(273 days)
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial and venous whole blood.
The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.
Potassium (cK+): Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa+): Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, delydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measure the concentration of lactate. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidity of the blood).
The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of balanced heparinized whole blood for electrolytes (cK+, cNa*, cCa²), glucose, and lactate. The ABL90 FLEX PLUS System has an automated sample inlet mechanism, which can collect blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode.
The provided text is a 510(k) Summary for the ABL90 FLEX PLUS System, an in vitro diagnostic device. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (ABL90 FLEX) rather than proving the device meets specific acceptance criteria as might be defined for a novel AI/ML device.
Therefore, much of the requested information regarding acceptance criteria for AI/ML performance, study design (test set, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of device and its regulatory submission.
The document primarily proves the analytical performance of the new device is comparable to the predicate device through various analytical studies.
Here's a breakdown of the applicable information based on the provided text, and an explanation of why other requested information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a pass/fail table for each performance metric in the way it might for a novel AI/ML device. Instead, it presents analytical performance data (linearity, precision, detection, method comparison, interference) which is implicitly compared against pre-defined internal specifications or what is considered acceptable for the similar predicate device. The goal is to show the new device performs equivalently to the predicate.
Below is a summary of the reported device performance from the tables in the document. The "Acceptance Criteria" column cannot be fully populated as precise numerical thresholds are not explicitly stated as "acceptance criteria" in this 510(k) summary, but are rather implied by the successful demonstration of performance often within CLSI guidelines and comparable to the predicate.
| Parameter (Unit) | Test Category | Reported Performance (Range / Values) | Implicit Acceptance Criteria (based on predicate equivalence and CLSI) |
|---|---|---|---|
| cCa2+ (mg/dL) | Linearity | Slope: 0.883, Intercept: 0.445, R^2: 1.000 | R^2 near 1.0, slope near 1.0, intercept near 0, demonstrating linearity over the reportable range. |
| LoQ | 1.26 | Established lower limit of reliable quantitation. | |
| Precision (QC) | Repeatability SD: 0.003-0.014, CV%: 0.1-0.3 | Low SD and CV%, demonstrating consistent results. | |
| Precision (Blood) | Repeatability SD: 0.003-0.022, CV%: 0.06-0.45 | Low SD and CV%, demonstrating consistent results within biological samples. | |
| Method Comp. (Bias at MD) | S65: 0.001-0.003, SP65: 0.003-0.009 | Low bias compared to the predicate device, indicating equivalent measurements. | |
| cK+ (mEq/L) | Linearity | Slope: 1.001, Intercept: 0.027, R^2: 1.000 | R^2 near 1.0, slope near 1.0, intercept near 0, demonstrating linearity over the reportable range. |
| LoQ | 1.6 | Established lower limit of reliable quantitation. | |
| Precision (QC) | Repeatability SD: 0.00-0.01, CV%: 0.1-0.2 | Low SD and CV%, demonstrating consistent results. | |
| Precision (Blood) | Repeatability SD: 0.007-0.026, CV%: 0.14-0.96 | Low SD and CV%, demonstrating consistent results within biological samples. | |
| Method Comp. (Bias at MD) | S65: 0.002-0.004, SP65: 0.004-0.008 | Low bias compared to the predicate device, indicating equivalent measurements. | |
| cNa+ (mEq/L) | Linearity | Slope: 1.001, Intercept: -0.642, R^2: 1.000 | R^2 near 1.0, slope near 1.0, intercept near 0, demonstrating linearity over the reportable range. |
| LoQ | 99 | Established lower limit of reliable quantitation. | |
| Precision (QC) | Repeatability SD: 0.1-0.2, CV%: 0.1 | Low SD and CV%, demonstrating consistent results. | |
| Precision (Blood) | Repeatability SD: 0.061-0.194, CV%: 0.05-0.14 | Low SD and CV%, demonstrating consistent results within biological samples. | |
| Method Comp. (Bias at MD) | S65: 0.265-0.290, SP65: 0.221-0.259 | Low bias compared to the predicate device, indicating equivalent measurements. | |
| cGlu (mg/dL) | Linearity | Slope: 1.032, Intercept: -1.073, R^2: 1.000 | R^2 near 1.0, slope near 1.0, intercept near 0, demonstrating linearity over the reportable range. |
| LoD/LoQ | LoD: 5, LoQ: 5 | Established lower limits of detection and reliable quantitation. | |
| Precision (QC) | Repeatability SD: 0.3-1.3, CV%: 0.5-1.1 | Low SD and CV%, demonstrating consistent results. | |
| Precision (Blood) | Repeatability SD: 0.207-2.221, CV%: 0.35-0.85 | Low SD and CV%, demonstrating consistent results within biological samples. | |
| Method Comp. (Bias at MD) | S65: -0.460 to -2.028, SP65: -0.663 to -2.045 | Low bias compared to the predicate device, indicating equivalent measurements. | |
| cLac (mg/dL) | Linearity | Slope: 0.971, Intercept: -0.433, R^2: 1.000 | R^2 near 1.0, slope near 1.0, intercept near 0, demonstrating linearity over the reportable range. |
| LoD/LoQ | LoD: -0.3, LoQ: 2 | Established lower limits of detection and reliable quantitation. (Note: Negative LoD likely a calculation artifact near zero) | |
| Precision (QC) | Repeatability SD: 0.2-0.3, CV%: 0.3-1.1 | Low SD and CV%, demonstrating consistent results. | |
| Precision (Blood) | Repeatability SD: 0.177-0.379, CV%: 0.75-2.25 | Low SD and CV%, demonstrating consistent results within biological samples. | |
| Method Comp. (Bias at MD) | S65: -0.116 to 0.013, SP65: -0.156 to -0.169 | Low bias compared to the predicate device, indicating equivalent measurements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (for performance validation):
- Linearity: The specific number of samples tested for linearity is not explicitly stated as 'N' values in Table 1 but ranges presented (e.g., 1.896-11.146 for cCa2+) imply a sufficient number of points across the range were used.
- Detection (LoB, LoD, LoQ): Not explicitly stated as 'N' values in Table 2.
- Precision (using stable, aqueous ampoule-based QC material): Varies per parameter/level, but generally 243-244 replicates (N) per parameter/level.
- Precision (using blood): Varies per parameter/mode/interval, ranging from 2 to 202 replicates (N).
- Method Comparison:
- Arterial blood (S65 mode): 221-225 samples (N) across parameters.
- Arterial blood (SP65 mode): 214-218 samples (N) across parameters.
- Venous blood (S65 mode): 231-234 samples (N) across parameters.
- Venous blood (SP65 mode): 219-225 samples (N) across parameters.
- Combined (S65 mode): 436-441 samples (N) for combined arterial/venous.
- Combined (SP65 mode): 420-425 samples (N) for combined arterial/venous.
- Interference: "Large panel of likely interferents" for paired-difference study; dose-response studies for significant interferents. Specific sample sizes for each interferent are not detailed in the summary.
- Data Provenance: The document states that precision studies using QC material were conducted at "three external sites." Method comparison and precision studies using blood were conducted using both arterial and venous blood, and in both sample collection modes. The country of origin for the data (patients or samples) is not specified in this summary. The studies are described as "analytical performance testing," implying they are prospective or controlled laboratory studies rather than retrospective analysis of existing clinical data.
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)
- Not Applicable: This device is an in vitro diagnostic (IVD) analyzer that quantitatively measures analytes. Its performance is evaluated against reference measurement procedures or highly controlled materials, not by expert interpretation of images or clinical cases requiring expert consensus or qualifications. Ground truth is established by the reference method itself or the known concentration of QC materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As this is an IVD device measuring quantitative analytes, there is no expert adjudication process in this context, unlike an AI/ML device interpreting medical images. Performance is determined by comparison to reference methods or statistical analysis against known values.
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
- Not Applicable: This is an IVD analyzer, not an AI/ML device that assists human readers. Therefore, an MRMC study is not relevant to its regulatory approval process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Applicable (in a different sense): The ABL90 FLEX PLUS System is a standalone automated analyzer. Its performance is measured directly (algorithm only, if you consider the device's internal measurement algorithm) against reference methods or known concentrations, without a human-in-the-loop interpretation being the primary output that's being evaluated for accuracy. The results presented (linearity, precision, method comparison) are representative of its standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Quantitative Reference Methods / Known Concentrations:
- Linearity/Detection: Ground truth is established by preparing samples with known, precise concentrations across the measurement range, or by the inherent properties of the measurement system for LoB/LoD/LoQ.
- Precision: Ground truth is the expected value of the quality control (QC) materials or the prepared blood samples, or simply the reproducibility of measurements on the same sample.
- Method Comparison: Ground truth is the measurement from the legally marketed predicate device (ABL90 FLEX, specifically "ABL90 FLEX PLUS analyzer as it was designed at the time of the clearance of K160153") that the new device is being compared against. This device itself serves as the "reference method" for substantial equivalence.
- Interference: Ground truth is the expected measurement of known samples, with and without the interferent, using a reference method, to identify if the interferent causes a clinically significant deviation.
8. The sample size for the training set
- Not Applicable (in the AI/ML sense): This document describes the analytical validation of a traditional IVD device, not an AI/ML algorithm. There is no "training set" in the machine learning sense for this type of submission. The device is a physical instrument with established chemical/electrochemical measurement principles.
9. How the ground truth for the training set was established
- Not Applicable: As there is no "training set" in the AI/ML context, this question is not relevant. The device's internal parameters and calibration would be established through a manufacturing and calibration process, not through a "training" phase with a ground truth dataset in the way an AI model is trained.
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January 14, 2025
Radiometer Medicals ApS Andrea Swingle Senior Specialist, Regulatory Affairs Åkandevej 21 2700 Brønshøj Denmark
Re: K241037
Trade/Device Name: ABL90 FLEX PLUS System Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, JGS, JFP, CGA, KHP Dated: December 10, 2024 Received: December 10, 2024
Dear Andrea Swingle:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K241037
Device Name ABL90 FLEX PLUS System
Indications for Use (Describe)
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial and venous whole blood.
The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.
Potassium (cK+): Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa+): Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, delydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measure the concentration of lactate. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidity of the blood).
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K240137
The information provided in this 510(k) summary are in accordance with 21 CFR 807.92
Submitter Information:
| Company Name: | Radiometer Medical ApS |
|---|---|
| ER Number: | 3002807968 |
| Address: | Aakandevej 212700 BroenshoejDenmark |
| Contact Person: | Hsiao-Qing Chow |
| Phone: | +45 31401578 |
Application Correspondent:
| Name: | Andrea Swingle |
|---|---|
| Function: | Senior Specialist, Regulatory Affairs |
| Email: | andrea.swingle@radiometeramerica.com |
| Phone: | +1 510 246 2559 |
Date prepared: January 14, 2024
Device Information
| Device Trade Name: | ABL90 FLEX PLUS System |
|---|---|
| Common Name: | Blood Gas Analyzer |
| Regulations: | - 21 CFR 862.1600, Potassium test system |
| - 21 CFR 862.1665, Sodium test system | |
| - 21 CFR 862.1145, Calcium test system | |
| - 21 CFR 862.1345, Glucose test system | |
| - 21 CFR 862.1450, Lactic acid test system | |
| Product Codes: | CEM, JGS, JFP, CGA, KHP |
| Device Class: | Class I for KHP; All others: Class II |
| Classification Panel: | Clinical Chemistry |
Predicate Device
| Device Trade Name: | ABL90 FLEX |
|---|---|
| Common Name: | Blood Gas Analyzer |
| 510(k) | K092686 |
| Regulations: | - 21 CFR 862.1600, Potassium test system |
| - 21 CFR 862.1665, Sodium test system | |
| - 21 CFR 862.1145, Calcium test system | |
| - 21 CFR 862.1345, Glucose test system | |
| - 21 CFR 862.1450, Lactic acid test system |
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Product Codes: Device Class: Classification Panels: CEM, JGS, JFP, CGA, KHP Class I for KHP; All others: Class II Clinical Chemistry
Device Description
The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of balanced heparinized whole blood for electrolytes (cK+, cNa*, cCa²), glucose, and lactate. The ABL90 FLEX PLUS System has an automated sample inlet mechanism, which can collect blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode.
Intended Use
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa*, cCa²+), glucose, and lactate in heparinized arterial and venous whole blood.
The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting.
These tests are only performed under a physician's order.
Potassium (cK+): Potassium measurements are used to monitor electrolyte balance in the diaqnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa+); Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measurements measure the concentration of lactate. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
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Substantial Equivalence Comparison
Substantial equivalence comparison table
| ABL90 FLEX PLUS System(This 510(k)) | ABL90 FLEX(510(k) K092686) | ||
|---|---|---|---|
| Manufacturer | Radiometer Medical ApS | Radiometer Medical ApS | |
| Indications forUse | The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automatedanalyzer that quantitatively measureselectrolytes (cK+, cNa+, cCa2+),glucose, and lactate in heparinizedarterial and venous whole blood. | The ABL90 FLEX is a portable,automated analyzer that measurespH, blood gases, electrolytes,glucose, lactate and oximetry inheparinized whole blood. The ABL90FLEX is intended for use by trainedtechnologists, nurses, physicians andtherapists. It is intended for use in alaboratory environment, near patientor point-of-care setting. | |
| Intended Use | Measurement of cK+, cNa+, cCa2+,cGlu and cLac | Measurement of cK+, cNa+, cCa2+,cGlu and cLac | |
| Intended useenvironment | Laboratory environment, near patientor point-of-care setting | Laboratory environment, near patientor point-of-care setting | |
| Prescription/OTCUse | Prescription | Prescription | |
| Sample requirements | |||
| Sample type | Heparinized whole blood (arterial,venous) | Heparinized whole blood (arterial,venous) | |
| Compatiblesampling devices | Radiometer samplers (in S65 mode)and non-Radiometer samplers (inSP65 mode) | Radiometer samplers and non-Radiometer samplers | |
| Sample volume | 65 µL | 65 µL | |
| Samplepreparation | With balanced heparin anticoagulant | With balanced heparin anticoagulant | |
| Device design | |||
| Operating | Potentiometry: cK+, cNa+, cCa2+ | Potentiometry: cK+, cNa+, cCa2+ | |
| principles | Amperometry: cGlu and cLac | Amperometry: cGlu and cLac | |
| Majorcomponents | ● Touch screen● Barcode reader● Sample mixer● Inlet module● Fluid transport system● Oximetry module● Electronics● Software● Printer● Optional battery pack● Communication ports | ● Touch screen● Barcode reader● Sample mixer● Inlet module● Fluid transport system● Oximetry module● Electronics● Software● Printer● Communication ports | |
| Consumables | ● Sensor cassette● Solution pack | ● Sensor cassette● Solution pack | |
| Performance characteristics | |||
| ABL90 FLEX PLUS System(This 510(k)) | ABL90 FLEX(510(k) K092686) | ||
| Reportableranges | cK+: | 2.1 - 10.5 mEq/L | cK+: 2.1 - 10.5 mEq/L |
| cCa2+: | 2.00 - 9.94 mg/dL | cCa2+: 2.00 - 9.92 mg/dL | |
| cNa+: | 116 - 180 mEq/L | cNa+: 116 - 180 mEq/L | |
| cGlu: | 18 - 738 mg/dL | cGlu: 9 - 738 mg/dL | |
| cLac: | 4 - 216 mg/dL | cLac: 4 - 216 mg/dL |
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Analytical Performance Testing Summary
The ABL90 FLEX PLUS System has been tested for analytical performance, including tests for linearity, limit of blank, detection and quantification, precision, bias, interference, stability. The tests were conducted in general accordance with Clinical Laboratory Standards Institute (CLSI) guidelines, all of which are FDA-recognized consensus standards.
Linearity
Linearity testing was conducted in general accordance with CLSI EP06, Evaluation of the Linearity of Quantitative Measurement Procedures, 2nd Edition and EP39, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition. The resulting linearity intervals are listed in Table 1.
| Parameter(unit) | ReportableRange | TestedRange | Slope | Intercept | R2 |
|---|---|---|---|---|---|
| cCa2+ (mg/dL) | 2.00-9.94 | 1.896-11.146 | 0.883 | 0.445 | 1.000 |
| cK+ (mEq/L) | 2.1-10.5 | 0.99-11.99 | 1.001 | 0.027 | 1.000 |
| cNa+ (mEq/L) | 116-180 | 90.0-194.9 | 1.001 | -0.642 | 1.000 |
| cGlu (mg/dL) | 18-738 | 17.5-926.1 | 1.032 | -1.073 | 1.000 |
| cLac (mg/dL) | 4-216 | 1.9-252.9 | 0.971 | -0.433 | 1.000 |
Table 1: Linearity results
Detection
Detection capability testing in terms of limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ) was conducted. in general accordance with CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, and EP39, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition. Table 2 shows the results of the detection testing.
| Parameter | Unit | LoB | LoD | LoQ |
|---|---|---|---|---|
| cCa2+ | mg/dL | N/A | N/A | 1.26 |
| cK+ | mEq/L | N/A | N/A | 1.6 |
| cNa+ | mEq/L | N/A | N/A | 99 |
| cGlu | mg/dL | -0.023 | 5 | 5 |
Table 2: Detection results
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| Parameter | Unit | LoB | LoD | LoQ |
|---|---|---|---|---|
| cLac | mg/dL | -0.7 | -0.3 | 2 |
N/A: Not applicable
Precision
Two precision studies were performed; both were in general accordance with CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures.
Precision using stable, aqueous ampoule-based QC material
The primary endpoints of the study were repeatability and within laboratory precision for pooled across several sites. The secondary endpoint was reproducibility between sites. The sample material was Radiometer QUALICHECK5+ QC ampoules, a QC material that comes in four "levels". Testing occurred at three external sites. Table 3 presents the data on the primary and secondary endpoints.
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| Parameter | QCampoule | N | Mean | Repeatability | Within Lab Precision | Reproducibility | |||
|---|---|---|---|---|---|---|---|---|---|
| SD | CV% | SD | CV% | SD | CV% | ||||
| cCa2+(mg/dL) | QC5+ L 1 | 243 | 3.99 | 0.010 | 0.3 | 0.018 | 0.5 | 0.019 | 0.5 |
| QC5+ L 2 | 244 | 2.11 | 0.003 | 0.1 | 0.012 | 0.6 | 0.013 | 0.6 | |
| QC5+ L 3 | 244 | 1.52 | 0.003 | 0.2 | 0.015 | 1.0 | 0.015 | 1.0 | |
| QC5+ L 4 | 244 | 6.34 | 0.014 | 0.2 | 0.030 | 0.5 | 0.036 | 0.6 | |
| cGlu(mg/dL) | QC5+ L 1 | 243 | 28 | 0.3 | 1.1 | 0.5 | 2.0 | 0.6 | 2.1 |
| QC5+ L 2 | 244 | 101 | 0.6 | 0.6 | 1.2 | 1.2 | 1.2 | 1.2 | |
| QC5+ L 3 | 244 | 247 | 1.3 | 0.5 | 5.4 | 2.2 | 6.3 | 2.5 | |
| cK+(meq/L) | QC5+ L 1 | 243 | 1.7 | 0.00 | 0.2 | 0.02 | 1.0 | 0.02 | 1.1 |
| QC5+ L 2 | 244 | 3.7 | 0.00 | 0.1 | 0.01 | 0.2 | 0.01 | 0.2 | |
| QC5+ L 3 | 244 | 5.4 | 0.01 | 0.1 | 0.01 | 0.2 | 0.01 | 0.2 | |
| QC5+ L 4 | 244 | 6.1 | 0.01 | 0.1 | 0.02 | 0.3 | 0.02 | 0.3 | |
| cLac(mg/dL) | QC5+ L 1 | 243 | 39 | 0.3 | 0.8 | 0.5 | 1.3 | 0.5 | 1.3 |
| QC5+ L 2 | 244 | 15 | 0.2 | 1.1 | 0.2 | 1.5 | 0.2 | 1.6 | |
| QC5+ L 3 | 244 | 97 | 0.3 | 0.3 | 1.2 | 1.3 | 1.2 | 1.3 | |
| cNa+(meq/L) | QC5+ L 1 | 243 | 162 | 0.2 | 0.1 | 0.2 | 0.1 | 0.3 | 0.2 |
| QC5+ L 2 | 244 | 141 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | |
| QC5+ L 3 | 244 | 126 | 0.1 | 0.1 | 0.2 | 0.1 | 0.2 | 0.1 | |
| OC5+ L 4 | 244 | 119 | 0.1 | 0.1 | 0.3 | 0.3 | 0.3 | 0.3 |
Table 3: Precision results using QC materials
N: Number of data points for analysis SD: Standard Deviation CV%: %Coefficient of Variation QC5+ L X: QUALICHECK5+ Level X
Precision using blood
The primary endpoint of the study was repeatability, designated SD, pooled across sites. Two levels of concentration were covered for all parameters. Testing was conducted in both samples collection modes: syringe/S65 mode and short probe/SP65 mode. Table 4 summarizes the results of the study.
| Repeatability | |||||
|---|---|---|---|---|---|
| Parameter | N | Test interval | Mean | SD | CV (%) |
| S65 Mode | |||||
| Ca2+ (mg/dL) | 18 | 2.605 - <3.407 | 3.165 | 0.007 | 0.23 |
| 70 | 3.407 - <4.609 | 4.403 | 0.016 | 0.37 | |
| 154 | 4.609 - <5.17 | 4.826 | 0.022 | 0.45 | |
| 4 | 5.17 - <5.812 | 5.313 | 0.003 | 0.06 | |
| K+ (mEq/L) | 18 | 2.5 - <3 | 2.682 | 0.009 | 0.35 |
| 4 | 3 - <3.4 | 3.185 | 0.007 | 0.22 | |
| 202 | 3.4 - <4.5 | 3.908 | 0.010 | 0.25 | |
| 22 | 4.5 - <6 | 5.090 | 0.007 | 0.14 |
Table 4: Precision results using whole blood
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| Parameter | N | Test interval | Mean | Repeatability | |
|---|---|---|---|---|---|
| SD | CV (%) | ||||
| Na+ (mEq/L) | 18 | 116 - <120 | 117.54 | 0.118 | 0.10 |
| 24 | 120 - <136 | 133.56 | 0.194 | 0.14 | |
| 164 | 136 - <146 | 140.95 | 0.194 | 0.14 | |
| 40 | 146 - <155 | 150.02 | 0.161 | 0.11 | |
| Glu (mg/dL) | 16 | 23 - <47 | 40.275 | 0.316 | 0.79 |
| 2 | 47 - <65 | 49.150 | 0.354 | 0.72 | |
| 200 | 65 - <200 | 140.29 | 1.018 | 0.73 | |
| 28 | 200 - <595 | 262.32 | 2.221 | 0.85 | |
| Lac (mg/dL) | 178 | 4 - <20 | 10.264 | 0.231 | 2.25 |
| 14 | 20 - <27 | 22.686 | 0.177 | 0.78 | |
| 14 | 27 - <36 | 30.236 | 0.379 | 1.25 | |
| SP65 Mode | |||||
| Ca2+ (mg/dL) | 18 | 2.605 - <3.407 | 3.171 | 0.005 | 0.16 |
| 66 | 3.407 - <4.609 | 4.389 | 0.013 | 0.31 | |
| 156 | 4.609 - <5.17 | 4.823 | 0.012 | 0.24 | |
| 4 | 5.17 - <5.812 | 5.258 | 0.008 | 0.14 | |
| K+ (mEq/L) | 18 | 2.5 - <3 | 2.673 | 0.026 | 0.96 |
| 8 | 3 - <3.4 | 3.280 | 0.005 | 0.15 | |
| 198 | 3.4 - <4.5 | 3.899 | 0.009 | 0.22 | |
| 20 | 4.5 - <6 | 5.031 | 0.007 | 0.14 | |
| Na+ (mEq/L) | 16 | 116 - <120 | 118.04 | 0.061 | 0.05 |
| 24 | 120 - <136 | 133.48 | 0.094 | 0.07 | |
| 160 | 136 - <146 | 140.93 | 0.083 | 0.06 | |
| 42 | 146 - <155 | 149.79 | 0.091 | 0.06 | |
| Glu (mg/dL) | 18 | 23 - <65 | 39.583 | 0.207 | 0.52 |
| 194 | 65 - <200 | 138.79 | 1.098 | 0.79 | |
| 32 | 200 - <595 | 263.24 | 0.912 | 0.35 | |
| Lac (mg/dL) | 178 | 4 - <20 | 10.222 | 0.200 | 1.96 |
| 14 | 20 - <27 | 22.818 | 0.235 | 1.03 | |
| 14 | 27 - <36 | 30.813 | 0.231 | 0.75 |
N: Number of data points for analysis Test interval: Range of values studied SD: Standard Deviation CV%: %Coefficient of Variation
Method comparison
Bias was determined by conducting a method comparison study in general accordance with CLSI EP09c, 3rd Edition, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. The comparator device was the ABL90 FLEX PLUS analyzer as it was designed at the time of the clearance of K160153, in terms of its characteristics related to analytical performance. Testing was conducted using both arterial and venous blood, and in both samples collection modes: syringe/S65 mode and short probe/SP65 mode. Analysis was performed by linear regression over the reportable range. Results are presented in Table 5 and Table 6.
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Г
| Parameter | Bloodtype | Mode | n | Min-max | Intercept | Slope | R2 | Medicaldecisionpoint | Bias atMD |
|---|---|---|---|---|---|---|---|---|---|
| cNa+(meq/L) | A | S65 | 225 | 117.2-179.5 | 0.039 | 1.002 | 0.999 | 136.00 | 0.287 |
| A | SP65 | 218 | 116.8-179.7 | -0.227 | 1.003 | 0.999 | 0.223 | ||
| V | S65 | 234 | 117.2-179.5 | -0.012 | 1.002 | 0.999 | 0.242 | ||
| V | SP65 | 224 | 116.8-179.7 | -0.276 | 1.004 | 0.999 | 0.220 | ||
| cK+(meq/L) | A | S65 | 222 | 2.12-10.4 | 0.018 | 0.996 | 0.999 | 3.400 | 0.004 |
| A | SP65 | 218 | 2.11-10.45 | 0.033 | 0.993 | 0.997 | 0.008 | ||
| V | S65 | 233 | 2.12-10.4 | 0.014 | 0.996 | 0.999 | 0.000 | ||
| V | SP65 | 225 | 2.11-10.45 | 0.033 | 0.992 | 0.997 | 0.007 | ||
| cCa2+(mg/dL) | A | S65 | 222 | 2.114-9.791 | -0.014 | 1.003 | 0.999 | 4.600 | 0.001 |
| A | SP65 | 214 | 2.127-9.651 | -0.046 | 1.011 | 0.999 | 0.003 | ||
| V | S65 | 231 | 2.114-9.791 | -0.019 | 1.004 | 0.999 | 0.000 | ||
| V | SP65 | 220 | 2.127-9.651 | -0.049 | 1.011 | 0.999 | 0.003 | ||
| cGlu(mg/dL) | A | S65 | 224 | 20.5-728.1 | 0.425 | 0.988 | 0.999 | 65.000 | -0.337 |
| A | SP65 | 215 | 20.1-712.7 | -0.024 | 0.990 | 0.999 | -0.664 | ||
| V | S65 | 232 | 20.5-728.1 | 0.184 | 0.989 | 0.999 | -0.558 | ||
| V | SP65 | 219 | 20.1-712.7 | -0.045 | 0.990 | 0.999 | -0.696 | ||
| cLac(mg/dL) | A | S65 | 221 | 4.1-209.7 | -0.182 | 1.007 | 0.995 | 18.000 | -0.053 |
| A | SP65 | 216 | 4-209.9 | -0.093 | 0.999 | 0.995 | -0.119 | ||
| V | S65 | 233 | 4.3-209.7 | -0.333 | 1.008 | 0.994 | -0.181 | ||
| V | SP65 | 223 | 4.3-209.9 | -0.202 | 1.000 | 0.995 | -0.208 |
Table 5: Method comparison results using reportable ranges specified in the protocol
A: Arterial
V: Venous
Min-max: Range of values measured
Table 6: Method comparison results, arterial and venous combined, additional medical decision levels
| Parameter | n | Intercept | Slope | R2 | Medicaldecisionpoint | Bias at MD |
|---|---|---|---|---|---|---|
| S65 | ||||||
| Ca (mg/dL) | 437 | -0.018 | 1.004 | 0.998 | 4.600 | 0.001 |
| 5.170 | 0.003 | |||||
| Glu (mg/dL) | 439 | 0.295 | 0.988 | 0.999 | 65.000 | -0.460 |
| 200.00 | -2.028 | |||||
| K (mEq/L) | 438 | 0.015 | 0.996 | 0.998 | 3.400 | 0.002 |
| 4.500 | -0.002 | |||||
| Lac (mg/dL) | 436 | -0.245 | 1.007 | 0.995 | 18.000 | -0.116 |
| 36.000 | 0.013 | |||||
| Na (mEq/L) | 441 | -0.077 | 1.003 | 0.999 | 136.00 | 0.265 |
| 146.00 | 0.290 | |||||
| SP65 | ||||||
| Ca (mg/dL) | 420 | -0.047 | 1.011 | 0.998 | 4.600 | 0.003 |
| 5.170 | 0.009 |
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| Parameter | n | Intercept | Slope | R2 | Medicaldecisionpoint | Bias at MD |
|---|---|---|---|---|---|---|
| Glu (mg/dL) | 420 | 0.002 | 0.990 | 0.999 | 65.000 | -0.663 |
| 200.00 | -2.045 | |||||
| K (mEq/L) | 425 | 0.029 | 0.993 | 0.997 | 3.400 | 0.004 |
| 4.500 | -0.004 | |||||
| Lac (mg/dL) | 422 | -0.143 | 0.999 | 0.995 | 18.000 | -0.156 |
| 36.000 | -0.169 | |||||
| Na (mEq/L) | 425 | -0.302 | 1.004 | 0.999 | 136.00 | 0.221 |
| 146.00 | 0.259 |
Interference
Interfering substances were evaluated based on testing conducted in general accordance with CLSI, EP07, Interference Testing in Clinical Chemistry, 3rd Edition, and CLSI EP37, Supplemental Tables for Interference Testing in Clinical Chemistry, 1st Edition. The interference testing consists of two parts: paired-difference and dose-response studies. The paired-difference study was conducted on a large panel of likely interferents, using clinically significant amount of the interferents. Dose-response studies were only conducted in cases where a clinically significant interferent effect was noted during the paired different study. Table 7 summarizes the testing that was performed. Specific values for level of interference are described in Table 8.
| Interferent | cCa2+ | cK+ | cNa+ | cGlu | cLac | Interferent | cGlu | cLac |
|---|---|---|---|---|---|---|---|---|
| Intralipid | - | - | X | - | - | Lactate | - | - |
| Hemolysis | X | X | X | - | - | Thiocyanate | X | X |
| Bilirubin (unconj) | - | - | - | - | - | Acetaminophen | - | - |
| Bilirubin (conj) | - | - | - | - | - | Acetoacetate | - | - |
| Biotin | - | - | - | - | - | Chlorpromazine HCl | - | - |
| Propofol | - | - | - | - | - | Creatinine | - | - |
| Fluoride | - | - | - | X | X | 2-deoxy Glucose | X | - |
| Potassium @ low level | - | - | - | - | - | EDTA | - | X |
| Potassium @ high level | - | - | - | - | - | Formaldehyde | - | - |
| Sodium @ low level | - | - | - | - | - | Formic acid | - | X |
| Sodium @ high level | - | - | - | - | - | Galactose | X | - |
| Calcium @ low level | - | - | - | - | - | Glucosamine HCl | - | - |
| Calcium @ high level | - | - | - | - | - | Glycolic acid | - | X |
| Lithium | - | - | - | - | - | Heparin | - | - |
| Ammoniumchloride | - | - | - | - | - | Ibuprofen | - | - |
| Ascorbate | - | - | - | - | - | Maltose | - | - |
| Benzalkonium chloride | X | X | X | - | - | Mannose | - | - |
| Leflunomide | X | - | - | - | - | Methanol | - | - |
| Nortriptyline | - | - | - | - | - | N-acetylcystein | - | X |
Table 7: Interference testing
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| Interferent | cCa²⁺ | cK⁺ | cNa⁺ | cGlu | cLac |
|---|---|---|---|---|---|
| Teriflunomide | × | × | × | ||
| Thiopental | - | ||||
| Magnesium | × | - | |||
| pH @ low level | × | ||||
| pH @ high level | × | ||||
| Perchlorate | - | ||||
| Strontium | - | ||||
| Oxalate | - | - | |||
| Salicylic acid | - | - | |||
| Acetylsalicylic acid | - | - | |||
| Citrate | - | × | |||
| Zinc | × | - | - |
| Interferent | cGlu | cLac |
|---|---|---|
| Pralidoxime chloride | - | - |
| Pyruvate | - | - |
| Urea | - | - |
| Uric acid | - | - |
| Xylose | - | - |
| DopamineHydrochloride | - | - |
| Ethanol | - | - |
| Povidone-iodine | X | - |
| D-Glucose | - | - |
Key
No clinically significant interference Clinically significant interference
י ×
Interferent not relevant to be tested for this parameter
Table 8: Interference values
| Interferent | Maximum testconcentration | Highestconcentration levelwhere interferencewas not significant | Impact on resultfor maximum testconcentration |
|---|---|---|---|
| cCa2+ (test level: 4.6 mg/dL) | |||
| Benzalkonium chloride | 2.4 mg/dL | 0.6 mg/dL | 1.94 mg/dL |
| Hemolysis | 20% | 5% | -1.43 mg/dL |
| Leflunomide | 30 mg/dL | 15 mg/dL | -0.73 mg/dL |
| Magnesium (-nitrate)(test matrix: Plasma) | 385 mg/dL | 96 mg/dL | 1.13 mg/dL |
| pH @ low level(test matrix: Plasmaᵃ) | 6.8 | Interference forpH < 7.2 | 1.58 mg/dL |
| pH @ high level(test matrix: Plasmaᵃ) | 8.0 | Interference forpH > 7.6 | -1.20 mg/dL |
| Zn+ (Zinc chloride) | 2.3 mg/dL | 1.7 mg/dL | 0.58 mg/dL |
| cCa2+ (test level: 6.0 mg/dL) | |||
| Benzalkonium chloride | 2.4 mg/dL | 0.45 mg/dL | 2.54 mg/dL |
| Hemolysis | 20% | 5% | -1.69 mg/dL |
| Leflunomide | 30 mg/dL | 22.5 mg/dL | -0.85 mg/dL |
| Magnesium (-nitrate)(test matrix: Plasma) | 385 mg/dL | 72 mg/dL | 1.53 mg/dL |
| pH @ low level(test matrix: Plasmaᵃ) | 6.8 | Interference forpH < 7.2 | 2.35 mg/dL |
| pH @ high level(test matrix: Plasmaᵃ) | 8.0 | Interference forpH > 7.7 | -0.84 mg/dL |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -0.79 mg/dL |
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| Interferent | Maximum testconcentration | Highestconcentration levelwhere interferencewas not significant | Impact on resultfor maximum testconcentration |
|---|---|---|---|
| Notes for Calcium: | |||
| a) A change in the pH of blood has the physiological effect of changing the concentrations ofionized calcium. An increase of 1 pH unit results in a decrease of approximately 2 mg/dLcCa2+. | |||
| cK+ (test level: 3.5 mEq/L) | |||
| Benzalkonium chloride | 2.4 mg/dL | 0.6 mg/dL | 1.11 mEq/L |
| Hemolysis | 20% | 0.25% | 13.1 mEq/L |
| Teriflunomide | 30 mg/dL | 15 mg/dL | -0.53 mEq/L |
| cK+ (test level: 5.0 mEq/L) | |||
| Benzalkonium chloride | 2.4 mg/dL | 0.6 mg/dL | 1.27 mEq/L |
| Hemolysis | 20% | 0.40% | 14.3 mEq/L |
| Teriflunomide | 30 mg/dL | 15 mg/dL | -0.88 mEq/L |
| cNa+ (test level: 135 mEq/L) | |||
| Benzalkonium chloride | 2.4 mg/dL | 0.12 mg/dL | 28.0 mEq/L |
| Hemolysis | 20% | 2.5% | -15.3 mEq/L |
| Intralipid | 2000 mg/dL | 1000 mg/dL | 5.0 mEq/L |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -4.3 mEq/L |
| cNa+ (test level: 145 mEq/L) | |||
| Benzalkonium chloride | 2.4 mg/dL | 0.11 mg/dL | 29.6 mEq/L |
| Hemolysis | 20% | 2.5% | -14.8 mEq/L |
| Intralipid | 2000 mg/dL | 1000 mg/dL | 4.8 mEq/L |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -4.8 mEq/L |
| cGlu (test level: 39.6 mg/dL) | |||
| 2-deoxy glucose | 164 mg/dL | 3.3 mg/dL | 158 mg/dL |
| Bromide (sodium-) a) | 391 mg/dL | 49 mg/dL | -5.81 mg/dL |
| Fluoride (sodium-) b) | 210 mg/dL | 105 mg/dL | -5.6 mg/dL |
| Galactose | 59 mg/dL | 44 mg/dL | 3.5 mg/dL |
| Povidone-iodine | 1000 mg/dL | 500 mg/dL | 6.9 mg/dL |
| Thiocyanate (sodium-) | 195 mg/dL | 1.2 mg/dL | 94 mg/dL |
| cGlu (test level: 220 mg/dL) | |||
| 2-deoxy glucose | 164 mg/dL | 25 mg/dL | 165 mg/dL |
| Thiocyanate (sodium-) | 195 mg/dL | 10 mg/dL | 99 mg/dL |
| Notes for Glucose:a) Paired-difference cGlu test level: 101 mg/dL. Dose-Response cGlu test level: 88 mg/dL.b) Do not use samples collected in fluorinated sampling tubes as exposure to highconcentrations of fluoride causes falsely low cGlu results and may cause falsely low cGlu resultsin subsequent sample measurements." | |||
| cLac (test level:9.0 mg/dL) | |||
| Bromide (sodium-) a), b) | 391 mg/dL | 49 mg/dL | -3.4 mg/dL |
| EDTA (edetate disodium2H2O) | 112 mg/dL | 84 mg/dL | -1.67 mg/dL |
| Formic acid e) | 115 mg/dL | 29 mg/dL | -1.36 mg/dL |
| Glycolic acid d) | 7.6 mg/dL | 0.2 mg/dL | 10 mg/dL |
| Interferent | Maximum testconcentration | Highestconcentration levelwhere interferencewas not significant | Impact on resultfor maximum testconcentration |
| N-acetylcysteine | 166 mg/dL | 125 mg/dL | -1.07 mg/dL |
| Thiocyanate (sodium-) | 195 mg/dL | 1.2 mg/dL | 16 mg/dL |
| cLac (test level: 15.3 mg/dL) | |||
| Citrate (trisodium citrate2H2O) | 1176 mg/dL | 882 mg/dL | -1.9 mg/dL |
| EDTA (edetate disodium2H2O) | 112 mg/dL | 56 mg/dL | -1.9 mg/dL |
| Fluoride (sodium-) c) | 210 mg/dL | 52.5 mg/dL | -1.5 mg/dL |
| Formic acid e) | 115 mg/dL | 86 mg/dL | -1.7 mg/dL |
| Glycolic acid d) | 7.6 mg/dL | 0.2 mg/dL | 27 mg/dL |
| N-acetylcysteine | 166 mg/dL | 83 mg/dL | -1.40 mg/dL |
| Thiocyanate (sodium-) | 195 mg/dL | 2.4 mg/dL | 21 mg/dL |
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Notes for Lactate:
a) Paired-difference cLac test level: 10.7 mg/dL. Dose-Response cLac test level: 28.6 mg/dL. b) Normal physiological levels of bromide do not interfere. Exposure to high concentrations of Bromide causes falsely low cLac results and may cause falsely low cLac results on any subsequent samples measured within 5 minutes.
c) Do not use samples collected in fluorinated sampling tubes as exposure to high concentrations of fluoride causes falsely low cLac results and may cause falsely low cLac results in subsequent sample measurements. "
d) Healthy patients have a glycolic acid concentration of 0.034 to 0.093 mg/dL. Ethylene glycol poisoning is a rare condition affecting about 20 people per million annually in the USA. Ethylene glycol poisoning may exhibit very high levels of glycolic acid. Levels up to 289 mg/dL have been reported. A glycolic acid level of 289 mg/dL may interfere with the lactate sensor for up to 5 minutes. If ethylene glycol poisoning is suspected or confirmed, do not use lactate for that sample or any subsequent samples measured within 5 minutes."
e) Healthy patients have a formic acid concentration of 0.1 to 0.9 mg/dL. Higher levels of formic acid may occur with methanol poisoning, which is a rare condition affecting about 6.4 persons per million annually in the USA.
Conclusion
The results above demonstrate the acceptable analytical performance of the ABL90 FLEX PLUS System and its substantial equivalence to its predicate.
§ 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.