(38 days)
Not Found
Not Found
No
The description focuses on a biosensor and electrical current measurement, with no mention of AI or ML terms or functionalities.
No
The device is an in vitro diagnostic (IVD) device used to monitor glucose levels, not to treat a condition. It provides information to aid in monitoring diabetes control, but it does not perform a therapeutic function on the patient's body.
Yes
The device is described as an "aid to monitor the effectiveness of diabetes control," which implies it provides information that helps in the management or understanding of a health condition, characteristic of a diagnostic device. It quantifies glucose in blood, a common diagnostic parameter.
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for blood sample)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
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.
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.
Glucosure BGM
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.
0
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 |
| Device | |
| Description: | 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 | |
| Intended Use: | 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. | |
| Functional and | |
| Safety Testing: | 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. | |
| Conclusion: | The modification to the original device does not adversely affect |
| performance and the modified device is substantially equivalent | |
| to the unmodified predicate device. |
..
1
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 .
2
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
3
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).
4
- 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.
5
| 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 |