(128 days)
No
The description focuses on the use of ion-selective electrodes and a microprocessor for automated analysis, with no mention of AI or ML.
No.
The device is an in-vitro diagnostic device used to measure levels of Sodium, Potassium, Chloride, and Lithium in patient samples to aid in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The device measures patient analytes (Sodium, Potassium, Chloride, Lithium) in clinical samples to aid in the diagnosis and treatment of various conditions, and the intended use explicitly states "For In Vitro Diagnostic Use".
No
The device is described as a bench-top analyzer that utilizes ion-selective electrodes and fluid packs, indicating 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:
- Explicit Statement: The document explicitly states "It is For In Vitro Diagnostic Use."
- Intended Use: The intended use clearly describes the device as being used in a clinical laboratory setting by laboratory professionals to analyze patient samples (whole blood, serum, plasma, and urine) in-vitro (outside the body) to aid in the diagnosis and treatment of various medical conditions related to electrolyte imbalance and lithium levels.
- Device Description: The device description reinforces that the analysis is performed in-vitro and that the analyzer and its components do not come into contact with the patient.
- Sample Types: The device analyzes biological samples (whole blood, serum, plasma, urine) which are typical for IVD devices.
- Clinical Context: The results obtained from the device are used to aid in the diagnosis and treatment of patients, which is a core function of IVD devices.
N/A
Intended Use / Indications for Use
The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
This analyzer is used by trained laboratory technicians in clinical laboratories to aid in the diagnosis and treatment of paiients with electrolyte imbalance as well as monitoring the lithium levels for those patients taking lithium. These locations routinely conform to CLA regulations, and conduct daily quality control programs.
The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride and lithium in whole blood, plasma, serum, and urine samples.
The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na 7K 7CI/Li. 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 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 PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na */K */C//Li. 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 PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na*/K*/Cl'/Li. 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).
It is For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
JIH, JGS, CEM, CGZ
Device Description
The PROLYTE Electrolyte Analyzer Na*/K'/Cl/Li* is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer Na K * (K102959). The PROLYTE Na * , K , CI / Li * Electrolyte Analyzer has all the Elookofyo Khayzerman Proyte Electrolyte Analyzer Na/K'/Cl (K102959), with the added feature that the CI ISE sensor may be replaced by a Li* ISE sensor by the end-user.
The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Lif is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, plasma, and serum of patients. Sodium, Potassium, and Chloride are also assessed in urine of patients. The analysis and scrum of pairons. Ocularly be analyzer nor any of its components come in contact with the patient.
This bench top analyzer is used by trained laboratory technicians in clinical laboratories to aid in the ring bonen top and freatment of patients with electrolyte imbalance as well for the monitoring drug levels in those patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.
It uses the Diamond Diagnostics Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration along with a flush solution and a waste container. The analyzer can be programmed to self-calibrate at set intervals or on request. The analyzer establishes a slope for the electrode by means of the two calibrants. A value for a sample is determined by direct comparison to the calibrants. Mission Controls (K033063) are the recommended quality control material to be used daily.
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
Clinical laboratory professionals by trained laboratory 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
Precision:
Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).
Lithium precision was calculated with results from five whole blood, plasma and serum samples.
For within run precision: 30 replicates of each sample without calibration between measurements were collected. The replicates were run consecutively in one day.
Total precision (run to run): Determined by measuring the plasma and serum samples twice each morning and twice each afternoon for ten days, resulting in 40 replicates. Whole blood total precision was conducted in a single day due to the instability of blood. For whole blood, four groups of 10 replicates separated by a calibration was collected. Lithium demonstrated precision within the limits defined in the reference range, 0.3 to 2.0 mEq/L.
Linearity:
Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).
Linearity for Lithium was evaluated by preparing stock solution with a high concentration of Li+ in whole blood, plasma, and serum. The stock was diluted serially (20%) to concentrations across the measuring ranges of each analyte and matrix. Linear regression was performed using expected values based on the stock sample dilution.
Results for Lithium Linearity (Measured compared to Expected Values, mEq/L):
Whole blood: Slope = 0.9854, Intercept = -0.0285, R2 = 0.9979, Range = 0.15 - 5.5, n = 100
Plasma: Slope = 0.9985, Intercept = -0.0315, R2 = 0.9997, Range = 0.1 - 5.9, n = 38
Serum: Slope = 1.0068, Intercept = 0.019, R2 = 0.9998, Range = 0.1 - 5.7, n = 44
The linearity studies support the reportable range for Li+: 0.15 - 5.0 mEq/L in Whole Blood, Plasma, Serum.
Clinical tests:
Method comparison to predicate device (GEMLYTE, K082462) was performed with whole blood, plasma, serum patient samples. Some samples were spiked or diluted to fully span the claimed measuring range.
Results for PROLYTE Li versus Predicate, GEMLYTE (K082462) in Various Matrices, Lithium mEq/L:
Whole Blood: Slope = 1.0096, Intercept = 0.0719, R2 = 0.9947, Range = 0.15 - 5.0, n = 94
Plasma: Slope = 0.9806, Intercept = 0.1292, R2 = 0.9971, Range = 0.16 - 5.0, n = 100
Serum: Slope = 0.9977, Intercept = 0.0133, R2 = 0.9881, Range = 0.17 - 4.7, n = 91
The method comparison studies support correlation in the reportable range of Li+: 0.15 - 5.0 mEq/L for Whole Blood, Plasma, Serum.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
KIZIIYO
5. 510(k) Summary- PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+
(1) Submitted by:
Diamond Diagnostics 333 Fiske St. Holliston, MA 01746
(2) Contact Person:
Kathy Cruz, Quality Assurance Manager 508-429-0450 (x358) Phone: 508-429-0452 Fax: kcruz@diamonddiagnostics.com E-mail:
(3) Summary Prepared:
April 13, 2012
(4) Device Trade Name:
PROLYTE Electrolyte Analyzer Na*/K*/CI/Li*
(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 |
| Lithium Test System | 862.3560 | Class II | JIH |
Panel: Chemistry, 75
(6) Predicate Device:
| Description | 510(k) | Analytes |
|---|---|---|
| GEMLTYE Electrolyte Analyzer Na+/K+/Cl- | ||
| Ca2+/Li+ | K082462 | Sodium, Potassium, Chloride, |
| Calcium, Lithium |
Statement of Technology Characteristics of the Device Compared to Predicate Device:
| Operating Principle | Predicate Device | PROLYTE |
|---|---|---|
| Potentiometric Na+, K+, Cl-, Li+ | ||
| Electrodes | K070104 | SAME |
(7) Device Description:
The PROLYTE Electrolyte Analyzer Na*/K'/Cl/Li* is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer Na K * (K102959). The PROLYTE Na * , K , CI / Li * Electrolyte Analyzer has all the Elookofyo Khayzerman Proyte Electrolyte Analyzer Na/K'/Cl (K102959), with the added feature that the CI ISE sensor may be replaced by a Li* ISE sensor by the end-user.
The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Lif is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, plasma, and serum of patients. Sodium, Potassium, and Chloride are also assessed in urine of patients. The analysis and scrum of pairons. Ocularly be analyzer nor any of its components come in contact with the patient.
This bench top analyzer is used by trained laboratory technicians in clinical laboratories to aid in the ring bonen top and freatment of patients with electrolyte imbalance as well for the monitoring drug levels in those
AUG 2222012
1
patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.
It uses the Diamond Diagnostics Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration along with a flush solution and a waste container. The analyzer can be programmed to self-calibrate at set intervals or on request. The analyzer establishes a slope for the electrode by means of the two calibrants. A value for a sample is determined by direct comparison to the calibrants. Mission Controls (K033063) are the recommended quality control material to be used daily.
(8) Intended Use:
a. Intended use(s):
The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
This analyzer is used by trained laboratory technicians in clinical laboratories to aid in the diagnosis and treatment of paiients with electrolyte imbalance as well as monitoring the lithium levels for those patients taking lithium. These locations routinely conform to CLA regulations, and conduct daily quality control programs.
b. Indication(s) for use:
The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride and lithium in whole blood, plasma, serum, and urine samples.
The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na 7K 7CI/Li. 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 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 PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na */K */C//Li. 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 PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na*/K*/Cl'/Li. 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).
It is For In Vitro Diagnostic Use.
(9) Technological Characteristics of the Device:
Measurement Principles:
The principles of measurement used in the PROLYTE Electrolyte Analyzer Na "K"/CI/Li" are identical to those principles existing in the predicate electrolyte analyzers GEMLYTE (K082462) and PROLYTE (K102959).
The PROLYTE Electrolyte Analyzer Na*/K'/Cl'/Li* measures sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine (except lithium), using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium and lithium electrodes incorporate a neutral carrier ionophore membrane. The chloride
2
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 Device:
The PROLYTE Na*, K*, Cl*, Li* Electrolyte Analyzer is an analyzer that has all the features of the Diamond Prolyte Nat, K*, Cl Electrolyte Analyzer (K102959), but the Cl ISE sensor may be replaced by a Li* ISE sensor by the end-user. This is similar to the second predicate device, GEMLYTE Na ', K ', Cl , Ca2* , Li* Electrolyte Analyzer (K082462) where the CI ISE sensor may be replaced by a Li* or Ca* ISE sensor by the end-user.
The default configuration of the PROLYTE Na*, K*, Cli, Li* Electrolyte Analyzer is Na* - K* - Cli. The user can select Li* under the Operator Functions menu in the same manner as the selection is made in the predicate, GEMLYTE. Moreover, the Fluid Pack (K031159) used for calibration, flushing and waste storage is the same as the predicate PROLYTE device and the candidate device. To simplify operation of the PROLYTE, the menu structure was modified to be similar to SMARLT YE where there is a single menu level. The predicate PROLYTE had a Main Menu that could step into a Second Menu for certain functions.
Comparison Table below shows primary similarities and differences between the candidate device and the predicate devices.
3
| Comparison to Predicate Device | |||
|---|---|---|---|
| Item | CANDIDATE DEVICE | PREDICATE | |
| Trade/proprietary name | PROLYTE ELECTROLYTE ANALYZER | GEMLYTE | |
| Model number | Na K Cl Li | Na K Cl Ca Li | |
| Manufacturer | Diamond Diagnostics Corp | Diamond Diagnostics Corp | |
| 510(k)/PMA reference number | K082462 | ||
| Intended use | Sodium, Potassium, Chloride, Lithium determination | Also has Calcium | |
| Sample Type | Blood, serum, plasma, urine | Same | |
| Measurement Principle | Ion Selective Electrodes | Same | |
| Analysis time, blood | 59 sec | 57 sec | |
| Analysis time, Urine | 69 sec | 57 | |
| Measurement Range, Blood | |||
| Na | 45 - 205 mEq/L | 40 - 200 mEq/L | |
| K | 1.5 - 11 mEq/L | 1.7 - 15 mEq/L | |
| Cl | 45 - 205 mEq/L | 50 - 200 mEq/L | |
| Li | 0.15 - 5.0 mEq/L | 0.2 - 5.5 mEq/L | |
| Measurement Range, Urine | |||
| Na | 25 - 1020 mEq/L | 3 - 300 mEq/L | |
| K | 10 - 505 mEq/L | 5 - 120 mEq/L | |
| Cl | 25 - 505 mEq/L | 15 - 300 mEq/L | |
| 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 | = 2 % | ≤ 1.5 % | |
| Expected, between run CV | = 2.5 % | ≤ 3 % | |
| Chloride: Blood, Plasma, Serum Precision | |||
| Expected, within run CV | = 2 % | ≤ 1 % | |
| Expected, between run CV | = 2.5 % | ≤ 3 % | |
| 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 | = 2.5 % | ≤ 5 % | |
| Expected, between run CV | = 5 % | ≤ 5 % | |
| Potassium: Urine Precision | |||
| Expected, within run CV | = 2.5 % | ≤ 5 % | |
| Expected, between run CV | = 5 % | ≤ 5 % | |
| Chloride: Urine Precision | |||
| Expected, within run CV | = 2.5 % | ≤ 5 % | |
| Expected, between run CV | = 5 % | ≤ 5 % | |
| Calibration | Automatic and on Demand | Same | |
| Reagent Pack | 800 ml Fluid Pack | 350 ml Fluid Pack | |
| QC storage | LEVELS 1, 2, 3 (500 each) | QC Levels 1, 2, 3 results, total 35 | |
| Sample Results Storage | 1000 | Last Sample | |
| Sample Data Recall | Recall by Date and Sample ID added | Last Sample | |
| Output | 32 character, 2 line alphanumeric display | Same | |
| 40 column thermal printer | 16 Column thermal printer | ||
| RS-232 Serial port | Same | ||
| Power Requirements | 100-240V 50/60Hz 1.6 A | Same | |
| Microcontroller processor | Microchip dsPIC33FJ256 | Freescale 68HC16 | |
| Within Run | Run to Run | ||
| Li+ | S.D. ≤ 0.03 | ≤ 0.09 | (0.3 – 2.0 mEq/L) |
・
.
4
(10) Summary of non-clinical tests:
Precision - Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).
Lithium precision was calculated with results from five whole blood, plasma and serum samples. The sample concentrations were at the reportable limits as well as low and high end of reference ranges and near the mid point range. For within run precision, 30 replicates of each sample without callbration between measurements were collected. The replicates were run consecutively in one day
Total precision was determined by measuring the plasma and serum samples twice each morning and twice each afternoon for ten days resulting in 40 replicates. Whole blood total precision was conducted in a single day due to the instability of blood. For whole blood, four groups of 10 replicates separated by a calibration was collected. Lithium demonstrated precision within the limits defined below in the reference range, 0.3 to 2.0 mEq/L..
The tables below show the precision results.
| Whole Blood, mEq/L | |||||
|---|---|---|---|---|---|
| WITHIN RUN | V Low | Low | Mid | High | V High |
| Mean | 0.216 | 0.607 | 1.035 | 1.727 | 4.153 |
| SD | 0.010 | 0.008 | 0.009 | 0.010 | 0.030 |
| %CV | 4.76 | 1.24 | 0.82 | 0.57 | 0.72 |
| N | 30 | 30 | 30 | 30 | 30 |
| Spec, BLD | 0.03 | 0.03 | 0.03 | 0.03 | 0.03 |
| PASS/FAIL | P | P | P | P | P |
| RUN TO RUN | V Low | Low | Mid | High | V High |
| Mean | 0.227 | 0.607 | 1.031 | 1.740 | 4.171 |
| SD | 0.014 | 0.009 | 0.010 | 0.009 | 0.036 |
| %CV | 6.31 | 1.56 | 0.95 | 0.52 | -0.85 |
| N | 40 | 40 | 40 | 40 | 40 |
| Spec, BLD | 0.09 | 0.09 | 0.09 | 0.09 | 0.09 |
| PASS/FAIL | P | P | P | P | P |
Plasma, mEg/L
| Within Run | V Low | Low | Mid | High | V High |
|---|---|---|---|---|---|
| Mean | 0.32130 | 0.62003 | 1.09253 | 2.29560 | 4.41513 |
| SD | 0.00531 | 0.00482 | 0.00308 | 0.01336 | 0.06310 |
| %CV | 1.65 | 0.78 | 0.28 | 0.58 | 1.43 |
| N | 30 | 30 | 30 | 30 | 30 |
| Spec, BLD | 0.03 | 0.03 | 0.03 | 0.03 | 0.03 |
| PASS/FAIL | P | P | P | P | F |
| Run to Run | V Low | Low | Mid | High | V High |
| Mean | 0.32668 | 0.62789 | 1.09495 | 2.28523 | 4.37893 |
| SD | 0.01462 | 0.00682 | 0.00666 | 0.02444 | 0.06651 |
| %CV | 4.47 | 1.09 | 0.61 | 1.07 | 1.52 |
| N | 40 | 44 | 40 | 40 | 41 |
| Spec, BLD | 0.09 | 0.09 | 0.09 | 0.09 | 0.09 |
| PASS/FAIL | P | P | P | P | P |
5
Carlim mCall
| Within Run | V Low | Low | Mld | High | V High |
|---|---|---|---|---|---|
| Mean | 0.25563 | 0.59367 | 1.05813 | 1.99907 | 4.30820 |
| SD | 0.00844 | 0.00646 | 0.00445 | 0.01166 | 0.04239 |
| %CV | 3.30 | 1.09 | 0.42 | 0.58 | 0.98 |
| N | 30 | 30 | 30 | 30 | 30 |
| Spec, BLD | 0.03 | 0.03 | 0.03 | 0.03 | 0.03 |
| PASS/FAIL | P | P | P | P | F |
| Run to Run | V Low | Low | Mid | High | V High |
| Mean | 0.2928 | 0.5956 | 1.0610 | 2.0073 | 4.3562 |
| SD | 0.0280 | 0.0164 | 0.0074 | 0.0425 | 0.0824 |
| %CV | 9.56 | 2.76 | 0.70 | 2.12 | 1.89 |
| N | 40 | 40 | 40 | 40 | 40 |
| Spec, BLD | 0.09 | 0.09 | 0.09 | 0.09 | 0.09 |
Linearity - Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).
Linearity was evaluated by preparing stock solution with a high concentration of Lit in whole blood, plasma, and serum. The stock was diluted serially (20%) to concentrations across the measuring ranges of each analyte and matrix. Linear regression was performed using expected values based on the stock sample dilution. The results are shown below.
Lithium Linearity, Measured compared to Expected Values, mEq/L
| Parameter | Slope | Intercept | R2 | Range | n |
|---|---|---|---|---|---|
| Whole blood | 0.9854 | -0.0285 | 0.9979 | 0.15 - 5.5 | 100 |
| Plasma | 0.9985 | -0.0315 | 0.9997 | 0.1 - 5.9 | 38 |
| Serum | 1.0068 | 0.019 | 0.9998 | 0.1 - 5.7 | 44 |
The linearity studies support the following reportable range.
and the state of the same of the same of the same of the same
| Measuring Range Whole Blood, Plasma, Serum | Li+: 0.15 - 5.0 mEq/L |
|---|---|
| -------------------------------------------- | ----------------------- |
(11) Summary of clinical tests submitted with the pre-market notification for the device.
Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).
Method comparison to predicate device was performed with whole blood, plasma, serum patient samples. Some samples were spiked or diluted to fully span the claimed measuring range. The results are summarized below.
PROLYTE Li versus Predicate, GEMLYTE (K082462) in Various Matrices, Lithium mEq/L
| Parameter | Slope | Intercept | R² | Range | n |
|---|---|---|---|---|---|
| Whole Blood | 1.0096 | 0.0719 | 0.9947 | 0.15 - 5.0 | 94 |
| Plasma | 0.9806 | 0.1292 | 0.9971 | 0.16 - 5.0 | 100 |
| Serum | 0.9977 | 0.0133 | 0.9881 | 0.17 - 4.7 | 91 |
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The method comparison studies support correlation in the reportable range.
| Measuring Range Whole Blood, Plasma, Serum | Li+: 0.15 - 5.0 mEq/L |
|---|---|
| Acres of consisted as a longer company of the first of the first of the first of the consisted | |
| Continues on a program annual consideration of the proportion of the property and |
(12) Conclusions drawn from the clinical and non-clinical testing.
Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical trails demonstrates that the Diamond Diagnostics PROLYTE Electrolyte Analyzer lithium test system is safe, effective and substantially equivalent to its predicate device, the GEMLYTE (K082462).
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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered horizontally in the image. There is a logo to the left of the text.
10903 New Hampshire Avenue Silver Spring, MD 20993
Diamond Diagnostics, Inc. c/o Kathy Cruz, Quality Assurance Manager 333 Fiske St. Holliston, MA 01746
Re: K121140
Trade Name: PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ Regulation Number: 21 CFR §862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Codes: JIH, JGS, CEM, CGZ Dated: July 24, 2012 Received: July 31, 2012
Dear Ms. Cruz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
V
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (k) Number (if known): 长 (2 (1 4 ວ
Device Name: PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li*
Indication For Use:
The PROLYTE Electrolyte Analyzer Na*/K'/CI/Li* is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, chloride and lithium in whole blood, plasma, and serum. Sodium, potassium, and chloride can be measured in urine samples.
The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/CI/Li*. 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 PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electroive Analyzer Na '/K'/C//Li*. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/CT/Li*. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na TK YCI /Lif. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of palients with mental disturbances, such as manic-depressive illness (bipolar disorder).
Prescription Use × And/Or (21 CFR Part 801 Subpart D)
Over the
(21 CFP
Over the Counter Use (21 CFR Part 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)
Ruel C. Wilson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k). K 121140
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