(147 days)
No
The description focuses on ion-selective electrode technology and microprocessor control, with no mention of AI or ML. The performance studies are standard analytical chemistry validations.
No.
This device is an in-vitro diagnostic (IVD) analyzer used to measure electrolytes in body fluids, which aids in diagnosis and treatment monitoring but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that measurements obtained by this device are used "in the diagnosis and treatment" of various diseases involving electrolyte imbalance.
No
The device description explicitly states it is an "automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes" and mentions hardware components like the analyzer itself and fluid packs. This indicates it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is used for the "measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples" and "sodium, chloride and calcium in dialysate samples." These are all biological samples taken from the human body.
- Purpose of Measurements: The intended use also details how these measurements are used in the "diagnosis and treatment" of various diseases and conditions involving electrolyte imbalance, metabolic disorders, parathyroid disease, bone diseases, chronic renal disease, tetany, and monitoring drug dosage for mental disturbances. This clearly indicates the device is used for medical purposes related to diagnosing and managing health conditions.
- Device Description: The device description confirms it's an "automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes" to perform these measurements on biological samples and quality control materials.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.
The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE 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 Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. 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 Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. 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 Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. 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).
Product codes
JGS, CEM, CGZ, JFP, JIH
Device Description
The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, 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, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Non-clinical tests:
Within run precision was calculated from three dialysate samples for each measurand. The sample concentrations were at the low and high end of reference ranges and near the mid point range. The protocol called for running 30 replicates of each sample without calibration between measurements. The replicates were run consecutively in one day.
Total precision was calculated for 3 samples with concentrations spanning the reportable range. The dialysate samples were run in groups of 10, with a calibration between each group of 10 replicates. This procedure was adopted due to the inherent instability of Calcium in the carbonate/bicarbonate environment which would result in Ca shifts.
Linearity was evaluated by preparing stock solutions with high concentrations of Na , CI and Ca in dialysate. 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. See "Summary of nonclinical tests submitted with the premarket notification for device".
Clinical tests:
Clinical testing was conducted to demonstrate the correlation of Diagnostics SMARTLYTE Analyzer to predicate devices operated by trained personnel. Dialysates were collected for testing on the SMARTLYTE and the predicate device, the Roche 9180. Some samples were spiked or diluted to fully span the claimed measuring ranges. See "Summary of clinical tests".
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
Precision study for Dialysate:
Within Run (n=30):
Na+: C.V. ≤ 1%
K+: C.V. ≤ 2%
Cl-: C.V. ≤ 2%
Ca++: SD ≤ 0.02
Between Run (for 3 samples with concentrations spanning the reportable range):
Na+: C.V. ≤ 2%
K+: C.V. ≤ 3%
Cl-: C.V. ≤ 3%
Ca++: SD ≤ 0.06
Linearity study for Dialysate (Measured compared to Expected Values for Sodium, Potassium, Chloride, Calcium):
Sodium: Slope 0.9806, Intercept 2.53, R2 0.9995, Range 24 – 205 (mV), Stevx 1.12, n=34
Potassium: Slope 1.0031, Intercept -0.37, R2 0.9976, Range 1.4 - 15.1 (mEq/L), Stevx 0.20, n=36
Chloride: Slope 0.9996, Intercept 1.60, R2 0.9998, Range 40 - 202 (mEq/L), Stevx 0.74, n=34
Calcium: Slope 0.9857, Intercept 0.06, R2 0.9972, Range 0.4 - 5.0 (mmol/L), Stevx 0.07, n=48
Clinical tests:
Method Comparison (SMARTLYTE versus AVL 9180 (K961458)) for Dialysate:
Sodium: Slope 1.0183, Intercept -2.52, R 0.9989, Range 49 – 179, n=43, Styx 1.31
Potassium: Slope 0.9882, Intercept 0.04, R 0.9996, Range 1.5 - 14, n=56, Styx 0.08
Chloride: Slope 0.9825, Intercept 2.86, R 0.9966, Range 52 - 199, n=51, Styx 2.25
Calcium: Slope 1.0021, Intercept 0.03, R 0.9956, Range 0.25 - 4.5, n=43 (implied from row), Styx 0.08
Key results: Regression analysis show good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04. The method comparison study supports correlation in the following reportable range: Na: 40 - 205 mEq /L, K: 1.7 - 11 mEq /L, Cl: 50 - 205 mEg /L, Ca: 0.3 - 5.5 mmol/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
K082462, K013850, K033063, K823480, K810615
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
(1) Submitted by:
Diamond Diagnostics 333 Fiske St. Holliston, MA 01746
(2) Contact Person:
Liann Voo, Director of Quality Assurance and Scientific Development Phone: 508-429-0450 (x 351) Fax: 508-429-0452 lvoo@diamonddiagnostics.com E-mail:
(3) Summary Prepared:
March 26, 2012
(4) Device Trade Name:
SMARTLYTE Electrolyte Analyzer
(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 |
| Calcium Test System | 862.1145 | Class II | JFP |
| Lithium Test System | 862.3560 | Class II | JIH |
(6) Predicate Devices:
| Description | 510(k) | Measurand |
|---|---|---|
| AVL 9180 | K961458 | Sodium, Potassium, Chloride, Calcium and Lithium |
Statement of Technology Characteristics of the Device Compared to Predicate Device
| Operating Principle | Predicate Device | SMARTLYTE |
|---|---|---|
| Potentiometric Na+, K+, Cl-, Ca++, Li+ | K961458 | Same |
(7) Indications for Use:
The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.
The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE 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 Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. 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.
AUG 3 0 2012
1
The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. 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 Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. 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).
(8) Device Descriptions:
The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, 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, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out 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.
(9) Technological Characteristics of the Device:
Principal of Measurement
The principles of measurements used in the SMARTLYTE 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 measures sodium, potassium, chloride and calcium in dialysate using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium and calcium 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, stable reference established 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 software has been modified to add a Dialysate mode. In addition the hardware was changed to allow saving of more than one sample or calibration result and increased QC storage capacity as well. 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 unchanged from the Predicate SMARTLTYE. The Dialysate Mode added is similar to the 9180 Bicarbonate Dialysate Mode.
The table below compares the Candidate Device to its predicates.
2
| Candidate Device | Predicate | |
|---|---|---|
| Trade/proprietary name | Diamond Electrolyte Analyzer | Roche Electrolyte Analyzer |
| Model number | SMARTLYTE | 9180 |
| Manufacturer | Diamond Diagnostics Corp | Roche Diagnostics GmBh |
| 510(k)/PMA reference number | K961458 | |
| Intended use | Sodium, Potassium, Chloride, Calcium, Lithium | |
| Determination | Same | |
| Sample Type | Blood, serum, plasma, urine, aqueous QC, Dialysate | Also has Acetate Dialysate Mode |
| Measurement Principle | Ion Selective Electrodes | Same |
| Analysis time | 57 sec | Same |
| Measurement Range, Whole Blood, Plasma, Serum, Dialysate | Na 40 - 200 mEq/L | |
| K 1.7 - 15 mEq/L | ||
| Cl 50 - 200 mEq/L | ||
| Ca 0.3 - 5 mmol/L | ||
| Li 0.2 - 5.5 mEq/L | 40 - 205 mEq/L | |
| 1.5 - 15 mEq/L | ||
| 50 - 200 mEq/L | ||
| 0.2 - 5.0 mmol/L | ||
| 0.1 - 6.0 mEq/L | ||
| Measurement Range, Urine | Na 3 - 300 mEq/L | |
| K 5 - 120 mEq/L | ||
| Cl 15 - 300 mEq/L | 1 - 300 mEq/L | |
| 4.5 - 120 mEq/L | ||
| 1 - 300 mEq/L | ||
| Expected, within run CV | ≤ 1 % | ≤ 1 % |
| Expected, between run CV | ≤ 2 % | ≤ 1 % |
| Expected, within run CV | ≤ 1.5 % | ≤ 2 % |
| Expected, between run CV | ≤ 3 % | ≤ 3 % |
| Expected, within run CV | ≤ 1 % | ≤ 1 % |
| Expected, between run CV | ≤ 3 % | ≤ 1 % |
| Expected, within run sd | ≤ 0.02 | ≤ 0.02 |
| Expected, between run sd | ≤ 0.06 | ≤ 0.04 |
| Expected, within run sd | ≤ 0.03 | ≤ 0.02 |
| Expected, between run sd | ≤ 0.09 | ≤ 0.08 |
| Urine Precision, Na | ||
| Expected, within run CV | ≤ 5 % | Same |
| Expected, between run CV | ≤ 5 % | ≤ 7 % |
| Urine Precision, K | ||
| Expected, within run CV | ≤ 5 % | Same |
| Expected, between run CV | ≤ 5 % | Same |
| Urine Precision, Cl | ||
| Expected, within run CV | ≤ 5 % | Same |
| Expected, between run CV | ≤ 5 % | Same |
| Calibration | Automatic and on Demand | Same |
| Reagent Pack | Standard A 350 ml | |
| Standard B 85 ml | ||
| Standard C 85 ml | ||
| Reference Solution 85 ml | ||
| Waste bag | ||
| R/W RFID Tag for monitoring individual fluid pack | ||
| consumption | ||
| No RFID Tag | ||
| Results Storage | Measurement results, 1000 | |
| QC Levels 1, 2, 3 results, each 500 | ||
| Calibration Results, 5 | Measurement results, 1 | |
| QC Levels 1, 2, 3 results, total 35 | ||
| Calibration Results, 1 | ||
| Output | 32 character, 2 line alphanumeric display | |
| thermal printer | ||
| RS-232 Serial port | ||
| USB ports (2) | ||
| RFID Board to R/W RFID Tag | Same | |
| Same | ||
| Same | ||
| Power | 100-115 - VAC 50-60 Hz, 0.8 A | |
| or | Same | |
| Same | ||
| 220-VAC 50/60 Hz, 0.4 A | Same |
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Calibration:
The SMARTLYTE performs a 2-point calibration (3-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: Whole Blood, Serum, Plasma, Urine; Dialysate - .
Sample Size: 95uL blood, plasma, serum, dialysate 95uL 1:3 dilution of urine .
| Measurement Range: | Parameter Matrix | Specified range |
|---|---|---|
| Na+ | ||
| B/P/S/D/Q | 40 - 200 mEq/L | |
| U | 1 - 300 mEq/L | |
| K+ | ||
| B/P/S/D/Q | 1.5 - 15 mEq/L | |
| U | 5 - 120 mEq/L | |
| (60 - 120 mEq/L with additional dilutions) | ||
| Cl- | ||
| B/P/S/D/Q | 50 - 200 mEq/L | |
| U | 1 - 300 mEq/L | |
| iCa++ | ||
| B/P/S/D/Q | 0.3 - 5 mmol/L | |
| Li+ | ||
| B/P/S/Q | 0.2 - 5.5 mEq/L |
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| B = Whole blood | P = Plasma | S = Serum |
|---|---|---|
| Q = Aqueous QC | U = Urine | D = Dialysate |
Display Resolution:
Blood, Plasma, Serum, Dialysate, Aqueous QC
| Na+: 0.1 mEq/L |
|---|
| K+: 0.1 mEq/L or 0.01 mEq/L |
| Cl-: 0.1 mEq/L |
| Ca++: 0.1 mmol/L or 0.01 mmol/L |
| Li+: 0.1 mEq/L or 0.01 mEq/L |
Urine
Na*: 0 mEq/L K*: 0.1 mEq/L Cl. 0 mEq/L
4
Reproducibility:
| Blood, Plasma, Serum, Dialysate | Kt | ||||||
|---|---|---|---|---|---|---|---|
| Within Range (n=30) | |||||||
| Between Run (10 days) | Na | ||||||
| C.V. ≤ 1% | |||||||
| C.V. ≤ 2% | C.V. ≤ 1.5% | ||||||
| C.V. ≤ 3% | Cl. | ||||||
| C.V. ≤ 2% | |||||||
| C.V. ≤ 3% | Ca** | ||||||
| SD ≤ 0.02 | |||||||
| SD |