(521 days)
Not Found
No
The device description focuses on chemical and electrochemical principles for measurement, with no mention of AI or ML. The performance studies also do not indicate the use of such technologies.
No.
This device is an in vitro diagnostic (IVD) test used to monitor long-term glucose control in individuals with diabetes mellitus by measuring HbAlc and glucose levels. It is used for diagnosis and monitoring, rather than treating or preventing a disease directly.
Yes
The device quantitatively measures percent concentration glycosylated hemoglobin and glucose in blood samples, which are used to monitor long-term glucose control and aid in the management of diabetes, indicating its role in providing information for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including an analyzer, test cartridges, check cartridges, printer, scanner, and cables, in addition to the glucose module and test strips. This indicates it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: Both the CLOVER Alc HbAlc assay and the CLOVER Alc 11 glucose assay are explicitly stated as "in vitro diagnostic test" and "in vitro diagnostic device" respectively in the "Intended Use / Indications for Use" section.
- Measurement of Analytes in Biological Samples: The device measures the concentration of glycosylated hemoglobin (HbA1c) and glucose in whole blood samples (capillary or venous), which are biological samples.
- Clinical Purpose: The measurements are used for clinical purposes: monitoring long-term glucose control in individuals with diabetes mellitus and aiding in the management of diabetes.
- Device Description: The description details the components and principles of operation for measuring these analytes in vitro (outside the body).
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
The CLOVER Alc HbAlc assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER Alcim is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The CLOVER Alc 11 glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER Alc 10 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
Product codes (comma separated list FDA assigned to the subject device)
CGA, LCP
Device Description
The CLOVER A1cm is a device which combines a Hemoglobin A1c monitoring system, and a blood glucose monitoring system.
The CLOVER A1c™ monitoring system includes Hemoglobin A1c Analyzer, Hemoglobin A1c Test cartridge, Hemoglobin A1c Check cartridge, Thermal printer, Barcode scanner, PC cable, and Fan filter.
The CLOVER A1c™ monitoring system is a fully automated boronate affinity assay for the determination of the percentage of hemogiobin A1c (HbA1c %) in human whole blood.
Hemoglobin A1c Test cartridge is composed of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin A1c, with a collection leg for blood sample collection.
The reagent pack is pre-filled with reaction solution and washing solution. The reaction solution contains agents that lyse erythrocytes and bind hemoglobin specifically, as well as a boronate resin that binds cis-diols of glycated hemoglobin.
Blood sample is collected at the collection leg of the reagent pack, and then the reagent pack is inserted into the cartridge. The assembled cartridge is inserted into the Hemoglobin A1c Analyzer and rotated so that the blood sample mixture is placed at the measurement zone of the cartridge, where the amount of total hemoglobin in the blood sample is photometrically measured. The measurement range is 4.0~14.0%. Acceptable anticoagulants for venous samples are EDTA, heparin, citrate and fluoride/oxalate.
The CLOVER A1c™ Glucose module is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary or venous whole blood samples
whole blood taken from the fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory and point of care use.
healthcare professionals.
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)
Clinical: The clinical performance evaluation using the CLOVER A1c™ device was conducted for the purpose of validating the glycosylated hemoglobin and glucose measuring accuracy. Test results showed substantial equivalence.
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the CLOVER A1c™ with respect to predicate devices. Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence.
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.
Not Found
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).
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
510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: January 13, 2010
JAN 1 4 2010
Submitter: 1.
| Submitted by: | Infopia Co.,ltd.
#891, Hogye-dong, Dongan-Gu
Anyang, Kyunggi 431-080, Korea
Phone +82-31-460-0400
Fax +82-31-460-0401 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Maria Griffin
mdi Consultants, Inc.
55 Northern Blvd., Ste. 200, Great Neck, NY 11021
516-482-9001 |
| Company Contact: | Bryan Oh
Phone: 1-321-267-9911
Fax: 1-321-267-5582 |
| | |
Device: 2.
| Propriety Name | CLOVER A1c ™ |
|---|---|
| Common Name | Test system for hemoglobin A1c, blood glucose |
| Classification Name: | Glycosylated Hemoglobin test system |
| Blood glucose test system | |
| Classification: | Class II |
| 21 CFR Part 864.7470 | |
| 21 CFR Part 862.1345 | |
| Product Code: | CGA, LCP |
3. Predicate Device:
DCA Vantage™, Test system for hemoglobin A1c, albumin and creatinine, K071466 Evolution™, Blood glucose monitoring system, K072369
4. Description:
The CLOVER A1cm is a device which combines a Hemoglobin A1c monitoring system, and a blood glucose monitoring system.
The CLOVER A1c™ monitoring system includes Hemoglobin A1c Analyzer, Hemoglobin A1c Test cartridge, Hemoglobin A1c Check cartridge, Thermal printer, Barcode scanner, PC cable, and Fan filter.
The CLOVER A1c™ monitoring system is a fully automated boronate affinity assay for the determination of the percentage of hemogiobin A1c (HbA1c %) in human whole blood.
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Hemoglobin A1c Test cartridge is composed of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin A1c, with a collection leg for blood sample collection.
The reagent pack is pre-filled with reaction solution and washing solution. The reaction solution contains agents that lyse erythrocytes and bind hemoglobin specifically, as well as a boronate resin that binds cis-diols of glycated hemoglobin.
Blood sample is collected at the collection leg of the reagent pack, and then the reagent pack is inserted into the cartridge. The assembled cartridge is inserted into the Hemoglobin A1c Analyzer and rotated so that the blood sample mixture is placed at the measurement zone of the cartridge, where the amount of total hemoglobin in the blood sample is photometrically measured. The measurement range is 4.0~14.0%. Acceptable anticoagulants for venous samples are EDTA, heparin, citrate and fluoride/oxalate.
The CLOVER A1c™ Glucose module is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
5. Indications for use:
The CLOVER A1c M HbA1c assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The CLOVER A1c™ glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
6. Comparison of Technological Characteristics with Predicate:
The CLOVER A1c™ has the same technological characteristics as the curent legally
marketed predicate devices, DCA Vantage ™ (K071466) by Siemens medical solutions diagnostics and Evolution 114 (K072369.) by Infopia Co., Ltd.
7. Performance Data:
Clinical: The clinical performance evaluation using the CLOVER A1c™ device was conducted for the purpose of validating the glycosylated hemoglobin and glucose measuring accuracy. Test results showed substantial equivalence.
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the CLOVER A1c™ with respect
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to predicate devices. Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence.
8. Conclusion:
The conclusion drawn from the clinical and non clinical tests is that the CLOVER A10™ is as safe, as effective, and performs as well as the legally marketed predicate device, the DAC Vantage TM and Evolution TM.
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Image /page/3/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 a stylized symbol that resembles an abstract human figure embracing or protecting something, with three curved lines representing the figure's arms or embrace.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Infopia Co., Ltd. c/o Ms. Maria F. Griffin Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
JAN 1 4 2010
Re: K082275
Trade Name: Clover Alc™ Glycosylated Hemoglobin Monitoring System Regulation Number: 21 CFR §864.7470 Regulation Name: Hemoglobin Alc Test System. Regulatory Class: Class II Product Codes: LCP, CGA Dated: January 8, 2010 Received: January 11, 2010
Dear Ms. Griffin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K082275
Device Name: CLOVER A1c™ Glycosylated Hemoglobin Monitoring System
Indication For Use:
The CLOVER Alc HbAlc assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER Alcim is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The CLOVER Alc 11 glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER Alc 10 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
Prescription Use X (21 CFR Part 801 Subpart D) And /Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K082275