ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222

K042005 · Taidoc Technology Corporation · NBW · Aug 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042005
• Device Name: ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Achtung TD-4207 / Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole blood from the finger. They are intended for use by healthcare professionals and people with diabetes as an aid in monitoring the effectiveness of diabetes control programs. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Device Story

Glucose test systems (Achtung TD-4207, Clever Chek TD-4209, TD-4222) measure glucose levels in capillary whole blood samples obtained from fingersticks. Systems utilize electrochemical biosensor technology to quantify glucose concentration. Designed for use by healthcare professionals and patients in clinical or home settings. Output provides numerical glucose concentration values to assist in monitoring diabetes management. Results aid in assessing effectiveness of diabetes control programs; not intended for diagnostic or screening purposes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of modified features.

Technological Characteristics

Electrochemical glucose test system. Measures glucose in capillary whole blood. Class II device (Product Codes: NBW, CGA).

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood by people with diabetes at home or in clinical settings as an aid to monitor the effectiveness of diabetes control.

Regulatory Classification

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
Re: Document Number k 042005 TAIDOC TECHNOLOGY
Corporation, Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 Blood Glucose Test System

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.)
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.
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 to: 1. the design of the mechanical appearance. 2. add the function of the product as follows: a) Glucose test result above 13.3 mmol/L (240mg/dL), "KETONE" "and"?" will appear on the meter display. b.) Readings can be selected to store in memory or not. c). Readings in memory can be selected to delete. d). 450 readings can be stored in memory. e). Control solution test mode is not stored in memory. f). Ambient temperature detection and display with temperature unit of °C and °F switch. g). Add 60 and 90 day readings average function.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.

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.