COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

K061048 · Roche Diagnostics Corp. · CFR · May 17, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061048
• Device Name: COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: CFR · Clinical Chemistry
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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

Device Story

The COBAS INTEGRA Glucose HK Gen. 3 is an in vitro diagnostic reagent system for use on COBAS INTEGRA clinical chemistry analyzers. It utilizes an enzymatic hexokinase-based method to measure glucose concentration in serum, plasma, urine, and CSF samples. The system processes samples automatically; the analyzer performs the reaction and provides quantitative glucose results. These results are used by clinicians to diagnose and monitor carbohydrate metabolism disorders. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance validation included precision (within-run and between-day CVs), linearity (0.12-40 mmol/L), lower detection limit (0.12 mmol/L), and interference studies (hemolysis, icterus, lipemia, and tetracycline). No clinical trials were required for this modification.

Technological Characteristics

In vitro diagnostic reagent for hexokinase (HK) enzymatic glucose assay. Automated chemistry analyzer format. Reagent composition modified from predicate. No changes to fundamental scientific technology.

Indications for Use

Indicated for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF) to aid in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell tumors.

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 Liquid (K972250)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K061048

Roche Diagnostics Corp. COBAS INTEGRA Glucose HK Gen. 3

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: The reagent composition has been changed.

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.

The modified Glucose HK Gen 3 has within-run precision CV's ranging from 0.41% to 0.47% for serum and plasma, 0.64% to 1.35% for urine, and 1.13% to 1.49% for CSF; and the predicate device has a CV of 3.8% to 4.0% listed. Glucose HK Gen 3 has a lower detection limit of 0.033 mmol/L for serum and plasma, 0.22 mmol/L for urine, and 0.023 mmol/L for CSF. Glucose HK Gen 3 has endogenous interferences listed for Hemolysis up to 1200 mg/dL, icterus up to 60 mg/dL, lipemia up to 1900, and falsely low results caused by tetracycline and therapeutic concentration in urine samples; the predicate device has no significant interferences listed for Hemolysis, icterus, lipemia, and falsely low results may be caused by elevated pyruvate levels.

4. 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.

5. 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.