(547 days)
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No
The description focuses on a reflectometry immunoassay system and standard performance testing, with no mention of AI or ML.
No.
The device measures HbA1c levels to monitor glycemic control but does not provide treatment or therapy.
No
The device is explicitly stated as "not for screening or diagnosis of diabetes." Its stated purpose is to "monitor long term glycemic control of persons previously diagnosed with diabetes."
No
The device description explicitly lists hardware components such as an analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This is a measurement performed in vitro (outside the body) on biological specimens.
- Sample Type: The device analyzes blood samples, which are biological specimens.
- Purpose: The purpose is to monitor long-term glycemic control in persons previously diagnosed with diabetes. This is a medical purpose achieved through the analysis of a biological sample.
- Device Description: The description reinforces that it's a reflectometry immunoassay used for quantitative measurement in blood samples.
- Control Materials: The inclusion of control materials (SD HbA1c Control Set) is typical for IVD devices to ensure the accuracy and reliability of the test results.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is for monitoring and not diagnosis, monitoring of a diagnosed condition using in vitro analysis of biological samples falls under the scope of IVDs.
N/A
Intended Use / Indications for Use
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.
The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.
The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJE, JJX
Device Description
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh capillary or venous whole blood samples. It is intended for professional use.
The SD HbA1c Control Set is intended for use as quality control materials for the SD A1cCare System.
The SD A1cCare System include the analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory and point-of-care use
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)
Bench testing addressed the following: NGSP certification, accuracy method comparison, linearity, precision, comparison of Spoit Type test kit performance, hematocrit range, interferences, hemoglobin variants, total hemoglobin, altitude, testing time, operating temperature range, optimal sample and mixture volume, anticoagulants, sample collection and preparation, stability of blood samples, vibration, temperature and humidity. EMC and electrical safety testing was done. Shelf-life testing was conducted on the reagent test panels and control sets. Software was subject to design control during development and comprehensive verification and validation testing. No animal testing was conducted. A user study clinical evaluation was conducted comparing home user results against a reference method which also evaluated ease-of-understanding of the instructions.
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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§ 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).
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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird's head and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
SD BIOSENSOR, INC. C/O PRISCILLA CHUNG OFFICIAL CORRESPONDENT 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92831
Re: K140827
Trade/Device Name: SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJE, JJE, JJX Dated: August 21, 2015 Received: August 28, 2015
Dear Priscilla Chung:
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 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) 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 devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140827
Device Name
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
Indications for Use (Describe)
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.
The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.
The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
(K140827)
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | SD Biosensor, Inc.
C-4th & 5th Floor, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu,
Suwon-si, Gyeonggi-do, Republic of Korea443-702 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yeon, Park
QA/RA Assistant Manager
Phone: 011-82-31-300-0416
FAX: 011-82-31-300-0497
py@sdbiosensor.com |
| Date Prepared: | September 29, 2015 |
| Trade Names: | SD A1cCareSystem
SD A1cCare Spoit Type Test Kit
SD HbA1c Control Set |
| Classifications: | 21 CFR 864.7470; Assay, Glycosylated Hemoglobin
21 CFR 862.1660; Quality control material (assayed and unassayed)
21 CFR 862.2160; Discrete photometric chemistry analyzer for clinical use |
| Product Codes: | LCP, JJE, JJX |
| Predicate Devices: | A1cNow+ (Professional Use) [K090413]; Bayer HealthCare Diabetes Care
Afinion HbA1c Contols [K110056]; AXIS-SHIELD POC AS |
| Device Description: | The SD A1cCare System is a reflectometry immunoassay used for the
quantitative measurement of glycated hemoglobin (HbA1c) levels in
fresh capillary or venous whole blood samples. It is intended for
professional use.
The SD HbA1c Control Set is intended for use as quality control materials
for the SD A1cCare System.
The SD A1cCare System include the analyzer, analyzer check strip, DC
power adapter, immunoassay test panels, lot-specific calibration code
chips, and control set. |
| Intended Use: | The SD A1cCare System is a reflectometry immunoassay used for the
quantitative measurement of glycated hemoglobin (%HbA1c) levels in
fresh fingerstick capillary blood or venous whole blood samples. This
system is intended for clinical laboratory and point-of-care use to monitor
long term glycemic control of persons previously diagnosed with diabetes.
This test is not for screening or diagnosis of diabetes.
The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It
includes the test panel that receives the blood sample and is used with the
SD A1cCare Analyzer for the quantitative measurement of glycated
hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole
blood samples. The system is intended for clinical laboratory and point-of- |
| | care use to monitor long term glycemic control in persons previously
diagnosed with diabetes. This test is not for screening or diagnosis of
diabetes.
The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level |
| | M are intended for use as quality control materials for the SD A1cCare
System. |
| Comparison of
Technological
Characteristics: | Like the predicate, the SD A1cCare System employs immunoassay
technology to measure HbA1c from both capillary and venous samples.
The SD A1cCare System provides quality control using a check strip,
control set, and a lot-specific code chip for reagent test panels; whereas,
the predicate has internal quality control checks for the analyzer, control
solutions, and requires the user to match meter and reagent test
cartridges to ensure proper calibration. Like the predicate, the SD
A1cCare System requires simple preparation of the blood sample prior to
application to the reagents. Like the predicate, the SD A1cCare System
requires a 5 µL blood samples and display test results on a Liquid Crystal
Display (LCD) within a few minutes. |
| | For control material, the predicate and the subject device have the same
indication for use and the principle of operation. There are differences in
number of levels, package, storage condition, shelf life time, use life time;
however, the results of the performance tests provided in this submission
support that the subject device is substantially equivalent to the
predicate device in safety and effectiveness. |
| Functional and Safety
Testing: | Bench testing addressed the following: NGSP certification, accuracy
method comparison, linearity, precision, comparison of Spoit Type test
kit performance, hematocrit range, interferences, hemoglobin variants,
total hemoglobin, altitude, testing time, operating temperature range,
optimal sample and mixture volume, anticoagulants, sample collection
and preparation, stability of blood samples, vibration, temperature and
humidity. EMC and electrical safety testing was done. Shelf-life testing
was conducted on the reagent test panels and control sets. Software was
subject to design control during development and comprehensive
verification and validation testing. No animal testing was conducted. A
user study clinical evaluation was conducted comparing home user
results against a reference method which also evaluated ease-of-
understanding of the instructions. |
| Conclusion: | The technological and functional characteristics of the SD A1cCare
systems are substantially equivalent to that of the predicate product. All
testing met acceptance criteria and support the contention that the SD
A1cCare systems are substantially equivalent to the predicate product. |
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