MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

K053566 · Diazyme Laboratories · MZV · Feb 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053566
• Device Name: MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
• Applicant: Diazyme Laboratories
• Product Code: MZV · Clinical Chemistry
• Decision Date: Feb 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Indications for Use

Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in serum. The values obtained by this assay are used to monitor electrolyte balance. Diazyme Potassium Enzymatic Assay has controls for normal serum potassium levels and abnormal serum potassium levels. These controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.

Device Story

In vitro diagnostic enzymatic assay for quantitative potassium measurement in human serum or plasma; utilizes enzymatic reaction principle; modified from previously cleared device (K042191) via changes to assay components and detection wavelength; validated for use on additional clinical chemistry analyzers; intended for use by laboratory professionals in clinical settings to support diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay for potassium quantification. Modification involves assay components and detection wavelength. Validated for use on clinical chemistry analyzers. Fundamental scientific technology remains consistent with predicate.

Indications for Use

Indicated for the quantitative in vitro determination of potassium in serum to monitor electrolyte balance in patients.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

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 k053566

Diazyme Potassium Enzymatic Assay

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.) k042191
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: a modification in the assay components and a change in the detection wavelength. The use of additional clinical chemistry analyzers was validated.

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

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.