(567 days)
No
The summary describes a standard in vitro diagnostic device that uses chemical reactions and a chemistry analyzer to measure potassium levels. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis focuses on traditional analytical performance metrics like precision, linearity, and method comparison.
No.
This device is an in vitro diagnostic test system used to measure potassium levels, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The intended use section explicitly states that potassium measurements obtained from this device are "used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss," which directly indicates its role in diagnosing and treating medical conditions.
No
The device description clearly states it is a "single-use, disposable system" (the test disc) used with a "portable clinical chemistry system" (the analyzer). These are physical components, not software only.
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 system is "intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description reinforces the in vitro nature by explaining how the system processes blood samples and uses reagents to perform chemical reactions for quantitative determination.
- Clinical Context: The intended use and the description of how the results are used in the diagnosis and treatment of various medical conditions (renal disease, adrenal insufficiency, etc.) further confirm its role as a diagnostic tool used outside the body.
N/A
Intended Use / Indications for Use
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
Product codes (comma separated list FDA assigned to the subject device)
MZV
Device Description
The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.
The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.
The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.
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
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Intended User / Care Setting
clinical laboratory setting or point-of-care location.
Professional use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was completed to demonstrate that the Piccolo® Potassium Test System is substantially equivalent in performance and safety and efficacy to the predicate Piccolo Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140).
Performance testing:
Analytical Performance:
- Precision: The precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures. The precision of the Piccolo Potassium Test System was evaluated at a CLIA waived site with three analyzers, one lot of reagent discs, over five days. Total precision and within-run were estimated for each level.
Plasma Precision Summary:
Control 1: Average 3.22 mmol/L, Within Run SD 0.09, Within Run %CV 2.79, Total SD 0.11, Total %CV 3.28
Control 2: Average 6.19 mmol/L, Within Run SD 0.09, Within Run %CV 1.38, Total SD 0.10, Total %CV 1.65
Plasma Pool 1: Average 3.22 mmol/L, Within Run SD 0.07, Within Run %CV 2.31, Total SD 0.09, Total %CV 2.89
Plasma Pool 2: Average 5.42 mmol/L, Within Run SD 0.09, Within Run %CV 1.58, Total SD 0.10, Total %CV 1.89
Whole Blood Precision: Tested at a CLIA waived site by two CLIA waiver operators. The study used four Piccolo Xpress Analyzers with 16 replicates per sample for four (4) fresh, lithium heparin whole blood samples.
Whole Blood 1 (N=16): Average K+ 3.9 mmol/L, Repeatability SD 0.06, Repeatability %CV 1.6, Between-Operator SD 0.02, Between-Operator %CV 0.4, Between-Analyzer SD 0.09, Between-Analyzer %CV 2.2, Total SD 0.11, Total %CV 2.8
Whole Blood 2 (N=16): Average K+ 4.0 mmol/L, Repeatability SD 0.11, Repeatability %CV 2.9, Between-Operator SD 0.00, Between-Operator %CV 0.0, Between-Analyzer SD 0.07, Between-Analyzer %CV 1.9, Total SD 0.14, Total %CV 3.4
Whole Blood 3 (N=16): Average K+ 4.0 mmol/L, Repeatability SD 0.11, Repeatability %CV 2.8, Between-Operator SD 0.03, Between-Operator %CV 0.9, Between-Analyzer SD 0.10, Between-Analyzer %CV 2.5, Total SD 0.15, Total %CV 3.9
Whole Blood 4 (N=16): Average K+ 4.0 mmol/L, Repeatability SD 0.11, Repeatability %CV 2.7, Between-Operator SD 0.02, Between-Operator %CV 0.6, Between-Analyzer SD 0.08, Between-Analyzer %CV 1.9, Total SD 0.13, Total %CV 3.4
- Linearity: The study was designed based on CLSI EP06-A: Evaluation of the linearity of quantitative measurement procedures. The linearity of Piccolo Potassium Test System on the Piccolo Xpress® chemistry analyzer was evaluated by preparing whole blood, serum, and plasma samples of varying analyte levels that spanned the reportable range of the tests. The Piccolo Potassium Test System demonstrated linearity over the reportable range.
Regression Parameter Estimates from CLSI Linear Model Fit:
Whole Blood (Reportable Range 1.5 – 8.5 mmol/L, Range Tested 1.2 to 8.5 mmol/L): R-square 0.987, Slope 0.985, Intercept 0.075
Plasma (Reportable Range 1.5 – 8.5 mmol/L, Range Tested 1.2 to 8.5 mmol/L): R-square 0.995, Slope 0.972, Intercept 0.032
Serum* (Reportable Range 1.5 – 8.5 mmol/L, Range Tested 1.0 to 9.5 mmol/L): R-square 0.995, Slope 1.002 (0.914 to 1.091), Intercept -0.128 (-0.577 to 0.321)
For all three matrices and various concentration ranges tested, the deviation from linearity (DL) estimate was within +/- 0.31, the repeatability test resulted in RMSE estimates 0.98, thus satisfying the conditions of linearity as per the CLSI EP-06A guidance. The DL estimates are within the current CLIA accuracy goal for potassium per 42 CFR 493.931, which identifies a target value of ± 0.5 mmol/L for acceptable performance and supports linearity for all three matrices for the current dynamic range of 1.5 to 8.5 mmol/L.
- Limit of Quantitation (LoQ): The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratorv Measurement Procedures. The LoQs for the Piccolo Potassium Test System were determined to be 1.5 mmol/L.
Comparison Study:
4. Method Comparison: Method comparison was demonstrated in a study comparing the Piccolo Potassium Test System performance on the Piccolo Xpress® chemistry analyzer to the Siemens VISTA ISE (K051087) comparative method. Correlation studies were conducted at two sites. Site 1 tested heparinized whole blood, heparinized plasma, and serum. Site 2 tested only fresh heparinized whole blood on the Abaxis analyzer.
Method Comparison Results:
Site 1 - Moderately Complex Site (Sample Type, N, Slope, Intercept, R2):
Whole Blood, 178, 0.98, 0.12, 0.969
Plasma, 178, 0.98, 0.03, 0.979
Serum, 178, 0.98, 0.06, 0.979
Site 2 - Waived Site:
Whole Blood, 130, 0.99, 0.13, 0.969
The results of the testing demonstrated the accuracy of the potassium test on the Piccolo Xpress® chemistry analyzer with the comparative method device. The results of the testing confirmed that subject device performs substantially equivalent to the predicate device Piccolo® Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140).
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.
Piccolo® Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140)
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.
The Siemens Dimension Vista® Integrated System (including the Potassium ISE Test) (K051087)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
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October 20, 2021
Abaxis, Inc. Julie Schoell Director, Regulatory Affairs 3240 Whipple Road Union City, California 94587
Re: K200865
Trade/Device Name: Piccolo® Potassium Test System Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: MZV Dated: April 2, 2021 Received: April 6, 2021
Dear Julie Schoell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Piccolo® Potassium Test System
Indications for Use (Describe)
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
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 logo for Abaxis. The word "ABAXIS" is written in bold, black, sans-serif font. A red arc starts above the "A" and curves down and under the "XIS" portion of the word. The arc is thicker at the top and tapers as it curves under the word.
510(k) Summary
This section provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
| 510(k) Number: | K200865 |
|---|---|
| 510(k) Owner: | Abaxis Inc. |
| Submitter/ Contact | |
| Person: | Julie Schoell |
| Manager II | |
| Attention: Abaxis Inc | |
| 3240 Whipple Road | |
| Union City, CA 94587 | |
| Phone: 269-312-2922 | |
| Date prepared: | October 15, 2021 |
| II. DEVICE | |
| Trade Name: | Piccolo® Potassium Test System |
| Common or Usual | |
| name: | Test, System, Potassium, Enzymatic Method |
| Classification | |
| name: | Potassium test system (21 CFR 862.1600) |
| Regulatory Class: | Class II |
| Product Code: | MZV |
III. PREDICATE DEVICE
Primary Predicate: Piccolo® Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140)
The Siemens Dimension Vista® Integrated System (including the Potassium ISE Test) (K051087) was used as the comparative method.
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Image /page/4/Picture/0 description: The image shows the logo for Abaxis. The logo consists of the word "ABAXIS" in bold, black sans-serif font. A red arc starts above the "A" and curves down and under the "XIS" portion of the word. The arc adds a dynamic and modern touch to the logo.
IV. SUBMISSION/DEVICE OVERVIEW
This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) for a modification to a previously cleared device - modification to the Piccolo® Potassium Test run on the Piccolo Xpress® chemistry analyzer.
Device Description
The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.
The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.
The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.
V. INDICATIONS FOR USE
Intended Use:
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use:
Potassium: The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis,
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Image /page/5/Picture/0 description: The image shows the logo for Abaxis. The word "ABAXIS" is written in bold, black, sans-serif font. A red arc starts at the top right of the "X" and curves around the bottom of the word, ending near the bottom of the first "A". The logo is simple and modern.
panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
The Indications for Use statement for the Subject device is identical to the Primary predicate device Piccolo® Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The Piccolo® Potassium Test is compared to its predicate device for substantial equivalence based on the following criteria:
- A. Principle of Operation
- B. Technological and Performance Characteristics
A. Principle of Operation
The principle of operation or principle of analysis of the Piccolo® Potassium Test is the same as the predicate which is based on the assay method (e.g., enzymatic), assay calibration, and mode of detection (e.g., photometric).
B. Technological and Performance Characteristics
The Piccolo® Potassium Test device and the predicate Piccolo® Potassium Test System (K992140) are based on the following technological elements:
| Characteristic | Piccolo® Potassium Test System
(Subject Device) | Piccolo® Potassium Test System
(included on Piccolo MetLyte 7
Reagent Panel) (K992140)
(Predicate Device) |
|---------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation/Methodology | Enzymatic colormetric assay | Enzymatic colormetric assay |
| Sample Type | Heparinized venous whole blood,
heparinized plasma, and serum | Heparinized venous whole blood,
heparinized plasma, and serum |
| Dynamic Range | 1.5 – 8.5 mmol/L | 1.5 – 8.5 mmol/L |
| Temperature of
Reaction | 37°C | 37°C |
| Calibration | Bar code with factory
calibrated lot specific data | Bar code with factory
calibrated lot specific data |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approximately 100 µL | Approximately 100 µL |
Table 1. Comparison of Subject and Predicate Device Technological Features
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Image /page/6/Picture/0 description: The image shows the logo for Abaxis. The word "ABAXIS" is written in black, bold, sans-serif font. A red and black swoosh design is located to the right of the word. The red portion of the swoosh is on the top, and the black portion is on the bottom.
VII. PERFORMANCE DATA
Performance testing was completed to demonstrate that the Piccolo® Potassium Test System is substantially equivalent in performance and safety and efficacy to the predicate Piccolo Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140).
(The analytical performance for the associated rotor panel analytes have been previously established in K934592, K993211, K010670, K022312, K040115, K091052, K051108, K130113. K950164. K942782. K992140.)
Performance Testing
Performance testing was performed to demonstrate the accuracy of the potassium test on the Piccolo Xpress® chemistry analyzer by a method comparison study for agreement with the comparative method device.
Analytical Performance
- Precision
The precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures.
The precision of the Piccolo Potassium Test System was evaluated at a CLIA waived site with three analyzers, one lot of reagent discs, over five days. Total precision and within-run were estimated for each level. The results of the study are shown in Table 2.
| Sample | Average
mmol/L | Within Run
SD | Within Run
%CV | Total SD | Total %CV |
|---------------|-------------------|------------------|-------------------|----------|-----------|
| Control 1 | 3.22 | 0.09 | 2.79 | 0.11 | 3.28 |
| Control 2 | 6.19 | 0.09 | 1.38 | 0.10 | 1.65 |
| Plasma Pool 1 | 3.22 | 0.07 | 2.31 | 0.09 | 2.89 |
| Plasma Pool 2 | 5.42 | 0.09 | 1.58 | 0.10 | 1.89 |
Table 2. Precision Summary of Piccolo Potassium Test System - Plasma
Whole blood precision was tested at a CLIA waived site by two CLIA waiver operators. The study used four Piccolo Xpress Analyzers with 16 replicates per sample for four (4) fresh, lithium heparin whole blood samples.
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Image /page/7/Picture/0 description: The image shows the logo for Abaxis. The logo consists of the word "ABAXIS" in bold, black, sans-serif font. A red swoosh-like graphic starts above the "X" and curves around the bottom of the word, ending near the "I". The logo is simple and modern.
| | | | Repeatability
(Within-Run) | | Between-
Operator | | Between-
Analyzer | | Total | |
|---------------|----|-------------------------|-------------------------------|-----|----------------------|-----|----------------------|-----|-------|-----|
| | | Average
K+
mmol/L | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample | N | | | | | | | | | |
| Whole Blood 1 | 16 | 3.9 | 0.06 | 1.6 | 0.02 | 0.4 | 0.09 | 2.2 | 0.11 | 2.8 |
| Whole Blood 2 | 16 | 4.0 | 0.11 | 2.9 | 0.00 | 0.0 | 0.07 | 1.9 | 0.14 | 3.4 |
| Whole Blood 3 | 16 | 4.0 | 0.11 | 2.8 | 0.03 | 0.9 | 0.10 | 2.5 | 0.15 | 3.9 |
| Whole Blood 4 | 16 | 4.0 | 0.11 | 2.7 | 0.02 | 0.6 | 0.08 | 1.9 | 0.13 | 3.4 |
Table 3. Whole Blood Precision (Each sample is N = 16)
2. Linearity
The study was designed based on CLSI EP06-A: Evaluation of the linearity of quantitative measurement procedures.
The linearity of Piccolo Potassium Test System on the Piccolo Xpress® chemistry analyzer was evaluated by preparing whole blood, serum, and plasma samples of varying analyte levels that spanned the reportable range of the tests. The Piccolo Potassium Test System demonstrated linearity over the reportable range as shown in Table 4. Regression Parameter Estimates.
For all three matrices and various concentration ranges tested, the deviation from linearity (DL) estimate was within +/- 0.31, the repeatability test resulted in RMSE estimates 0.98, thus satisfying the conditions of linearity as per the CLSI EP-06A guidance.
The DL estimates are within the current CLIA accuracy goal for potassium per 42 CFR 493.931, which identifies a target value of ± 0.5 mmol/L for acceptable performance and supports linearity for all three matrices for the current dynamic range of 1.5 to 8.5 mmol/L.
| Sample
Type | Reportable
Range
mmol/L | Range
Tested,
mmol/L | R-
square | Slope (95%
CI) | Intercept (95%
CI) |
|----------------|-------------------------------|----------------------------|--------------|---------------------------|-----------------------------|
| Whole
Blood | 1.5 – 8.5 | 1.2 to 8.5 | 0.987 | 0.985 | 0.075 |
| Plasma | 1.5 – 8.5 | 1.2 to 8.5 | 0.995 | 0.972 | 0.032 |
| Serum* | 1.5 – 8.5 | 1.0 to 9.5 | 0.995 | 1.002
(0.914 to 1.091) | -0.128
(-0.577 to 0.321) |
Table 4. Regression Parameter Estimates from CLSI Linear Model Fit
- Weighted Deming Regression Analysis
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-
- Limit of Quantitation (LoQ)
The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratorv Measurement Procedures.
- Limit of Quantitation (LoQ)
The LoQs of the Piccolo Potassium Test System were evaluated on the Piccolo Xpress® chemistry Analyzer using whole blood, plasma and serum prepared by taking a native blood sample of known K+ concentration and diluting it to the target concentration using dialyzed (K+ free) serum/plasma as the diluent concentrations and two reagent disc lots, four low level samples of known measurand concentration, across a minimum of three days. The LoQs for the Piccolo Potassium Test System were determined to be 1.5 mmol/L.
Comparison Study
-
- Method Comparison
Method comparison was demonstrated in a study comparing the Piccolo Potassium Test System performance on the Piccolo Xpress® chemistry analyzer to the Siemens VISTA ISE (K051087) comparative method. Correlation studies were conducted at two sites. Site 1 tested heparinized whole blood, heparinized plasma, and serum. Site 2 tested only fresh heparinized whole blood on the Abaxis analyzer. Whole blood, serum, and plasma were evaluated and analyzed on the Piccolo Xpress® chemistry analyzer against plasma and serum specimens on the Siemens VISTA ISE. A Deming linear regression analysis was performed. Results are presented in Table 5.
- Method Comparison
| Site 1 - Moderately Complex Site | ||||||
|---|---|---|---|---|---|---|
| Sample Type | N | Slope | Intercept | R2 | ||
| Whole Blood | 178 | 0.98 | 0.12 | 0.969 | ||
| Plasma | 178 | 0.98 | 0.03 | 0.979 | ||
| Serum | 178 | 0.98 | 0.06 | 0.979 | ||
| Site 2 - Waived Site | ||||||
| Whole Blood | 130 | 0.99 | 0.13 | 0.969 |
| Table 5. Method Comparison Results | |||
|---|---|---|---|
| -- | -- | ------------------------------------ | -- |
The results of the testing demonstrated the accuracy of the potassium test on the Piccolo Xpress® chemistry analyzer with the comparative method device. The results of the testing
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confirmed that subject device performs substantially equivalent to the predicate device Piccolo® Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140).
VIII. CONCLUSIONS
The results of the performance and clinical data demonstrate the Piccolo® Potassium Test System will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.