(226 days)
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No
The summary describes a standard wet chemistry analyzer and its performance characteristics. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of analytes in serum, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes," and "Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance," and "Potassium measurements are used in monitoring electrolyte balance and in the diagnosis and treatment of diseases/conditions characterized by low or high blood potassium levels," and "Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders." These phrases strongly indicate that the device is intended for diagnostic purposes. Additionally, the text explicitly states, "It is for in vitro diagnostic use."
No
The device description explicitly details a physical analyzer unit with hardware components such as incubation rotors, photometer, carousels, probes, and an ISE module, in addition to the operations computer and screen. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "for the in vitro quantitative determination of Glucose in serum" and "for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum". It also mentions that these measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders including diabetes" and "diseases involving electrolyte imbalance". This clearly indicates the device is intended for testing biological samples (serum) outside of the body (in vitro) to provide information for diagnosis and treatment.
- Device Description: The description refers to the device as a "Clinical Chemistry Analyzer" and states it is "designed for the qualitative and quantitative analyses of various diagnostic test systems." It also explicitly states "It is for in vitro diagnostic use."
- Intended User/Care Setting: The system is intended for use in "clinical laboratories," which is a typical setting for IVD devices.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diatron Glucose Hexokinase Method is for the in vitro quantitative determination of Glucose in serum for use with Diatron Pictus 700 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes.
Diatron ISE is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum on the Diatron Pictus 700 Chemistry Analyzer. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used in monitoring electrolyte balance and in the diagnosis and treatment of diseases/conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Diatron Pictus 700 Clinical Chemistry Analyzer is a wet-chemistry analyzer for the direct determination of sodium, potassium, chloride and glucose concentrations in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. It is for in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
CFR, JGS, CEM, CGZ, JJE
Device Description
The Pictus 700 Clinical Chemistry Analyzer is an automatic, floor-standing, wet chemistry system, designed for the qualitative and quantitative analyses of various diagnostic test systems. This premarket notification is for the direct quantitative measurements of Na (sodium), K (potassium), CI (chloride) and glucose in serum samples. Additionally, other types of chemistry assays may be performed on the analyzer, provided that suitable colorgenerating reactions or reactions with variation of color are used. The system is intended for use in clinical laboratories.
The instrument consists of an analyzer unit and an operations computer with a screen that allows the user to input commands for system operation and data display. The analyzer unit includes two temperature-controlled incubation rotors and a multi-wavelength photometer, a cooled carousel for loading barcoded sample tubes or micro cups and reagent cartridges, and two probes that deliver reagents and samples to the incubation rotors and the ISE measurement flow cell. The analyzer unit also houses containers for wash solution and waste. An ISE module, installed on the analyzer unit, is used to measure sodium, potassium and chloride ionic activity in serum.
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
Clinical lab
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Limits of detection/functional sensitivities:
- For the glucose assay, conventional LoB/D/Q testing was performed according to CLSI EP17-A2; the LoQ was measured as 7 mg/dL.
- For functional sensitivity, normal sample pools were serially diluted nine times in 10% increments (total of 10 samples), and, 5 replicates per dilution were measured for each test system. Mean values of results were calculated for each dilution, and were compared to the calculated ion activities or glucose concentrations. The highest dilution (lowest concentration) with less than 10 %CV was compared to the low linearity claim. Acceptable results were those where the highest dilution concentration was lower than, or equal to, the low-end linearity claim.
- Sodium: The 1:9 dilution, resulting in sodium ion activity of 27.6 mmol/L, corresponded to a %CV of 3.02%; therefore, the low end claim of linearity of 110 mmol/L was verified.
- Potassium: At all dilutions, the %CVs were substantially lower than the 10% maximum. Even at the 1:10 dilution, resulting in potassium ion activity of 1.05 mmol/L, the CV was 0.00%; therefore, the low end claim of linearity from 1.0 mmol/L was verified.
- Chloride: The 1:9 dilution, resulting in chloride ion activity of 14.8 mmol/L, corresponded to a %CV of 3.02%; therefore, the low end claim of linearity from 50 mmol/L was verified.
- Glucose: Testing the neat sample, depleted of Glucose y standing > 24 hrs exposed to red cells in the sample draw. The LOQ CV was 1.3%. This verified the low end LOD and LOQ claim of 7 mg/dL.
Linearity:
Eleven levels of each analyte were tested. The samples were assigned their reference values arithmetically from the labeled values and were tested in duplicate by the Pictus 700. The mean Pictus (y-axis) were plotted against the assigned values (x-axis).
Acceptance Criteria: Sodium: +/- 10% and or +/- 5 mmol/L; Potassium +/- 10% and or +/- 1.0 mmol/L; Chloride: +/- 10% and or +/- 5 mmol/L; Glucose: +/- 10% and or +/- 5 mg/dL.
- Sodium- The assay is linear from 13 mmol/L to 196 mmol/L. The claimed range will be 115 to 196 mmol/L.
- Potassium- The assay is linear from 0.9 to 12.8 mmol/L. The claimed range will be 1.1 to 8.8 mmol/L.
- Chloride- The assay is linear from 41 mmol/L to 200 mmol/L. The claimed range will be 49 mmol/L to 152 mmol/L.
- Glucose- The assay is linear from 13 mg/dL to 632 mg/dL. The claimed range will be 13 to 500 mg/dL.
Precision:
Following CLSI EP5-A2, control samples (low, middle, and high levels) were tested in duplicate, twice a day, for 20 days, for a total of 80 results per level. The results were tabulated and the data were analyzed for means and percent coefficient of variation (%CVs).
- Sodium:
- Low Level (126 mmol/L): Within-run %CV 0.6%, Total %CV 0.9%
- Med. Level (143 mmol/L): Within-run %CV 0.5%, Total %CV 1.4%
- High Level (159 mmol/L): Within-run %CV 0.7%, Total %CV 1.0%
- Potassium:
- Low Level (3.4 mmol/L): Within-run %CV 0.00%, Total %CV 1.05%
- Med. Level (4.5 mmol/L): Within-run %CV 0.00%, Total %CV 1.65%
- High Level (5.8 mmol/L): Within-run %CV 0.78%, Total %CV 1.41%
- Chloride:
- Low Level (87 mmol/L): Within-run %CV 0.6%, Total %CV 0.9%
- Med. Level (98 mmol/L): Within-run %CV 0.5%, Total %CV 1.2%
- High Level (109 mmol/L): Within-run %CV 0.5%, Total %CV 0.8%
- Glucose:
- Low Level (45 mg/dL): Within-run %CV 1.6%, Total %CV 3.2%
- Med. Level (92 mg/dL): Within-run %CV 0.9%, Total %CV 3.0%
- High Level (309 mg/dL): Within-run %CV 1.2%, Total %CV 3.1%
Interferences:
The study evaluated increasingly higher levels of: bilirubin, hemoglobin, and triglycerides for all parameters. A two-level control set with low and high levels of each analyte was spiked to seven or eight levels (depending on the interferent) and the spiked samples plus the neat samples were tested in duplicates by the Pictus 700 using its standard operating procedure; the results were averaged. In each case, the spiked sample result mean was compared to its neat (zero interferent) mean result, and recoveries were calculated.
- Sodium: Hemolysis (600 mg/dL), Lipemia (2500 mg/dL), Bilirubin (24 mg/dL) all ≤ 10 % Change or ≤ 3 mmol/L.
- Potassium: Do not use hemolyzed serum, Lipemia (2500 mg/dL), Bilirubin (24 mg/dL) all ≤ 10 % Change or ≤ 3 mmol/L.
- Chloride: Hemolysis (600 mg/dL), Lipemia (2500 mg/dL), Bilirubin (24 mg/dL) all ≤ 10 % Change or ≤ 3 mmol/L.
- Glucose: Hemolysis (600 mg/dL), Lipemia (700 mg/dL), Bilirubin (12 mg/dL) all ≤ 10 % Change or ≤ 3 mmol/L.
Method Comparisons:
Clinical specimens (n = 69, 69, 69, and 136 for sodium, chloride, and glucose, respectively), spanning the dynamic ranges, were assayed in singleton and in a blinded fashion by the Pictus 700 (y-axis) and the predicate system. The specimens were previously-collected serum samples that had been stored frozen and then thawed prior to analysis. Deming regression analysis data:
- Sodium (N=69): Correlation Coefficient (r) 0.995, Slope (95% CIs) 1.002 (0.978 to 1.027), Intercept -1.02 (-4.7 to 2.2).
- Potassium (N=69): Correlation Coefficient (r) 0.998, Slope (95% CIs) 0.999 (0.984-1.014), Intercept 0.02 (-0.05 to 0.09).
- Chloride (N=69): Correlation Coefficient (r) 0.997, Slope (95% CIs) 1.015 (0.996 to 1.035), Intercept -1.90 (-3.9 to 0.1).
- Glucose (N=136): Correlation Coefficient (r) 0.999, Slope (95% CIs) 0.993 (0.987 to 1.000), Intercept 1.2 (-0.1 to 2.4).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
January 14, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DIATRON US, INC. C/O ERIKA AMMIRATI PRESIDENT 575 SHIRLYNN COURT LOS ALTOS CA 94022
Re: K151487 Trade/Device Name: Diatron ISE. Diatron Glucose Hexokinase Method Diatron Pictus 700 Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JGS, CEM, CGZ, JJE Dated: November 30, 2015 Received: December 1, 2015
Dear Erika Ammirati:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For:
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151487
Device Name Diatron Glucose Hexokinase Method Diatron ISE Diatron Pictus 700 Clinical Chemistry Analyzer
Indications for Use (Describe)
Diatron Glucose Hexokinase Method is for the in vitro quantitative determination of Glucose in serum for use with Diatron Pictus 700 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes.
Diatron ISE is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum on the Diatron Pictus 700 Chemistry Analyzer. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used in monitoring electrolyte balance and in the diagnosis and treatment of diseases/conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Diatron Pictus 700 Clinical Chemistry Analyzer is a wet-chemistry analyzer for the direct determination of sodium, potassium, chloride and glucose concentrations in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. It is for in vitro diagnostic use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Diatron Group logo. The logo features a blue abstract shape on the left, followed by the word "Diatron" in a combination of green and blue. Below "Diatron" is the word "GROUP" in green. A green arc is above the word Diatron.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K151487.
| 807.92 (a)(1): Name: | Diatron, US, Inc. |
|---|---|
| Address: | 2304 W 78th Street |
| Hialeah, FL 33016 | |
| Phone: | 877-684-1139 |
| FAX: | 913-344-9958 |
| Contact: | Mr. Frank Matusazak |
807.92 (a)(2): Device name- trade name and common name, and classification
Diatron ISE, Diatron Glucose Hexokinase Method Trade Name: Diatron Pictus 700 Clinical Chemistry Analyzer
Common Name: Routine chemistry analyzer for glucose, and ISE technology for sodium, potassium, and chloride
Classification Name(s):
21 CFR § 862.1345- Glucose test system
21 CFR § 862.1665- Sodium test system
21 CFR § 862.1600- Potassium test system
21 CFR § 862.1170- Chloride test system
21 CFR § 862.2160- Discrete photometric chemistry analyzer for clinical use
807.92 (a)(3): Identification of the legally marketed predicate devices
Diatron Pictus 400 – K101741
807.92 (a)(4): Device Description
The Pictus 700 Clinical Chemistry Analyzer is an automatic, floor-standing, wet chemistry system, designed for the qualitative and quantitative analyses of various diagnostic test systems. This premarket notification is for the direct quantitative measurements of Na (sodium), K (potassium), CI (chloride) and glucose in serum samples. Additionally, other types of chemistry assays may be performed on the analyzer, provided that suitable colorgenerating reactions or reactions with variation of color are used. The system is intended for use in clinical laboratories.
The instrument consists of an analyzer unit and an operations computer with a screen that allows the user to input commands for system operation and data display. The analyzer unit includes two temperature-controlled incubation rotors and a multi-wavelength photometer, a cooled carousel for loading barcoded sample tubes or micro cups and reagent cartridges, and two probes that deliver reagents and samples to the incubation rotors and the ISE measurement flow cell. The analyzer unit also houses containers for wash solution and waste. An ISE module, installed on the analyzer unit, is used to measure sodium, potassium and chloride ionic activity in serum.
2304-10 West 78th Street
Hialeah, Fl 33016
4
Image /page/4/Picture/0 description: The image shows the logo for Diatron Group. The logo features a blue abstract shape on the left, followed by the word "Diatron" in green. Below "Diatron" is the word "GROUP" in green. A green arc is above and to the right of the word "Diatron".
System operation:
After a sample tube or cup is placed into the carousel, and appropriate reagents have been installed and properly calibrated, the operator programs a test request. The analyzer pipettes reagent(s) and the sample, at appropriate volumes and times dictated by the test application stored in the analyzer memory, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator, the analyzer measures the absorbance of the test solution at wavelengths dictated by the test application. and, based on the absorbance readings, it calculates the concentration of analyte in the sample using appropriate mathematical formulas dictated by the test application. The test system can measure analytes in serum and results are available in approximately 2 minutes for the electrolyte tests and 10 minutes for glucose determinations.
Chemistry reactions:
Sodium, Potassium and Chloride.
The ISE module measures sodium, potassium, and chloride in serum using ion-selective electrode technology. The electrodes are flow-through and use selective membranes, especially formulated to be sensitive to sodium, potassium, and chloride ions. The electric potential of each electrode is measured relative to a fixed, stable voltage established by a double-junction silver/silver chloride reference electrode. The voltage developed varies with the concentration of the corresponding ion logarithmically, as expressed by the Nernst equation.
The method of measurement is comparative. First, the ISE module measures the potentials developed when the sample is positioned in front of the electrodes. Next, Calibrant A is positioned in front of the electrodes. The difference between the two potentials is related logarithmically to the concentration of the measured ions in the sample, divided by their respective concentrations in the calibrant solution. Since the difference in potentials and the concentration of the sodium, potassium, and chloride ions in the calibrant solution are known, the computer can calculate the concentration of the ions in the sample.
Glucose:
The concentration of glucose in serum is performed enzymatically, according to the hexokinase method, based on the following reactions: b.D-glucose in the sample reacts with adenosine triphosphate (ATP) under the catalytic action of hexokinase, to produce glucose 6phosphate and adenosine diphosphate (ADP). Glucose 6-phosphate consequently reacts with oxidized nicotinamide-adenine nucleotide (NAD') to produce D-gluconic acid 6-phosphate and reduced nicotinamide-adenine nucleotide (NADH), under the catalytic action of glucose-6-phosphate dehydrogenase (G-6PDH).
The reduced nucleotide (NADH) absorbs strongly at 340 nm, whereas its oxidized form (NAD+) does not. The difference in absorbance between the final reading and the blank, monitored bichromatically at 340 nm and 380 nm, is directly proportional to the concentration of b,D-glucose in the sample. The analyzer photometer reads the absorbance at 340 nm and 380 nm at time intervals dictated by the glucose application stored in the analyzer memory, and the change in absorbance is calculated automatically.
2304-10 West 78th Street
Hialeah, Fl 33016
5
Image /page/5/Picture/0 description: The image shows the Diatron Group logo. The logo features a blue water droplet-like shape on the left, followed by the word "Diatron" in a combination of green and blue colors. The word "GROUP" is written in smaller blue letters below "Diatron". A green arc is above the word Diatron.
807.92 (a)(5): Intended Use
Diatron Glucose Hexokinase Method is for the in vitro quantitative determination of Glucose in serum for use with Diatron Pictus 700 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes.
Diatron ISE is for the in vitro quantitative determination of Sodium (Na+), and Chloride (Cl-) concentrations in serum on the Diatron Pictus 700 Chemistry Analyzer. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used in monitoring electrolyte balance and in the diagnosis and treatment of diseases/conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Diatron Pictus 700 Clinical Chemistry Analyzer is a wet-chemistry analyzer for the direct determination of sodium, potassium, chloride and glucose concentrations in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. It is for in vitro diagnostic use.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| Characteristic | Candidate System (K151487)
Diatron Pictus 700 Analyzer | Predicate System
Pictus 400, K101741 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------|
| Instrument Platform | Pictus 700 | Pictus 400 |
| Mode of Detection | Photometric | Same |
| Photometric Detector | Photodiode | Same |
| Optical Modes | Monochromatic, Bi-chromatic, | Same |
| Analytical Measure | Endpoint and kinetic with
sample blanking | Same |
| Wavelengths | 340, 380, 405, 450, 490, 505, 550,
590, 620, 650, 700, 750 | 330, 405, 450, 505, 550, 570, 600,
650, 700 |
| # of Photometer Filters | 12 | 9 |
| Linear Absorbance Range | -0.1 to 3.6 | Same |
| Photometric Tests/Hour | 600 | 280 |
| Reagent Volume Range | 180 to 700 microliters | Same |
| Reagents On-board Capacity | 72 | 48 |
| Sample On-board Capacity | 95 | 48 |
| Device Class, Regulation Code,
Product Code | Class I, 21 CFR 862.2160 (discrete
photometric chemistry analyzer), JJE | Same |
| ISE Test System, Glucose System | | |
| Device Class, Regulation Code | Class II,
Sodium- 21 CFR 862.1665
Potassium- 21 CFR 862.1600
Chloride- 21 CFR 862.1170 | Same |
The following chart describes similarities and differences between the two test systems.
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Image /page/6/Picture/0 description: The image shows the logo for Diatron Group. The logo features a blue abstract shape on the left, followed by the word "Diatron" in green. Below "Diatron" is the word "GROUP" in blue. A green arc is above and to the right of the word "Diatron".
| Diatron Pictus 700 Analyzer
Characteristic | | Predicate-
Pictus 400, K101741 | |
|-----------------------------------------------|------------------------------------------------------------------------|-----------------------------------|--|
| | Sodium- JGS | | |
| | Potassium- CEM | Same | |
| Classification Product Code | Chloride- CGZ | | |
| | Glucose- CFR | | |
| | Quantitative determinations of | | |
| Intended Use | sodium, potassium, and chloride
using ion selective electrodes, and | Same | |
| | glucose by photometry in serum. | | |
| | | | |
| Testing Environment | Clinical lab | Same | |
| | | | |
| | ISE potentiometry (electrolytes) and | Same | |
| Test Principle | photometry (glucose) | | |
| Specimen Type | Human serum | Human serum, plasma, or urine | |
| Method Comparisons | Sodium-0.995 (69, 120-181) | Sodium-0.986 (41, 116-189) | |
| (Correlation coefficients, | Potassium-0.998 (69, 1.7-8.7) | Potassium-0.980 (46, 2.1-8.4) | |
| # of Samples, Testing Ranges) | Chloride-0.997 (69, 55-134) | Chloride-0.991 (46, 61-151) | |
| [mmol/L: ISE, mg/dL: glucose] | Glucose - 0.999 (136, 26 to 484) | Glucose - 0.976 (62, 28-499) | |
| | Sodium- 115-196 mmol/L | Sodium- 115-196 mmol/L | |
| Linearity/Reportable Ranges | Potassium- 1.1-8.8 mmol/L | Potassium- 1.1 to 8.8 mmol/L | |
| | Chloride- 49-152 mmol/L | Chloride- 49-152 mmol/L | |
| | Glucose- 13-500 mg/dL | Glucose 10-500 mg/dL | |
| Sensitivity-Detection Limits | Sodium- 27.6 mmol/L @ 3.02%CV | N/A | |
| (ISE Functional Sensitivity. | Potassium-1.05 mmol/L @ 0%CV | N/A | |
| Glucose- standard LOB/LOD) | Chloride- 14.8 mmol/L @ 3.02%CV | N/A | |
| | Glucose 7 mg/dL @ 2.6%CV | N/A | |
| | %CV Ranges | %CVs Ranges: | |
| Within-run Precision | Sodium- 0.4 to 0.5%CV | Sodium- 0.50 to 1.06 %CV | |
| (across 3 levels- low, middle, high) | Potassium-0.00 to 0.78 %CV | Potassium- 0.99 to 1.15 %CV | |
| | Chloride-0.5 to 0.6 %CV | Chloride- 0.60 to 1.50 %CV | |
| | Glucose-0.9 to 1.6 %CV | Glucose- 0.50 to 1.00%CV | |
| | %CV Ranges | %CVs ranges: | |
| | Sodium-0.9-1.4 %CV | Sodium- 0.40 to 0.65 %CV | |
| Between-run (Total) Precision | Potassium-1.05-1.65 %CV | Potassium- 0.40 to 2.00 %CV | |
| | Chloride- 0.8-1.2 %CV | Chloride- 0.73 to 1.49 %CV | |
| | Glucose- 3.0-3.2 %CV | Glucose- 1.40 to 4.50 %CV | |
807.92 (b)(1): Brief Description of Nonclinical Data
Limits of detection/functional sensitivities:
For the glucose assay, conventional LoB/D/Q testing was performed according to CLSI EP17-A2; the LoQ was measured as 7 mg/dL.
For functional sensitivity, normal sample pools were serially diluted nine times in 10% increments (total of 10 samples), and, 5 replicates per dilution were measured for each test system. Mean values of results were calculated for each dilution, and were compared to the calculated ion activities or glucose concentrations. The highest dilution (lowest concentration) with less than 10 %CV was compared to the low linearity claim. Acceptable results were those where the highest dilution concentration was lower than, or equal to, the low-end linearity claim.
Hialeah, Fl 33016
7
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Sodium: Functional Sensitivity
The 1:9 dilution, resulting in sodium ion activity of 27.6 mmol/L, corresponded to a %CV of 3.02%; therefore, the low end claim of linearity of 110 mmol/L was verified.
Potassium: Functional Sensitivity
At all dilutions, the %CVs were substantially lower than the 10% maximum. Even at the 1:10 dilution, resulting in potassium ion activity of 1.05 mmol/L, the CV was 0.00%; therefore, the low end claim of linearity from 1.0 mmol/L was verified.
Chloride: Functional Sensitivity
The 1:9 dilution, resulting in chloride ion activity of 14.8 mmol/L, corresponded to a %CV of 3.02%; therefore, the low end claim of linearity from 50 mmol/L was verified.
Glucose: EP protocol. LOB/LOD/LOQ - Glucose depleted samples
Testing the neat sample, depleted of Glucose y standing > 24 hrs exposed to red cells in the sample draw. The LOQ CV was 1.3%. This verified the low end LOD and LOQ claim of 7 mg/dL.
Linearity:
Eleven levels of each analyte were tested. The samples were assigned their reference values arithmetically from the labeled values and were tested in duplicate by the Pictus 700. The mean Pictus (y-axis) were plotted against the assigned values (x-axis). The acceptance criteria are described below.
Acceptance Criteria: Sodium: +/- 10% and or +/- 5 mmol/L Potassium +/- 10% and or +/- 1.0 mmol/L Chloride: +/- 10% and or +/- 5 mmol/L Glucose: +/- 10% and or +/- 5 mg/dL
Sodium- The assay is linear from 13 mmol/L to 196 mmol/L. The claimed range will be 115 to 196 mmol/L.
Potassium- The assay is linear from 0.9 to 12.8 mmol/L. The claimed range will be 1.1 to 8.8 mmol/L.
Chloride- The assay is linear from 41 mmol/L to 200 mmol/L. The claimed range will be 49 mmol/L to 152 mmol/L.
Glucose- The assay is linear from 13 mg/dL to 632 mg/dL. The claimed range will be 13 to 500 mg/dL.
Precision:
Following CLSI EP5-A2, control samples (low, middle, and high levels) were tested in duplicate, twice a day, for 20 days, for a total of 80 results per level. The results were tabulated and the data were analyzed for means and percent coefficient of variation (%CVs).
Hialeah, Fl 33016
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| Mean | Within-run %CV | Total %CV | |
|---|---|---|---|
| Low Level | 126 mmol/L | 0.6% | 0.9% |
| Med. Level | 143 mmol/L | 0.5% | 1.4% |
| High Level | 159 mmol/L | 0.7% | 1.0% |
Sodium values for each level assaved on the Pictus 700 Analyzer
Potassium values for each level assayed on the Pictus 700 Analyzer
| Mean | Within-run %CV | Total %CV | |
|---|---|---|---|
| Low Level | 3.4 mmol/L | 0.00% | 1.05% |
| Med. Level | 4.5 mmol/L | 0.00% | 1.65% |
| High Level | 5.8 mmol/L | 0.78% | 1.41% |
Chloride values for each level assayed on the Pictus 700 Analyzer
| Mean | Within-run %CV | Total %CV | |
|---|---|---|---|
| Low Level | 87 mmol/L | 0.6% | 0.9% |
| Med. Level | 98 mmol/L | 0.5% | 1.2% |
| High Level | 109 mmol/L | 0.5% | 0.8% |
Glucose values for each level assayed on the Pictus 700 Analyzer
| Mean | Within-run %CV | Total %CV | |
|---|---|---|---|
| Low Level (45) | 45 mg/dL | 1.6% | 3.2% |
| Med. Level (92) | 92 mg/dL | 0.9% | 3.0% |
| High Level (309) | 309 mg/dL | 1.2% | 3.1% |
Interferences:
The study evaluated increasingly higher levels of: bilirubin, hemoglobin, and triglycerides for all parameters. A two-level control set with low and high levels of each analyte was spiked to seven or eight levels (depending on the interferent) and the spiked samples plus the neat samples were tested in duplicates by the Pictus 700 using its standard operating procedure; the results were averaged. In each case, the spiked sample result mean was compared to its neat (zero interferent) mean result, and recoveries were calculated.
| ≤ 10 % Change or ≤ 3 mmol/L up to: | |||
|---|---|---|---|
| Hemolysis | Lipemia | Bilirubin | |
|---|---|---|---|
| Sodium | 600 mg/dL | 2500 mg/dL | 24 mg/dL |
| Potassium | Do not use hemolyzed serum | 2500 mg/dL | 24 mg/dL |
| Chloride | 600 mg/dL | 2500 mg/dL | 24 mg/dL |
| Glucose | 600 mg/dL | 700 mg/dL | 12 mg/dL |
Method Comparisons:
Clinical specimens (n = 69, 69, 69, and 136 for sodium, chloride, and glucose, respectively), spanning the dynamic ranges, were assayed in singleton and in a blinded fashion by the Pictus 700 (y-axis) and the predicate system. The specimens were previously-collected
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Image /page/9/Picture/0 description: The image is a logo for Diatron Group. The word "Diatron" is written in a combination of green and blue colors, with the "Dia" in green and the "tron" in blue. Above the word "GROUP" is a green arc. To the left of the word "Diatron" is a blue graphic.
serum samples that had been stored frozen and then thawed prior to analysis. Deming regression analysis data appear below.
| Sodium | Result | Potassium | Result |
|---|---|---|---|
| N | 69 | N | 69 |
| Correlation Coefficient (r) | 0.995 | Correlation Coefficient (r) | 0.998 |
| Slope (95% CIs) | 1.002 | ||
| (0.978 to 1.027) | Slope (95% CIs) | 0.999 | |
| (0.984-1.014) | |||
| Intercept | -1.02 | ||
| (-4.7 to 2.2) | Intercept | 0.02 | |
| (-0.05 to 0.09) | |||
| CI = confidence intervals | |||
| Chloride | Result | Glucose | Result |
| N | 69 | N | 136 |
| Correlation Coefficient (r) | 0.997 | Correlation Coefficient (r) | 0.999 |
| Slope (95% CIs) | 1.015 | ||
| (0.996 to 1.035) | Slope (95% CIs) | 0.993 | |
| (0.987 to 1.000) | |||
| Intercept | -1.90 | ||
| (-3.9 to 0.1) | Intercept | 1.2 | |
| (-0.1 to 2.4) |
807.92 (b)(2): Brief Description of Clinical Data
Not applicable
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
The Diatron Pictus 700 Clinical Chemistry Analyzer is substantially equivalent to the Pictus 400 system, (K101741), and is safe and effective for the claimed intended use.