COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

K092603 · Roche Diagnostics · CFR · Dec 4, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092603
• Device Name: COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
• Applicant: Roche Diagnostics
• Product Code: CFR · Clinical Chemistry
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors.

Device Story

The COBAS INTEGRA Glucose HK Gen. 3 Assay is an in vitro diagnostic reagent system used on COBAS INTEGRA systems. It utilizes an enzymatic hexokinase reference method to quantitatively measure glucose levels in serum, plasma, urine, and cerebrospinal fluid. The device is operated by laboratory professionals in clinical settings. The system processes samples to produce a quantitative glucose concentration value. Healthcare providers use these results to diagnose and monitor carbohydrate metabolism disorders, such as diabetes mellitus and various forms of hypoglycemia. The assay provides clinical utility by enabling accurate glucose assessment, which informs therapeutic decisions and patient management.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to assess impact of modified reaction timing on assay performance. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Hexokinase (HK) enzymatic assay; photometric measurement. Operates on Roche COBAS INTEGRA systems. Modification: reduced reaction time post-R2 reagent addition. Wavelength, sample/reagent volumes, and calibration parameters unchanged. Software-based calculation of glucose concentration adjusted for new timing parameters.

Indications for Use

Indicated for the quantitative determination of glucose in human serum, plasma, and urine on Roche COBAS INTEGRA systems.

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

• COBAS INTEGRA Glucose HK Gen. 3 Assay (K061048)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k092603

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the Roche COBAS INTEGRA Glucose HK Gen. 3 Assay:

1. The name and 510(k) number of Roche's previously cleared device, COBAS INTEGRA Glucose HK Gen. 3 Assay, cleared under k061048.
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 for the reaction time (after R2) of the regular assay which was shortened and glucose measurements are now calculated based on a reduction of the second measurement time. The first measurement time remains unchanged. Wavelength, sample/reagent volumes and calibration remain unchanged. As a result of the reduced measurement time, the measuring range for the stat application has a reduced upper limit to the measuring range.

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