DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B

K082763 · Diazyme Laboratories · MZU · Nov 12, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082763
• Device Name: DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
• Applicant: Diazyme Laboratories
• Product Code: MZU · Clinical Chemistry
• Decision Date: Nov 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Device Story

Modification to previously cleared device (K042189); transition of reagent state from freeze-dried powder to liquid; adjustment of reagent component concentrations; fundamental scientific technology remains unchanged; design control activities performed to assess impact of modifications; verification and validation activities confirmed predetermined acceptance criteria met.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical of enzymatic sodium assays.

Technological Characteristics

Reagent-based diagnostic device; modification involves transition from lyophilized (freeze-dried) powder to liquid state and adjustment of component concentrations.

Indications for Use

Indicated for quantitative in vitro determination of sodium in serum for patients suspected of electrolyte imbalance, including conditions such as aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, and inappropriate antidiuretic hormone secretion.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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 K082763

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.) k042189
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. Change in state of reagents supplied from freeze-dried powder to liquid.
B. Change in concentration of components in reagents

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.