PICCOLO MAGNESIUM TEST SYSTEM

K091910 · Abaxis, Inc. · JGJ · Oct 1, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091910
• Device Name: PICCOLO MAGNESIUM TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Oct 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Indications for Use

The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Device Story

Piccolo Magnesium Test System; in vitro diagnostic device; analyzes heparinized whole blood, plasma, or serum samples. Modification involves recalibration using Inductively Coupled Plasma-Atomic Optical Emission spectroscopy (ICP-OES) reference method; Magnesium now included in Basic Metabolic Panel Plus Reagent Disc and Renal Function Panel Plus Reagent Disc. Device operates via reagent disc; provides quantitative magnesium levels to clinicians for diagnosis/treatment of magnesium-related metabolic disorders.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance validation of the assay system.

Technological Characteristics

In vitro diagnostic test system for magnesium; utilizes Piccolo Chemistry Analyzer platform. Quantitative colorimetric or enzymatic assay principle. Compatible with heparinized whole blood, plasma, or serum. Designed for point-of-care or clinical laboratory use.

Indications for Use

Indicated for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum to aid in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.

Regulatory Classification

Identification

A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

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: k091910

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.)

Abaxis, Inc., Piccolo Magnesium Test System: k040115.

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 the calibration of the device. The calibration is now conducted using the reference method, Inductively Coupled Plasma-Atomic Optical Emission spectroscopy (ICP-OES).

b) Magnesium is now included in the Basic Metabolic Panel Plus Reagent Disc, in addition to the Renal Function Panel Plus Reagent Disc (k040115).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics. Included were method comparisons of the original calibration vs. ICP-OES, and the re-calibrated assay vs. ICP-OES.

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.