(212 days)
No
The summary describes a microprocessor-controlled analyzer using ion-selective electrodes for direct measurement of electrolytes. There is no mention of AI, ML, or any complex algorithms that would suggest their use. The performance studies focus on standard analytical metrics like precision, linearity, and method comparison, not metrics typically associated with AI/ML performance.
No.
This device is an in-vitro diagnostic device used to measure electrolyte levels for diagnostic purposes, not to directly treat a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism...or other diseases involving electrolyte imbalance." This directly indicates its role in diagnosing and monitoring medical conditions.
No
The device description explicitly states it is an "automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes" and is a "direct replacement for the SmartLyte® Electrolyte Analyzer (K082462)". This indicates it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in-vitro diagnostic use only."
- Nature of the Device: The device measures analytes (sodium, potassium, chloride, calcium, lithium) in biological samples (Serum, Plasma, Whole Blood, Urine). This is the core function of an in vitro diagnostic device.
- Purpose of Measurements: The measurements obtained are used to "monitor electrolyte balance in the diagnosis and treatment of..." various diseases and conditions. This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that the analysis is performed "in-vitro, and neither the analyzer nor any of its components come in contact with the patient." This is a key characteristic of an IVD.
N/A
Intended Use / Indications for Use
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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
CEM, JGS, CGZ, JFP, JIH, JJE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by laboratory trained technicians in clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Precision - Within Run:
- Sample size (N): 30 replicates of each sample.
- Data source: Venous Whole Blood, Serum, Sodium Heparin Plasma, aqueous, and Urine samples. Anticoagulant used for collecting Venous Whole Blood and Sodium Heparin Plasma samples was Sodium Heparin.
- Annotation protocol: Samples were at low, high, and mid-range concentrations. Replicates were run consecutively in one day without calibration between measurements.
Precision – Total:
- Sample size (N): 20 days for Sodium Heparin Plasma, Serum, and Urine (each in duplicate); 20 samples from 2 instruments over a 2-hour period for Venous Whole Blood (total 40 replicates).
- Data source: Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine samples with concentrations spanning the reportable range.
- Annotation protocol: For Sodium Heparin Plasma, Serum, and Urine, each sample was tested in duplicate over 20 days. Venous Whole Blood samples were tested over a 2-hour period on 2 instruments with calibration at the beginning and middle of testing.
Detection Limit:
- Data source: Altered Serum, Sodium Heparin Plasma, and Venous Whole Blood samples. Samples prepared from Serum and heparin Venous Whole Blood and Sodium Heparin Plasma. Blank samples for Ca++ created by adding sodium citrate to bind ionized calcium. Blank samples for Li+ made by spiking (1M LiCl solution) or diluting samples with saline solution.
- Annotation protocol: All prepared samples were analyzed on the reference analyzer (Flame Photometer SN 86011421) to obtain target values.
Method Comparison:
- Data source: Venous Whole Blood, Serum, Sodium Heparin Plasma and Urine samples. Anticoagulant used was Sodium Heparin. Some samples were spiked or spanned the claimed measuring ranges.
- Annotation protocol: Samples were tested on the SmartLyte® Plus and the predicate device, the SmartLyte®.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision - Within Run:
- Study type: Precision study
- Sample size: 30 replicates per sample
- Key results:
- Serum/Blood/Plasma: Na+ C.V. ≤ 1%, K+ C.V. ≤ 1.5%, Cl- C.V. ≤ 1%, Ca++ SD ≤ 0.02, Li+ SD ≤ 0.03. All studies passed criteria.
- Urine: Na+, K+, Cl- C.V. ≤ 5%. All studies passed criteria.
Precision – Total (Run to Run):
- Study type: Precision study
- Sample size: 40 replicates (or 20 days for Serum/Plasma/Urine, 20 samples/2 instruments for Whole Blood)
- Key results:
- Serum/Blood/Plasma: Na+ C.V. ≤ 2%, K+ C.V. ≤ 3%, Cl- C.V. ≤ 3%, Ca++ SD ≤ 0.06, Li+ SD ≤ 0.09. All studies passed criteria.
- Urine: Na+, K+, Cl- C.V. ≤ 5%. All studies passed criteria.
Linearity:
- Study type: Linearity study
- Key results: Supports the claimed measuring ranges for Serum, Plasma, Whole Blood, and Urine with R2 values mostly >= 0.99 for all parameters. All parameters and matrices showed good linearity.
Detection Limit:
- Study type: Detection Limit study
- Key results: LoB, LoD, LoQ values were determined for Ca++ and Li+ in Serum, Plasma, and Whole Blood, with %TE values below the 21.6% acceptance criterion.
Method Comparison:
- Study type: Method Comparison study
- Key results: Regression analysis comparing SmartLyte® Plus to SmartLyte® (K082462) showed good correlation with correlation coefficients (R2) typically greater than 0.99 and slope values between 0.97 and 1.03 for Serum, Plasma, Whole Blood, and Urine across all parameters. The study supports the claimed reportable ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Key metrics reported are precision (CV, SD), R2, Slope, Intercept, Steyx, LoB, LoD, LoQ.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 chemistry | |||
| analyzer 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/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 | same | ||||
| Measurement Range, Urine | |||||
| Na 3 - 300 mmol/L | |||||
| K 5 - 120 mmol/L | |||||
| Cl 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 ml | |||||
| Standards B and C 85 ml each | |||||
| Reference Solution 85 ml | |||||
| Waste Bag | same | ||||
| Reagent Pack | R/W RFID Tag for monitoring individual | ||||
| fluid 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 display | ||||
| 16 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 |
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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 demand | ||||||
| 2-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. (