(163 days)
No
The description focuses on microprocessor control and ion-selective electrodes, with no mention of AI or ML.
No
This device is an analyzer used for measuring various electrolytes in biological samples, providing diagnostic information rather than directly treating a condition.
Yes
The device measures levels of various analytes (sodium, potassium, chloride, calcium, lithium) in bodily fluids, and these measurements are specifically stated to be "used in the diagnosis and treatment of diseases conditions" or various specific diseases (e.g., aldosteronism, diabetes insipidus, cystic fibrosis, parathyroid disease, manic-depressive illness). This direct application to diagnosis and guiding treatment classifies it as a diagnostic device.
No
The device description explicitly states it is an "automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes". This indicates the presence of hardware components beyond just software.
Yes
N/A
Intended Use / Indications for Use
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte 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 GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte 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 GemLyte Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. 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 GemLyte 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 GemLyte 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 and prediluted urine samples. GemLyte analyzer is designed with the user in mind, it is fully automated with simple .Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (less than a minute for samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. 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
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
Not Found
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
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Summary of Performance Studies
Nonclinical tests for precision and linearity were submitted.
Precision:
- Within-Run Precision: Determined for blood, serum, and urine samples (30 replicates each) within a single period without recalibration. Standard deviation (SD) and Coefficient Variation (%CV) calculated. Results were within performance specifications and not different from the predicate device (AVL 9180, K961458).
- Blood/Plasma/Serum: Na+ C.V. ≤0.6%, K+ C.V. ≤1.5%, Cl- C.V. ≤1%, Ca++ SD ≤0.02, Li+ SD ≤0.04
- Urine (1:10 dilution): Na+ C.V. ≤5%, K+ C.V. ≤5%, Cl- C.V. ≤2%
- Between-Run or Total Precision: Determined by testing 2 runs per day (AM & PM) with 2 replicates per run for 10 days for each sample type. SD and/or %CV calculated. Results were similar to predicate device (AVL 9180, K961458) and within specifications.
- Serum/Blood/Serum: Na+ C.V. ≤1.5%, K+ C.V. ≤3%, Cl- C.V. ≤3%, Ca++ SD ≤0.06, Li+ SD ≤0.09
- Urine (1:3 dilution): Na+ C.V. ≤4%, K+ C.V. ≤5%, Cl- C.V. ≤3%
- Note: For whole blood potassium, a total imprecision test was conducted using multiple instruments (4) over an hour due to instability of potassium in whole blood.
Linearity:
- Whole blood, plasma, serum, and urine were linear across the claimed performance range.
- A minimum of 5 levels were tested for each sample type.
- Dilutions were made from starting stock solutions and regression analysis was performed.
- Correlation coefficients were all greater than 0.99.
Clinical tests were conducted to demonstrate correlation to predicate devices.
Correlation Studies:
- Studies compared Diamond GEMLYTE to Roche 9180 using whole blood, plasma, serum, and spot urine samples.
- Regression analysis showed good correlation to predicate devices for all sample types with correlation coefficients typically greater than 0.99.
- Key results (Slope, Intercept, R², Range, n, Steyx for whole blood, plasma, and serum; Slope, Intercept, R2, Range, n, Stey for urine):
- Whole Blood (mmol/L):
- Sodium: Slope 0.988, Intercept 1.04, R² 0.9962, Range 42.3 - 188.1, n 128, Steyx 1.13
- Potassium: Slope 0.972, Intercept 0.223, R² 0.9957, Range 1.51 - 14.46, n 112, Steyx 0.16
- Chloride: Slope 1.011, Intercept -0.49, R² 0.9882, Range 54.0 - 191.4, n 123, Steyx 1.76
- Calcium: Slope 0.994, Intercept 0.019, R² 0.9885, Range 0.304 - 4.514, n 124, Steyx 0.07
- Lithium: Slope 0.983, Intercept -0.049, R² 0.9919, Range 0.255 - 5.410, n 123, Steyx 0.079
- Plasma (mmol/L):
- Sodium: Slope 0.987, Intercept 0.87, R² 0.9977, Range 43.5 - 194.4, n 105, Steyx 1.06
- Potassium: Slope 1.006, Intercept -0.014, R² 0.9973, Range 1.55 - 13.97, n 107, Steyx 0.178
- Chloride: Slope 1.022, Intercept -3.23, R² 0.9879, Range 55.2 - 193.2, n 115, Steyx 2.58
- Calcium: Slope 0.971, Intercept 0.042, R² 0.9915, Range 0.363 - 4.386, n 123, Steyx 0.059
- Lithium: Slope 0.993, Intercept 0.002, R² 0.9878, Range 0.298 - 5.071, n 115, Steyx 0.092
- Serum (mmol/L):
- Sodium: Slope 0.99, Intercept 0.03, R² 0.9964, Range 44.6 - 196.9, n 122, Steyx 1.37
- Potassium: Slope 0.981, Intercept 0.085, R² 0.9979, Range 1.58 - 14.64, n 127, Steyx 0.118
- Chloride: Slope 1.021, Intercept -2.57, R² 0.9687, Range 50.7 - 185.7, n 125, Steyx 3.79
- Calcium: Slope 0.970, Intercept 0.036, R² 0.9842, Range 0.655 - 4.309, n 120, Steyx 0.082
- Lithium: Slope 1.004, Intercept 0.092, R² 0.9876, Range 0.213 - 5.149, n 131, Steyx 0.122
- Urine (Spot) (mmol/L):
- Sodium: Slope 0.983, Intercept -2.57, R2 0.9843, Range 8 - 296, n 118, Stey 8.42
- Potassium: Slope 0.965, Intercept 0.34, R2 0.9934, Range 5.3 - 118.2, n 108, Stey 2.22
- Chloride: Slope 0.976, Intercept -1.86, R2 0.9807, Range 15 - 272, n 118, Stey 8.99
- Whole Blood (mmol/L):
Key Metrics
Not Found
Predicate Device(s)
K961458, K000926, K823480, K810615
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOr2462
FEB - 6 2009
5. 510(k) Summary – GemLyte Electrolyte Analyzer
(1) Submitted by:
Diamond Diagnostics 333 Fiske St. Holliston, MA 01746
(2) Contact Person:
Liann Voo, Director of Quality Assurance and Scientific Development 508-429-0450 (x 351) Phone: 508-429-0452 Fax: lvoo@diamonddiagnostics.com E-mail:
(3) Summary Prepared:
August 25, 2008
(4) Device Trade Name:
GemLyte Electrolyte Analyzer Na*/K*/CI'/Ca**/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 |
| Calcium Test System | 862.1145 | Class II | JFP |
| Lithium Test System | 862.3560 | Class II | JIH |
(6) Predicate Devices:
| Description | 510(k) | Analytes |
|---|---|---|
| AVL9180 | K961458 | Sodium, Potassium, Chloride, Calcium and Lithium |
| IL 943 Flame Photometer | K823480 | Sodium, Potassium, Chloride |
| EasyLyte | K000926 | Sodium, Potassium, Chloride |
| 925 Chloridometer | K810615 | Chloride |
Statement of Technology Characteristics of the Device Compared to Predicate Device
| Operating Principle | Predicate Device | GemLyte |
|---|---|---|
| Potentiometric | ||
| Na+, K+, Cl-, Ca++, Li+ | K000926 | |
| K961458 | Same |
1
(7) Device Description and Indications for Use:
The GemLyte 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 and prediluted urine samples. GemLyte analyzer is designed with the user in mind, it is fully automated with simple .Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (less than a minute for samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. 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.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, serum, plasma, and urine on the GemLyte 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 GemLyte Sodium Assay is intended to measure sodium in serum, plasma, and urine on the GemLyte 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 GemLyte Chloride Assay is intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The GemLyte Calcium Assay is intended to measure the total calcium level in serum. 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 GemLyte Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in serum or plasma. 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) Technological Characteristics of the Device: Principal of Measurement
The principles of measurements used in the GemLyte Analyzer are identical to those principles existing in the electrolyte analyzers K000926 (EasyLyte) and K961458 (AVL 9180) and are substantially equivalent to the K823480 (IL Flame Photometer) and K810615 (925 Chloridometer)
2
Calibration:
The GemLyte performs a 2-point calibration (3-point calibration if lithium) every 4 hours or software permits calibration on demand. A 1-point calibration is performed automatically with each measurement.
Analyzer tests samples for Na*/K*/CI/Ca*/Li* Technical Specifications:
| Sample Types: | Whole Blood, Serum, Plasma or Urine |
|---|---|
| --------------- | -------------------------------------------- |
Sample Size: 95uL blood, plasma, serum 95uL 1:3 dilution of urine
| Measurement Range: Parameter | Matrix | Specified range | |
|---|---|---|---|
| Na+ | B/P/S/Q | 40 - 200 mmol/L | |
| U | 1 - 300 mmol/L | ||
| K+ | B/P/S/Q | 1.5 - 15 mmol/L | |
| U | 5 - 120 mmol/L | ||
| Cl- | B/P/S/Q | 50 - 200 mmol/L | |
| U | 1 - 300 mmol/L | ||
| iCa++ | B/P/S/Q | 0.3 - 5 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+: 0.1 mmol/L or Cli: 0.1 mmol/L 0.01 mmol/L Ca**: 0.1 mmol/L or 0.01 mmol/L Li : 0.1 mmol/L Or
Urine
Na*: 0 mmol/L / K*: 0.1 mmol/L . Cli: 0 mmol/L
Reproducibility:
| Blood, Plasma, Serum | |||||
|---|---|---|---|---|---|
| Na+ | K+ | Cl- | Ca++ | Li+ | |
| Within Range (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
| Na+ | K+ | Cl- | |
|---|---|---|---|
| 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% |
3
Analysis Time Calibration
57 seconds Every 4 hours on demand 2 point calibration Na ,K+,CI¯,Ca** 3 point calibration Li*
Power
5 Hz, 6 A or 120 VAC 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. ( Trade Name: GemLyte Electrolyte Analyzer Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Codes: JGS, CEM, CGZ, JFP, JIH Dated: January 27, 2009 Received: January 28, 2009
Dear Ms. Voo:
1
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
C
Courthey C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics Device Evaluation and Safety Center for Devices and Radiological Health
7
510(k) Number (if known): K082462 Device Name: GemLyte Electrolyte Analyzer Indication For Use:
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte 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 GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte 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 GemLyte Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. 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 GemLyte 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).
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
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 Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082462