(240 days)
No
The device description details a standard electrochemical biosensor system for measuring glucose, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction. The calibration is described as an implicit coding process based on the test strip.
No.
The device is a blood glucose monitoring system, used for diagnostic purposes (monitoring glucose levels), not for treating or preventing a disease.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use." This indicates it is not a diagnostic device.
No
The device description explicitly lists hardware components such as a Glucose Meter, Test Strips, Control Solutions, and a Check Strip, and describes an electrochemical biosensor system with an LCD monitor. This indicates it is a hardware-based medical device with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The PRECICHEK Cloudia Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- Definition of IVD: IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device measures glucose in a blood sample taken from the fingertip, which fits this definition.
- Control Solution: The description of the "Control Solution" also states it is "intended for in vitro diagnostic use".
N/A
Intended Use / Indications for Use
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Product codes
NBW, LFR, JJX
Device Description
PRECICHEK Cloudia Blood Glucose Monitoring System consists of:
- (1)Glucose Meter
- (2)Glucose Test Strips
- (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
- (4)Check Strip
- (5)Instruction for use
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips only
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self testing outside the body (in vitro diagnostic use) by people with diabetes at home
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)
PRECICHEK Cloudia Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met.
The subject device was tested to evaluate its safety and effectiveness, including the followings:
- (1) ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- (2) IEC/EN 60601-1:2005 + CORR. 1(2006) + CORR. 2(2007), EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- (3) IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility- Requirements and tests
- CLSI/NCCLS EP05-A2: Evaluation of Precision Performance of (4) Quantitative Measurement Methods
- CLSI EP06-A: Evaluation of the Linearity of Quantitative (5) Measurement.
- (6) CLSI EP07-A2: Interference Testing in Clinical Chemistry
- CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation (7) Using Patient Samples
- FDA Guidance: Guidance for the Content of Premarket (8) Submissions for Software Contained in Medical Devices, May 11, 2005
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KI20064
HMD BioMedical Inc.
510(k) Summary
| 1. Submitter Information | SEP | 5 2012 | |||
|---|---|---|---|---|---|
| Company name: | HMD BioMedical Inc. | ||||
| Contact person: | Jessica Tung | ||||
| Address: | No. 181, Minsheng St., Xinpu Township, Hsinchu | ||||
| County, Taiwan | |||||
| Phone: | 886-3-6017000 | ||||
| FAX: | 886-3-5885500 | ||||
| E-mail: | jessica-tung@hmdbio.com | ||||
| Date Prepared: | August 7, 2012 |
-
- Name of Device
Trade/Proprietary Name:
- Name of Device
,
PRECICHEK Cloudia Blood Glucose Monitoring System
| Common name: | Blood Glucose Test System |
|---|---|
| Classification name: | Glucose Test System |
| Classification Panel: | Clinical Chemistry (75) |
| Regulation no.: | 862.1345 (Class II), 862.1660 (Class I) |
| Product code: | NBW, LFR, JJX |
-
- Predicate Device
| Trade/Proprietary name: | Telcare Blood Glucose Monitoring System | ||
|---|---|---|---|
| Common name: | Blood Glucose Test System | ||
| Submitter: | Telcare, Inc. | ||
| 510(k) no.: | K110571 | ||
| Product code: | CGA, NBW, JJX, JQP |
1
| Common name: | Glucose Control Solution |
|---|---|
| Submitter: | HMD BioMedical, Inc. |
| 510(k) no.: | K032985 |
| Product code: | JJX |
-
- Device Description
PRECICHEK Cloudia Blood Glucose Monitoring System consists of:
- Device Description
-
(1)Glucose Meter
-
(2)Glucose Test Strips
-
(3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
-
(4)Check Strip
-
(5)Instruction for use
[Test Principle]
PRECICHEK Cloudia Blood Glucose Monitoring System is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the PRECICHEK Cloudia Blood Glucose monitoring system and PRECICHEK ACH Blood Glucose Test strips. There are two levels of controls (Levels 1,2).
2
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.
5. Intended Use
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
-
- Comparison of Subject Devices and predicate device
3
Technological Characteristics Comparison Table of PRECICHEK Cloudia Blood Glucose Monitoring System and Telcare Blood Glucose Monitoring System (K110571)
| Item | Subject Device | Predicate Device |
|---|---|---|
| PRECICHEK Cloudia BGMS | Telcare BGMS | |
| Similarities | ||
| Intended use | It is designed to quantitatively | |
| measure the concentration of | ||
| glucose in fresh capillary whole | ||
| blood | Same | |
| Detection method | Amperometry: | |
| Current produced by chemical | ||
| reaction | Same | |
| Test range | 20~600mg/dL | Same |
| Operating | ||
| conditions | 50 | Same |
| Autocoding | Yes | Same |
| Differences | ||
| Enzyme | Glucose Dehydrogenase (FAD) | |
| (Aspergillus oryzae) | Glucose Oxidase | |
| Capillary testing | ||
| site | Fingertips only | Alternate site testing |
| Sample volume | 0.5ul | 0.8ul |
| Memory | 999 | 300 |
| Average | 7, 14, 21, 28 days | 7, 14, 30 days |
| Test time | 5 sec | 6 sec |
| data transmission | N/A | GSM |
-
- Discussion of Clinical Tests Performed
4
PRECICHEK Cloudia Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met.
-
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The subject device was tested to evaluate its safety and effectiveness, including the followings:
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
-
(1) ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
-
(2) IEC/EN 60601-1:2005 + CORR. 1(2006) + CORR. 2(2007), EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
(3) IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility- Requirements and tests
-
CLSI/NCCLS EP05-A2: Evaluation of Precision Performance of (4) Quantitative Measurement Methods
-
CLSI EP06-A: Evaluation of the Linearity of Quantitative (5) Measurement.
-
(6) CLSI EP07-A2: Interference Testing in Clinical Chemistry
-
CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation (7) Using Patient Samples
-
FDA Guidance: Guidance for the Content of Premarket (8) Submissions for Software Contained in Medical Devices, May 11, 2005
-
- Conclusion
5
The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate device.
6
Image /page/6/Picture/2 description: The image shows an address. The address is "10903 New Hampshire Avenue, Silver Spring, MD 20993". The text is black and the background is white.
HMD BioMedical Inc c/o Jessica Tung No. 181, Minsheng St Xinpu Township, Hsinchu County 305, Taiwan
SEP 5 2012
Re: K120064
Trade Name: PreciChek Cloudia Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: August 24, 2012 Received: August 28, 2012
Dear Ms Tung:
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).
7
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your dories on our lecting and Safety at (301) 796-5450. Also, comact the Office of in Vitto Diagnosing by reference to premarket notification" (21) please note the regulation chitted, "Misoraname" of conveillance, please contact CDRH301 C.FK Pat 607.97). For questions regarding possimation of Postmarket Surveillance at (301)
Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance a Office of Surveinance and Brometre 3 (OBF of DF interest events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
CFK Part 805), please go to mip.7 www.idea.go r 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 You may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address (800) 038-2041 01 (501) 770 5000 es Resourcesfor You/Industry/default.htm
Sincerely yours,
N. L. Rowe
Couriney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): __k120064
Device Name [Trade Name]:
PRECICHEK Cloudia Blood Glucose Monitoring System
Indications for Use:
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The PRECICHEK Cloudia Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood-Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120064
Page 1 of ____________________________________________________________________________________________________________________________________________________________________