(273 days)
No
The document describes a standard in vitro diagnostic analyzer and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) analyzer used to measure various substances in blood; it does not directly treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer..." and describes its use in diagnosing and treating various disease conditions based on measurements of electrolytes, glucose, and lactate.
No
The device description explicitly states that the system consists of an analyzer, sensor cassette, solution pack consumables, and related accessories, indicating it includes hardware components beyond just software.
Yes, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer..."
N/A
Intended Use / Indications for 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 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).
Product codes (comma separated list FDA assigned to the subject device)
CEM, JGS, JFP, CGA, KHP
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Intended User: trained technologists, nurses, physicians and therapists.
Care Setting: laboratory environment, near patient, or point-of-care setting.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
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.
Key Results: The resulting linearity intervals showed R2 values of 1.000 for cCa2+, cK+, cNa+, cGlu, and cLac.
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.
Key Results: LoQ values were 1.26 mg/dL for cCa2+, 1.6 mEq/L for cK+, 99 mEq/L for cNa+, 5 mg/dL for cGlu, and 2 mg/dL for cLac.
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:
Study Type: Repeatability, within laboratory precision, and reproducibility between sites using QC material.
Sample Size: N=243 or 244 for each parameter across four QC levels.
Key Results: Low Coefficients of Variation (CV%) were observed across all parameters (cCa2+, cGlu, cK+, cLac, cNa+) for repeatability, within laboratory precision, and reproducibility, generally under 2.5%. -
Precision using blood:
Study Type: Repeatability in two sample collection modes: syringe/S65 mode and short probe/SP65 mode.
Sample Size: Varies per parameter and interval (e.g., cCa2+ (S65): 18 to 154 samples; cK+ (S65): 4 to 202 samples; cNa+ (S65): 18 to 164 samples; cGlu (S65): 2 to 200 samples; cLac (S65): 14 to 178 samples). Similar sample sizes for SP65 mode.
Key Results: Low CV% values were observed for repeatability across all parameters in both S65 and SP65 modes, largely below 2.5%.
Method comparison:
Study Type: Bias determination comparing the ABL90 FLEX PLUS System to the comparator device (ABL90 FLEX PLUS analyzer at time of K160153 clearance).
Sample Size: For S65 mode, n ranged from 221 to 234 for individual parameters and blood types (Arterial/Venous). For SP65 mode, n ranged from 214 to 225. Combined arterial and venous data n ranged from 420 to 441.
Key Results: Analysis showed high R2 values (0.994-0.999) indicating good correlation. Bias at medical decision points was generally small, e.g., for cNa+ (S65, arterial): 0.287 mEq/L, for cGlu (S65, arterial): -0.337 mg/dL, for cLac (S65, arterial): -0.053 mg/dL.
Interference:
Study Type: Evaluation of interfering substances using paired-difference and dose-response studies. 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.
Key Results: Identified various clinically significant interferences for cCa2+ (e.g., Benzalkonium chloride, Hemolysis, pH), cK+ (e.g., Benzalkonium chloride, Hemolysis), cNa+ (e.g., Benzalkonium chloride, Hemolysis, Intralipid), cGlu (e.g., 2-deoxy glucose, Thiocyanate), and cLac (e.g., Glycolic acid, Thiocyanate). Specific impact on results for maximum test concentrations were provided (e.g., for cCa2+ at 4.6 mg/dL, Benzalkonium chloride showed +1.94 mg/dL impact).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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).
1
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.
2
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
3
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 21 |
| 2700 Broenshoej | |
| Denmark | |
| 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 for
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 is a portable,
automated analyzer that measures
pH, blood gases, electrolytes,
glucose, lactate and oximetry in
heparinized whole blood. The ABL90
FLEX 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. | |
| Intended Use | Measurement of cK+, cNa+, cCa2+,
cGlu and cLac | Measurement of cK+, cNa+, cCa2+,
cGlu and cLac | |
| Intended use
environment | Laboratory environment, near patient
or point-of-care setting | Laboratory environment, near patient
or point-of-care setting | |
| Prescription/OTC
Use | Prescription | Prescription | |
| Sample requirements | | | |
| Sample type | Heparinized whole blood (arterial,
venous) | Heparinized whole blood (arterial,
venous) | |
| Compatible
sampling devices | Radiometer samplers (in S65 mode)
and non-Radiometer samplers (in
SP65 mode) | Radiometer samplers and non-
Radiometer samplers | |
| Sample volume | 65 µL | 65 µL | |
| Sample
preparation | 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 | |
| Major
components | ● 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) |
| Reportable
ranges | 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) | Reportable
Range | Tested
Range | 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 | QC
ampoule | 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 - S65 | |||
| Ca (mg/dL) | 437 | -0.018 | 1.004 | 0.998 | 4.600 |
| 5.170 | |||||
| Glu (mg/dL) | 439 | 0.295 | 0.988 | 0.999 | 65.000 |
| 200.00 | |||||
| K (mEq/L) | 438 | 0.015 | 0.996 | 0.998 | 3.400 |
| 4.500 | |||||
| Lac (mg/dL) | 436 | -0.245 | 1.007 | 0.995 | 18.000 |
| 36.000 | |||||
| Na (mEq/L) | 441 | -0.077 | 1.003 | 0.999 | 136.00 |
| 146.00 | |||||
| SP65 | |||||
| Ca (mg/dL) | 420 | -0.047 | 1.011 | 0.998 | 4.600 |
| 5.170 |
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| Parameter | n | Intercept | Slope | R2 | Medical
decision
point | 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 | - | - |
| Dopamine | ||
| Hydrochloride | - | - |
| 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 test
concentration | Highest
concentration level
where interference
was not significant | Impact on result
for maximum test
concentration |
|-----------------------------------------------|-------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------|
| 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 for
pH 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 for
pH 7.7 | -0.84 mg/dL |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -0.79 mg/dL |
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| Interferent | Maximum test
concentration | Highest
concentration level
where interference
was not significant | Impact on result
for maximum test
concentration |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------|
| Notes for Calcium: | | | |
| a) A change in the pH of blood has the physiological effect of changing the concentrations of
ionized calcium. An increase of 1 pH unit results in a decrease of approximately 2 mg/dL
cCa2+. | | | |
| | 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 high
concentrations of fluoride causes falsely low cGlu results and may cause falsely low cGlu results
in 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 disodium
2H2O) | 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 test
concentration | Highest
concentration level
where interference
was not significant | Impact on result
for maximum test
concentration |
| 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 citrate
2H2O) | 1176 mg/dL | 882 mg/dL | -1.9 mg/dL |
| EDTA (edetate disodium
2H2O) | 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 |
15
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.