CARESIDE LYTESTM For in vitro diagnostic use with the CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance.

CARESIDE Analyzer™ For in vitro diagnostic use by laboratory professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes.

Device Description

The CARESIDE LYTES™, a single-use disposable in vitro diagnostic test cartridge, is used with the CARESIDE Analyzer™ to perform a simultaneous quantitative measurement of sodium, potassium and chloride ion concentrations from a single sample of anti-coagulated whole blood, plasma or serum. Each cartridge has a test element containing sodium-, potassium-, and chloride-selective electrodes. The CARESIDE LYTESTM test cartridge aids in specimen separation and delivers a measured volume of plasma or serum to the electrochemistry to initiate the measurement of sodium, potassium and chloride ion concentrations. The cartridge (patent pending) contains all reagents necessary to measure the concentration of sodium, potassium and chloride ions.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings for the CARESIDE LYTES™ device, based on the provided document:

CARESIDE LYTES™ Device Performance and Acceptance Criteria

The CARESIDE LYTES™ device, used with the CARESIDE Analyzer™, measures sodium, potassium, and chloride ion concentrations. The acceptance criteria are largely implied by the comparative performance characteristics against a legally marketed predicate device (Vitros Na+, K+, Cl- DT Slides and Vitros DT 60 II / DTE II). The study demonstrates that the CARESIDE LYTES™ performs "as well as or better than" the predicate device, indicating that performance comparable to or exceeding the predicate device's established levels constitutes acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implied by Predicate Performance)	Reported CARESIDE LYTES™ Performance
Sodium (Na)
Detection Limit	95 mmol/L	75 mmol/L
Reportable Range	95 to 215 mmol/L	75 to 240 mmol/L
Accuracy	Not provided for predicate	Mean recovery 99%
Precision (Total CV)	1.3% at 143 mmol/L	1.5% at 146 mmol/L
Method Comparison (vs. Reference)	N/A	1.01 (Flame Photometry) - 1.34 mmol/L, r= 1.00
Method Comparison (vs. Predicate)	N/A	1.04 (Vitros Na⁺) - 2.78 mmol/L, r = 0.99
Interference	Ethanol and benzalkonium chloride cause positive interference	No significant interference observed at tested concentration
Potassium (K)
Detection Limit	1.0 mmol/L	1.0 mmol/L
Reportable Range	1.0 to 11.0 mmol/L	1.0 to 14.0 mmol/L
Accuracy	Not provided for predicate	Mean recovery 99%
Precision (Total CV)	1.4% at 5.2 mmol/L	1.8% at 5.4 mmol/L
Method Comparison (vs. Reference)	N/A	1.00 (Flame Photometry) + 0.01 mmol/L, r= 1.00
Method Comparison (vs. Predicate)	N/A	1.07 (Vitros K⁺) - 0.16 mmol/L, r = 1.00
Interference	None	No significant interference observed at tested concentration
Chloride (Cl)
Detection Limit	65 mmol/L	50 mmol/L
Reportable Range	65 to 140 mmol/L	50 to 170 mmol/L
Accuracy	Not provided for predicate	Mean recovery 102%
Precision (Total CV)	1.5% at 108 mmol/L	1.3% at 107 mmol/L
Method Comparison (vs. Reference)	N/A	0.98 (Coulometry) + 2.13 mmol/L, r= 0.99
Method Comparison (vs. Predicate)	N/A	0.97 (Vitros Cl⁻) + 2.54 mmol/L, r = 0.99
Interference	Bromide and iodide cause positive interference	Bromide causes positive interference (Iodide: No significant interference observed)

Note: Acceptance criteria are inferred based on the predicate device's performance where direct criteria are not explicitly stated for the CARESIDE LYTES™ device. The submission aims to prove substantial equivalence, meaning performance should be comparable or better.

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

The document does not explicitly state the sample size used for the test set in terms of number of patient samples. It provides performance metrics like "Mean recovery", "Total CV" at specific concentrations, and "Method comparison" data (slope, intercept, and correlation coefficient r). This suggests a series of experiments were conducted.

The data provenance is not explicitly stated. However, given it's a 510(k) submission to the FDA, the data would typically originate from studies conducted under controlled laboratory conditions, likely in the US, and may involve both prospective lab-controlled samples and potentially retrospective clinical samples. The type of study presented here (method comparison, linearity, interference) is generally prospective laboratory testing.

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

This question is not applicable in the context of this device. The ground truth for chemical analytes like sodium, potassium, and chloride is established using recognized reference methods (e.g., Flame Photometry for Na/K, Coulometry for Cl) performed by qualified laboratory personnel, not by medical experts making diagnostic assessments. The document explicitly lists these reference methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable to this type of chemical analyzer validation. Adjudication methods are typically used in studies where subjective interpretation (e.g., image reading) requires consensus among experts. Here, the "ground truth" is determined by objective analytical measurements from established reference instruments.

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 question is not applicable. The CARESIDE LYTES™ is an in vitro diagnostic device for quantitative chemical analysis, not an AI or imaging device involving human readers or interpretation.

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

Yes, a standalone performance assessment was done. The reported performance characteristics (Detection limit, Reportable range, Accuracy, Precision, Method comparison, Linearity, Interference) all reflect the intrinsic analytical performance of the CARESIDE LYTES™ cartridge and CARESIDE Analyzer™ system without human interpretative intervention in the measurement result. The device automates the measurement process.

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

The ground truth for the performance studies was established using recognized reference methods:

Sodium: Flame Photometry
Potassium: Flame Photometry
Chloride: Coulometry

8. The sample size for the training set

The document does not provide information on a "training set" in the context of machine learning or AI. This device is an analytical instrument based on established electrochemical principles, not a machine learning model that requires training data in the conventional sense. The development likely involved calibration and verification studies, but these are not typically referred to as "training sets" for this type of device.

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

This question is not applicable as there is no mention or indication of a "training set" for an AI or machine learning model in this submission. The device's functionality is based on established electrochemical principles and analytical validation.

Summary

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3/18/99

CARESIDE, Inc.
Page 11

K990036

CARESIDE LYTES™
December 29, 1998

510(K) SUMMARY: CARESIDE LYTES™ SAFETY IV. AND EFFECTIVENESS

I. Applicant Information

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

II. Device Information

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

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 December 29, 1998

CARESIDE LYTESTM, CARESIDE Analyzer™

Sodium Test System	(75JGS)
Potassium Test System	(75CEM)
Chloride Test System	(75CGZ)
Micro chemistry analyzer for clinical use	(75JJF)

Clinical Chemistry PanelTest System Name	RegulationNumber	RegulatoryClass
Sodium test System	862.1665	2
Potassium Test System	862.1600	2
Chloride Test system	862.1170	2
Micro chemistry analyzerfor clinical use	862.2170	1

None applicable D. Special controls and performance standards

Substantial Equivalence Claim III.

General equivalency claim A.

The ability to monitor sodium, potassium and chloride by ion-selective electrodes based upon the technique of direct differential potentiometry is widely recognized and has gained widespread acceptance.

Sodium, Potassium and Chloride in vitro diagnostic products and associated instruments to measure these analytes using direct and indirect differential potentiometry in conjunction with ion-specific electrodes are already on the U.S. market.

B. Specific equivalency claim
The CARESIDE LYTESTM test cartridge is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of sodium, potassium and chloride ions on the Vitros DT 60 II / DTE II. The CARESIDE Analyzer™ is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros DT 60 II / DTE II. Johnson and Johnson (formerly Eastman Kodak, Inc.) manufactures all three slides and the instrument.

Name of Predicate Devices:	Predicate Device 510K number	Product Code
Vitros Na+ DT Slides	K912844	75JGS/75CHH
Vitros K+ DT Slides	K912844	75CEM/75CHH
Vitros Cl- DT Slides	K912844	75CGZ/75CHH
Vitros DT 60 II / DTE II	K912844	75JFF/75CHH

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IV. Device Description

The CARESIDE LYTES™, a single-use disposable in vitro diagnostic test cartridge, is used with the CARESIDE Analyzer™ to perform a simultaneous quantitative measurement of sodium, potassium and chloride ion concentrations from a single sample of anti-coagulated whole blood, plasma or serum. Each cartridge has a test element containing sodium-, potassium-, and The CARESIDE LYTESTM test cartridge aids in specimen chloride-selective electrodes. separation and delivers a measured volume of plasma or serum to the electrochemistry to initiate the measurement of sodium, potassium and chloride ion concentrations. The cartridge (patent pending) contains all reagents necessary to measure the concentration of sodium, potassium and chloride ions.

Explanation of Device Function A.

The measurement of sodium, potassium, and chloride ion concentration is each based upon the technique of differential potentiometry using a direct (undiluted) specimen. Each CARESIDE LYTES™ cartridge consists of a slide containing two identical sodium-, potassium-, and chloride-selective electrodes mounted in a plastic base with a hinged lid. Each electrode consists of a silver and silver chloride layer with an overlying membrane that is selective for the particular ion. A reference solution containing known concentrations of sodium, potassium, and chloride ions is contained within a pouch in the test cartridge.

The user introduces the whole blood 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 specimen to 37°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. Forty-five microliters of sample remain in the metering passage. Any excess sample flows into an overflow well. A plunger opens the reference solution pouch and dispenses the reference solution. The metered volume of specimen is dispensed onto the test element by a plunger displacing a flexible seal that covers the Sample Well while a second plunger seals the cartridge vent. As the flexible seal is displaced, air is pushed through the metering passage, forcing the specimen onto the test element. Reference fluid is applied to one set of electrodes (reference electrodes) at the same time as the specimen is applied to the second set of electrodes (specimen electrode). The reference and specimen fluids spread towards each other over a thread that serves as an ionic bridge, forming a stable liquid junction at the center. A voltage develops at each electrode in response to the concentration of the ion to which it is selective. Terminals move into contact with the test element electrodes and measure the voltage difference between the specimen and reference side of the test element.

The difference in voltage between the reference and specimen electrode for each ion is proportional to the logarithm of the ion concentration in the specimen. Based upon the principle of differential potentiometry, the CARESIDE Analyzer™ uses the voltage difference to calculate sodium, potassium, and chloride ions concentrations.

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B. Test Summary

Measurement of sodium, potassium, and chloride ions from blood is useful in the diagnosis and treatment of patients with electrolyte imbalance.

Sodium

Blood sodium levels can be elevated due to dehydration, diabetes insipidus, salt poisoning, skin losses, hyperaldosteronism, and CNS disorders. Conditions that can decrease sodium levels include cirrhosis, dehydration, and syndrome of inappropriate anti-diuretic hormone.

Potassium

Blood potassium levels can be elevated due to renal glomerular disease, adrenocortical insufficiency, diabetic ketoacidosis, sepsis, and in vitro hemolysis. Decreases in potassium levels can be caused by renal tubular disease, hyperaldostronism, treatment of diabetic ketoacidsosis, hyperinsulinism, metabolic alkalosis, and diuretic therapy.

Chloride

Blood chloride levels can be elevated due to prolonged diarrhea, renal tubular disease, hyperparathyroidism, and dehydration. Decreased blood chloride levels can be caused by prolonged vomiting, burns, salt-losing renal disease, over-hydration, and diuretic therapy.

V. Intended Use

A. Intended Use

The CARESIDE LYTES™ cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE™ Analyzer to quantitatively measure sodium, potassium and chloride ion concentrations in anti-coagulated whole blood, plasma or serum.

B. Indications for Use

CARESIDE LYTESTM To be used with the CARESIDE Analyzer™ to measure sodium, potassium, and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with disorders of electrolyte imbalance.

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Technological Characteristics VI.

A. Similarities

	CARESIDE LYTEST™Test Cartridge	VitrosNa+, K+, Cl- DT Slides
Intended Use	CARESIDE LYTEST™To measure sodium, potassium, and chloride ionsto aid in the diagnosis and treatment of patients with electrolyte imbalance.CARESDIE Analyzer™Intended for the measurement of various analytes using reflectance photometry measurements and electrochemical detection.	Vitros Na+, K+, Cl- SlidesSame.Vitros DT 60 II / DTE IISame.
Indications	For in vitro diagnostic use.For professional laboratory use.	For in vitro diagnostic use
Measurement	Quantitative	Same
Method Principle	Measurement is based upon the technique of differential potentiometry using a direct (undiluted) specimen. The test element contains two identical ion-selective electrodes for each ion. Each electrode consists of a silver and silver chloride layer with an overlying membrane that is selective for the particular electrolyte.	Same
Specimen dilution	Not required	Same
Materials	Sodium/Potassium/ChlorideThe active ingredients include silver, silver chloride, and salts of sodium, potassium, and chloride ions.	Same
Test time	Approx. 4-minute warm-up (on-board) plus 1 minute test time.	3 minutes test time.
Reference Method	SodiumFlame PhotometryPotassiumFlame PhotometryChlorideCoulometry	SodiumFlame PhotometryPotassiumFlame PhotometryChlorideCoulometry
Sample Type	Whole blood, serum, plasma	serum, plasma
Specimen volume	45 µl test volume/3 tests(85 ± 15µl applied volume)	10 µl for each test
Calibration	Calibration information bar-coded on each cartridge.Calibration information may change with each lot.	Run Vitros DT calibrators whenever a new slide lot is used or when necessary.
Quality Control	2 levels	Same
Reporting Units	mEq/L or mmol/L	mmol/L
Reaction Temp.	37 °C	Same
	CARESIDE LYTESTMTest Cartridge	VitrosNa+, K+, Cl- DT Slides
SpecimenProcessing	No. Either unprocessedwhole blood or processedserum or plasma may be used	Yes, requires separation ofserum or plasma from whole blood prior to sampleapplication
Accurate pipetting	Not required	Required
Reagent pre-warming	Not required	Required
Reagents required	Single cartridge yields resultsfor all three analytes	Three separate (analyte-specific) slides required forthe three results.

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B. Differences

C. Comparative Performance Characteristics

	CARESIDE LYTESTMTest Cartridge	VitrosNa+, K+, Cl DT Slides
Detection limit	Sodium 75 mmol/LPotassium 1.0 mmol/LChloride 50 mmol/L	Sodium 95 mmol/LPotassium 1.0 mmol/LChloride 65 mmol/L
Reportable range	Sodium 75 to 240 mmol/LPotassium 1.0 to 14.0 mmol/LChloride 50 to 170 mmol/L	Sodium 95 to 215 mmol/LPotassium 1.0 to 11.0 mmol/LChloride 65 to 140 mmol/L
Accuracy	Na Mean recovery 99%K Mean recovery 99%Cl Mean recovery 102%	Not provided
Precision	Na Total CV, 146 mmol/L, 1.5%K Total CV, 5.4 mmol/L, 1.8%Cl Total CV, 107 mmol/L, 1.3%	Na Total CV, 143 mmol/L, 1.3%K Total CV, 5.2 mmol/L, 1.4%Cl Total CV, 108 mmol/L, 1.5%
Methodcomparison(vs. Reference)	CARESIDE™ Na = 1.01 (Flame Photometry) - 1.34 mmol/L, r= 1.00CARESIDE™ K=1.00 (Flame Photometry) + 0.01 mmol/L, r= 1.00CARESIDE™ Cl = 0.98 (Coulometry) + 2.13 mmol/L, r= 0.99
Methodcomparison(vs. Predicate)	CARESIDE™ Na = 1.04 (Vitros Na⁺) - 2.78 mmol/L, r = 0.99CARESIDE™ K = 1.07 (Vitros K⁺) - 0.16 mmol/L, r = 1.00CARESIDE™ Cl = 0.97 (Vitros Cl⁻) + 2.54 mmol/L, r = 0.99
Linearity	Linearity yielded slope andcorrelation coefficient withinacceptable limits.	Not provided
Interference	Sodium/Potassium/ChlorideNo significant interference observed at tested concentrationof interferent for sodium, potassium, and chloride:Bilirubin..................................20 mg/dLEthanol...................................33 mmol/LHemoglobin............................50 mg/dLIodide.....................................2 mmol/LTriglyceride..........................2000 mg/dLChlorideBromide causes positive interference	SodiumEthanol and benzalkonium chloride cause positive interference.PotassiumNoneChlorideBromide and iodide cause positive interference.

D. Conclusion

The nonclinical and clinical data provided demonstrate that the individual constituent tests of the CARESIDE LYTES™ cartridge (sodium, potassium, and chloride) and its associated CARESIDE Analyzer™ 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The overall design is simple and conveys a sense of health and well-being.

MAR 1 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth B. Asarch, Ph.D. Vice President Ouality Systems and Regulatory Affairs CARESIDE, Inc. 6100 Bristol Parkway Culver City, California 90230

Re: K990036

Trade Name: CARESIDE LYTES™, CARESIDE Analyzer TM Regulatory Class: II Product Code: JGS, CEM, CGZ, JJE Dated: December 29, 1998 Received: January 6, 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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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 Sutman

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:

CARESIDE LYTESTM and CARESIDE Analyzer™ Device Name:

Indications for use:

CARESIDE LYTESTM diagnostic use with the For in vitro CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance.

CARESIDE Analyzer™ laboratory For in vitro v diagnostic use by professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes.

ean Coogen

(Division Sign-Off) Division of Clinical Laboratory . view 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 Usel (Per 21 CFR 801.109) OR

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

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.