(212 days)
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.
The SmartLyte® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SmartLyte® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of Sodium, Potassium, Chloride, Calcium and Lithium in Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout the day or on request. Sodium. Potassium. Chloride and Calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).
The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, 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.
The document describes the performance of the SmartLyte® Plus Electrolyte Analyzer. This device is an in-vitro diagnostic instrument, and the provided information details its analytical performance characteristics rather than the performance of an AI algorithm with human readers or a medical imaging device. Therefore, many of the requested points related to AI, MRMC studies, human experts, and ground truth establishment for complex data like images are not directly applicable or available in this document.
However, I can extract and present the acceptance criteria and reported device performance for the SmartLyte® Plus Electrolyte Analyzer as it relates to its analytical accuracy and precision.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document presents performance data for Precision and Linearity for each analyte (Na+, K+, Cl-, Ca++, Li+) across different sample types (Serum, Plasma, Whole Blood, Urine). The acceptance criteria are implicitly quantitative, as the 'Status' for each test is reported as "Pass" against numerical criteria.
1. Table of Acceptance Criteria and Reported Device Performance (Summary)
Since the document provides extensive tables for precision (within-run and run-to-run) and linearity for each analyte and matrix, I will summarize the general acceptance criteria and indicate that the device passed all these criteria as reported in the document. Presenting every single data point for all analytes and matrices would be too large for this format.
Precision (for Serum/Blood/Plasma)
| Analyte | Within Run Criterion (CV or SD) | Between Run Criterion (CV or SD) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 1% | CV ≤ 2% | Pass |
| K+ | CV ≤ 1.5% | CV ≤ 3% | Pass |
| Cl- | CV ≤ 1% | CV ≤ 3% | Pass |
| Ca++ | SD ≤ 0.02 | SD ≤ 0.06 | Pass |
| Li+ | SD ≤ 0.03 | SD ≤ 0.09 | Pass |
Precision (for Urine)
| Analyte | Within Run Criterion (CV) | Between Run Criterion (CV) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 5% | CV ≤ 5% | Pass |
| K+ | CV ≤ 5% | CV ≤ 5% | Pass |
| Cl- | CV ≤ 5% | CV ≤ 5% | Pass |
Linearity (General Acceptance Criterion)
| Performance Metric | Implicit Acceptance Criteria | Device Performance (Status) |
|---|---|---|
| Slope | Near 1.0 (actual ranges provided in tables are typically 0.97 to 1.03) | Achieved (Values reported) |
| Intercept | Near 0.0 (actual values reported) | Achieved (Values reported) |
| R² (Coefficient of Determination) | High value, typically > 0.99 (actual values reported are 0.9939 to 0.9997, indicating strong linear correlation) | Achieved (Values reported) |
| Reportable Range | The linearity studies supported the claimed measurement ranges for each analyte and matrix. | Supported |
Detection Limit
| Analyte | Acceptance Criteria for %TE | Claimed Measurement Range | Device Performance (%TE) | Device Performance (Status) |
|---|---|---|---|---|
| Ca++ | 21.6% | 0.3 - 5.0 mmol/L | 5.541% - 11.868% | Pass (LoQ < Range min) |
| Li+ | 21.6% | 0.2 - 6.0 mmol/L / 0.2-5.5 mmol/L | 6.208% - 14.085% | Pass (LoQ < Range min) |
Method Comparison (General Acceptance Criterion)
The criteria for method comparison are implicitly that the SmartLyte® Plus shows a "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.97 and 1.03."
The documented R² values are all greater than 0.99 (ranging from 0.9939 to 0.9987), and slope values are indeed within 0.97 and 1.03.
Study that Proves the Device Meets Acceptance Criteria:
The document describes several non-clinical and clinical tests performed to demonstrate that the SmartLyte® Plus Electrolyte Analyzer meets its performance claims and is substantially equivalent to its predicate device (SmartLyte® K082462).
2. Sample Size and Data Provenance:
- Precision Test Set Sample Sizes:
- Within Run: 30 replicates (n=30) for each sample type (Serum, Plasma, Whole Blood, Urine) and analyte.
- Between Run/Total Precision:
- Serum/Plasma/Urine: Duplicate measurements over 20 days (total of 40 replicates).
- Venous Whole Blood: 20 samples from 2 instruments over a 2-hour period (total of 40 replicates).
- Linearity Test Set Sample Sizes (n):
- Serum: Sodium (48), Potassium (75), Chloride (45), Calcium (72), Lithium (70)
- Plasma: Sodium (75), Potassium (75), Chloride (39), Calcium (42), Lithium (42)
- Whole Blood: Sodium (54), Potassium (69), Chloride (42), Calcium (52), Lithium (39)
- Urine: Sodium (19), Potassium (19), Chloride (19)
- Method Comparison Test Set Sample Sizes (n):
- Serum: 109-125 samples per analyte
- Plasma: 110-125 samples per analyte
- Whole Blood: 108-112 samples per analyte
- Urine: 115-118 samples per analyte
- Data Provenance: The document does not specify the country of origin of the data. It indicates that samples were collected for testing. The nature of the study (analytical performance of a medical device) typically implies controlled laboratory conditions rather than broad population-based data. The studies are described as "non-clinical" and "clinical tests," but the "clinical" aspect refers to using human biological samples for analytical validation in a lab setting, not a direct patient outcome study. The studies appear to be prospective, designed specifically for this 510(k) submission.
3. Number of Experts and Qualifications: Not applicable. This is an analytical performance study of an in-vitro diagnostic device, not an image-based AI study requiring expert readers for ground truth establishment. The performance is assessed against quantitative measurements and statistical methods (CLSI guidelines).
4. Adjudication Method: Not applicable. (See #3)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, not applicable. This is not an AI-assisted diagnostic imaging device study. The device functions as a standalone analyzer that measures electrolyte concentrations. Its "comparison" is against a predicate device (another equivalent analyzer), not human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone analyzer. Its performance is measured as output values (mmol/L) directly from the instrument. The 'algorithm' here refers to the internal software and hardware that processes the ion-selective electrode signals to produce the final measurement. The performance data presented (precision, linearity, detection limit, method comparison) are the standalone performance of the device.
7. The type of ground truth used:
- For Precision, Linearity, and Detection Limit: The "ground truth" or reference for these studies refers to the accurate measurement of known concentrations in control materials or diluted stock solutions (for linearity), and statistical evaluation of repeatability. For detection limit, reference to a "reference analyzer (Flame Photometer SN 86011421)" is made for target values.
- For Method Comparison: The "ground truth" for the method comparison study was established by comparing the results of the SmartLyte® Plus Analyzer to those obtained from the predicate device, SmartLyte® (K082462), implying the predicate device serves as the established reference for comparison.
8. The Sample Size for the Training Set: Not applicable in the context of typical AI/ML model training. This is an analytical instrument, not a learning algorithm that requires a separate "training set" of data in the AI sense. The development of the device's measurement principles and internal parameters would rely on established chemical and engineering principles and internal validation.
9. How the ground truth for the training set was established: Not applicable for the reasons stated in #8. The device's "training" is its design, calibration, and validation processes based on quantitative chemical and electrical measurement principles, not from a data-driven learning approach. Calibration standards traceable to NIST (National Institute of Standards and Technology) are used for the actual device calibration.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2020
Diamond Diagnostics Inc. Kathy Fisher Director, Quality Assurance 333 Fiske Street Holliston, MA 01746
Re: K200544
Trade/Device Name: SmartLyte® Plus Electrolyte Analyzer Nat/K+/Cl7/Ca+/Lit Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, JGS, CGZ, JFP, JIH, JJE Dated: August 12, 2020 Received: September 1, 2020
Dear Kathy Fisher:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez- Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200544
Device Name
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Indications for Use (Describe)
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.
The SmartLyte® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SmartLyte® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. There is a graphic between the "O" and the "N" that looks like a diamond with a red blood drop on it. Underneath the word "DIAMOND" are the words "Smart Lab Solutions" in a smaller font.
510(k) 200544 Summary– SmartLyte® Plus Electrolyte Analyzer
(1) Submitted by:
Diamond Diagnostics, Inc. 333 Fiske St. Holliston, MA 01746
(2) Contact Person:
| Kathy Fisher, Director Quality Assurance | |
|---|---|
| Phone: | 508-429-0450 (x 358) |
| Fax: | 866-771-9608 |
| E-mail: | kfisher@diamonddiagnostics.com |
(3) Summary Prepared:
September 25, 2020
(4) Device Trade Name:
SmartLyte® Plus Electrolyte Analyzer Nat/K*/CIr/Ca**/Li*
(5) Regulatory Information
| Description | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Discrete photometric chemistryanalyzer for clinical use | 862.2160 | Class I | JJE |
| Sodium Test System | 862.1665 | Class II | JGS |
| Potassium Test System | 862.1600 | Class II | CEM |
| Chloride Test System | 862.1170 | Class II | CGZ |
| Calcium Test System | 862.1145 | Class II | JFP |
| Lithium Test System | 862.3560 | Class II | JIH |
(6) Predicate Devices:
| Description | 510(k) | Measurand |
|---|---|---|
| SmartLyte® (GEMLYTE) | K082462 | Sodium, Potassium, Chloride, Calcium and Lithium |
Statement of Technology Characteristics of the Device Compared to Predicate Device
| Operating Principle | Predicate Device | SmartLyte® Plus |
|---|---|---|
| Potentiometric Na+, K+, Cl-, Ca++, Li+ | K082462 | Same |
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(7) Device Description:
The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of Sodium, Potassium, Chloride, Calcium and Lithium in Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout the day or on request. Sodium. Potassium. Chloride and Calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).
The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, 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 and drug (lithium) requlations routinely conform to CLIA regulations and conduct daily quality control programs.
(8) Indications for Use:
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diuted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.
The SmartLyte® Plus Potassium Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by his device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood. Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
The SmartLyte® Plus Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
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Technological Characteristics of the Device:
(9) Measurement Principles:
The principles of measurements used in the SmartLyte® Plus Electrolyte Analyzer are identical to those principles existing in the current SmartLyte® electrolyte analyzer (K082462) and AVL 9180 (K961458) and are substantially equivalent to the K823480 (IL Flame Photometer) and K810615 (925 Chloridometer).
The SmartLyte® Plus measures sodium, potassium, chloride, calcium and lithium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium, calcium and lithium each incorporate neutral carrier ionophore membranes which are highly selective for their respective ions. The chloride contains an ionophore covalently bound to a substrate which is sensitive to negatively charged ions. The potential of each electrode is measured relative to a fixed, stablished by a silver/silver chloride electrode in concentrated salt solution. The measured potential varies with the concentration of the ion sensed by the electrode.
Comparison to Predicate Devices:
The SmartLyte® Plus software has been modified to measure samples within 30 seconds. In addition, the hardware was changed to allow saving of more than one sample or calibration result and increased QC storage capacity as well. The Hardware has also been modified to enable the instrument to have internet connection via LAN or WiFi. Moreover, an RFID board was added to the CPU board so that individual reagent packs can be monitored for fluid consumption. All other functionality has remained from the Predicate SmartLyte®
The table below compares the Candidate Device to its predicates.
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Image /page/7/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. The "O" in "DIAMOND" is replaced with a diamond shape that has a red drop inside. Below the word "DIAMOND" is the phrase "Smart Lab Solutions" in smaller, gray letters.
| Comparison to Predicate Devices | |||||
|---|---|---|---|---|---|
| Item | CANDIDATE DEVICE | PREDICATE 1 | |||
| Trade/proprietary name | Smartlyte Plus Electrolyte Analyzer | Smartlyte Electrolyte Analyzer | |||
| Model number | Na K Cl Ca Li | Na K Cl Ca Li | |||
| Manufacturer | Diamond Diagnostics Inc. | Diamond Diagnostics Inc. | |||
| 510(k)/PMA reference number | K082462 | ||||
| Intended use | Sodium, Potassium, Chloride, Calcium,Lithium determination | same | |||
| Sample Type | Blood, serum, plasma, urine | same | |||
| Measurement Principle | Ion Selective Electrodes | same | |||
| Analysis time, blood | 30 sec | 57 sec | |||
| Analysis time, Urine | 30 sec | 57 sec | |||
| Measurement Range, Blood | |||||
| Na 40 - 200 mmol/LK 1.7 - 15 mmol/LCl 50 - 200 mmol/LCa 0.3 - 5.0 mmol/LLi 0.2 - 5.5 mmol/L | same | ||||
| Measurement Range, Urine | |||||
| Na 3 - 300 mmol/LK 5 - 120 mmol/LCl 15 - 300 mmol/L | same | ||||
| Sodium: Blood, Plasma, Serum Precision | |||||
| Expected, within run CV ≤ 1 % | same | ||||
| Expected, between run CV ≤ 2 % | same | ||||
| Potassium: Blood, Plasma, Serum, Precision | |||||
| Expected, within run CV ≤ 1.5 % | same | ||||
| Expected, between run CV ≤ 3 % | same | ||||
| Chloride: Blood, Plasma, Serum Precision | |||||
| Expected, within run CV ≤ 1 % | same | ||||
| Expected, between run CV ≤ 3 % | same | ||||
| Ionized Calcium: Blood, Plasma, Serum, Precision | |||||
| Expected, within run sd ≤ 0.02 | same | ||||
| Expected, between run sd ≤ 0.06 | same | ||||
| Lithium: Blood, Plasma, Serum, Precision | |||||
| Expected, within run sd ≤ 0.03 | same | ||||
| Expected, between run sd ≤ 0.09 | same | ||||
| Sodium: Urine Precision | |||||
| Expected, within run CV ≤ 5 % | same | ||||
| Expected, between run CV ≤ 5 % | same | ||||
| Potassium: Urine Precision | |||||
| Expected, within run CV ≤ 5 % | same | ||||
| Expected, between run CV ≤ 5 % | same | ||||
| Chloride: Urine Precision | |||||
| Expected, within run CV ≤ 5 % | same | ||||
| Expected, between run CV ≤ 5 % | same | ||||
| Calibration | Automatic and on Demand | same | |||
| Standard A 350 mlStandards B and C 85 ml eachReference Solution 85 mlWaste Bag | same | ||||
| Reagent Pack | R/W RFID Tag for monitoring individualfluid pack consumption | same | |||
| QC storage | LEVELS 1, 2, 3 (500 each) | LEVELS 1, 2, 3 (500 each) | |||
| Sample Results Storage | 10000 | 1000 | |||
| Sample Data Recall | Recall by Date, Sample ID, Last Sample,All Daily, All Weekly, All | same | |||
| Output | 5" touchscreen color display16 Column thermal printer | RS-232 Serial port | 32 character, 2 line alphanumeric display | same | |
| USB Ports (4) | USB Ports (2) | ||||
| RFID Board to R/W RFID Tag | same | ||||
| Power Requirements | 100-240V 50/60Hz 1.6 A | same | |||
| Microcontroller processor | STM32F407BG | LM3S5B91 | |||
| Program Flow | Multi level menu structure | Single level menu structure |
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Image /page/8/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. To the right of the word "DIAMOND" is a graphic of a diamond shape with a drop of blood on the top left corner. Below the word "DIAMOND" is the phrase "Smart Lab Solutions" in smaller, lighter blue letters.
Calibration:
The SmartLyte® Plus performs a 2-point calibration if lithium) every 4 hours. The software also permits calibration on demand. A 1-point calibration is performed automatically with each measurement.
| Technical Specifications: | Analyzer tests samples for Na+/K+/Cl-/Ca+/Li+ | ||
|---|---|---|---|
| Sample Types: | Venous Whole Blood, Serum, Sodium Heparin Plasma, Aqueous, Urine | ||
| Sample Size: | 95µL Whole Blood, Plasma, Serum, | 180µL 1:3 dilution of Urine | |
| Measurement Range: | Parameter | Matrix | Specified range |
| Na+ | B/P/S/Q | 40 - 200 mmol/L | |
| U | 3 - 300 mmol/L | ||
| K+ | B/P/S/Q | 1.7 - 15 mmol/L | |
| U | 5 - 120 mmol/L | ||
| Cl- | B/P/S/Q | (60 - 120 mmol/L with additional dilutions)50 - 200 mmol/L | |
| U | 15 - 300 mmol/L | ||
| iCa++ | B/P/S/Q | 0.3 - 5.0 mmol/L | |
| Li+ | B/P/S/Q | 0.2 - 5.5 mmol/L |
B = Whole Blood P = Plasma S = Serum Q = Aqueous QC U = Urine
Display Resolution:
Blood, Plasma, Serum, Aqueous QC Na+: 0.1 mmol/L 0.01 mmol/L K+: Cl-: 0.1 mmol/L Catt: 0.001 mmol/L
- Lit: 0.001 mmol/L
Urine
| Na+: | 0.1 mmol/L |
|---|---|
| K+: | 0.01 mmol/L |
| Cl-: | 0.1 mmol/L |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. To the right of the "O" is a white diamond shape with a red blood drop on it. Underneath the word "DIAMOND" is the phrase "Smart Lab Solutions" in a smaller, lighter font.
Precision:
| Blood, Plasma, Serum | Na+ | K+ | Cl- | Ca++ | Li+ | ||
|---|---|---|---|---|---|---|---|
| Within Run (n=30) | C.V. ≤ 1% | C.V. ≤ 1.5% | C.V. ≤ 2% | SD ≤ 0.02 | SD ≤ 0.03 | ||
| Between Run (10 days) | C.V. ≤ 2% | C.V. ≤ 3% | C.V. ≤ 3% | SD ≤ 0.06 | SD ≤ 0.09 | ||
| Urine | |||||||
| Within Range (n=30) | C.V. ≤ 5% | C.V. ≤ 5% | C.V. ≤ 5% | ||||
| Between Run (10 days) | C.V. ≤ 5% | C.V. ≤ 5% | C.V. ≤ 5% | ||||
| Analysis Time | 30 seconds | ||||||
| Calibration | Every 4 hours, on demand2-point calibration Na+, K+, Cl-, Ca++3-point calibration Li+ |
Power
120 VAC, 5 Hz, 6 A or 220-240 VAC, 24 Hz, 2 A (Factory set)
Size and Weight
12.4" (31.5cm) W x 13.2" (33.5cm) H x 11.6" (29.5cm) D, 13 lbs. (<6 kg)
(10) Summary of nonclinical tests submitted with the premarket notification for device.
Precision - Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine.
REFERENCE
Precision was evaluated based on the following reference:
- Clinical Laboratory Standard Institute CLSI, EP5-A3 Evaluation of Quantitative Measurement ● Procedures: A Statistical Approach; Approved Guideline-3rd Edition.
Precision - Within Run
Within run precision was calculated using Venous Whole Blood, Serum, Sodium Heparin Plasma, aqueous, and Urine samples for each measurand. Anticoagulant used for collecting Venous Whole Blood and Sodium Heparin Plasma samples was Sodium Heparin. The sample concentrations were at the low and high end of reference ranges and near the mid-point range. The protocol called for unning 30 replicates of each sample without calibration between measurements. The replicates were run consecutively in one day.
| Serum/Blood/Plasma | Urine (1:3 dilution) | |
|---|---|---|
| Na+ | C.V. ≤ 1% | C.V. ≤ 5% |
| K+ | C.V. ≤ 1.5% | C.V. ≤ 5% |
| Cl- | C.V. ≤ 1% | C.V. ≤ 5% |
| Ca++ | SD ≤ 0.02 | |
| Li+ | SD ≤ 0.03 |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. To the right of the "M" is a white diamond shape with a red blood drop at the top left corner. Below the word "DIAMOND" is the text "Smart Lab Solutions" in a smaller font.
Precision – Total
Total precision was calculated for all the Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine samples with concentrations spanning the reportable range. For Sodium Heparin Plasma, Serum, and Urine, each sample was tested in duplicate over a period of 20 days. Venous Whole Blood samples were tested over a 2-hour time period on 2 instruments with a calibration at the beginning and in the middle of testing. This was done since Sodium heparin Venous Whole Blood is not stable for long periods of time. A total of 20 samples were collected from 2 instruments to achieve a total of 40 replicates
| Serum/Blood/Plasma | Urine (1:3 dilution | |
|---|---|---|
| Na+ | C.V. ≤ 2% | C.V. ≤ 5% |
| K+ | C.V. ≤ 3% | C.V. ≤ 5% |
| Cl- | C.V. ≤ 3% | C.V. ≤ 5% |
| Ca++ | SD ≤ 0.06 | |
| Li+ | SD ≤ 0.09 |
Precision Serum, mmol/L
| Within Run | Na+ | K+ | Cl- | Ca++ | Li+ | Within Run | Na+ | K+ | Cl- | Ca++ | Li+ | Within Run | Na+ | K+ | Cl- | Ca++ | Li+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 115.13 | 2.610 | 76.24 | 0.4503 | 0.5612 | Mean | 132.48 | 4.167 | 103.41 | 1.0923 | 1.1763 | Mean | 162.35 | 6.859 | 131.02 | 1.5722 | 2.2646 |
| SD | 0.95 | 0.031 | 0.47 | 0.0033 | 0.0050 | SD | 0.20 | 0.011 | 0.33 | 0.0041 | 0.0101 | SD | 0.44 | 0.035 | 0.38 | 0.0068 | 0.0220 |
| %CV | 0.82 | 1.20 | 0.62 | 0.74 | 0.89 | %CV | 0.15 | 0.27 | 0.32 | 0.37 | 0.86 | %CV | 0.27 | 0.51 | 0.29 | 0.43 | 0.97 |
| N | 30 | 30 | 30 | 30 | 30 | N | 30 | 30 | 30 | 30 | 30 | N | 30 | 30 | 30 | 30 | 30 |
| Criteria | ≤1 | ≤1.5 | ≤1 | ≤0.02 | ≤0.03 | Criteria | ≤1 | ≤1.5 | ≤1 | ≤0.02 | ≤0.03 | Criteria | ≤1 | ≤1.5 | ≤1 | ≤0.02 | ≤0.03 |
| Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass |
| Run to Run | Na+ | K+ | Cl- | Ca++ | Li+ | Run to Run | Na+ | K+ | Cl- | Ca++ | Li+ | Run to Run | Na+ | K+ | Cl- | Ca++ | Li+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 115.20 | 2.52 | 76.81 | 0.45 | 0.56 | Mean | 132.43 | 4.95 | 104.70 | 1.09 | 1.18 | Mean | 161.91 | 6.82 | 132.18 | 1.57 | 2.27 |
| SD | 1.15 | 0.04 | 1.10 | 0.00 | 0.00 | SD | 0.80 | 0.06 | 0.66 | 0.00 | 0.01 | SD | 1.42 | 0.18 | 1.41 | 0.01 | 0.02 |
| %CV | 1.00 | 1.63 | 1.44 | 0.59 | 0.88 | %CV | 0.60 | 1.20 | 0.63 | 0.27 | 0.89 | %CV | 0.87 | 2.69 | 1.07 | 0.33 | 0.88 |
| N | 40 | 40 | 40 | 40 | 40 | N | 40 | 40 | 40 | 40 | 40 | N | 40 | 40 | 40 | 40 | 40 |
| Criteria | ≤2 | ≤3 | ≤3 | ≤0.06 | ≤0.09 | Criteria | ≤2 | ≤3 | ≤3 | ≤0.06 | ≤0.09 | Criteria | ≤2 | ≤3 | ≤3 | ≤0.06 | ≤0.09 |
| Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass |
Precision Plasma, mmol/L
| Within Run | Nat | K+ | C | Ca++ | Li+ | Within Run | Na+ | K+ | Cla | Ca++ | -1+ | Within Run | Nat | K+ | Ci- | Ca++ | Li+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 108.63 | 2.533 | 83.20 | 0.5028 | 0.4120 | Mean | 135.42 | 3.327 | 107.73 | 1.3297 | 1.0684 | Mean | 167.73 | 6.885 | 140.93 | 1.6685 | 1.7837 |
| SD | 0.32 | 0.016 | 0.28 | 0.0021 | 0.0033 | SD | 0.43 | 0.015 | 0.38 | 0.0040 | 0.0194 | SD | 0.72 | 0.037 | 0.73 | 0.0077 | 0.0157 |
| %CV | 0.29 | 0.62 | 0.33 | 0.42 | 0.79 | %CV | 0.32 | 0.46 | 0.35 | 0.30 | 1.81 | %CV | 0.43 | 0.54 | 0.52 | 0.46 | 0.88 |
| N | 30 | · 30 ··· | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 | N | 30 | 30 | · 30 ··· | 30 | 30 | |
| Criteria | ਵੀ | ≤1.5 | ইঞ্জিন বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ করে বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ করে বিশ্বকাপ করে বিশ্বকাপ করে বিশ্বকাপে প্রতিষ্ঠান করে আর করে | ≤0.02 | ≤0.03 | Criteria | স | ≤1.5 | ল | ≤0.02 | ≤0.03 | Criteria | <1 | ত | ≤0.02 | ≤0.03 | |
| Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass |
| Run to Run | Nat | K+ | Cl- | Ca++ | Li+ | Run to Run | Na* | K+ | Cl- | Ca++ | 1+ | Run to Run | Na* | K+ | C - | Ca++ | Li+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 108.54 | 2.54 | 84.19 | 0.50 | 0.41 | Mean | 135.15 | 4.10 | 108.83 | 1.33 | 1.06 | Mean | 167.16 | 6.88 | 142.60 | 1.67 | 1.79 |
| SD | 0.72 | 0.03 | 1.20 | 0.00 | 0.00 | SD | 0.88 | 0.06 | 0.92 | 0.00 | 0.02 | SD | 1.58 | 0.26 | 1.66 | 0.01 | 0.01 |
| %CV | 0.66 | 1.36 | 1.42 | 0.43 | 0.84 | %CV | 0.65 | 1.53 | 0.85 | 0.24 | 1.67 | %CV | 0.94 | 3.78 | 1.17 | 0.54 | 0.73 |
| N | 40 | 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - - 40 - - - - - - - - - - - - - - - | . 40 | 40 | 40 | N | 40 | 40 | 40 | 40 - | 40 | No No and | 40 | 40 40 - 1 - 1 | 40 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | 40 | 40 |
| Criteria | ଜ | ಸಾ | રેરે | ≤0.06 | ≤0.09 | Criteria | ଜ୍ଞ | ട്ടി | दें | ≤0.06 | ≤0.09 | Criteria | <2 | র্মান্তর হয় | દર્શન દિવેલા દિવેલા દિવેલા ગુજરાત રાજ્યના તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પત્ન મહત્વના તાલુકામા | ≤0.06 | <0.09 |
| Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. The letter "O" is replaced with a diamond shape with a red drop inside. Below the word "DIAMOND" are the words "Smart Lab Solutions" in a smaller font.
CI-152.85 1.87 1.22 40 રહ Pass
Precision Whole Blood, mmol/L
| Within Run | Na+ | K+ | Cl- | Ca++ | Li+ | Within Run | Na+ | K+ | Cl- | Ca++ | Li+ | Within Run | Na+ | K+ | Cl- | Ca++ | Li+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 103.35 | 2.717 | 81.15 | 0.6546 | 0.5242 | Mean | 139.28 | 3.575 | 105.22 | 1.0664 | 0.9842 | Mean | 163.33 | 7.177 | 139.91 | 1.6935 | 1.5573 |
| SD | 0.48 | 0.032 | 0.71 | 0.0029 | 0.0036 | SD | 0.66 | 0.049 | 0.76 | 0.0157 | 0.0122 | SD | 0.96 | 0.025 | 0.85 | 0.0197 | 0.0285 |
| %CV | 0.47 | 1.19 | 0.88 | 0.45 | 0.69 | %CV | 0.47 | 1.38 | 0.72 | 1.47 | 1.24 | %CV | 0.59 | 0.35 | 0.61 | 1.16 | 1.83 |
| N | 30 | 30 | 30 | 30 | 30 | N | 30 | 30 | 30 | 30 | 30 | N | 30 | 30 | 30 | 30 | 30 |
| Criteria | ≤1 | ≤1.5 | ≤1 | ≤0.02 | ≤0.03 | Criteria | ≤1 | ≤1.5 | ≤1 | ≤0.02 | ≤0.03 | Criteria | ≤1 | ≤1.5 | ≤1 | ≤0.02 | ≤0.03 |
| Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass |
| Run to Run | Nat | K+ | Cl | Ca++ | Li+ | Run to Run | Na+ | K+ | Cl- | Ca++ | Li+ | Run to Run | Nat | K+ | C - | Ca++ | Li+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 103.10 | 2.72 | 81.75 | 0.65 | 0.52 | Mean | 139.34 | 4.36 | 106.57 | 1.07 | 0.97 | Mean | 163.18 | 7.15 | 141.54 | 1.67 | 1.52 |
| SD | 0.37 | 0.02 | 0.86 | 0.01 | 0.01 | SD | 0.53 | 0.03 | 0.84 | 0.02 | 0.01 | SD | 0.63 | 0.17 | 1.16 | 0.03 | 0.05 |
| %CV | 0.36 | 0.63 | 1.05 | 1.05 | 1.60 | %CV | 0.38 | 0.75 | 0.78 | 1.83 | 1.52 | %CV | 0.38 | 2.44 | 0.82 | 1.57 | 3.33 |
| N | 40 | 40 - | 40 40 - 40 - 40 | 40 | 40 | 40 | 40 | 40 | 40 - | 40 | 40 | 40 | 40 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | 40 - 40 - 1 | 40 | ||
| Criteria | র বাবে বাংলাদেশ করে আনা বাংলাদেশ করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আ | র্মান্তর সঙ্গে ফেরতে পারে। প্রতিষ্ঠান করে তার বিরুদ্ধে প্রতিষ্ঠান করে তার বিরুদ্ধে প্রতিষ্ঠান করে তার করে তার করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে | दें उ | ≤0.06 | ≤0.09 | Criteria | ≤2 | દર્ડિ | दें उ | ≤0.06 | 0.09 | Criteria | <2 | ଦିନ ଦିନ | র্মান্তর করে পারে। প্রারম্ভিক বিশ্বকাপের বিরুদ্ধে বিশ্বকাপের প্রায় প্রথম বিশ্বকাপের প্রায় প্রতিষ্ঠান করে বিশ্বকাপে প্রায় প্রতিষ্ঠা করে পারে। এরপর পরিবার বিরুদ্ধে প্রতিষ্ঠ | ≤0.06 | ≤0.09 |
| Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass | Status | Pass | Pass | Pass | Pass | Pass |
Precision Urine, mmol/L
| Within Run | Na+ | K+ | Cl- | Within Run | Na+ | K+ | Cl- | Within Run | Na+ | K+ | Cl- |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 62.61 | 28.811 | 90.38 | Mean | 108.92 | 46.644 | 139.83 | Mean | 248.66 | 171.262 | 151.70 |
| SD | 1.03 | 0.147 | 0.96 | SD | 0.94 | 0.121 | 0.96 | SD | 1.62 | 0.967 | 0.92 |
| %CV | 1.64 | 0.51 | 1.06 | %CV | 0.87 | 0.26 | 0.69 | %CV | 0.65 | 0.56 | 0.61 |
| N | 30 | 30 | 30 | N | 30 | 30 | 30 | N | 30 | 30 | 30 |
| Criteria | ≤5 | ≤5 | ≤5 | Criteria | ≤5 | ≤5 | ≤5 | Criteria | ≤5 | ≤5 | ≤5 |
| Status | Pass | Pass | Pass | Status | Pass | Pass | Pass | Status | Pass | Pass | Pass |
| Run to Run | Na+ | K+ | Cl- | Run to Run | Na+ | K+ | Cl- | Run to Run | Na+ | K+ | Cl- |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 67.87 | 31.01 | 90.97 | Mean | 108.77 | 46.30 | 137.34 | Mean | 250.10 | 169.93 | |
| SD | 2.69 | 1.00 | 2.44 | SD | 1.85 | 0.77 | 2.05 | SD | 2.18 | 1.44 | |
| %CV | 3.97 | 3.23 | 2.68 | %CV | 1.70 | 1.66 | 1.49 | %CV | 0.87 | 0.85 | |
| N | 40 | 40 | 40 | N | 40 | 40 | 40 | N | 40 | 40 | |
| Criteria | ≤5 | ≤5 | ≤5 | Criteria | ≤5 | ≤5 | ≤5 | Criteria | ≤5 | ≤5 | |
| Status | Pass | Pass | Pass | Status | Pass | Pass | Pass | Status | Pass | Pass |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for DIAMOND Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. To the right of the word "DIAMOND" is a graphic of a diamond shape with a red blood drop inside. Below the word "DIAMOND" is the phrase "Smart Lab Solutions" in a smaller font.
Linearity - Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine.
REFERENCE
Linearity was evaluated based on the following reference:
- . Clinical Laboratory Standard Institute – CLSI, EP6-A Evaluation of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.
Linearity was evaluated by preparing stock solutions with high concentrations of Nat, K*, Cland Ca** in pooled Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine solutions. These stocks were diluted to concentrations across the measuring ranges of each analyte and matrix. Linear regression was performed on the results using expected values based on the stock sample dilution. The results are shown below.
Serum, measured compared to Expected Values, mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.01 | 2.60 | 0.9990 | 40 - 200 | 1.82 | 48 |
| Potassium | 1.02 | 0.03 | 0.9992 | 1.7 - 15 | 0.12 | 75 |
| Chloride | 1.00 | 1.89 | 0.9991 | 50 - 200 | 1.73 | 45 |
| Calcium | 0.98 | -0.22 | 0.9939 | 0.3 - 5.0 | 0.12 | 72 |
| Lithium | 1.03 | -0.05 | 0.9995 | 0.2 - 5.5 | 0.04 | 70 |
Plasma, measured compared to Expected Values, mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.00 | 5.29 | 0.9988 | 40 - 200 | 1.99 | 75 |
| Potassium | 1.01 | 0.07 | 0.9993 | 1.7 - 15 | 0.12 | 75 |
| Chloride | 0.97 | 6.29 | 0.9997 | 50 - 200 | 0.71 | 39 |
| Calcium | 1.01 | 0.06 | 0.9970 | 0.3 - 5.0 | 0.08 | 42 |
| Lithium | 1.00 | -0.08 | 0.9983 | 0.2 – 5.5 | 0.06 | 42 |
Whole Blood, measured compared to Expected Values, mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.02 | -4.52 | 0.9986 | 40 - 200 | 2.00 | 54 |
| Potassium | 1.02 | -0.15 | 0.9990 | 1.7 - 15 | 0.14 | 69 |
| Chloride | 0.97 | 12.07 | 0.9974 | 50 - 200 | 2.61 | 42 |
| Calcium | 1.00 | -0.09 | 0.9983 | 0.3 - 5.0 | 0.07 | 52 |
| Lithium | 0.97 | 0.13 | 0.9977 | 0.2 - 5.5 | 0.07 | 39 |
Urine, measured compared to Expected Values, mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.00 | 2.83 | 0.9988 | 3 – 300 | 3.43 | 19 |
| Potassium | 1.00 | -0.48 | 0.9984 | 5 – 120 | 1.71 | 19 |
| Chloride | 1.03 | -7.24 | 0.9987 | 15 – 300 | 4.00 | 19 |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. To the right of the "M" is a white diamond shape with a red blood drop in the upper left corner. Below the word "DIAMOND" is the phrase "Smart Lab Solutions" in a smaller font.
The linearity studies support the following reportable range.
| Measuring Range Serum | Na: 40 - 200 mmol/L |
|---|---|
| K: 1.7 - 15 mmol/L | |
| Cl: 50 - 200 mmol/L | |
| Ca: 0.3 - 5.0 mmol/L | |
| Li: 0.2 - 5.5 mmol/L | |
| Measuring Range Plasma | Na: 40 - 200 mmol/L |
| K: 1.7 - 15 mmol/L | |
| Cl: 50 - 200 mmol/L | |
| Ca: 0.3 - 5.0 mmol/L | |
| Li: 0.2 - 5.5 mmol/L | |
| Measuring Range Whole Blood | Na: 40 - 200 mmol/L |
| K: 1.7 - 15 mmol/L | |
| Cl: 50 - 200 mmol/L | |
| Ca: 0.3 - 5.0 mmol/L | |
| Li: 0.2 - 5.5 mmol/L | |
| Measuring Range Urine | Na: 3 - 300 mmol/L |
| K: 5 - 120 mmol/L | |
| Cl: 15 - 300 mmol/L |
Interference –
Please refer to previous investigation carried out on predicate device SmartLyte® 510k 082462.
Traceability -
The SmartLyte® Plus Na assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST).
The SmartLyte® Plus K assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the NIST.
The SmartLyte® Plus Cl assay is traceable to a coulometric reference method, which uses reference materials from the NIST.
The SmartLyte® Plus Ca++ assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the NIST.
The SmartLyte® Plus Li+ assay is traceable flame emission spectrophotometry reference method, which uses reference materials from the NIST.
{14}------------------------------------------------
Detection Limit -
The sponsor performed a study to evaluate the limit of blank (LoB), limit of detection (LoD) and limit of quantification for ionized calcium and ionized lithium using attered Serum, Sodium Heparin Plasma, and Venous Whole Blood samples. Study samples were prepared from Serum and heparin) Venous Whole Blood and Sodium Heparin Plasma samples. Varying amounts of sodium citrate were added to some samples to bind the ionized calcium and create blank and low level samples for Ca++. Blank samples for Li+ were made by spiking (using 1M LiCl solution) or dilution of the various sample types using saline solution. All the prepared samples were analyzed on the reference analyzer (Flame Photometer SN 86011421) to obtain the target values.
| Analyte | Units | LoB | LoD | %TE | LoQ | AcceptanceCriteria for%TE | ClaimedMeasurementRange |
|---|---|---|---|---|---|---|---|
| Serum -Ca++ | mmol/L | 0.047 | 0.089 | 5.541 | 0.299 | 21.6% | 0.3 - 5.0 |
| Serum - Li+ | mmol/L | 0.041 | 0.079 | 8.501 | 0.199 | 21.6% | 0.2 - 6.0 |
| Plasma -Ca++ | mmol/L | 0.035 | 0.072 | 11.868 | 0.302 | 21.6% | 0.3 – 5.0 |
| Plasma -Li+ | mmol/L | 0.040 | 0.053 | 14.085 | 0.174 | 21.6% | 0.2 – 5.5 |
| Whole Blood- Ca++ | mmol/L | 0.043 | 0.094 | 7.393 | 0.295 | 21.6% | 0.3 - 5.0 |
| Whole Blood- Li+ | mmol/L | 0.029 | 0.077 | 6.208 | 0.204 | 21.6% | 0.2 – 5.5 |
The performance at the lower end of the measuring range for calcium and lithium is supported by the linearity studies.
(11) Summary of clinical tests
Method Comparison - Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine.
REFERENCE
Method Comparison for Serum was evaluated based on the following reference:
- Clinical Laboratory Standard Institute CLSI, EP09-A3 Measurement Procedure Comparison and Bias Estimation . Using Patient Samples; Approved Guideline 3rd Edition.
Method Comparison testing was conducted to demonstrate the correlation of Diamond Diagnostics SmartLyte® Plus Analyzer to predicate devices operated by trained personnel. Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine samples were collected for testing on the SmartLyte® Plus and the predicate device, the SmartLyte®. The anticoagulant used for all the samples was Sodium Heparin. Some samples were spiked or fully span the claimed measuring ranges. The results are summarized below. Regression analysis show good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.97 and 1.03.
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Serum Comparison SmartLyte® Plus versus SmartLyte® (K082462), mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.01 | -0.98 | 0.9960 | 42.5 - 200.7 | 1.33 | 117 |
| Potassium | 1.02 | -0.23 | 0.9972 | 1.7 - 14.9 | 0.09 | 118 |
| Chloride | 1.01 | -1.60 | 0.9958 | 50.1 - 198.5 | 1.08 | 125 |
| Calcium | 1.01 | -0.02 | 0.9963 | 0.3 - 5.0 | 0.04 | 117 |
| Lithium | 1.00 | 0.08 | 0.9939 | 0.2 - 5.3 | 0.06 | 109 |
Plasma Comparison SmartLyte®Plus versus SmartLyte® (K082462), mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.02 | -3.04 | 0.9962 | 40.6 – 198.5 | 1.40 | 110 |
| Potassium | 1.00 | -0.13 | 0.9945 | 1.8 – 14.8 | 0.13 | 125 |
| Chloride | 0.99 | 0.33 | 0.9954 | 52.7 - 200.1 | 1.24 | 118 |
| Calcium | 1.03 | -0.04 | 0.9982 | 0.3 – 4.6 | 0.03 | 113 |
| Lithium | 0.98 | 0.12 | 0.9940 | 0.2 - 5.3 | 0.05 | 122 |
Whole Blood Comparison SmartLyte® Plus versus SmartLyte® (K082462), mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.00 | 0.77 | 0.9987 | 43.7 - 198.6 | 0.67 | 109 |
| Potassium | 0.97 | -0.08 | 0.9953 | 2.1 - 14.9 | 0.10 | 109 |
| Chloride | 1.03 | -5.35 | 0.9952 | 51.4 - 197.8 | 1.16 | 108 |
| Calcium | 1.00 | 0.03 | 0.9983 | 0.3 - 5.1 | 0.02 | 112 |
| Lithium | 1.01 | 0.09 | 0.9960 | 0.2 - 5.4 | 0.05 | 110 |
Urine Comparison SmartLyte® Plus versus SmartLyte® (K082462), mmol/L
| Parameter | Slope | Intercept | R2 | Range | Steyx | n |
|---|---|---|---|---|---|---|
| Sodium | 1.01 | -2.48 | 0.9985 | 5.0 – 290.0 | 1.91 | 117 |
| Potassium | 1.03 | -0.49 | 0.9984 | 5.4 – 119.5 | 0.83 | 115 |
| Chloride | 1.00 | 2.42 | 0.9977 | 17.0 – 297.2 | 2.18 | 118 |
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Image /page/16/Picture/0 description: The image shows the logo for Diamond Smart Lab Solutions. The word "DIAMOND" is written in large, bold, blue letters. To the right of the word is a graphic of a white diamond shape with a red blood drop on it. Below the word "DIAMOND" is the phrase "Smart Lab Solutions" in smaller, gray letters.
The method comparison study supports correlation in the following reportable range.
| Measuring Range Serum | Na: | 40 - 200 mmol/L |
|---|---|---|
| K: | 1.7 - 15 mmol/L | |
| Cl: | 50 - 200 mmol/L | |
| Ca: | 0.3 - 5.0 mmol/L | |
| Li: | 0.2 - 5.5 mmol/L | |
| Measuring Range Plasma | Na: | 40 - 200 mmol/L |
| K: | 1.7 - 15 mmol/L | |
| Cl: | 50 - 200 mmol/L | |
| Ca: | 0.3 - 5.0 mmol/L | |
| Li: | 0.2 - 5.5 mmol/L | |
| Measuring Range Whole Blood | Na: | 40 - 200 mmol/L |
| K: | 1.7 - 15 mmol/L | |
| Cl: | 50 - 200 mmol/L | |
| Ca: | 0.3 - 5.0 mmol/L | |
| Li: | 0.2 - 5.5 mmol/L | |
| Measuring Range Urine | Na: | 3 - 300 mmol/L |
| K: | 5 - 120 mmol/L | |
| Cl: | 15 - 300 mmol/L |
(12) Conclusions drawn from the clinical and non-clinical testing.
Analysis of the Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine comparative measurements presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and nonclinical trials demonstrates that the Diamond Diagnostics SmartLyte® Plus Electrolyte Analyzer (with Nat, K*, Cl; Ca**, Li*) is safe, effective and substantially equivalent to the predicate devices, SmartLyte® ISE Analyzer (K082462).
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.