(166 days)
Not Found
No
The summary describes a sample collection kit and a laboratory test for Hemoglobin A1c. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The performance studies focus on sample collection and test correlation, not algorithmic performance.
No.
The device is a test kit designed to measure glycosylated hemoglobin, which is used to assess the level of control of a patient's diabetes and determine insulin dosage, but it does not directly treat or prevent a disease.
No
The device description explicitly states, "This product is not indicated for the diagnosis of diabetes mellitus." Instead, it is used to assess the level of control of a patient's diabetes and to determine proper insulin dosage, which falls under monitoring or disease management rather than initial diagnosis.
No
The device description clearly states it is a kit containing physical components like test strips, lancets, and a return envelope, indicating it is a hardware-based medical device for sample collection.
Based on the provided text, the Accu-Chek A1c Hemoglobin Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to collect a whole blood sample for the measurement of glycosylated hemoglobin. This measurement is used to assess the level of control of a patient's diabetes. This clearly falls under the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The device is a kit containing materials to collect a blood sample on a test strip and send it to a laboratory for analysis. This process involves testing a biological sample outside of the body.
- Performance Studies: The performance studies evaluate the precision and correlation of the test, which are typical evaluations for IVD devices.
- Predicate Devices: The predicate devices listed are also IVD devices (Tina Quant Hemoglobin A1c Assay and Flexsite Diagnostics EZCHEK/HBA Blood Collection Kit).
While the device itself is primarily a sample collection kit, its intended use is directly tied to an in vitro diagnostic test (the measurement of glycosylated hemoglobin by a laboratory). Therefore, the kit as a whole is considered an IVD device because it is an accessory to and facilitates an in vitro diagnostic procedure.
N/A
Intended Use / Indications for 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.
Product codes
LCP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at-home or in-office use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY | 3 1998
.
510(k) Summary
ﯾﺎ ﮐﮧ ﺍﯾﮏ ﺳﯿ
| 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: November 14, 1997 |
| 2) Device name | Proprietary name: Accu-Chek A1cTM Hemoglobin Test |
| | Common name: Hemoglobin A1c Test |
| | Classification name: Glycosylated Hemoglobin Assay |
| 3) Predicate
device | The device is an accessory to our Tina Quant Hemoglobin A1c Assay. We
claim our own device as the predicate device (#K934070). |
| | In addition, a secondary predicate device may be considered. The role of the
Accu-Chek A1c Hemoglobin TestTM in the overall process is substantially
equivalent to the intended use of the Flexsite Diagnostics EZCHEK/HBA
Blood Collection Kit (#K971919). |
| 4) Device
Description | 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. |
| | Continued on next page |
1
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
022
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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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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 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
4
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)