← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K093941

# CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 (K093941)

_Taidoc Technology Corporation · CGA · Mar 26, 2010 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K093941

## Device Facts

- **Applicant:** Taidoc Technology Corporation
- **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md)
- **Decision Date:** Mar 26, 2010
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Pediatric

## Indications for Use

This system is intended for use outside the body (in vitro diagnostic use only). It is used for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the finger and the following sites: the palm, forearm, upper arm, calf and thigh. It is intended for use by people with diabetes mellitus at home and by health care professionals in clinical settings as an aid to monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not for use on neonates. The alternative site testing in the above system can be used only during steady-state blood glucose conditions.

## Device Story

System comprises glucose meter, test strips, and control solutions; utilizes electrochemical biosensor technology with glucose oxidase to measure glucose in capillary whole blood. Used by patients at home or clinicians in clinical settings to monitor diabetes control effectiveness. Device provides quantitative glucose readings; aids clinical decision-making regarding diabetes management. Alternative site testing restricted to steady-state conditions.

## Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of software and hardware modifications.

## Technological Characteristics

Electrochemical biosensor using glucose oxidase. System includes meter, test strips, and control solutions. Operates via electronic circuit design. No specific materials or connectivity standards provided.

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- TaiDoc Technology Corporation FORA G30 blood glucose monitoring system ([K090187](/device/K090187.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k093941

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

TaiDoc Technology Corporation FORA G30 blood glucose monitoring system, k090187

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A) Modification to the software to: remove the one pre-set code from displaying on the screen to having no coding information displayed when the test strip is inserted
B) Removing the C button (control) and merging this function into the M button
C) Reducing the memory from 450 measurements to 150 measurement
D) Removing the ketone warning for glucose readings above 240 mg/dL
E) Changing the data port connection RS232 interface cable to a USB cable
F) Physical appearance of meter
G) Labeling modified to reflect changes of device and name of the device

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K093941](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K093941)

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