(567 days)
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.
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.
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implied by CLIA goals or standard practices) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within Run %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 2.79% | |
| - Control 2 (6.19 mmol/L) | 1.38% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.31% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.58% | |
| Total %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 3.28% | |
| - Control 2 (6.19 mmol/L) | 1.65% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.89% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.89% | |
| Total %CV (Whole Blood, range 3.9-4.0 mmol/L) | Lower is better | 2.8% - 3.9% |
| Linearity | Deviation from linearity (DL) within ±0.5 mmol/L (per 42 CFR 493.931) | For all three matrices and various concentration ranges tested, the DL estimate was within +/- 0.31. R-square estimates were all > 0.98. RMSE estimates <= 0.32. |
| Limit of Quantitation (LoQ) | Not explicitly stated, but generally, the lowest concentration at which the device can reproducibly measure. | Determined to be 1.5 mmol/L. |
| Method Comparison (Accuracy vs. Siemens VISTA ISE) | Linear regression analysis (slope, intercept, R²) indicating strong correlation and minimal bias. Slope close to 1, Intercept close to 0, R² close to 1. | |
| - Site 1 Whole Blood (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.12, R²: 0.969 |
| - Site 1 Plasma (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.03, R²: 0.979 |
| - Site 1 Serum (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.06, R²: 0.979 |
| - Site 2 Whole Blood (N=130) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.99, Intercept: 0.13, R²: 0.969 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Precision (Plasma): Sample details (number of unique patient samples) are not explicitly stated, but the study used "Control 1, Control 2, Plasma Pool 1, Plasma Pool 2," indicating pooled or control materials. Tested over five days.
- Precision (Whole Blood): Four (4) fresh, lithium heparin whole blood samples. Each sample was replicated 16 times (N=16 for each sample type).
- Linearity: Whole blood, serum, and plasma samples of varying analyte levels that spanned the reportable range of the tests. Specific number of samples not given, but refers to "various concentration ranges tested."
- Limit of Quantitation (LoQ): Not specified beyond "four low level samples."
- Method Comparison:
- Site 1: 178 samples for Whole Blood, 178 for Plasma, and 178 for Serum.
- Site 2: 130 samples for Whole Blood.
- Provenance: Not explicitly stated, but the mention of "CLIA waived site" and "Moderately Complex Site" suggests the studies were conducted in the United States. The data appears to be prospective as it involves active testing of samples using the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- The document does not mention the use of human experts to establish ground truth for the test set in the context of diagnostic interpretation. This is an in vitro diagnostic device that quantifies potassium levels.
- For the analytical performance studies (Precision, Linearity, LoQ, Method Comparison), the "ground truth" or reference values are established by the comparative method device (Siemens VISTA ISE) and controlled materials with known concentrations. The studies were run by operators at different sites, including a CLIA waived site, indicating standard laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable to the evaluation of this in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where multiple readers interpret images, and discrepancies need to be resolved. For a potassium test, the output is a quantitative value, not subject to subjective interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks involving human readers and AI assistance. This device is a quantitative assay, not an imaging or interpretative AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies (Precision, Linearity, LoQ, Method Comparison) represent the standalone performance of the device (Piccolo® Potassium Test System on the Piccolo Xpress® chemistry analyzer). While human operators physically load samples and start the tests, the analysis and quantification are performed by the device's integrated system (chemistry analyzer and reagent disc) without human interpretation steps that could be influenced by the device's output. The results presented are the direct output of the device compared against reference methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the analytical performance studies was established using:
- Comparative Method Device: Siemens Dimension Vista® Integrated System (Potassium ISE Test, K051087) as the reference method for the method comparison studies.
- Controlled Materials: For precision, control materials and plasma pools with known or expected potassium concentrations were used.
- Prepared Samples: For linearity, samples were prepared to span the reportable range. For LoQ, native blood samples were diluted to target concentrations.
8. The sample size for the training set:
- This device is an in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device would involve its chemical design, optical system calibration, and reagent formulation derived from extensive R&D, rather than a data-driven training set used for AI model development. Therefore, a specific "training set sample size" as typically understood for AI models is not applicable.
9. How the ground truth for the training set was established:
- As mentioned above, the concept of a "training set" and its "ground truth" for this type of in vitro diagnostic device (a chemical assay) is not directly analogous to AI/machine learning. The device's operational parameters and accuracy are established through its engineering design, chemical principles, and extensive internal validation and calibration processes during development and manufacturing. The comparisons to predicate devices and reference methods serve to validate its performance post-development.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
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) |
|---|---|
| -------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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/ ContactPerson: | Julie SchoellManager IIAttention: Abaxis Inc3240 Whipple RoadUnion City, CA 94587Phone: 269-312-2922 |
| Date prepared: | October 15, 2021 |
| II. DEVICE | |
| Trade Name: | Piccolo® Potassium Test System |
| Common or Usualname: | Test, System, Potassium, Enzymatic Method |
| Classificationname: | 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.
{4}------------------------------------------------
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,
{5}------------------------------------------------
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 7Reagent Panel) (K992140)(Predicate Device) |
|---|---|---|
| Principle ofOperation/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 ofReaction | 37°C | 37°C |
| Calibration | Bar code with factorycalibrated lot specific data | Bar code with factorycalibrated 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
{6}------------------------------------------------
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 | Averagemmol/L | Within RunSD | 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.
{7}------------------------------------------------
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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| AverageK+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 <= 0.32, and the R-square estimates were all > 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.
| SampleType | ReportableRangemmol/L | RangeTested,mmol/L | R-square | Slope (95%CI) | Intercept (95%CI) |
|---|---|---|---|---|---|
| WholeBlood | 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
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Abaxis. The word "ABAXIS" is written in bold, black, sans-serif font. A red arc begins at the bottom right of the "X" and curves over the top of the word, ending near the top right of the "A". The logo is simple and modern.
-
- 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
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Abaxis. The logo is black, except for a red arc that goes over the "X" in Abaxis. The text is in all caps and is sans-serif.
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.
§ 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.