CONTREX PLUS LOW CONTROL SOLUTION by APEX BIO TECHNOLOGY CORP

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.

Device Description

Control solution containing D-glucose as its reactive component for use as a quality control material for blood glucose monitoring systems.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Contrex Plus Low Control Solution. This device is a quality control material for blood glucose monitoring systems, not an AI-powered diagnostic device, so many of the requested AI/MRMC specific questions are not applicable.

Here's the information based on the provided text, with "N/A" (Not Applicable) for questions that don't fit the scope of this type of device or for which information is not provided.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Control Solution Qualification: All results for range testing must fall within the assigned control solution range (40-70 mg/dL).	All results fell within the assigned control solution range.
Use Life Study (Open Vial): All test strip results must be within the assigned control solution range for a claimed 3-month open bottle use life. Testing conducted on Days 0, 1, 2, and 3 months with daily opening to express a drop.	All test strip results were within the assigned control solution range.
Use Life Study (Un-opened Vial): All test strip results must be within the assigned control solution range for a claimed 3-month use life. Testing conducted on Days 0, 1, 2, and 3 months with a single opening for each test point.	All test strip results were within the assigned control solution range.
Shelf Life Study: All test values must be within the assigned control solution range for a claimed 2-year (104 weeks) shelf life. Testing at weeks 0, 2, 5, 8, 13, 26, 39, 52, 78, 104, and 108.	All test values were within the assigned control solution range.
Substantial Equivalence: The device should perform at least as well as the predicate device (Contrex Plus Level 1 and Level 2 Control Solutions) and present at least as good safety. This is demonstrated by the formulation being similar and all qualification and stability testing meeting specifications.	"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 where all results fell within the assigned control solution range."

Study Details

A table of acceptance criteria and the reported device performance: (See table above)
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Control Solution Qualification: 80 test strips over 10 days (for one lot of control solution).
- Use Life Study: 5 meters, one lot of test strips. Three lots of low control solution were tested, with 8 bottles per lot (4 for open-bottle testing, 4 for un-opened vial testing).
- Shelf Life Study: Two lots of test strips, ten meters. Three lots of low control solution were tested. For each lot, 10 test strips were tested at each test point.
- Data Provenance: Not explicitly stated, but the submitter is Apex BioTechnology Corp. from Hsinchu Science Park, CHINA (TAIWAN). The studies appear to be prospective, laboratory-based testing for product quality control.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. This is a quality control material where "ground truth" is defined by the expected chemical concentration range of glucose in the solution, and its interaction with a device. No human expert interpretation is involved in establishing the "ground truth" of the control solution's performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically relevant for diagnostic or image-based studies where expert consensus resolves discrepancies. For a control solution, the results are quantitative measurements against predefined ranges.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a control solution for a blood glucose monitoring system, not an algorithm. The "performance" is the accuracy of the glucose meter reading the control solution within its specified range.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the control solution's performance is the assigned control solution range (40-70 mg/dL), which is presumably established through rigorous chemical analysis during the manufacturing process of the control solution itself. The conformity of the meter's reading to this known chemical range is the measure of the system's performance.
The sample size for the training set:
- N/A. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- N/A. No training set is applicable.

Summary

{0}------------------------------------------------

K100747

APR 1 4 2010

510(k) Summary
Submitter:	Thomas Y.S. Shen, Chairman & CEOApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078, CHINA (TAIWAN)
Contact Person:	Thomas Y.S. Shen, Chairman & CEOApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078, CHINA (TAIWAN)email: tyshen@apexbio.comPhone: 011-886-3-5641952FAX: 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 useas a quality control material for blood glucose monitoring systems.
Intended Use:	The purpose of the control solution test is to validate the performance ofthe GlucoSure STAR & GlucoTRACK Blood Glucose MonitoringSystems using a testing solution with a known range of glucose. Acontrol test that falls within the acceptable range indicates the user'stechnique is appropriate and the test strip and meter are functioningproperly.
Comparison ofTechnologicalCharacteristics:	The modified Contrex Plus Control Solution (Contrex Plus Low ControlSolution) is identical to the predicate in so far as it also contains D-Glucose as the reactive ingredient and contains the same non-reactiveingredients (including buffers, stabilizer and preservative). The glucoserange 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

・

{1}------------------------------------------------

510(k) Summary
Functional andSafety Testing:	Control solution qualification and stability testing was conducted and allresults met specifications.Control solution qualification was conducted on one lot of controlsolution by range testing 80 test strips over 10 days. All results fellwithin 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 testingwas done on 5 meters and one lot of test strips to support the claim of a3-month open bottle use life. Three (3) lots of low control solution weretested. Eight (8) bottles were tested for each of the 3 lots. For each lot ofcontrol solution, a) 4 bottles were used for repeated testing in which theywere opened every other day to express a drop of control solution andthen tested on a test strip on Day 0 and months 1, 2 and 3 (open bottletesting) and b) 4 bottles were opened once for one-time testing on Days 0and months 1, 2, and 3 (un-opened vial testing). All test strip resultswere within the assigned control solution range. Shelf Life testing wasdone on three (3) lots of low control solution stored at 30°C. Two lots oftest strips and ten (10) meters were used. For each of the 3 lots of controlsolution, 10 test strips were tested at each test point. The test pointsoccurred at weeks 0, 2, 5, 8, 13, 26, 39, 52, 78, 104, and 108. Theclaimed 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 thepredicate other than using a lower glucose level and therefore presents atleast as good safety as the predicate. Qualification testing shows thatContrex Plus Low Control Solution is effective as a control solution andperforms at least as well as the predicate, as shown by testing were allresults fell within the assigned control solution range. Use Life and ShelfLife testing show that the Contrex Plus Low Control Solution performsproperly during its claimed use life and shelf life periods. These resultsfrom 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 substantiallyequivalent to the predicate device.

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 .

. . . . . . . .

{2}------------------------------------------------

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).

{3}------------------------------------------------

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/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,

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

{4}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K100747

Device Name: Contrex Plus Low Control Solution

Indications for Use:

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

Page 1 of 1

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

Regulation Number and Section

§ 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.