ACE MAGNESIUM REGENT

K122302 · Alfa Wassermann Diagnostics Technologies, LLC · JGJ · Aug 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122302
• Device Name: ACE MAGNESIUM REGENT
• Applicant: Alfa Wassermann Diagnostics Technologies, LLC
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Aug 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Indications for Use

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

ACE Magnesium Reagent; in vitro diagnostic reagent for quantitative determination of magnesium in human serum or plasma. Modification includes new alkaline vehicle buffer (pH 11.2, 25°C); updated product reorder number; increased on-board stability (5 to 30 days); decreased calibration frequency (1 to 30 days). Used in clinical laboratory settings by trained personnel. Output provides magnesium concentration levels to assist in clinical diagnosis and monitoring of magnesium-related disorders.

Clinical Evidence

Bench testing only. Precision studies (n=4 levels, ≥21 days) showed within-run CV 1.9-6.7%, total CV 2.8-7.5%. POL site precision (3 sites, 5 days) showed within-run CV 1.2-5.4%, total CV 1.4-5.8%. Correlation study (n=110 samples, 0.4-5.5 mg/dL) vs. predicate yielded r=0.9735. POL site correlation studies yielded r=0.9919-0.9959. Detection limit 0.3 mg/dL.

Technological Characteristics

Single reagent bottle containing Xylidyl blue-1 and EGTA. System uses bichromatic photometry (525 nm/692 nm) via photodiode array. Reaction temperature 37°C. Instrument features: 40-reagent capacity, 12°C reagent cooling, closed-tube sampling, optional barcode identification, disposable cuvettes. Connectivity via integrated Panel PC for data management and remote upload/download.

Indications for Use

Indicated for quantitative determination of serum magnesium in patients to diagnose and treat hypomagnesemia and hypermagnesemia. Intended for use in clinical or physician office laboratories.

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).

Predicate Devices

• ACE Magnesium Reagent on the Alfa Wassermann ACE Axcel Clinical Chemistry System (K113435)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k122302

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 SUBMITTER’S previously cleared device: k113435; ACE Magnesium Reagent.

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:

1. New alkaline vehicle buffer for the ACE Magnesium Reagent (pH 11.2, 25°C).
2. The product reorder number has changed.
3. The on-board stability has increased from 5 to 30 days.
4. The calibration frequency has decreased from one day to once every 30 days.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics and performance comparison analysis.

5. A Design Control Activities Summary which includes: FMEA

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

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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.