VITROS Chemistry Products Mg Slides For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.

VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Device Description

The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide. The system is comprised of two main elements: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry slides.

AI/ML Overview

The provided text describes a 510(k) submission for a modified medical device, the VITROS Chemistry Products Mg Slides and VITROS Chemistry Products Calibrator Kit 1. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, precision targets). Instead, it relies on demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing the characteristics and overall performance of the modified device to the predicate device.

Device Characteristic	Acceptance Criteria (Implied: Substantial Equivalence to Predicate)	Reported Device Performance
Device Model / Name	Equivalence to VITROS Chemistry Products Mg Slide (current) and VITROS Chemistry Products Calibrator Kit 1	VITROS Chemistry Products Mg Slides (modified) and VITROS Chemistry Products Calibrator Kit 1.
Intended Use	No Change from Predicate Device	No Change. For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure Magnesium (MG) concentration use in serum, plasma, and urine. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA. Ca. CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
Basic Principle	No Change from Predicate Device	No Change. Dry, multilayered slide utilizing reflectance spectrophotometry.
Sample Type	No Change from Predicate Device	No Change. Serum, plasma, urine.
Reportable Range (Serum, Plasma)	No Change from Predicate Device	No Change. 0.20 - 10.00 mg/dL.
Reportable Range (Urine)	No Change from Predicate Device	No Change. 1.20 - 60.00 mg/dL (after multiplying by a 6X dilution factor).
Instrumentation	No Change from Predicate Device	No Change. VITROS 250, 500, 750 and 950 Series Analyzers.
Incubation time and temperature	No Change from Predicate Device	No Change. Approximately 5 minutes at 37°C.
Sample volume	Demonstrated equivalence despite change from predicate	Modified Device: 5 µL. Predicate Device: 10 µL. While this is a change, the study would have shown that despite this change, the performance (e.g., accuracy, precision) remains equivalent to the predicate.
Quantity of Reactive Ingredients per slide (test)	Demonstrated equivalence despite change from predicate	Modified Device: 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 272.1 µg and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 46.19 µg. Predicate Device: 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 542.3 µg and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 92.06 µg. Similar to sample volume, this changes, but overall performance is still shown to be equivalent.
Concentrations of Slide Reactive Ingredients per cm-squared	No Change from Predicate Device	No Change. This is a crucial point, suggesting that while the total quantity of reactive ingredients changed due to the reduced sample volume, the concentration per unit area remained the same, implying a consistent reaction environment despite the reduction in overall analyte.
Overall Performance	Substantially equivalent to cleared predicate device	"The performance of the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is substantially equivalent to the cleared predicate device."

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

Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions "patient and quality control samples."
Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as using "patient and quality control samples with measured Magnesium values spanning the assay range," implying real-world or simulated clinical samples. It is a retrospective or prospective study as it involves testing the modified device against the predicate using samples. The nature of the study (e.g., in-house validation or multi-site trial) is not detailed.

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

This information is not applicable and therefore, not provided. For this type of in-vitro diagnostic device (a chemistry assay), the "ground truth" for Magnesium concentration is established by a reference method or a highly accurate, previously validated method, rather than expert consensus on images or clinical assessments. The reference values for calibrators/controls would typically be determined by highly accurate analytical chemistry techniques.

4. Adjudication Method for the Test Set

This information is not applicable and therefore, not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human readers and subjective interpretations (e.g., radiology studies). For a quantitative diagnostic assay, the "adjudication" is inherent in the analytical measurement process and statistical comparison of results with the predicate device or reference method.

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

This information is not applicable and therefore, not provided. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a key component. This device is a quantitative chemistry assay where the output is a numerical concentration, not an image requiring human interpretation or AI assistance in that interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is partially applicable but not explicitly detailed. The device itself is an "algorithm only" in the sense that it is an automated assay system. The study described compares the performance of the modified assay (the "device") to a predicate assay (the "existing device"). There isn't a "human-in-the-loop" component in the direct measurement of Mg concentration by these devices. The study effectively assesses the standalone performance of the modified device against the predicate.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the test set was established by the measured Magnesium values spanning the assay range in both "patient and quality control samples." For quality control samples, the "ground truth" would be pre-assigned target values based on established reference methods. For patient samples, the "ground truth" would likely be values obtained from a comparative method or the predicate device itself, assuming it's considered a highly accurate reference in this context for demonstrating equivalence. It's essentially reference analytics or comparative method data.

8. The Sample Size for the Training Set

This information is not applicable and therefore, not provided. This device is a chemistry assay, not a machine learning or AI model that requires a "training set" in the traditional sense. The development of the assay (e.g., optimizing reagent concentrations) would involve experimental data, but this is distinct from an AI model's training data.

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

This information is not applicable as there is no "training set" for a chemistry assay in the context of AI. The "ground truth" for the experimental data used during the development and optimization of the assay would have been established through standard analytical chemistry techniques and reference methods to determine accurate concentrations for various samples.

Summary

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DEC 1 0 2002

Summary Information

510(k) Summary

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.

The assigned 510(k) number is: KC23876

Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, contact (585) 453-4041
Contact Person: Marlene A. Hanna
Date Special 510(k) prepared: November 20, 2002 2. Preparatio n date
Trade or Proprietary Name: 3. Device VITROS Chemistry Products Mg Slides name VITROS Chemistry Products Calibrator Kit 1 Common Name Classification Name: Magnesium test system ( 21 CFR 862.1495).
The VITROS Chemistry Products Mg Slides (modified) and VITROS 4. Predicate device Chemistry Products Calibrator Kit 1 are substantially equivalent to the VITROS Chemistry Products Mg Slides (current slide) and VITROS Chemistry Products Calibrator Kit 1.

Continued on next page

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510(k) Summary, Continued

The VITROS Chemistry System uses Vitros Slides to perform discrete 5. Device chemistry tests on body fluid specimens. All reactions necessary for a single description quantitative measurement take place within the multi-layered analytical element of a Vitros Slide. The system is comprised of two main elements: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry slides. Multiple VITROS Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K890928, K890929, K922072, K946090 and K922072). The VITROS Chemistry System and Calibrators are dedicated specifically for use only with the VITROS Chemistry Products range of products. 6. Device VITROS Mg Slides intended For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure Magnesium (MG) concentration use in serum, plasma, and urine. VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA. Ca. CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC. Continued on next page

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The VITROS Chemistry Products Mg Slide (modified) and VITROS 7. Comparison Chemistry Products Calibrator Kit 1 are substantially equivalent to VITROS to Chemistry Products Mg Slide and VITROS Chemistry Products Calibrator Kit predicate 1 that were cleared by the FDA for in vitro diagnostic use. device Mg Slide: (K861386, Cleared August 26, 1986) Calibrator Kit 1: (K001885 Cleared July 20, 2000)
Table 1 lists the characteristics of the tests performed using the VITROS Mg Slide (modified) and the VITROS Mg Slide (current).

DeviceCharacteristic	New DeviceVITROS Mg Slide(Modified)	Predicate DeviceVITROS Mg Slide(Current)
Sample volume	5 µL	10 µL
Quantity ofReactiveIngredients perslide (test)	1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 272.1 µgand1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 46.19 µg	1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 542.3 µg and1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 92.06 µg
Concentrationsof SlideReactiveIngredients percm-squared	No Change.	1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 302.3 µg and1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 51.32 µg
Intended Use	No change.	For in vitro diagnostic use only.VITROS Mg Slides quantitatively measuremagnesium (Mg) concentration in serum,plasma and urine.
Basic principle	No Change.	Dry, multilayered slide utilizing reflectancespectrophotometry
Sample type	No Change.	Serum , plasma , urine
ReportableRange
Serum,Plasma:	No Change.	0.20 - 10.00 mg/ dL
Urine:	No Change.	1.20 - 60.00 mg/dL (after multiplying by a 6Xdilution factor)
Instrumentation	No Change.	VITROS 250, 500, 750 and 950 SeriesAnalyzers
Incubation timeand temperature	No Change.	Approximately 5 minutes at 37°C

Table 1 List of Slide Characteristics: Comparison to Predicate Device

Continued on next page

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510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that 8. Conclusions the performance of the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured Magnesium values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 0 2002

Ms. Marlene A. Hanna Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

K023876 Re:

Trade/Device Name: VITROS Chemistry Products Mg Slides/ VITROS Chemistry Products Calibrator Kit 1

Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX; JGJ Dated: November 20, 2002 Received: November 21, 2002

Dear Ms. Hanna:

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.

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Page 2

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 (OS) regulation (21 CFR Part 820). 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). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use
	Page 1 of 1
510(k) Number (if known):	K023876
Device Name:	VITROS Chemistry Products Mg SlidesVITROS Chemistry Products Calibrator Kit 1
Intended Use:	VITROS Chemistry Products Mg SlidesFor in vitro diagnostic use only.VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.
	VITROS Calibrator Kit 1For in vitro diagnostic use only.VITROS Calibrator Kit 1 is intended for use in calibration of theVITROS Chemistry Systems for the quantitative measurement ofBUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
Summary and Explanation of Test:	Magnesium is predominantly an intracellular cation and is essential in enzyme reactions. Magnesium deficiency may cause weakness, tremors, tetany, and convulsions. Hypomagnesemia is associated with hypocalcemia, alcoholism, some types of malnutrition, chronic hemodialysis, and pregnancy. Increased serum magnesium concentrations occur in patients with renal failure, dehydration, and Addison's disease. 1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Carol C Benson for Jean Cooper
(Division Sign-Off)
Division	Clinical Laboratory Devices
510(k) Number	K023876

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.