(168 days)
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No
The document describes a standard uric acid monitoring system based on test strips and a meter, with no mention of AI, ML, or related technologies in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) system used for monitoring uric acid levels, not for treating or providing therapy. Its intended use is to aid in monitoring the effectiveness of uric acid control, not to alter treatment unless specifically instructed by a healthcare professional.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is for "in vitro diagnostic use."
No
The device description explicitly states that the system includes a "FORA MD6/ FORA MD6 Pro Meter," which is a hardware component. It also includes test strips and control solutions, which are also physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for use outside the body (in vitro diagnostic use)..." and "It is for in vitro diagnostic use only."
- Nature of Measurement: The device measures uric acid in capillary whole blood, which is a biological sample taken from the body and analyzed in vitro (outside the body).
- Purpose: The purpose is to aid in monitoring the effectiveness of uric acid control, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
Prescription home use:
The FORA MD6 Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. It is intended foruse outside the body (in vitro diagnostic use) by people with hyperuricemia or gout as an aid to monitor the effectiveness of uric acid control. The system is intended for single-patient home use by prescription only and should not be shared. The system should only be used with FORA MD6 Uric Acid Test Strips, and FORA Uric Acid Control Solutions.
The system should not be used to alter hyperuricemia or gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional.
Point-of-care use:
The FORA MD6 Pro Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. This system should only be used with single-use, auto-disabling lancing devices. It is for in vitro diagnostic use only.
This system is intended for multiple patient use by health care professionals at point of care sites as an aid to monitor the effectiveness of uric acid control in people with hyperuricemia or gout.
Product codes (comma separated list FDA assigned to the subject device)
PTC, LFQ
Device Description
FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System includes the FORA MD6/ FORA MD6 Pro Meter, the FORA MD6/ FORA MD6 Pro Uric Acid Test Strips and the Uric Acid Control Solutions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertip (for capillary whole blood)
Indicated Patient Age Range
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Intended User / Care Setting
Prescription home use: people with hyperuricemia or gout, single-patient home use by prescription only.
Point-of-care use: health care professionals at point of care sites.
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)
The performance of the FORA MD6 Uric Acid Monitoring System/FORA MD6 Pro Uric Acid Monitoring System. was studied in the laboratory and in clinical settings by healthcare professional and lay users. The studies demonstrated that the intended users can obtain uric acid results that are substantially equivalent to the current methods for uric acid measurements.
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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§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 10, 2018
TaiDoc Technology Corporation Yvette Chang Senior Regulatory Affairs Specialist B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K181675
Trade/Device Name: FORA MD6 Uric Acid Monitoring System FORA MD6 Pro Uric Acid Monitoring System Regulation Number: 21 CFR 862.1775 Regulation Name: Uric acid test system Regulatory Class: Class I. reserved Product Code: PTC, LFQ Dated: November 7, 2018 Received: November 8, 2018
Dear Yvette Chang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K181675
1. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Yvette Chang |
| Title: | Senior Regulatory Affairs Specialist |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei |
| City, 24888, Taiwan | |
| Phone: | +886-2-6625-8188 |
| Fax: | +886-2-6625-0288 |
| E-mail: | Yvette.Chang@taidoc.com.tw |
| Prepared Date: | JUNE 15th, 2018 |
2. Regulatory information:
| Proprietary Name: | FORA MD6 Uric Acid Monitoring System
FORA MD6 Pro Uric Acid Monitoring System |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Product Code: | PTC - Uric Acid Test System, For At Home Prescription Use
LFQ - Acid, Uric Reduction of Ferric Ion |
| Classification Panel: | Clinical chemistry |
| Classification: | Class I, reserved (for PTC)
Class I, meets limitations of exemptions
21 CFR §862.9(c)(9) (for LFQ) |
| Regulation Citation: | 21 CFR 862.1775 Uric acid test system |
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3. Primary Predicate Device
Compur Easy Touch Uric Acid Reagent (K832785)
4. Intended Use
Prescription home use:
The FORA MD6 Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. It is intended foruse outside the body (in vitro diagnostic use) by people with hyperuricemia or gout as an aid to monitor the effectiveness of uric acid control. The system is intended for single-patient home use by prescription only and should not be shared. The system should only be used with FORA MD6 Uric Acid Test Strips, and FORA Uric Acid Control Solutions.
The system should not be used to alter hyperuricemia or gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional.
Point-of-care use:
The FORA MD6 Pro Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. This system should only be used with single-use, auto-disabling lancing devices. It is for in vitro diagnostic use only.
This system is intended for multiple patient use by health care professionals at point of care sites as an aid to monitor the effectiveness of uric acid control in people with hyperuricemia or gout
ട. Device Description:
FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System includes the FORA MD6/ FORA MD6 Pro Meter, the FORA MD6/ FORA MD6 Pro Uric Acid Test Strips and the Uric Acid Control Solutions.
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6. Comparison to the Predicate:
| Similarities and Differences | ||
|---|---|---|
| Item | Subject Device, | |
| FORA MD6 Uric Acid | ||
| Monitoring System | ||
| K181675 | Predicate Device, | |
| Compur Easy Touch | ||
| Uric Acid Reagent | ||
| K832785 | ||
| Intended use | Intended for the | |
| quantitative | ||
| measurement of uric | ||
| acid. | Same | |
| Measuring range | 3 to 13 mg/dL | 0.3 to 20 mg/dL |
| Specimen type | Capillary whole blood | |
| from fingertip | Serum and plasma | |
| Methodology | Amperometry | Enzymatic colorimetric |
| assay | ||
| Sample volume | 2 µ L | 25 µ L |
| Similarities and Differences | ||
|---|---|---|
| Item | Subject Device | |
| FORA MD6 Pro Uric | ||
| Acid Monitoring System | ||
| K181675 | Predicate Device, | |
| Compur Easy Touch | ||
| Uric Acid Reagent | ||
| K832785 | ||
| Intended use | Intended for the | |
| quantitative | ||
| measurement of uric | ||
| acid. | Same | |
| Measuring range | 3 to 13 mg/dL | 0.3 to 20 mg/dL |
| Specimen type | Capillary whole blood | |
| from fingertip | Serum and plasma | |
| Methodology | Amperometry | Enzymatic colorimetric |
| assay | ||
| Sample volume | 2 μ L | 25 μ L |
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7. Test Principle:
FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System utilizes a non-enzymatic uric acid detection approach. Through the reduction of ferric ion. Uric acid produces one electron. An electrical current resulting from this reaction is measured and correlated to uric acid concentration by the meter.
8. Performance Studies:
The performance of the FORA MD6 Uric Acid Monitoring System/FORA MD6 Pro Uric Acid Monitoring System. was studied in the laboratory and in clinical settings by healthcare professional and lay users. The studies demonstrated that the intended users can obtain uric acid results that are substantially equivalent to the current methods for uric acid measurements.
9. Conclusion:
Based on the results of laboratory and clinical studies provided in this submission, FORA MD6 Uric Acid Monitoring System/FORA MD6 Pro Uric Acid Monitoring System. is substantially equivalent to the predicate devices in uric acid testing.
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