ABL90 FLEX PLUS System
Device Facts
| Record ID | K241037 |
|---|---|
| Device Name | ABL90 FLEX PLUS System |
| Applicant | Radiometer Medicals Aps |
| Product Code | CEM · Clinical Chemistry |
| Decision Date | Jan 14, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1600 |
| Device Class | Class 2 |
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, 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).
Device Story
Portable, automated in vitro diagnostic analyzer; measures electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial/venous whole blood. Operates via potentiometry (electrolytes) and amperometry (glucose, lactate). Features automated sample inlet mechanism supporting syringe (S65) and short probe (SP65) modes. Used in laboratory, near-patient, or point-of-care settings by trained clinicians. Input: 65 µL blood sample. Output: Quantitative concentration values displayed on touch screen. Assists clinicians in monitoring electrolyte balance, diagnosing metabolic/endocrine disorders, and evaluating acid-base status. Benefits patient through rapid, point-of-care diagnostic information for timely clinical decision-making.
Clinical Evidence
No clinical data. Performance supported by analytical bench testing: precision/reproducibility (multi-day, multi-site), linearity (CLSI EP06-A2), analytical specificity/interference (paired-difference and dose-response), and method comparison (CLSI EP09c-ED3) against predicate using 353 heparinized whole blood samples. Deming regression showed high correlation (R2 ≥ 0.994) across all parameters.
Technological Characteristics
Portable analyzer; potentiometric sensors (cK+, cNa+, cCa2+); amperometric sensors (cGlu, cLac). Consumables: sensor cassette, solution pack. Sample volume: 65 µL. Modes: S65 syringe, SP65 short probe. Connectivity: barcode reader, communication ports. User interface: touch screen. Power: optional battery pack. Software-controlled fluid transport and analysis.
Indications for Use
Indicated for trained technologists, nurses, physicians, and therapists to quantitatively measure electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial and venous whole blood in laboratory, near-patient, or point-of-care settings under physician order. Used for monitoring electrolyte balance, diagnosing/treating electrolyte imbalances (aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, SIADH), parathyroid/bone/renal diseases, tetany, carbohydrate metabolism disorders (diabetes mellitus, idiopathic hypoglycemia, pancreatic islet cell carcinoma), and evaluating acid-base status/lactic acidosis.
Regulatory Classification
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.
Predicate Devices
- ABL90 Flex (K092686)
Related Devices
- K160153 — ABL90 FLEX PLUS · Radiometer Medical Aps · Nov 4, 2016
- K223090 — GEM Premier ChemSTAT · Instrumentation Laboratory CO · Jan 27, 2023
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K241037
B Applicant
Radiometer Medicals ApS
C Proprietary and Established Names
Ab190 FLEX PLUS System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CEM | Class II | 21 CFR 862.1600 - Potassium Test System | CH - Clinical Chemistry |
| JGS | Class II | 21 CFR 862.1665 - Sodium test system | CH - Clinical Chemistry |
| JFP | Class II | 21 CFR 862.1145 - Calcium test system | CH - Clinical Chemistry |
| CGA | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |
| KHP | Class I, meets the limitations of exemptions per 862.9(c)(9) | 21 CFR 862.1450 - Lactic acid test system | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modification to a previously cleared device.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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B Measurand:
Potassium (cK+), Sodium (cNa+), Calcium (cCa2+), Glucose (cGlu), Lactate (cLac)
C Type of Test:
Potentiometry: Potassium, Sodium, Calcium
Amperometry: Glucose and Lactate
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) 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, 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).
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
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D Special Instrument Requirements:
ABL90 FLEX PLUS System
IV Device/System Characteristics:
A Device Description:
The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette (SC) and solution pack (SP) consumables, and related accessories for the analyzer. The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of balanced heparinized whole blood for the parameters cK+, cNa+, cCa2+, glucose and lactate.
The ABL90 FLEX PLUS Analyzer is a portable analyzer that contains the inlet module, the sample mixer, the fluid transport system, a barcode reader, a printer, and all the electronics and software to control the analyzer and for data management. The ABL90 FLEX PLUS Analyzer has an automated sample inlet mechanism, which can collect the blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode.
The ABL90 FLEX Sensor Cassette (SC) includes sensors for potentiometric measurements of cK+, cNa+, and cCa2+ and the amperometric measurements of cGlu and cLac. The SC comes in different versions. The versions are the same with respect to physical and chemical characteristics and differ only in a memory chip that encodes the maximum number of tests and availability of sensors for use in each SC.
The ABL90 FLEX PLUS Solution Pack (SP) provides solutions and gas mixtures for calibration, rinse and quality control of the measuring system, and sealed pouches for collection of waste from the analyzer. The SP comes in two versions that differ in the amount of liquid chemicals to support the maximum number of activities, where an "activity" can be a patient sample, QC measurement, a calibration, or a rinse, all of which use liquids from the SP.
This submission addresses modifications in the cGlu, cLac, cK+, cNa+, and cCa2+ electrode manufacturing process that were made to the device cleared in K160153.
The ABL90 FLEX PLUS Analyzer for the quantitative measurement of pH, blood gas (pO2), Oximetry (sO2, ctHb, FO2Hb, FCOHb, FMetHb, and FHHb) was cleared in K240998.
B Principle of Operation:
There are two different measuring principles employed by the ABL90 FLEX PLUS system to measure cGlu, cLac, cK+, cNa+, and cCa2:
Potentiometry: The potential of an electrode chain is measured by a voltmeter and related to the concentration of the sample (the Nernst equation). The potentiometric measuring principle is applied in cK+, cNa+, cCa2+ sensors.
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Amperometry: The magnitude of an electrical current that flows through an electrode chain is proportional to the concentration of the substance that is oxidized or reduced at an electrode in the chain. The amperometric measuring principle is applied in the cGlu and cLac sensors.
# V Substantial Equivalence Information:
A Predicate Device Name(s):
ABL90 Flex
B Predicate 510(k) Number(s):
K092686
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K241037 | K092686 |
| --- | --- | --- |
| Device Trade Name | ABL90 FLEX PLUS System | ABL90 FLEX |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | An in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa+, cCa2+), glucose and lactate. | Same |
| Intended Use environment | Laboratory environment, near patient or point-of-care setting | Same |
| Reportable Range | cK+: 2.1 – 10.5 mmol/L | Same |
| | cNa+: 116 – 180 mmol/L | Same |
| | cCa2+: 2.00 – 9.94 mg/dL | Same |
| | cLac: 4 – 216 mg/dL | Same |
| General Device Characteristic Differences | | |
| Reportable Range | cGlu: 18 – 738 mg/dL | cGlu: 9 – 738 mg/dL |
# VI Standards/Guidance Documents Referenced:
Clinical and Laboratory Standards Institute (CLSI) EP05-A3 - Evaluation of Precision of Quantitative Measurement Procedures
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CLSI EP09c 3rd Edition – Measurement Procedure Comparison and Bias Estimation Using Patient Samples
CLSI EP17-A2 2nd Edition – Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline
CLSI EP06-2nd Edition – Evaluation of Linearity of Quantitative Measurement Procedures.
CLSI EP07-3rd Edition – Interference Testing in Clinical Chemistry
CLSI EP37 1st Edition – Supplemental Tables for Interference Testing in Clinical Chemistry
CLSI EP39 1st Edition – A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
#### i. Precision/Reproducibility:
Two point-of-care precision (POC) studies were conducted at three sites using at least three POC operators. The first was a multi-day precision study performed using four concentrations of aqueous control solutions and 3 reagent lots. At each site, each level was tested as two replicates per run, two runs per day, for twenty days. The second was a multi-day precision study conducted with balanced heparinized whole blood at levels within the reportable range of each analyte using both the S65 and SP65 sampling modes. The results supported that modifications made to the ABL90 FLEX PLUS did not impact the precision of cGlu, cLac, cK+, cNa+, and cCa2+.
#### ii. Linearity:
Linearity testing was conducted in general accordance with CLSI EP06-A2. The results supported that modifications made to the ABL90 FLEX PLUS did not impact the linearity of cGlu, cLac, cK+, cNa+, and cCa2+.
#### iii. Analytical Specificity/Interference:
Interference testing was conducted in two parts: paired-difference testing and dose-response experiments.
a. The paired-difference testing was conducted on all potential interferents. Matched samples were tested, one with no interferent and the other with the interferent. If no interference was found, no further testing was performed.
b. The dose-response experiment was only conducted on interferents found to have an effect via the paired-difference testing. This was carried out to determine the concentration at which clinically significant interference occurred.
Freshly drawn heparinized human plasma samples or whole blood samples were used as starting material for all interference studies. Interference testing was conducted at two levels (i.e., low and high) for Ca2+, K+, Na+, Glu and Lac. The results supported that modifications made to the ABL90 FLEX PLUS did not significantly impact the substances that interfere with cGlu, cLac, cK+, cNa+, and cCa2+. The following information is provided in the labeling.
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Highest concentration tested at which no significant interference is observed.
| Potential interferent for parameter cK+ | Concentration |
| --- | --- |
| Ascorbate (-sodium) | 392 mg/dL |
| Bilirubin, conjugated | 40 mg/dL |
| Bilirubin, unconjugated | 40 mg/dL |
| Biotin | 0.351 mg/dL |
| Calcium (-chloride) | 22.0 mg/dL |
| Hemolysis | 0.25% |
| Intralipid | 2000 mg/dL |
| Leflunomide | 30 mg/dL |
| Lithium (-nitrate) | 3.2 mmol/L |
| Nortriptyline (hydrochloride) | 0.113 mg/dL |
| Propofol | 4.8 mg/dL |
| Sodium (-chloride) | 190.0 mmol/L |
| Zinc (-chloride) | 2.3 mg/dL |
| Potential interferent for parameter cNa+ | Concentration |
| Ascorbate (-sodium) | 392 mg/dL |
| Bilirubin, conjugated | 40 mg/dL |
| Bilirubin, unconjugated | 40 mg/dL |
| Biotin | 0.351 mg/dL |
| Calcium (-chloride) | 22 mg/dL |
| Hemolysis | 2.5% |
| Leflunomide | 30 mg/dL |
| Lithium (-nitrate) | 3.2 mmol/L |
| Magnesium (-nitrate) | 15.0 mmol/L |
| Nortriptyline (hydrochloride) | 0.113 mg/dL |
| Potassium (-chloride) | 17 mmol/L |
| Propofol | 4.8 mg/dL |
| Thiopental | 1.66 mmol/L |
| Zinc (-chloride) | 2.3 mg/dL |
| Potential interferent for parameter cCa2+ | Concentration |
| Sodium Ascorbate | 392 mg/dL |
| Bilirubin, conjugated | 40 mg/dL |
| Bilirubin, unconjugated | 40 mg/dL |
| Biotin | 0.351 mg/dL |
| Intralipid | 2000 mg/dL |
| Lithium (-nitrate) | 22 mg/dL |
| Nortriptyline (hydrochloride) | 0.113 mg/dL |
| Perchlorate (-potassium) | 1.50 mmol/L |
| Potassium (-chloride) | 17 mmol/L |
| Propofol | 4.8 mg/dL |
| Potential interferent for parameter cGlu | Concentration |
| Acetaminophen | 30 mg/dL |
| Acetoacetate (lithium-) | 22 mg/dL |
| Acetylsalicylic acid | 65 mg/dL |
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| Ascorbate (-sodium) | 392 mg/dL |
| --- | --- |
| Bilirubin, conjugated | 40 mg/dL |
| Bilirubin, unconjugated | 40 mg/dL |
| Biotin | 0.351 mg/dL |
| Chlorpromazine (HCl) | 7.1 mg/dL |
| Citrate (-trisodium) | 1176 mg/dL |
| Creatinine | 34 mg/dL |
| Dopamine hydrochloride | 19 mg/dL |
| EDTA (edetate disodium 2H_{2}O) | 112 mg/dL |
| Ethanol | 599 mg/dL |
| Formaldehyde | 30 mg/dL |
| Formic acid | 115 mg/dL |
| Glucosamine (HCl) | 43 mg/dL |
| Hemolysis | 20% |
| Heparin (-sodium) | 8000 iU/dL |
| Ibuprofen (-sodium) | 50 mg/dL |
| Intralipid | 2000 mg/dL |
| Lactate (-sodium) | 280 mg/dL |
| Maltose (monohydrate) | 180 mg/dL |
| Mannose | 18 mg/dL |
| Methanol | 240 mg/dL |
| N-acetylcysteine | 166 mg/dL |
| Oxalate (-sodium) | 134 mg/dL |
| Pralidoxime chloride | 0.78 mg/dL |
| Propofol | 4.8 mg/dL |
| Pyruvate (sodium-) | 22 mg/dL |
| Salicylic acid | 59 mg/dL |
| Urea | 505 mg/dL |
| Uric acid | 25 mg/dL |
| Xylose (D-xylose) | 15 mg/dL |
| Potential interferent for parameter cLac | Concentration |
| 2-deoxy glucose | 164 mg/dL |
| Acetaminophen | 30 mg/dL |
| Acetoacetate (-lithium) | 22 mg/dL |
| Acetylsalicylic acid | 65 mg/dL |
| Ascorbate (-sodium) | 392 mg/dL |
| Bilirubin, conjugated | 40 mg/dL |
| Bilirubin, unconjugated | 40 mg/dL |
| Biotin | 0.351 mg/dL |
| Calcium (-chloride) | 0.4 mg/dL |
| Chlorpromazine HCl | 7.1 mg/dL |
| Creatinine | 34 mg/dL |
| D-Glucose | 1000 mg/dL |
| Dopamine hydrochloride | 19 mg/dL |
| Ethanol | 599 mg/dL |
| Formaldehyde | 30 mg/dL |
| Galactose | 59 mg/dL |
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For those substances that on initial screening were found to interfere, dose response testing was conducted to establish the concentration limit below which no significant interference is expected. The results are summarized in the table below:
| Interferent | Maximum test concentration | Highest concentration level without interference | Impact on result |
| --- | --- | --- | --- |
| cCa^{2+} (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) | 385 mg/dL | 96 mg/dL | 1.13 mg/dL |
| pH @ low level | 6.8 | Interference for pH ≤ 7.2 | 1.58 mg/dL |
| pH @ high level | 8.0 | Interference for pH ≥ 7.6 | -1.20 mg/dL |
| Teriflunomide | 30 mg/dL | No interference | N/A |
| Zn+ (-chloride) | 2.3 mg/dL | 1.7 mg/dL | 0.58 mg/dL |
| cCa^{2+} (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 |
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| Interferent | Maximum test concentration | Highest concentration level without interference | Impact on result |
| --- | --- | --- | --- |
| Magnesium (-nitrate) (test matrix: Plasma) | 385 mg/dL | 72 mg/dL | 1.53 mg/dL |
| pH @ low level | 6.8 | Interference for pH ≤ 7.2 | 2.35 mg/dL |
| pH @ high level | 8.0 | Interference for pH ≥ 7.7 | -0.84 mg/dL |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -0.79 mg/dL |
| Zn+ (-chloride) | 2.3 mg/dL | No interference | N/A |
| **cK^{+} (test level: 3.5 mmol/L)** | | | |
| Benzalkonium chloride | 2.4 mg/dL | 0.6 mg/dL | 1.11 mmol/L |
| Hemolysis | 20% | 0.25% | 13.1 mmol/L |
| Teriflunomide | 30 mg/dL | 15 mg/dL | -0.53 mmol/L |
| **cK^{+} (test level: 5.0 mmol/L)** | | | |
| Benzalkonium chloride | 2.4 mg/dL | 0.6 mg/dL | 1.27 mmol/L |
| Hemolysis | 20% | 0.40% | 14.3 mmol/L |
| Teriflunomide | 30 mg/dL | 15 mg/dL | -0.88 mmol/L |
| **cNa^{+} (test level: 135 mmol/L)** | | | |
| Benzalkonium chloride | 2.4 mg/dL | 0.11 mg/dL | 28.0 mmol/L |
| Hemolysis | 20% | 2.5% | -15.3 mmol/L |
| Intralipid | 2000 mg/dL | 1000 mg/dL | 5.0 mmol/L |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -4.3 mmol/L |
| Thiopental | 40 mg/dL | No interference | NA |
| **cNa^{+} (test level: 145 mmol/L)** | | | |
| Benzalkonium chloride | 2.4 mg/dL | 0.11 mg/dL | 29.6 mmol/L |
| Hemolysis | 20% | 2.5% | -14.8 mmol/L |
| Intralipid | 2000 mg/dL | 1000 mg/dL | 4.8 mmol/L |
| Teriflunomide | 30 mg/dL | 22.5 mg/dL | -4.8 mmol/L |
| Thiopental | 40 mg/dL | 30 mg/dL | -3.0 mmol/L |
| **cGlu (test level: 39.6 mg/dL)** | | | |
| 2-deoxy glucose | 164 mg/dL | 3.3 mg/dL | 158 mg/dL |
| Bromide (-sodium) | 391 mg/dL | 49 mg/dL | -5.81 mg/dL |
| Fluoride (-sodium) | 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 |
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| Interferent | Maximum test concentration | Highest concentration level without interference | Impact on result |
| --- | --- | --- | --- |
| 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 |
| **cLac (test level: 9.0 mg/dL)** | | | |
| Bromide (sodium-) | 391 mg/dL | 49 mg/dL | -3.4 mg/dL |
| Citrate (trisodium citrate 2H2O) | 1176 mg/dL | No interference | -0.37 mg/dL |
| EDTA (edetate disodium 2H2O) | 112 mg/dL | 84 mg/dL | -1.67 mg/dL |
| Fluoride (-sodium) | 210 mg/dL | No interference | -0.52 mg/dL |
| Formic acid | 115 mg/dL | 29 mg/dL | -1.36 mg/dL |
| Glycolic acid | 7.6 mg/dL | 0.2 mg/dL | 10 mg/dL |
| 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-) | 210 mg/dL | 52.5 mg/dL | -1.5 mg/dL |
| Formic acid | 115 mg/dL | 86 mg/dL | -1.7 mg/dL |
| Glycolic acid | 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 |
The sponsor included the following limitations in their labeling:
- Do not use samples collected in fluorinated sampling tubes as exposure to high concentrations of fluoride causes falsely low cGlu and cLac results and may cause falsely low cGlu and cLac results in subsequent sample measurements.
- A change in the pH of blood has the physiological effect of changing the concentrations of ionized calcium. An increase in 1 unit of pH results in a decrease of approximately 2 mg/dL in cCa2+.
- 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
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the lactate sensor for up to 5 minutes. If ethylene glycol poisoning is suspected or confirmed, do not use lactate results for that sample or any subsequent samples measured within 5 minutes.
- 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.
iv. Assay Reportable Range:
The results from the studies support the claimed measuring ranges:
cCa2+: 2.00 – 9.94 mg/dL
cK+: 2.1 – 10.5 mmol/L
cNa+: 116 – 180 mmol/L
cGlu: 18 – 738 mg/dL
cLac: 4 – 216 216 mg/dL
v. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
cCa2+ is traceable to SRM915 (NIST) Standard Reference Material.
cNa+ is traceable to NIST SRM 84I through a commercially available certified standard.
cK+ is traceable to NIST SRM 3141a through a commercially available certified standard.
cGlu is traceable to SRM917 (NIST) Standard Reference Material.
cLac is traceable to a certified reference standard.
vi. Detection Limit:
Detection capability testing was conducted in general accordance with CLSI EP17-A2. The results demonstrate that the detection limits of the ABL90 FLEX PLUS was not significantly impacted by the modifications and support substantial equivalence to the predicate (See Assay Reportable Range above).
vii. Assay Cut-Off:
Not applicable.
B Comparison Studies:
i. Method Comparison with Predicate Device:
Method comparison studies were conducted in general accordance with CLSI EP09c-ED3. Heparinized arterial and venous whole blood specimens from a total of 353 subjects were collected across 4 POC sites with at least two POC operators per site were compared to whole blood specimens tested on a comparative method. Each sample were measured once on the ABL90 FLEX PLUS in both the S65 and SP65 modes and once on the predicate device in the same mode. Less than 10% contrived samples were used for each analyte. Evaluations were performed per each combination of parameter, blood type, and sampling
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mode by Deming regression analysis. The regression analysis for these samples are summarized below:
Method Comparison Results for S65 mode
| Parameter | n | Blood Type | Slope | Intercept | R2 |
| --- | --- | --- | --- | --- | --- |
| cK+ (mmol/L) | 222 | Arterial | 0.996 | 0.018 | 0.999 |
| | 233 | Venous | 0.996 | 0.014 | 0.999 |
| cNa+ (mmol/L) | 225 | Arterial | 1.002 | 0.039 | 0.999 |
| | 234 | Venous | 1.004 | -0.276 | 0.999 |
| cCa2+ (mg/dL) | 222 | Arterial | 1.003 | -0.014 | 0.999 |
| | 231 | Venous | 1.004 | 0.019 | 0.999 |
| cGlu (mg/dL) | 224 | Arterial | 0.988 | 0.425 | 0.999 |
| | 232 | Venous | 0.989 | 0.184 | 0.999 |
| cLac (mg/dL) | 221 | Arterial | 1.007 | -0.182 | 0.995 |
| | 233 | Venous | 1.008 | -0.333 | 0.994 |
Method Comparison Results for SP65 mode
| Parameter | n | Blood Type | Slope | Intercept | R2 |
| --- | --- | --- | --- | --- | --- |
| cK+ (mmol/L) | 218 | Arterial | 0.993 | 0.033 | 0.997 |
| | 225 | Venous | 0.992 | 0.033 | 0.997 |
| cNa+ (mmol/L) | 224 | Arterial | 1.003 | -0.227 | 0.999 |
| | 224 | Venous | 1.004 | -0.276 | 0.999 |
| cCa2+ (mg/dL) | 214 | Arterial | 1.011 | -0.046 | 0.999 |
| | 220 | Venous | 1.001 | -0.049 | 0.999 |
| cGlu (mg/dL) | 215 | Arterial | 0.990 | -0.024 | 0.999 |
| | 219 | Venous | 0.990 | -0.045 | 0.999 |
| cLac (mg/dL) | 216 | Arterial | 0.999 | -0.093 | 0.995 |
| | 223 | Venous | 1.000 | -0.202 | 0.995 |
ii. Matrix Comparison:
Not Applicable.
C Clinical Studies:
i. Clinical Sensitivity:
Not applicable.
ii. Clinical Specificity:
Not applicable.
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{12}
iii. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
The sponsor included reference range information in the labeling.
VIII Proposed Labeling:
The labeling support the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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