(29 days)
Contrex Plus Level 1 and Level 2 Control Solutions
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No
The device is a control solution for validating blood glucose monitoring systems and does not involve any computational processing or learning.
No.
This device is a control solution used to validate the performance of blood glucose monitoring systems, not to directly treat a medical condition.
No
This device is a control solution used to validate the performance of blood glucose monitoring systems, not to diagnose a patient's condition.
No
The device description clearly states it is a "Control solution containing D-glucose," which is a physical substance, not software. The performance studies also focus on the stability and qualification of this solution.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the control solution is used to "validate the performance of the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring Systems." This validation is done by testing a solution with a known glucose range to ensure the meter and test strips are functioning properly. This is a key characteristic of an IVD - a product used to examine specimens (in this case, the control solution) to provide information about a physiological state or condition (in this case, the proper functioning of the blood glucose monitoring system).
- Device Description: The description states it's a "quality control material for blood glucose monitoring systems." Quality control materials are a type of IVD used to verify the accuracy and precision of diagnostic tests.
- Predicate Device: The mention of "Contrex Plus Level 1 and Level 2 Control Solutions" as predicate devices further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and control solutions for blood glucose monitoring are well-established IVDs.
While the device itself doesn't directly diagnose a patient's condition, it is an essential component used with an IVD (the blood glucose monitoring system) to ensure the accuracy and reliability of the diagnostic results. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The purpose of the control solution test is to validate the performance of the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring Systems using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Control solution containing D-glucose as its reactive component for use as a quality control material for blood glucose monitoring systems.
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
Not Found
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)
Control solution qualification and stability testing was conducted and all results met specifications.
Control solution qualification was conducted on one lot of control solution by range testing 80 test strips over 10 days. All results fell within the assigned control solution range.
Control solution stability verification was conducted in a Use Life study (open vial and un-opened vial) and in a Shelf Life study. Use Life testing was done on 5 meters and one lot of test strips to support the claim of a 3-month open bottle use life. Three (3) lots of low control solution were tested. Eight (8) bottles were tested for each of the 3 lots. For each lot of control solution, a) 4 bottles were used for repeated testing in which they were opened every other day to express a drop of control solution and then tested on a test strip on Day 0 and months 1, 2 and 3 (open bottle testing) and b) 4 bottles were opened once for one-time testing on Days 0 and months 1, 2, and 3 (un-opened vial testing). All test strip results were within the assigned control solution range. Shelf Life testing was done on three (3) lots of low control solution stored at 30°C. Two lots of test strips and ten (10) meters were used. For each of the 3 lots of control solution, 10 test strips were tested at each test point. The test points occurred at weeks 0, 2, 5, 8, 13, 26, 39, 52, 78, 104, and 108. The claimed shelf life period for the control solution is 2 years (104 weeks). All test values were within the assigned control solution range.
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.
Contrex Plus Level 1 and Level 2 Control Solutions
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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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APR 1 4 2010
·
| 510(k) Summary | |
|---|---|
| Submitter: | Thomas Y.S. Shen, Chairman & CEO |
| Apex BioTechnology Corp. | |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078, CHINA (TAIWAN) | |
| Contact Person: | Thomas Y.S. Shen, Chairman & CEO |
| Apex BioTechnology Corp. | |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078, CHINA (TAIWAN) |
email: tyshen@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
| Date Prepared: | April 14, 2010 |
| Trade Name: | Contrex Plus Low Control Solution |
| Classification: | Quality control material (assayed and unassayed), 21 CFR 862.1660,
Class I (reserved). |
| Product Code: | JJX |
| Predicate Device: | Contrex Plus Level 1 and Level 2 Control Solutions |
| Device Description: | Control solution containing D-glucose as its reactive component for use
as a quality control material for blood glucose monitoring systems. |
| Intended Use: | The purpose of the control solution test is to validate the performance of
the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring
Systems using a testing solution with a known range of glucose. A
control test that falls within the acceptable range indicates the user's
technique is appropriate and the test strip and meter are functioning
properly. |
| Comparison of
Technological
Characteristics: | The modified Contrex Plus Control Solution (Contrex Plus Low Control
Solution) is identical to the predicate in so far as it also contains D-
Glucose as the reactive ingredient and contains the same non-reactive
ingredients (including buffers, stabilizer and preservative). The glucose
range for the modified, Low Control Solution is 40-70 mg/dL; whereas,
the ranges for the predicate Level 1 and Level 2 control solutions are 87-
131 mg/dL and 186-280 mg/dL, respectively. |
P:IPROJECTS\Apex\Contrex GS Star Low Control\FDA response info\13 April responses[K100747](https://510k.innolitics.com/search/K100747) 510k l summary 14 Apr 2010.doc
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| 510(k) Summary | |
|---|---|
| Functional and | |
| Safety Testing: | Control solution qualification and stability testing was conducted and all |
| results met specifications. |
Control solution qualification was conducted on one lot of control
solution by range testing 80 test strips over 10 days. All results fell
within the assigned control solution range. |
| | Control solution stability verification was conducted in a Use Life study
(open vial and un-opened vial) and in a Shelf Life study. Use Life testing
was done on 5 meters and one lot of test strips to support the claim of a
3-month open bottle use life. Three (3) lots of low control solution were
tested. Eight (8) bottles were tested for each of the 3 lots. For each lot of
control solution, a) 4 bottles were used for repeated testing in which they
were opened every other day to express a drop of control solution and
then tested on a test strip on Day 0 and months 1, 2 and 3 (open bottle
testing) and b) 4 bottles were opened once for one-time testing on Days 0
and months 1, 2, and 3 (un-opened vial testing). All test strip results
were within the assigned control solution range. Shelf Life testing was
done on three (3) lots of low control solution stored at 30°C. Two lots of
test strips and ten (10) meters were used. For each of the 3 lots of control
solution, 10 test strips were tested at each test point. The test points
occurred at weeks 0, 2, 5, 8, 13, 26, 39, 52, 78, 104, and 108. The
claimed shelf life period for the control solution is 2 years (104 weeks).
All test values were within the assigned control solution range. |
| Conclusion: | Contrex Plus Low Control Solution has the same formulation as the
predicate other than using a lower glucose level and therefore presents at
least as good safety as the predicate. Qualification testing shows that
Contrex Plus Low Control Solution is effective as a control solution and
performs at least as well as the predicate, as shown by testing were all
results fell within the assigned control solution range. Use Life and Shelf
Life testing show that the Contrex Plus Low Control Solution performs
properly during its claimed use life and shelf life periods. These results
from testing show that the Contrex Plus Low Control Solution is safe,
effective, and performs at least as well as the predicate device.
We conclude that the Contrex Plus Low Control Solution is substantially
equivalent to the predicate device. |
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P:IPROJECTS\Apex\Contrex GS Star Low Control\TDA response info\13 April responses[K100747](https://510k.innolitics.com/search/K100747) 510k 2 summary 14 Apr 2010.doc .
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Apex BioTechnology Corp. c/o Mr. Thomas Y.S. Shen Regulatory Affairs Specialist No. 7 Li-Hsin Road V, Hsinchu Science Park Hsinchu, China (Taiwan) 30078
APR 14 2010
K100747 Re:
Trade Name: Contrex Plus Low Control Solution Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: March 11, 2010 Received: March 16, 2010
Dear Mr. Shen:
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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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/Safetv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
AC
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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Indications for Use Form
510(k) Number (if known): K100747
Device Name: Contrex Plus Low Control Solution
Indications for Use:
The purpose of the control solution test is to validate the performance of the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring Systems using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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): K100747
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P:PROJECTS\Apex\Contrex GS Star Low ControllFDA response info\Response to name change\final name change response[K100747](https://510k.innolitics.com/search/K100747) Indications for 8 Apr 2010.doc
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