The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).

Device Description

The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.

AI/ML Overview

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

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Linear Range	0.1 to at least 5.0 mg/dL (Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55
Detection Limit	0.1 mg/dL (calculated as mean + 2 standard deviations from 30 assays of normal saline, rounded up)
Precision	Serum 1 (1.2 mg/dL): Within Run 1SD = 0.03, %CV = 2.2%; Total 1SD = 0.4, %CV = 3.2% Serum 2 (2.2 mg/dL): Within Run 1SD = 0.02, %CV = 0.8%; Total 1SD = 0.3, %CV = 1.1% Serum 3 (3.3 mg/dL): Within Run 1SD = 0.02, %CV = 0.7%; Total 1SD = 0.3, %CV = 1.0%
Correlation	Selectra = 0.3 mg/dL + 0.889 x Competitive Reagent, syx = 0.04 mg/dL (range = 1.5 - 5.2 mg/dL, n = 118)
Stability	14-day onboard reagent stability (total imprecision < 0.1 mg/dL) 7-day calibration stability (total imprecision < 0.1 mg/dL)

Study Details

Sample size used for the test set and the data provenance:
- Linear Range: n = 55 (linearity related solutions)
- Detection Limit: 30 assays of normal saline.
- Precision: 60 replicate assays for each of the three control serum samples.
- Correlation: 58 serum specimens (1.5 to 5.2 mg/dL magnesium) and 60 heparinized plasma specimens (1.5 to 2.8 mg/dL magnesium) from adult patients.
- Stability: Serum controls were used over the claimed periods.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the studies were conducted by Clinical Data, Inc. (Brea, CA), suggesting the data is likely from the United States. The studies appear to be retrospective observational studies using collected patient specimens and controlled lab samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a reagent for an in vitro diagnostic (IVD) assay measuring a quantitative analyte (magnesium). The "ground truth" for such devices is typically established through reference methods, calibration, and highly standardized laboratory procedures, not through expert human interpretation in the same way an imaging or AI diagnostic might be.
- The document does not mention the use of experts to establish ground truth for the test set beyond standard laboratory practices and reference measurements. Qualifications of individuals performing these reference measurements or calibrations are not provided.
Adjudication method for the test set:
- Not applicable. This is an IVD reagent, and its performance is evaluated against quantitative measurements and statistical methods, not through human adjudication of diagnostic findings.
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:
- Not applicable. This is an IVD reagent and does not involve human readers interpreting results in a way that AI assistance would be relevant. The "reader" here is the Vitalab Selectra Analyzer.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is essentially a standalone performance evaluation of the reagent used with the Vitalab Selectra Analyzer. The performance characteristics (linearity, detection limit, precision, correlation, stability) are determined by the reagent and instrument system, independent of direct human interpretive input after the assay is run and before the result is generated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device is based on reference methods and statistically validated measurements. For linearity, this involves comparing recoveries to standard concentrations. For precision, it involves repeated measurements of control sera with known values. For correlation, it involves comparing results against another commercially available and presumably validated method.
The sample size for the training set:
- Not applicable. This is an IVD reagent, not a machine learning or AI model that requires a training set in the conventional sense. The "development" of the reagent would involve biochemical formulation and optimization, followed by performance validation, rather than algorithmic training.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance of the reagent system itself is established through analytical validation studies using reference materials and established laboratory practices.

Summary

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K040508

Brea, CA 92821 F (714) 672-3554 T (714) 672-3553

Summary of 510(k) Safety and Effectiveness Information Vitalab Magnesium Reagent

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitted by:

Clinical Data, Inc.1075 West Lambert Road, Building DBrea, California 92861
Contact Person:	Wynn StockingRegulatory Affairs Manager
Date Submitted:	February 4, 2004

Device Names:

Proprietary name:	Vitalab Magnesium Reagent
Common name:	Magnesium reagent
Classification Name:	Photometric method, magnesium

Device Description:

The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.

Intended Use:

The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Predicate Device:

Vitalab Magnesium Reagent Kit is substantially equivalent to the Roche Magnesium Reagent, product no. 11489330, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN

Summary of Performance Data:

The linear range of the Vitalab Magnesium Reagent is from 0.1 to at least 5.0 mg/dL, as shown by the Usable Range: recovery of linearity related solutions that span the linear range. Least squares regression statistics, forced through the origin, compare recoveries to standard concentrations.

(Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55

510(k) Notification, Vitalab Magnesium Reagent Kit - Additional Information Clinical Data, Brea, California

February 4, 2004 Page 49

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Detection Limit: Normal saline was assayed thirty times in a single analytical run. The mean and started on organisand was steplation and start the results are both 0.0 mg/dL. The minimum detection limit, calculated as the mean plus two standad the results are oour overy values, is rounded up to 0.1 mg/dL, which is the round off error of the test.
Precision is demonstrated by the replicate assay of commercially available control serum. Precision Precision: statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

Sample	n	mean	Within Run		Total
			1SD	%CV	1SD	%CV
Serum 1	60	1.2	0.03	2.2%	0.4	3.2%
Serum 2	60	2.2	0.02	0.8%	0.3	1.1%
Serum 3	60	3.3	0.02	0.7%	0.3	1.0%

Fifty eight serum specimens ranging from 1.5 to 5.2 mg/dL magnesium and 60 heparinized plasma Correlation: specimens ranging from 1.5 to 2.8 mg/dL magnesium were collected from adult patients and were assayed for magnesium using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

Selectra = 0.3 mg/dL + 0.889 x Competitive Reagent syx = 0.04 mg/dL range = 1.5 - 5.2 mg/dL n = 118

The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.1 mg/dL.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 8 2004

Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: K040508

Trade/Device Name: Vitalab Magnesium Reagent Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I Product Code: JGJ Dated: February 27, 2004 Received: February 27, 2004

Dear Mr. Devine:

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 (for 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device. please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Image /page/4/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "K040508". The characters are written in a bold, sans-serif font, and they appear to be handwritten. A horizontal line is present beneath the sequence of characters.

Device Name:

Vitalab Magnesium Reagent

Indications for Use:

prescription

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benam

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040508

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.