(602 days)
DS-A Blood Glucose Monitoring System (K082965)
Not Found
No
The summary describes a standard electrochemical biosensor for blood glucose measurement and does not mention any AI or ML components.
No.
The device is a blood glucose monitoring system, which aids in monitoring diabetes control by measuring glucose levels. It is a diagnostic device, not a therapeutic one that directly treats or cures a condition.
Yes
The device is an in vitro diagnostic use device intended for self-testing outside the body to measure glucose levels, which is a diagnostic purpose.
No
The device description explicitly mentions a "Blood Glucose Meter" and "Blood Glucose Test Strips," which are hardware components necessary for the device's function. The system relies on electrochemical biosensor technology and capillary action, indicating a physical interaction with a blood sample, not solely software processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The i-QARE DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. This device measures glucose in blood samples taken from the body.
- Purpose: The intended use is to "monitor the effectiveness of diabetes control," which is a diagnostic purpose performed outside the body.
Therefore, the device fits the definition and is explicitly labeled as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The i-QARE DS-W 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 i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, i-QARE DS-W Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, palm
Indicated Patient Age Range
Not for neonatal use.
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
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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)
Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.
The differences between the subject device and the predicate device are not critical to the intended therapeutic, diagnostic, or surgical uses of the device. Therefore, these differences do not raise any safety and effectiveness concerns. They are substantially equivalent.
The conclusions drawn from the clinical and the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
DS-A Blood Glucose Monitoring System (K082965)
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
§ 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.
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April 20, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ALLIANCE INTERNATIONAL CO., LTD. JEN KE-MIN OFFICIAL CORRESPONDENT NO.54 YING TAO RD. YING DISTRICT NEW TAIPEI CITY, 239 23942, TAIWAN
Re: K132663
Trade/Device Name: i-QARE DS-W Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: March 31, 2015 Received: April 10, 2015
Dear Jen Ke-min:
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.
1
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/Resourcesfor You/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) K132663
Device Name
i-QARE DS-W Blood Glucose Monitoring System
Indications for Use (Describe)
The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The i-QARE DS-W 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 i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Alliance+. The word "Alliance" is written in bold, black letters. Below the word is a white plus sign. The word and plus sign are superimposed on a yellow, crescent-shaped background. The logo is surrounded by a white border.
5. 510(K) Summary of Safety and Effectiveness
(Per 21 CFR 807.92)
5.1. General Information Establishment
| ■ | The assigned 510(k) number is : | K 132663 |
|---|---|---|
| ■ | Manufacturer: | Alliance International Co., Ltd. |
| ■ | Address: | No.54, Ying Tao Rd. Yinge District, New Taipei City, 239, |
| Taiwan, R.O.C. | ||
| ■ | Owner Number: | 9099902 |
| ■ | Contact Person: | Dr. Jen, Ke-Min |
| E-mail: ceirs.jen@msa.hinet.net | ||
| (Tel)+886-2-86781007; | ||
| (Fax)+886-2-86781006 | ||
| ● | Date Prepared: | March 27, 2015 |
| ● | Proprietary Name: | i-QARE DS-W Blood Glucose Monitoring System |
| Trademark: i-QARE | ||
| Model: DS-W (i.e. “DS-Walkie”) | ||
| ● | Common Name: | Blood Glucose Monitoring System |
| ● | Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, |
| OVER THE COUNTER. Class II |
- Product Code: NBW
5.2. Safety and Effectiveness Information
● Predicate Device: Claim of Substantial Equivalence (SE) is made to DS-A Blood Glucose Monitoring System (K082965)
- Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, i-QARE DS-W Blood Glucose Monitoring System only needs a small amount of blood. Capillary action
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Image /page/4/Picture/0 description: The image is a logo for Alliance+. The logo features the word "Alliance" in bold, black letters, stacked on top of a white plus sign. The plus sign is centered within a yellow, crescent-shaped graphic that resembles a stylized flame or wing. The entire logo is set against a white background with a thin, gray border.
亞蘭斯國際股份有限公司 Alliance International Co., Ltd.
No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, Taiwan TEL: 886-2-8678-1007 FAX: 886-2-8678-1006 E-mail: miller.brenda@gmail.com
- at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.
● Intended Use:
The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The i-OARE DS-W 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 i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strip are for us with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Synopsis of Test Methods and Results ●
Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.
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Image /page/5/Picture/0 description: The image is a logo for an organization called "Alliance+". The word "Alliance" is written in bold, black letters, stacked on top of a plus sign. The plus sign is white and is set against a yellow, curved shape that resembles a flame or a stylized yin-yang symbol. The entire logo is enclosed in a white frame with rounded corners.
亞蘭斯國際股份有限公司 Alliance International Co., Ltd. No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, Taiwan TEL: 886-2-8678-1007 FAX: 886-2-8678-1006 E-mail: miller.brenda@gmail.com Comparison Table
Similarities:
| Item | Predicate device | Subject device |
|---|---|---|
| Manufacturer | Alliance International | Alliance International |
| Proprietary | ||
| Name: | DS-A Blood Glucose | |
| Monitoring System | i-QARE DS-W Blood Glucose | |
| Monitoring System | ||
| 510(k) No. | K082964 | K132663 |
| Indications for use | The A-CHECK DS-A Blood | |
| Glucose Monitoring System is used | ||
| with DS-A Test Strips and 3-level | ||
| Controls for the measurement of | ||
| glucose in fresh capillary whole | ||
| blood from the finger. Testing is | ||
| done outside the body ( in vitro | ||
| diagnostic use). It is indicated for | ||
| use at home ( over the counter | ||
| [OTC] ) by person with diabetes, or | ||
| in clinical setting by health care | ||
| professionals, as an aid to monitor | ||
| the effectiveness of diabetes | ||
| control. There are not intended | ||
| for diagnosis of or screening for | ||
| diabetes mellitus, and are not | ||
| intended for use on neonates. | The i-QARE DS-W Blood Glucose | |
| Monitoring System is intended to be | ||
| used for the quantitative measurement | ||
| of glucose (sugar) in fresh capillary | ||
| whole blood samples drawn from the | ||
| fingertips, forearm or palm. The | ||
| i-QARE DS-W Blood Glucose | ||
| Monitoring System is intended to be | ||
| used by a single person and should not | ||
| be shared. The i-QARE DS-W 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 | ||
| i-QARE DS-W Blood Glucose | ||
| Monitoring System should not be used | ||
| for the diagnosis of or screening of | ||
| diabetes or for neonatal use. Alternative | ||
| site testing should be done only during | ||
| steady-state times (when glucose is not | ||
| changing rapidly). The i-QARE DS-W | ||
| Draw-in Blood Glucose Test Strip are | ||
| for us with the i-QARE DS-W Blood | ||
| Glucose Meter to quantitatively measure | ||
| glucose (sugar) in fresh capillary whole | ||
| blood samples drawn from the | ||
| fingertips, forearm or palm. | ||
| Test Principle | Electrochemical biosensor with | |
| carbon electrodes | same | |
| Measuring Time | 6 sec | same |
| Detecting Range | 20 ~ 600 mg/dL | same |
| Operating | ||
| Temperature | 10 to 40 °C | same |
| Image: Alliance logo | ||
| 亞蘭斯國際股份有限公司 | ||
| Alliance International Co., Ltd. | ||
| No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, Taiwan | ||
| TEL: 886-2-8678-1007 FAX: 886-2-8678-1006 | ||
| E-mail: miller.brenda@gmail.com | ||
| Strip Storage | ||
| Temperature | 4 to 32 °C | same |
| Battery Power | One 3V Lithium CR 2032 battery | same |
| Data Recall | By button (memory capacity: 20 | |
| sets) | same |
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Differences:
| Item | Predicate device | Subject device |
|---|---|---|
| Limitations | DS-A Draw-In test strips are | |
| designed for use with fresh capillary | ||
| whole blood sample. Do Not use | ||
| serum or plasma samples. |
-
It should not be used in Intensive
Care settings or if the patient is
dehydrated, hypotensive, hypoxic,
in diabetic ketoacidosis, in shock,
or in a
hyperglycemic/hyperosmolar
state. -
Hematocrit: Variation in sample
hematocrit between 30% and 55%
has no significant effect on test
results. Very high (above 55%)
and very low (below 30%)
hematocrit can cause inaccurate
results. -
Neonates: Do not use Draw-In test
strips to test neonates. The
performance of this system has not
been validated with neonatal
samples. -
Blood concentration of Ascorbic
Acid > 1.2mg/dL or Uric Acid >
7mg/dL will cause overestimation
of blood glucose results. -
Therapeutic levels of L-dopa
(>10mg/dL) or Dopamine (>
1.25mg/dL) may result in
inaccurate (elevated) glucose
readings with the system. -
Acetaminophen (