ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM

K081389 · Roche Diagnostics · NBW · Jul 15, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081389
• Device Name: ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Roche Diagnostics
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The ACCU-CHEK Compact Test Drums are used with the ACCU-CHEK Compact or Compact Plus Meter. The ACCU-CHEK Compact and Compact Plus systems are designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The devices are indicated for professional use and over-the-counter sale. The ACCU-CHEK Compact and Compact Plus systems are indicated for lay use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.

Device Story

System measures glucose concentration in capillary and venous whole blood; utilizes test drums with meter. Designed for professional and lay use; enables self-monitoring of blood glucose. Input: whole blood sample applied to test strip. Output: quantitative glucose concentration displayed on meter. Modifications from predicate include ergonomic/physical design and electronic/hardware changes. System includes lancing device for sample collection. Healthcare providers use output to assess glycemic control; patients use output for diabetes management.

Clinical Evidence

No clinical data; bench testing and design control verification/validation performed to confirm safety and performance of modifications.

Technological Characteristics

Lancing device; mechanical capillary blood sampling mechanism. Modification allows attachment to ACCU-CHEK Compact Plus meter. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for use as a lancing device for capillary blood sampling.

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.

Predicate Devices

• ACCU-CHEK Softclix (K031755)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K081389

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.) k031755
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 ACCU-CHEK Softclix lancing device to create the ACCU-CHEK Softclix Plus lancing device. The ACCU-CHEK Softclix Plus device can be used either attached or detached from the side of the ACCU-CHEK Compact Plus meter.
B. Decreased read time (no change to algorithm or reaction)

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