PROLYTE ELECTROLYTE ANALYZER

K070104 · Diamond Diagnostics, Inc. · JGS · May 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K070104
• Device Name: PROLYTE ELECTROLYTE ANALYZER
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: May 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

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 Story

Automated, microprocessor-controlled analyzer; utilizes ion-selective electrodes (ISE) to measure sodium, potassium, and chloride levels in whole blood, serum, plasma, or prediluted urine. Operated by laboratory technicians in clinical settings; provides results in approximately 55 seconds for blood and 90 seconds for urine. Device features simple menu navigation; performs automatic 1-point calibration per measurement and scheduled 2-point calibrations. Output displayed on-screen and sent to printer/computer; stores up to 125 patient results and 20 QC results. Aids clinicians in diagnosing and managing renal, metabolic, and cardiovascular disorders by identifying electrolyte imbalances.

Clinical Evidence

Bench testing and clinical correlation studies performed. Precision evaluated via within-run (n≥30) and between-run (2 runs/day for 10 days) testing; CVs for Na+, K+, and Cl- in blood/serum/urine were within specified limits (≤1% to ≤5%). Linearity confirmed across claimed ranges with correlation coefficients >0.99. Clinical correlation study compared proLYTE to predicate devices using whole blood, plasma, serum, and urine samples; regression analysis demonstrated correlation coefficients >0.99.

Technological Characteristics

Ion-selective electrode (ISE) potentiometric measurement. Dimensions: 9.5"W x 16.5"H x 8.0"D; Weight: 13 lbs. Power: 100-115 VAC or 220 VAC. Connectivity: Printer/computer output port. Software: Microprocessor-controlled with automated calibration and menu-driven interface. Sample types: Whole blood, serum, plasma, urine.

Indications for Use

Indicated for clinical laboratory use to measure sodium, potassium, and chloride in whole blood, serum, plasma, and urine to aid in the diagnosis and management of patients with renal, metabolic, and cardiovascular disorders associated with electrolyte imbalance.

Regulatory Classification

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.

Predicate Devices

• IL 943 Flame Photometer (K823480)
• EasyLyte (K000926)
• AVL 9180 (K961458)
• 925 Chloridometer (K810615)

Reference Devices

• Mission Diagnostics ILyte 800 Fluid Pack (K031159)
• Mission Controls (K033063)

Submission Summary (Full Text)

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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: [phone] E-mail: [e-mail]

#### (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 |
|--------------------------------|------------------|---------|
| Potentiometric<br>Na+, K+, Cl- | K000926 | SAME |
| | K961458 | |

# (7) Device Description and Indications for Use:

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

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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/L<br>K+: 1.5 - 11 mmol/L<br>Cl-: 45 - 205 mmol/L | Urine | Na+: 30 - 1020 mmol/L<br>K+: 20 - 505 mmol/L<br>Cl-: 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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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 [phone]. 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 [phone] or [phone] 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:

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device

510(k) K071104

Diamond Diagnostics 510(k) 070104 Submission for proL YTE

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