For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure magnesium from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with hypomagnesemia or hypermagnesmia. It is intended professional laboratory use: not for point of care or physician office laboratory use.

Device Description

CARESIDE™ Mg cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure magnesium in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Mg cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma or serum to a dry film to initiate the measurement of magnesium concentration. The film cartridge (patent pending) contains all reagents necessary to measure magnesium concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ Mg, based on the provided text:

CARESIDE™ Mg Acceptance Criteria and Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	CARESIDE™ Mg Performance	Predicate Device (Vitros Mg DT Slides) Performance
Detection Limit	0.2 mg/dL	0.2 mg/dL	0.2 mg/dL
Reportable Range	0.2 to 7.0 mg/dL	0.2 to 7.0 mg/dL	0.2 to 7.0 mg/dL
Accuracy	Not explicitly stated, but clinical equivalency to predicate is the goal.	Mean recovery 97%	Not provided
Precision	Not explicitly stated, but comparable to predicate is the goal.	Total CV, 1.2 mg/dL, 4.3%	Total CV, 1.1 mg/dL, 3.6%
Method Comparison	High correlation (r) with predicate and reference methods.	CARESIDE™ Mg = 0.98 (Hitachi 902/BMD) – 0.086 mg/dL, r = 0.99CARESIDE™ Mg = 0.82 (Vitros DT 60 II) + 0.31 mg/dL, r = 0.99	Not applicable (it is the predicate)
Linearity	Slope and correlation co-efficient within acceptable limits.	Linearity yielded slope and correlation coefficient within acceptable limits.	Not provided
Interference	No significant interference at specified concentrations.	No significant interference observed at tested concentrations of:Ascorbic Acid, 10 mg/dLBilirubin, 60 mg/dLCalcium, 20 mg/dLInorg. Phosphorus, 9 mg/dLTotal Protein, 9 g/dLTriglycerides, 2000 mg/dL	Calcium 20 mg/dLInorg. Phosphorus 9 mg/dL

Notes on Acceptance Criteria:

Implicit Nature: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device (Vitros Mg DT Slides). The studies are designed to demonstrate that the CARESIDE™ Mg performs "as well as or better than" the predicate.
Specific Values: For detection limit and reportable range, the acceptance criteria are a direct match to the predicate. For precision, the CARESIDE™ Mg is slightly higher (4.3% vs 3.6%), but is presented as acceptable. For method comparison, high correlation coefficients (r=0.99) demonstrate agreement with established methods.
Interference Test: The CARESIDE™ Mg tested against a broader range of interferents than the predicate, demonstrating non-inferiority or superiority in this aspect.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the specific number of samples for each test (accuracy, precision, method comparison, linearity, interference).
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, not necessarily in a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This device is an in vitro diagnostic (IVD) for quantitative measurement of magnesium. The ground truth for such devices is established through reference methods, calibrated instruments, and known sample concentrations, not human expert consensus like in image interpretation tasks.

4. Adjudication method for the test set:

Not Applicable: Given that the ground truth is established by objective laboratory methods, there is no need for human adjudication for the test set measurements.

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:

Not Applicable: This is an in vitro diagnostic device, not an AI-powered diagnostic imaging tool that would involve human readers.

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

Yes, this is a standalone device/algorithm. The CARESIDE™ Mg cartridge, in conjunction with the CARESIDE Analyzer™, is designed to quantitatively measure magnesium without human intervention in the result generation beyond operating the analyzer. The comparative performance characteristics (Accuracy, Precision, Method Comparison, Linearity, Interference) are all measures of the algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the CARESIDE™ Mg performance evaluation is established through:
- Reference methods: Primarily indicated by the method comparison against the Hitachi 902/BMD and Vitros DT 60 II systems, which serve as established, accepted methods for magnesium measurement.
- Known concentrations: For tests like linearity and interference, samples with precisely known magnesium levels or known concentrations of interfering substances would be used.

8. The sample size for the training set:

Not Applicable: This document describes an in vitro diagnostic device that uses enzymatic reactions and reflectometry, not a machine learning model that requires a "training set" in the conventional sense. The "lot-specific standard curve" mentioned in the device description serves a similar purpose to calibration in traditional analytical chemistry, which is distinct from large-scale data-driven machine learning training.

9. How the ground truth for the training set was established:

Not Applicable: As there is no "training set" in the machine learning sense, this question is not relevant. The device relies on chemical principles and a calibrated measurement system. The "standard curve" for each lot of cartridges is established using reference materials with known magnesium concentrations (though the details of this process are not provided in this summary).

Summary

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CARESIDE, Inc. Page 10

AUG 11 1999

510(K) SUMMARY: CARESIDE™ MG SAFETY A IV. EFFECTIVENESS

I. Applicant Information

Applicant Name A.
Applicant/Manufacturer Address B.
Telephone Number C.
Contact Person D.
E. FAX Number
F. e-Mail Address
Date 510(k) Summary prepared G.

II. Device Information

A. Device Name (Trade)
Device Name (Classification) B.
C. Device Classification

CARESIDE, Inc.

6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 AsarchK@CARESIDE.com May 19, 1999

CARESIDE™ Mg

Magnesium test system Clinical chemistry panel Mg test system Regulation Number: 21 CFR 862.1495 Regulatory Class I Classification Number: 75JGJ None applicable

D. Special controls and performance standards

III. Substantial Equivalence Claim

General equivalency claim A.
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in clinical chemistry assays.

Magnesium in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market. In vitro diagnostic products in dry film format also employ enzymatic coupling to indirectly measure the analyte of interest.

B. Specific equivalency claim

This CARESIDE™ Mg test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of magnesium for use on the Vitros DT 60 II system.

Name of Predicate Device:	Johnson and Johnson's (formerly Eastman Kodak,Inc.) Vitros Mg DT Slides for use on the Vitros DT60 II system (formerly Eastman Kodak's DT 60 II).
Predicate Device 510K number:	K912844/A
Product Code:	75JGJ

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IV. Device Description

A. Explanation of Device Function

Each CARESIDE™ Mg cartridge consists of a magnesium-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™.

Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained speciment to 37°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 µL microliters of sample remains in the metering passage. Any excess sample flows into the Overflow Well.

The sample is automatically dispensed onto the multi-layer film. The spreading layer distributes the sample evenly on the film before it moves onto a reaction layer where magnesium in the sample complexes with ATP to serve as a substrate in the glycerol kinase (GK) catalyzed reaction with glycerol to form L-a-glycerol-3-phosphate. Hydrogen peroxide (H202) and dihydroxyacetone phosphate (DAP) is formed in a glycerol phosphate oxidase (GPO) catalyzed reaction of L-α-glycerol-3-phosphate (L-a-GP) with oxygen. The H202 produced reacts with a leuco dye in a peroxidase (POD) catalyzed reaction to form a green dye. The rate of change of the color intensity of the dye, as measured by the time course of reflected light at 655 nanometers, and directly relates to the magnesium concentration of the specimen.

Test Reaction Sequence:

Mg-ATP + Glycerol ------------------------------------------------------------------------------------------------------------------------------------------------------------GPO → H2O2 + DAP L-a-GP + 02 -H2O2 + Leuco Dye - POD -> Green Dye + 2 H2O

As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate the magnesium concentration.

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B. Test Summary

Magnesium has essential functions intracellularly, extracellularly, and in the skeleton in the human body. Intracellularly, magnesium is a cofactor for more than 300 enzymes. Magnesium is needed for the physiological processes of oxidative phosphorylation, glycolysis, cell replication, nucleotide metabolism, and protein biosynthesis. Extracellularly, magnesium is involved in the regulation of nerve conduction and neuromuscular transmission. Magnesium is incorporated into the mineral lattice of the About one-third of the skeletal magnesium is exchangeable with the skeleton. extracellular fluid which in turn serves as a source for maintaining intracellular magnesium.

Magnesium deficiency is a very common sign in a variety of diseases. Causes of hypomagnesemia include gastrointestinal disorders, renal disease, alcohol and other drugs, metabolic acidosis, diabetes mellitus, increased sodium or calcium excretion, and phosphate depletion. Hypomagnesemia most commonly presents with neuromuscular hyperexcitability, although the features of the primary disease process causing the magnesium deficiency may mask the signs and symptoms.

Hypermagnesemia is encountered less commonly than hypomagnesemia. Causes of hypermagnesemia include excessive magnesium intake, renal failure, familial hypocalciuric hypercalcemia, and lithium ingestion. Hypermagnesemia most commonly presents with neuromuscular symptoms, such as the disappearance of the deep tendon reflex.

V. Intended Use

Intended Use A.

The CARESIDE™ Mg cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure magnesium concentration in anti-coagulated whole blood, plasma or serum.

B. Indications for Use

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VI. Technological Characteristics

Similarities A.

	CARESIDE™ Mg	Vitros Mg DT Slides
Intended Use	Primarily to aid in the diagnosisand treatment of patients withwith hypomagnesemia orhypermagnesmia.	Same.
Indications	For in vitro diagnostic use.For professional laboratory:not for point of care orphysician office laboratory use.	For in vitro diagnostic use
Measurement	Quantitative	Same
Method Principle	Reflectometry of enzymaticallycoupled production of dye frommagnesium reaction product.	Complexation of magnesiumwith formazan dye to form acolored complex.
Specimen dilution	Not required	Same
Materials	Glycerol, glycerol kinase,glycerol kinase oxidase, andleuco dye.	Formazan dye
Detector	Reflectance (655 nm)	Reflectance (660 nm)
Test time	4 minute warm-up (on-board)plus 4.5 minute test time.	15 minutes slide warm-up(off-line) plus 5 minutes testtime.
Sample Type	Anti-coagulated whole blood,plasma, or serum	Plasma or serum
Specimen volume	8.5 µl test volume(85 ± 15 µl applied volume)	10 µl
Calibration	Calibration informationbar-coded on each cartridge.Calibration information maychange with each lot.	Run Vitros DT II calibratorswhenever a new slide lot isused or when necessary.
Quality Control	2 levels	Same
Reporting Units	mg/dL	Same
Reaction Temp.	37°C	Same

B. Differences

	CARESIDE™ Mg	Vitros Mg DT Slides
Accuratepipetting	Not required	Required
Reagentpre-warming	Not required	Required

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、

C. Comparative Performance Characteristics

	CARESIDE™ Mg	Vitros Mg DT Slides
Detection limit	0.2 mg/dL	0.2 mg/dL
Reportable range	0.2 to 7.0 mg/dL	0.2 to 7.0 mg/dL
Accuracy	Mean recovery 97%	Not provided
Precision	Total CV, 1.2 mg/dL, 4.3%	Total CV, 1.1 mg/dL, 3.6%
Methodcomparison	CARESIDE™ Mg = 0.98 (Hitachi 902/BMD) – 0.086 mg/dL, r = 0.99CARESIDE™ Mg = 0.82 (Vitros DT 60 II) + 0.31 mg/dL, r = 0.99
Linearity	Linearity yielded slope andcorrelation coefficient withinacceptable limits.	Not provided
Interference	No significant interferenceobserved at testedconcentration of interferent:Ascorbic Acid, 10 mg/dLBilirubin, 60 mg/dLCalcium, 20 mg/dLInorg. Phosphorus, 9 mg/dLTotal Protein, 9 g/dLTriglycerides, 2000 mg/dL	Calcium 20 mg/dLInorg. Phosphorus 9 mg/dL

D. Conclusion

The nonclinical and clinical data provided demonstrate that the CARESIDE™ Mg product is as safe, effective, and performs as well as or better than the legally marketed predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 10 1999

Mr. Kenneth B. Asarch, Ph.D. VP Quality Systems and Regulatory Affairs Careside, Inc. 6100 Bristol Parkway Culver City, California 90230

Re: K991717

Trade Name: CARESIDE™ Magnesium (Mg) Regulatory Class: II Product Code: JGJ Dated: May 19, 1999 Received: May 20, 1999

Dear Dr. Asarch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE VI.

510(k) Number:

K 9917i7

Device Name:

CARESIDE™ Mg

For in vitro diagnostic use with the CARESIDE Analyzer™ to · Indications for use: montitatively measure magnesium from anti-coagulated whole blood, plasma, or serum speciments to aid in the diagnosis and treatment of patients with hypomagnesemia or specifical to the in the intended professional laboratory use: not for point of care or physician office laboratory use.

Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use (Optional Format 1-2-96)

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.