The proLYTE Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.

For In Vitro Diagnostic Use

Device Description

The proLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and prediluted urine samples, proLYTE analyzer is designed with the user in mind, it is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer an be programmed to self-calibrate using Mission Diagnostics ILyte 800 Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) J33063) are the recommended quality control material to be used daily.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the proLYTE Electrolyte Analyzer:

1. Table of Acceptance Criteria and Reported Device Performance:

Analyte	Sample Type	Acceptance Criteria (Within-Run Precision)	Reported Device Performance (Within-Run Precision)	Acceptance Criteria (Between-Run Precision)	Reported Device Performance (Between-Run Precision)	Linearity (Correlation Coefficient)
Na+	Serum/Blood	C.V. ≤ 1%	"within performance specifications"	C.V. ≤ 2%	"within performance specifications"	> 0.99
K+	Serum/Blood	C.V. ≤ 2%	"within performance specifications"	C.V. ≤ 2.5%	"within performance specifications"	> 0.99
Cl-	Serum/Blood	C.V. ≤ 2%	"within performance specifications"	C.V. ≤ 2.5%	"within performance specifications"	> 0.99
Na+	Urine (1:10 dil.)	C.V. ≤ 2.5%	"within performance specifications"	C.V. ≤ 2.5%	"within performance specifications"	> 0.99
K+	Urine (1:10 dil.)	C.V. ≤ 2.5%	"within performance specifications"	C.V. ≤ 2.5%	"within performance specifications"	> 0.99
Cl-	Urine (1:10 dil.)	C.V. ≤ 2.5%	"within performance specifications"	C.V. ≤ 5%	"within performance specifications"	> 0.99

Note: The reported performance for precision states "within performance specifications." This indicates that the measured CV values were equal to or less than the specified acceptance criteria.

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

Precision (within-run): Minimum of 30 replicates for each sample type (blood, serum, urine).
Precision (between-run): 2 runs per day (AM & PM) with 2 replicates per run for 10 days for each sample type. This equates to 40 measurements per sample type (2 runs/day * 2 replicates/run * 10 days).
Linearity: Minimum of 5 levels tested for each sample type.
Clinical Testing (Correlation to Predicate Device): Not explicitly stated, but "All sample types, whole blood, plasma, serum and urine were collected for testing." The exact number of samples is not provided in this summary.
Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it's highly likely to be prospective data collected specifically for validation, but this isn't confirmed.

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

None specified. For an electrolyte analyzer measuring quantitative values, the ground truth is typically established by reference methods or predicate devices, not by expert consensus in the same way an image analysis algorithm might use radiologists. The "ground truth" in this context is the actual concentration of the analytes as determined by a highly accurate and precise method. The clinical testing portion compares the proLYTE analyzer to "predicate devices operated by trained personnel," implying the predicate device serves as the reference for comparison.

4. Adjudication Method for the Test Set:

Not applicable. As the device measures quantitative chemical analytes, there is no "adjudication" in the traditional sense of human readers disagreeing on an interpretation. The comparison is statistical (regression analysis) against reference measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is typically for evaluating the diagnostic performance of human readers (e.g., radiologists) with and without AI assistance on a set of cases. This device is a quantitative analytical instrument, not an AI-assisted diagnostic tool for human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, this is a standalone device. The proLYTE Electrolyte Analyzer is an automated instrument that performs measurements directly. Its performance summarized in the document (precision, linearity, correlation) represents its standalone capability without human interpretation being part of the measurement process itself. Human operators introduce the sample and initiate the analysis, but the measurement and result generation are entirely automated.

7. The Type of Ground Truth Used:

Reference measurements from predicate devices and/or highly accurate laboratory methods. For precision and linearity studies, the ground truth is often established by making known dilutions or using control materials with certified values. For clinical correlation, the ground truth is established by the measurements obtained from legally marketed predicate devices, which are assumed to be accurate and reliable. The summary states: "Clinical testing was conducted to demonstrate the correlation of Diamond Diagnostics proLYTE Analyzer to predicate devices operated by trained personnel."

8. The Sample Size for the Training Set:

Not applicable. The proLYTE Electrolyte Analyzer is an electrochemical instrument based on ion-selective electrodes, not a machine learning or AI-driven system that requires a "training set" in the computational sense. Its "training" is inherent in its design, calibration, and manufacturing processes, not in learning from a dataset.

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

Not applicable. As above, there is no "training set" for this type of device. The accuracy and calibration are based on established scientific principles of electrochemistry and the use of known calibrant solutions.

Summary

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K070104

MAY - 7 2008

5. 510(k) Summary- proLYTE Electrolyte Analyzer

(1) Submitted by:

Diamond Diagnostics 333 Fiske St. Holliston, MA 01746

(2) Contact Person:

Liann Voo, Chemistry Manager 508-429-0450 (x351) Phone: Fax: 508-429-0452 E-mail: lvoo@diamonddiagnostics.com

(3) Summary Prepared:

April 22, 2008

(4) Device Trade Name:

proLYTE Electrolyte Analyzer Na+/K+/CI-

(5) Regulatory Information:

Description	CFR Section	Device Class	Product Code
Sodium Test System	862.1665	Class II	JGS
Potassium Test System	862.1600	Class II	CEM
Chloride Test System	862.1170	Class II	CGZ

(6) Predicate Devices:

Description	510(k)	Analytes
IL 943 Flame Photometer	K823480	Sodium, Potassium
EasyLyte	K000926	Sodium, Potassium, Chloride
AVL 9180	K961458	Sodium, Potassium, Chloride
925 Chloridometer	K810615	Chloride

Statement of Technology Characteristics of the Device Compared to Predicate Device:

Operating Principle	Predicate Device	proLYTE
PotentiometricNa+, K+, Cl-	K000926	SAME
	K961458

(7) Device Description and Indications for Use:

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intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) J33063) are the recommended quality control material to be used daily.

(8) Technological Characteristics of the Device: Principal of Measurement

The principles of measurement used in the prol. YTE Electrolyte Analyzer are identical to those principles existing in the electrolyte analyzers K000926 (EasyLyte) and K961458 (AVL 9180) and are substantially equivalent to the K823480 (IL 943 Flame Photometer) and K810615 (925 Chloridometer).

Calibration:

The proLYTE performs a 2-point calibration daily and permits calibration on demand. A 1-point calibration is performed automatically with each measurement.

Technical Specifications:

		Analyzer tests samples for Na +/K+/Cl-
Sample:	Whole Blood, Serum, Plasma or Urine
Sample Size:	100 µL Whole Blood, Serum, Plasma or 400 µL diluted (1:10) Urine
Measurement Range:	Blood	Na+: 45 - 205 mmol/LK+: 1.5 - 11 mmol/LCl-: 45 - 205 mmol/L	Urine	Na+: 30 - 1020 mmol/LK+: 20 - 505 mmol/LCl-: 25 - 505 mmol/L
Display Resolution:		Na+: 0.1 mmol/L	K+: 0.01 mmol/L	Cl-: 0.1 mmol/L
Analysis Time	55 sec. (Blood), 90 sec. (Urine)		Data storage, (on board RAM)	125 Patient results, up to 20 QC results normal and abnormal
Calibration	automatic and/or on demand

Analyzer has an output for a printer/computer.

Power

100-115 ~ VAC 50-60 Hz, 0.8 A or 220~VAC 50/60 Hz, 0.4 A (Factory set)

Size & Weight 9.5" (24cm) W x 16.5" (42cm) H x 8.0" (20cm) D, 13 lbs. (5.8 kg)

(9) Summary of nonclinical tests submitted with the premarket notification for the device.

Precision -

Within-Run Precision is determined for each of the different sample types, blood, serum and urine, by collecting multiple replicates of each sample type, minimum of 30, within a single period of time without re-calibration of the instrument. amples of blood, plasma and serum are measured in standard blood/plasmalserum mode while urine samples are

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measured in 'Urine Mode'. The standard deviation (SD) and Coefficient of Variation (%CV) are calculated. Results were vithin performance specifications which are similar to predicate device, Easylyte (K000926).

	Serum/Blood	Urine (1:10 dilution)
Na+	C.V. ≤ 1%	C.V. ≤ 2.5%
K+	C.V. ≤ 2%	C.V. ≤ 2.5%
Cl-	C.V. ≤ 2%	C.V. ≤ 2.5%

Between-Run or Total Precision is determined by testing 2 runs per day (AM & PM) with 2 replicates per run for 10 days for each sample type. The standard deviation (SD) and Coefficient of Variation (%CV) are calculated. Results were within performance specifications summarized below and are similar to predicate device, Easylyte (K000926).

	Serum/Blood	Urine (1:10 dilution)
Na+	C.V. ≤ 2%	C.V. ≤ 2.5%
K+	C.V. ≤ 2.5%	C.V. ≤ 2.5%
Cl-	C.V. ≤ 2.5%	C.V. ≤ 5%

Linearity

Whole blood, Plasma, Serum and Urine are linear across the claimed performance range. A minimum of 5 levels were tested for each type of sample. Dilutions were made from starting stock solutions and regression analysis done. Correlation coefficients were all greater than 0.99.

(10) Summary of clinical tests submitted with the pre-market notification for the device.

Clinical testing was conducted to demonstrate the correlation of Diamond Diagnostics proLYTE Analyzer to predicate devices operated by trained personnel. All sample types, whole blood, plasma, serum and urine were collected for testing in the proLYTE as well as another predicate device. Regression analysis show good correlation to predicate devices for all sample types, whole blood, plasma, serum and urine with correlation coefficients typically greater than 0.99.

(11) Conclusions drawn from the clinical and non-clinical testing.

Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and non-clinical trails demonstrates that the Diamond Diagnostics proLYTE ISE Analyzer (with Na+, K+, Cl-) is safe, effective and equivalent to those predicate devices to which it is compared.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diamond Diagnostics, Inc. c/o Ms. Liann Voo 333 Fiske Street Holliston, MA 01746

MAY - 7 2008

Re: K070104 Trade Name: proLYTE Electrolyte Analyzer Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System. Regulatory Class: Class II Product Code: JGS, CEM, CGZ Dated: April 24, 2008 Received: April 24, 2008

Dear Ms. Voo:

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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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4. Indications for Use Statement

510(k) Number (if known): K070104

Device Name: proLYTE Electrolyte Analyzer

Indications For Use:

For In Vitro Diagnostic Use

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 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)

Division Sign-Off

Office of In Vitro Diagnostic Device

510(k) K071104

Diamond Diagnostics 510(k) 070104 Submission for proL YTE

Page 9 of 140

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.