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 Description

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ACE Magnesium Reagent based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values (e.g., "The CV must be less than X%"). Instead, it reports the performance values achieved by the device. The "acceptance criteria" are implied by the reported performance being deemed sufficient for substantial equivalence.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Satisfactory CV values	Within-run CV: 1.9% to 6.7% (≥21 days)
		Total CV: 2.8% to 7.5% (≥21 days)
		POL (within-run CV): 1.2% to 5.4% (5 days)
		POL (total CV): 1.4% to 5.8% (5 days)
Accuracy	Satisfactory correlation coefficient, SE estimate, and confidence intervals for slope and intercept	Correlation Coefficient: 0.9735 (110 samples)
		Standard Error Estimate: 0.14 (110 samples)
		Confidence Interval Slope: 1.000 to 1.092 (110 samples)
		Confidence Interval Intercept: -0.28 to -0.08 (110 samples)
		POL Correlation Coeff: 0.9919 to 0.9959
		POL SE Estimate: 0.09 to 0.14
		POL Conf. Interval Slope: 1.001 to 1.086
		POL Conf. Interval Intercept: -0.10 to 0.15
Detection Limit	Acceptable detection limit	0.3 mg/dL

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Accuracy Test Set: 110 samples for the primary correlation study.
Sample Size for Precision Test Set: Not explicitly stated as a count of individual samples, but "four magnesium levels for ≥21 days" and "three separate Physician Office Laboratory (POL) sites over 5 days" implies multiple measurements across different samples or levels.
Data Provenance: The document does not specify the country of origin. It conducted studies "at four magnesium levels" and "at three separate Physician Office Laboratory (POL) sites," suggesting internal testing and potentially external POL sites. The studies are retrospective as they involve analyzing samples for performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes an in vitro diagnostic reagent for quantitative determination of magnesium. The ground truth for such devices is established by comparison to a reference method or predicate device, not by expert interpretation of images or clinical assessments.

Number of Experts: Not applicable in the context of this type of diagnostic device.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative diagnostic device. Ground truth is established by comparing the device's output to a known reference method or another validated device (the predicate).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: No, this is not an AI/human reader study. This document describes a chemical reagent for an automated clinical chemistry system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (precision, accuracy, detection limit) are for the ACE Magnesium Reagent operating on the ACE Axcel Clinical Chemistry System in a standalone manner. The measurements are automated, and the results are quantitative values obtained directly from the system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the accuracy study was established by comparing the results from the ACE Magnesium Reagent on the ACE Axcel Clinical Chemistry System against the results from the predicate device, the "Alfa Wassermann ACE Clinical Chemistry System."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For an in vitro diagnostic reagent, the development process involves formulating the reagent and optimizing its performance characteristics. The validation studies (precision, accuracy, detection limit) on the ACE Axcel Clinical Chemistry System served as the testing of the final product, not a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is not an AI/machine learning device with a distinct training set in that sense. The "ground truth" during the development and validation phase would be derived from known-concentration controls, reference materials, and comparative analysis against established methods (like the predicate device).

Summary

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AUG 27 2012

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510(k) SUMMARY

510(k) Owner:	Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006
	Contact:	Hyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237
Date SummaryPrepared:	July 27, 2012
Device:	Trade Name:	ACE Magnesium Reagent
	Classification:	Class I, reserved
	Common/Classification Name:	Photometric Method, Magnesium(21 C. F.R. § 862.1495)Product Code JGJ
PredicateDevices:	Manufacturer for analyzer/reagent system predicate:ACE Magnesium Reagent on the Alfa Wassermann ACE Axcel ClinicalChemistry System (K113435)
DeviceDescriptions:	Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium toproduce a red complex which is measured bichromatically at 525 nm/692 nm.The intensity of color produced is directly proportional to the magnesiumconcentration in the sample. EGTA prevents calcium interference by preferentialchelation of calcium present in the sample. A surfactant system is included toremove protein interference.The ACE Axcel Clinical Chemistry System consists of two major components,the chemistry instrument and an integrated Panel PC. The instrument accepts thephysical patient samples, performs the appropriate optical or potentiometricmeasurements on those samples and communicates that data to an integral PanelPC. The Panel PC uses keyboard or touch screen input to manually enter a varietyof data, control and accept data from the instrument, manage and maintain systeminformation and generate reports relative to patient status and instrumentperformance. The Panel PC also allows remote download of patient requisitionsand upload of patient results via a standard interface.

7/30/2012

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Intended Use:	Indications for Use:
	The ACE Magnesium Reagent is intended for the quantitative determination ofmagnesium concentration in serum using the ACE Axcel Clinical ChemistrySystem. Magnesium measurements are used in the diagnosis and treatment ofhypomagnesemia (abnormally low serum levels of magnesium) andhypermagnesemia (abnormally high serum levels of magnesium). This test isintended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only.
TechnologicalCharacteristics:	The ACE Magnesium Reagent is composed of a single reagent bottle. Thereagent contains Xylidyl blue-1 and EGTA.
	The following is a description of the major features of the ACE Axcel ClinicalChemistry System: System throughput is approximately 160 test results per hour for routine, single reagent chemistries. System throughput will be higher when the test workload includes ISE's. The instrument has a capacity of 40 reagent containers on board. A reagent cooling system maintains the reagents at 12°C during instrument operation. Reagent containers are identified by computer coded labels to simplify system operation. All reagents in the system must include an identification label on the container. Sample and reagent sensing notify the operator of a depleted condition during operation. The system performs analysis at a reaction temperature of 37°C. An electrolyte subsystem capable of measuring sodium, potassium and chloride concentrations is included. Primary draw tubes may be introduced one at a time into the system for closed tube sampling. Positive tube identification can be achieved with an optional barcode scanner. An aliquot volume sufficient for all tests ordered is transferred and stored and the closed tube is returned to the user. Sample cups are introduced to the system one at a time or by sample ring segment. Disposable cuvettes are loaded in bulk and then automatically injected as needed by a cuvette hopper system. The ACE Axcel clinical chemistry optical system is capable of monitoring a maximum of 48 cuvettes at one time. The absorbance optical system is capable of absorbance measurements in a linear range of 0.0 to 2.0 absorbance units (at 0.67 cm pathlength). Sixteen wavelengths are measured simultaneously using a photodiode array.
PerformanceData:	Performance data for the Alfa Wassermann ACE Reagents run on the AlfaWassermann ACE Axcel Clinical Chemistry System included precision,accuracy, and detection limit data.
	ACE Magnesium Reagent
	Precision: In testing conducted at four magnesium levels for ≥21 days, the within-run CV ranged from 1.9 to 6.7%, and total CV ranged from 2.8 to 7.5%. Inprecision studies at three separate Physician Office Laboratory (POL) sites over 5days, the within-run CV ranged from 1.2 to 5.4% and total CV ranged from 1.4 to5.8%.
	Accuracy: In the correlation study, 110 samples with magnesium values rangingfrom 0.4 to 5.5 mg/dL were assayed on the Alfa Wassermann ACE AxcelClinical Chemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x). Least squares regression analysis yielded a correlationcoefficient of 0.9735, a standard error estimate of 0.14, a confidence intervalslope of 1.000 to 1.092, and a confidence interval intercept of -0.28 to -0.08. Inpatient correlation studies at three separate POL sites, using the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACEClinical Chemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9919 to 0.9959, standard error estimates of 0.09 to0.14, confidence interval slopes of 1.001 to 1.086, and a confidence intervalintercepts of -0.10 to 0.15.Detection limit: The detection limit was 0.3 mg/dL.
Conclusions:	Based on the foregoing data, the device is safe and effective. These data alsoindicate substantial equivalence to the predicate device.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

ALFA WASSERMANN Diagnostic Technologies, Inc c/o Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006

AUG 27 2012

Re: K122302

Trade Name: ACE Magnesium Reagent Regulation Number: 21 CFR §862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I, reserved Product Codes: JGJ Dated: July 30, 2012 Received: August 1, 2012

Dear Dr. Katz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (fix the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 productions including regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Four may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours.

$\mathcal{V}$

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

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510(k) Number (if known): ≤ 122302 ___________________________________________________________________________________________________________________________________________

Device Name: ACE Magnesium Reagent

Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use. (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In vitro Diagnostic Devices (OIVD)

Yung Chan

Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety

510(k) K122302

Page 1 of 1

Regulation Number and Section

§ 862.1495 Magnesium test system.

(a)
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).(b)
Classification. Class I.