use of the Flexsite Diagnostics EZCHEK/HBABlood Collection Kit (#K971919). | |
| 4) DeviceDescription | The device is a kit containing the materials required to collect a whole bloodsample on a test strip and mail it to a laboratory for determination ofHemoglobin A1c. The kit contains test strips, disposable lancets, instructionsbooklet, other related labeling, a return envelope, and a patient identificationcard for returning a result to the patient and/or his/her doctor. |
| Continued on next page |
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510(k) Summary, Continued
portuners .
| 5) Intended use | The Accu-Chek A1c Hemoglobin Test is designed for use with BMC Hitachi reagents that measure glycosylated hemoglobin. The test has not been evaluated using any other methodology. The device is intended for at-home or in-office use to collect a whole blood sample. The product will be marketed over-the-counter. Our proposed labeling contains instructions for patients that test results should be evaluated together with a personal doctor. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. This product is not indicated for the diagnosis of diabetes mellitus. |
|---|---|
| 6) Comparison to predicate device | Use of the Accu-Chek A1c Hemoglobin Test with the Tina Quant assay only affects the pre-analytical stage of the testing process. All procedural steps and performance specifications associated with the analytical and post analytical stages of the assay are unaffected by the introduction of this accessory device. The Tina Quant Hemoglobin A1c Test was evaluated for several performance characteristics, including precision and correlation. Additionally, the Accu- Chek A1c Hemoglobin Test was evaluated for reagent and sample stability when exposed to abusive environmental conditions. Actual use situations (user studies) were also performed. Study participants filled out questionnaires regarding the ease of use. The evaluation studies provide evidence that results produced using samples collected by untrained lay persons using the accessory device correlate well with whole blood samples collected and handled directly by health care professionals following the procedure cleared in the original 510(k) file. Study participants indicated that the kit is acceptable as designed. |
and the comments of the comments of
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 3 1998
Mike Flis . Regulatory Affairs Specialist Boehringer Mannheim Corporation 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re : K974491 Accu-Chek Aze™ Hemoglobin Test Regulatory Class: II Product Code: LCP Dated: March 27, 1998 Received: March 30, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 Reqister. 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 Bitman
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 Aie™ Hemoglobin Test Indications for Use:
The Accu-Chek A1,™ Hemoglobin Test is designed for use with BMC Hitachi reagents that measure glycosylated hemoglobin. The test has not been evaluated using any other methodology. The device is intended for at-home or in-office use to collect a whole blood sample. The product will be marketed over-the-counter. Test results should be evaluated together with a personal doctor.
Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. This product is not indicated for the diagnosis of diabetes mellitus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Veronica J. Calvin for A.W. Montgomery
Division of Clinical Laboratory Devices
510(k) Number K974491
OR
Image /page/4/Picture/7 description: The image shows the text "Prescription Use (Per 21 CFR 801.109)" along with a signature. The text indicates that the image is related to prescription use and references a specific section of the Code of Federal Regulations. The signature is illegible and appears to be scribbled.
Over-The-Co
Over-The-Counter Use
(Optional Format 1-2-96)
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).