DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

K061296 · Diazyme Laboratories · LPS · Jun 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061296
• Device Name: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
• Applicant: Diazyme Laboratories
• Product Code: LPS · Clinical Chemistry
• Decision Date: Jun 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Indications for Use

The Diazyme Homocysteine Enzymatic Assay is intended for the in vitro quantitative determination of total L-homocysteine in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Device Story

In vitro diagnostic assay for quantitative measurement of total L-homocysteine in human serum or plasma; intended for clinical laboratory use on Cobas Integra® automated chemistry analyzers. Assay utilizes enzymatic methodology to determine homocysteine levels; results assist clinicians in diagnosing and monitoring hyperhomocysteinemia and homocystinuria. Device provides quantitative data to healthcare providers to inform clinical decision-making regarding patient metabolic status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay; reagents applied to Cobas Integra analyzer. Specimen type: serum or heparinized plasma. Fundamental technology unchanged from predicate.

Indications for Use

Indicated for quantitative determination of total L-homocysteine in human serum or heparinized plasma for diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

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 k061296

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.) Diazyme Enzymatic Homocysteine Assay, k042448
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: Application of Diazyme homocysteine reagents on the Cobas Integra®

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and traceability. The test principle, reagent formulation, and specimen type (serum or heparinized plasma) are the same as the predicate. The only difference between the two devices is the packaging.
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 The sponsor performed Failure Mode Effects and Criticality Analysis (FMECA).
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.