(38 days)
The Assure 4 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure 4 consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control. The Assure 4 measures electrical current generated by the interaction of glucose with glucose oxidase in its biosensor test strip. It uses a code chip for strip lot calibration.
The provided text describes the Assure 4 Blood Glucose Monitoring System and its modifications compared to the Assure 3, but does not include detailed acceptance criteria or a study proving the device meets specific performance criteria with numerical results.
The document K070088 is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full study results against explicit acceptance criteria. While it mentions "Clinical testing was done with persons with diabetes in addition to in-house testing for precision, interferences, linearity, altitude effects, hematocrit effects, minimum sample volume, stability, control solution functionality, and temperature and humidity effects," it lacks the specific data, acceptance thresholds, sample sizes, and expert details requested.
Therefore, many of the requested fields cannot be fully populated from the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Not explicitly stated/quantified in provided text) | Reported Device Performance (Not explicitly stated/quantified in provided text) |
|---|---|---|
| Precision | Not specified | Clinical testing performed |
| Interferences | Not specified | Clinical testing performed |
| Linearity | Not specified | Clinical testing performed |
| Altitude Effects | Not specified | Clinical testing performed (up to 7,000 ft listed as a characteristic) |
| Hematocrit Effects | Not specified | Clinical testing performed (30-55% listed as a characteristic) |
| Minimum Sample Volume | Not specified, but Assure 4 changed to 1.5 µL | 1.5 µL (for Assure 4) |
| Stability | Not specified | Clinical testing performed |
| Control Solution Functionality | Not specified | Clinical testing performed |
| Temperature & Humidity Effects | Not specified | Clinical testing performed (Operating T° Range: 57-104°F, Humidity: <85%) |
| Test Range (mg/dL) | Not applicable (characteristic) | 30-550 mg/dL |
| Test Time (seconds) | Not applicable (characteristic) | 10 seconds |
Limitations: The document states that clinical and in-house testing was performed for various factors, but it does not provide the specific acceptance criteria or the numerical results that demonstrate the device meets these criteria. The table above reflects the characteristics of the device but not the performance metrics of the study conducted.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states "Clinical testing was done with persons with diabetes."
- Data Provenance: Not specified, but the submitter is from Hsinchu, Taiwan (ROC). The regulatory body is the US FDA. Given this, the clinical data could be from Taiwan, the US, or other locations. It does not state if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the given text.
4. Adjudication method for the test set
- Adjudication method is not mentioned.
5. 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
- This information is not applicable. The device is a Blood Glucose Monitoring System, an in vitro diagnostic device, not an image interpretation or AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance improvement are not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not directly stated in terms of a "standalone" study separate from the clinical testing. However, the device itself is an automated system for measuring glucose. The "testing is done outside the body (In Vitro diagnostic use)." The performance of the system (meter and test strip) is its standalone performance. The document states "Clinical testing was done with persons with diabetes in addition to in-house testing for precision, interferences, linearity, altitude effects, hematocrit effects, minimum sample volume, stability, control solution functionality, and temperature and humidity effects," which implies the system's performance was evaluated.
7. The type of ground truth used
- For blood glucose monitoring systems like this, the "ground truth" would typically be established by a laboratory reference method (e.g., a YSI analyzer or similar glucose oxidase-based laboratory instrument) against which the device's readings are compared. The document states, "Reference: Plasma," indicating that the device's measurements for whole blood are compared to plasma glucose values obtained from a laboratory reference method.
8. The sample size for the training set
- This information is not provided. The document describes modifications to an existing device and discusses clinical and in-house testing for performance validation, but does not detail a separate "training set" or its size, which might be relevant for AI/machine learning models but not typically for a biosensor like this unless complex algorithms were being trained.
9. How the ground truth for the training set was established
- As a "training set" is not explicitly mentioned and the device's fundamental chemistry and algorithm are stated to be "Identical base software and algorithm" to the predicate, it's unlikely a distinct ground truth for a new training set was established for the purpose of a novel algorithm unless incremental model updates were done, which is not detailed here. If a training set was used for initial algorithm development for the Assure 3, its ground truth would have also likely been established via a laboratory reference method (e.g., plasma glucose).
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5 510(k) Summary
| 5 510(k) Summary | K070088 |
|---|---|
| Submitter: | Thomas Y.S. Shen |
| Contact Person: | Thomas Y.S. Shen |
| Date Prepared: | January 8, 2007 |
| Trade Name: | Assure 4 Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA |
| Predicate Device: | Glucosure BGM |
| DeviceDescription: | Assure 4 consists of a meter, test strips, and control solutions foruse in measuring blood glucose as an aid to monitor theeffectiveness of diabetes control |
| Intended Use: | The Assure 4 Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose in fresh capillary wholeblood. Testing is done outside the body ( In Vitro diagnostic use).It is indicated for use at home (over the counter [OTC]) bypersons with diabetes or in clinical settings by healthcareprofessionals, as an aid to monitor the effectiveness of diabetescontrol. |
| Functional andSafety Testing: | Clinical testing was done with persons with diabetes in additionto in-house testing for precision, interferences, linearity, altitudeeffects, hematocrit effects, minimum sample volume, stability,control solution functionality, and temperature and humidityeffects. |
| Conclusion: | The modification to the original device does not adversely affectperformance and the modified device is substantially equivalentto the unmodified predicate device. |
..
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Modified Device Information 9
NOTE:
- . We refer to the modified device as the "Assure 4" or the "Modified Assure 4".
- We refer to the unmodified device as "Assure 3" or the "Unmodified Assure 3". ●
Description of Modified Device 9.1
Appendix 1 shows engineering diagrams of the Modified Assure 4 meter, code chip and test strip.
The Assure 4 measures electrical current generated by the interaction of glucose with glucose oxidase in its biosensor test strip. It uses a code chip for strip lot calibration.
Among the changes that have been made (described in Section 9.2), the code chip and test strip have been modified in shape and size to prevent Assure 4 and Assure 3 code chips and test strips from being used interchangeably.
9.2 Comparison to Unmodified Device
Table 1 (page 22) summarizes the similarities and differences between the Modified Assure 4 and the Unmodified Assure 3.
9.2.1 Similarities
The Modified Assure 4 device has the following similarities to the Unmodified Assure 3:
- . Identical intended use statements
- . Identical operating principle
- . Identical fundamental chemistry
- . Identical control solutions
- � Identical base software and algorithm
- Identical meter LCD .
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9.2.2 Modifications
-
- Modifications of Code Chip
- a. The Assure 4 code chip and meter code chip port were changed to prevent interchangeability with the Unmodified Assure 3 meter. The Assure 4 code chip physically cannot fit into the Assure 3 meter code chip port. The Assure 3 code chip is too short to make electrical contact, if inserted into the Assure 4 meter code chip port. (See Table 1. page 22. item 14).
-
- Modifications of Test Strip
- a. The drop volume of the active chemistry was reduced from 5 uL to 2 uL.
- b. The concentration of glucose oxidase was increased to compensate for the decrease in absolute volume of active chemistry. This ensures that a sufficient electrical signal is generated and that glucose oxidase is not a ratelimiting step for high glucose levels. The resultant electrical signal can be accommodated with the existing algorithm and calibration procedures. Minor changes were also made in the concentration of the enzyme protector and non-reactive ingredients. (See Table 1, page 22, item 15 and Table 2, page 24).
- c. A mesh was eliminated from the Unmodified Assure 3 test strip. Elimination of the mesh allows the reduction in drop volume of the active chemistry, as the mesh absorbs and disperses the active chemistry; thereby increasing the size of the drop of active chemistry needed.
- d. A PET (polyethylene terephthalate) laminate film was added above the active chemistry "well" to create a capillary fill channel that directs the blood to the active chemistry site. Because the channel takes a small amount of blood to fill and because of the increased concentration of glucose oxidase, the test strip is now accurate to a minimum sample volume of 1.5 µL, instead of 3.0 uL. The design requires filling the Modified Assure 4 test strip from the side. (See Table 1, page 22, items 16 and 17).
The Unmodified Assure 3 test strip also had the active chemistry site oriented so that it faced the side of the test strip (rather than being on the end of the test strip). The Unmodified Assure 3 test strip can be filled from the top or the side; whereas, the Modified Assure 4 test strip can be filled only from the side by touching the opening of the capillary channel.
- e. Strip length was reduced from 48 mm to 38 mm, reducing raw material costs, (See Table 1, page 22, item 18).
- ﺳﺘﻨ To eliminate interchangeability of Assure 4 and Assure 3 test strips and meters, the Assure 4 meter has a "post" in the test strip holder which prevents insertion of the Assure 3 test strip. The Assure 4 test strip has a slot that allows insertion into the Assure 4 meter, bypassing the test strip holder "post". The Assure 4 test strip does not work in the Assure 3 meter because the slot in the Assure 4 test strip prevents the strip from pressing the switch wire in
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the Assure 3 test strip holder. Therefore, insertion of the Assure 4 strip into the Assure 3 meter does not turn on the Assure 3 meter. The switch wire in the Assure 4 meter strip holder is off to one side. such that the slotted Assure 4 strip is able to turn on the Assure 4 meter. (See Table 1, page 22, item 19).
-
- Modifications of Meter
- a. The code chip port for the Modified Assure 4 was changed to match the altered shape of the Assure 4 code chip. The Assure 4 code chip physically cannot fit into the Assure 3 meter. The Assure 3 code chip is too short to make electrical contact, if inserted into the Assure 4 meter code chip port. (See Table 1, page 22, item 14).
- b. The Modified Assure 4 meter test strip holder has a "post" to prevent usage of Unmodified Assure 3 test strips in the Modified Assure 4 meter. (See Table 1, page 22, item 19).
- c. The outer case of the Assure 4 meter was changed to:
- i. Improve aesthetics (curved shape on sides as opposed to straight sides of Unmodified Assure 3). (See Table 1, page 22, item 20).
- ii. Differentiate Assure 4 from Assure 3 for commercial reasons.
- iii. Accommodate the two AAA batteries used in the Modified Assure 4. The Assure 4 has a larger battery compartment and a new battery compartment door design. The Unmodified Assure 3 uses the smaller CR-2032 wafer battery. (See Table 1, page 22, item 29).
- d. The single meter button used to operate the meter has been made oval (instead of circular) for improved aesthetics. (See Table 1, page 22, item 21).
- e. Assure 4 units of measurement are mg/dL only and cannot be changed to mmol/L. (See Table 1, page 22, item 22).
- Assure 4 meter display shows numbers (9, 8, 7, etc.) for count down after f. blood application, instead of dashes (- - -, - -) used by the Assure 3. This change was made for aesthetic and commercial reasons. (See Table 1, page 22, item 23).
- g. Increased memory capacity to 50 results (up from 10) and added sequential number to all memory results. (See Table 1, page 22, item 24).
- h. New system for conducting control solution testing and resistive checking.
- i. In the Assure 3 meter, the user must sequentially insert both ends of a Check Strip into the test strip holder. This checks the meter function by applying a known resistive value to the meter. It also activates the Control Solution Mode for the meter. In the control solution mode, the Assure 3 meter uses the control solution calibration curves and does not store the control solution result in memory. (See Table 1. page 22, item 25).
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- ii. In the Modified Assure 4 meter:
-
- an internal resistance has been added to the circuitry and this is checked upon start up of the meter, eliminating the need for the Check Strip. (See Table 1, page 22, item 25).
-
- The user enters the control mode by inserting a test strip and pressing the single meter button once for Level 1 Control Solution, twice for Level 2 Control Solution. (See Table 1, page 22, item 26).
-
- Control solution results are stored in memory and are marked with "c". (See Table 1, page 22, item 27).
-
- i. Meter allows operation in a wider operating temperature range of 57°F -104°F. The Unmodified Assure 3 operating range is 65°F - 100°F. For commercial reasons, we tested the Modified Assure 4 further and found that the system supports the wider 57°F - 104°F Operating Temperature range there is sufficient temperature compensation in the algorithm to support this wider range. Both the Assure 4 and Assure 3 give out an error message (flashing temperature icon) when the meter is used outside its thermal operating range. (See Table 1, page 22, item 28).
- Changed power supply from one CR-2032 battery to two AAA batteries, increasing the number of tests that can be run from 1000 to 3000 test per each set of batteries. (See Table 1, page 22, items 29 and 30).
- k. Assure 4 dimensions and weight are slightly different from that of the Assure 3 meter. (See Table 1, page 22, item 31).
Table 1 (page 22) summarizes the similarities and differences between the Modified Assure 4 and the Unmodified Assure 3.
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| Table 1: Substantial Equivalence Table | |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
....
:
| # | Characteristic | Assure 4 | Assure 3 | |
|---|---|---|---|---|
| 1 | Manufacturer | Apex | Identical | |
| 2 | Methodology | Biosensor | Identical | |
| 3 | Reference | Plasma | Identical | |
| 4 | Blood Sample Type | Fresh capillary whole blood | Identical | |
| 5 | Lot Calibration | Code Chip | Identical | |
| 6 | Test Time (seconds) | 10 | Identical | |
| 7 | Test Range (mg/dL) | 30-550 | Identical | |
| 8 | On/Off w/ strip insertion | Yes | Identical | |
| 9 | Auto Shut Off | Yes | Identical | |
| 10 | Hematocrit Range | 30-55% | Identical | |
| 11 | Humidity Range | <85% | Identical | |
| 12 | Altitude | 7,000 ft | Identical | |
| 13 | # of Meter Buttons | 1 | Identical | |
| 14 | Code ChipConfiguration | Code chip too large to workwith Assure 3 | Code chip too short to workwith Assure 4 | |
| 15 | Concentration of StripIngredients per cm² | See Table 2, page 24 | See Table 2, page 24 | |
| 16 | Minimum Sample Vol. | 1.5 µL | 3 µL | |
| 17 | Strip Fill | Capillary side fill | Non-capillary, top or side fill | |
| 18 | Strip Length | 38 mm | 48 mm | |
| 19 | Configuration of Stripand Meter Strip Holder | Strip slot and meter stripholder "post" to preventusage with Assure 3 | No slot in strip, therebypreventing usage with Assure4 | |
| 20 | Configuration of MeterCase | Changes from Assure 3 foraesthetic reasons and toaccommodate AAA batteries | Original Assure 3 aestheticsand battery compartment | |
| 21 | Meter Button Shape | Oval | Round | |
| 22 | Units of Measurement | mg/dL only | mg/dL or mmol/L | |
| 23 | Count Down Method | Numbers (9, 8, 7...) | Dashes (---, --, -) | |
| 24 | Memory Capacity | 50 results, with sequentialnumbering | 10 results, with nosequential numbering | |
| 25 | Meter Resistive Check | Automatic resistive checkoccurs at meter turn on,using internal resistors | Insert Check Strip with 2known resistive values duringcontrol solution testing process | |
| 26 | Control SolutionMode | Insert strip; press buttononce for Level 1, twice forL 2; use control solution | Insert both ends of CheckStrip, insert test strip, usecontrol solution | |
| 27 | Memory for ControlSolution Results | Control solution testsstored and marked with "c" | ||
| 28 | Operating T° Range | 57-104°F | ||
| 29 | Battery Supply,Battery compartment | Two AAA batteries andcompartment to match | One CR2032 andcompartment to match | |
| 30 | Tests/Battery Set | 3,000 | 1,000 | |
| 31 | Size/Weight | 3.9" x 2.3" x 1.0"/2.5 oz. | 3.9" x 2.3" x 0.8"/ 2.2 oz. |
CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and a circular border. The text "U.S. Department of Health & Human Services" is written around the border of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Thomas Y. S. Shen Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 Taaiwan, ROC
FEB 1 6 2007
Re: K070088
Trade/Device Name: Assure 4 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA Dated: February 6, 2007 Received: February 12, 2007
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, Dr u and Cosmetic Act (Act (Act (Act 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, isting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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 Statement
510(k) Number (if known): {{076688
Device Name: Assure 4 Blood Glucose Monitoring System
Indications For Use:
Assure 4 Blood Glucose Meter:
The Assure 4 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
A
Diagnostic Device
/0720XX
§ 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.