ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
Device Facts
| Record ID | K043218 |
|---|---|
| Device Name | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX |
| Applicant | Radiometer Medical Aps |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | May 10, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Indications for Use
The ABL800 FLEX with FLEXQ Module is intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF) as well as for in vitro testing of samples of expired air for the parameters PO₂ and PCO₂.
Device Story
The ABL800 FLEX with FLEXQ Module is an automated blood gas, electrolyte, and metabolite analyzer. It accepts up to three vented arterial blood samplers (safePICO) in a tray. The FLEXQ module uses an optical switch to detect samplers, a barcode reader for identification, and a rotating magnet system to mix samples with an internal steel ball. The analyzer aspirates blood via an inlet probe. It uses electrochemical sensors for pH, blood gases, and electrolytes, and a 128-wavelength spectrophotometer for co-oximetry and bilirubin. The system is used in clinical settings by healthcare professionals. Output data (e.g., pH, pO2, pCO2, electrolytes, glucose, lactate, hemoglobin fractions) are displayed to clinicians to assess patient metabolic and respiratory status, guiding clinical decision-making regarding oxygen therapy, ventilation, and electrolyte management.
Clinical Evidence
Bench testing only. Precision, reproducibility, and linearity were established using 11 ABL8xx FLEX analyzers and 5 ABL735 reference analyzers over 11 days. Method comparison studies between the ABL800 FLEX with FLEXQ and the predicate ABL800 FLEX showed high correlation (r > 0.99) across all measured parameters (pH, pO2, pCO2, electrolytes, glucose, lactate, tHb, sO2, tBil). Interference testing was conducted for various substances including Intralipid, bilirubin, and common medications.
Technological Characteristics
Electrochemical sensors (potentiometric/amperometric) for pH, gases, electrolytes, glucose, and lactate. Optical system (128-wavelength spectrophotometer, 478-672 nm) for co-oximetry and bilirubin. Connectivity via serial/Ethernet (TCP/IP) to LIS/HIS. Complies with IEC 61010-1 and EN 61326-1 (EMC).
Indications for Use
Indicated for in vitro diagnostic testing of whole blood and expired air samples to monitor acid-base balance, oxygenation, electrolyte balance, glucose/lactate metabolism, and bilirubin levels in patients requiring clinical assessment of respiratory, metabolic, or circulatory status.
Regulatory Classification
Identification
A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Predicate Devices
Reference Devices
- safePICO (subject of separate 510(k))
Related Devices
- K041874 — ABL800 FLEX · Radiometer Medical Aps · Oct 8, 2004
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM · Radiometer America, Inc. · Feb 9, 1998
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k043218
B. Purpose for Submission:
Additional features added to previously marketed device
C. Measurand:
The ABL800 FLEX with FLEXQ Module is intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FHHb and FHbF) as well as for in vitro testing of samples of expired air for the parameters PO₂ and PCO₂.
D. Type of Test:
With respect to sensor technology, the ABL800 FLEX is substantially equivalent to the predicate device ABL700 Series upgrade
| | ABL800 FLEX Sensor Technology | ABL700 Series Upgrade Sensor Technology |
| --- | --- | --- |
| Blood gases and pH | Electrochemical | Electrochemical |
| Sodium | Electrochemical | Electrochemical |
| Potassium | Electrochemical | Electrochemical |
| Calcium | Electrochemical | Electrochemical |
| Glucose | Electrochemical | Electrochemical |
| Lactate | Electrochemical | Electrochemical |
| Co-oximetry parameters | Optical | Optical |
| Bilirubin | Optical | Optical |
E. Applicant:
Radiometer Medical ApS
F. Proprietary and Established Names:
ABL800 FLEX with FLEXQ Module
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# G. Regulatory Information:
Regulation section:
| | CFR Section | Device Class | Product Code |
| --- | --- | --- | --- |
| Blood gases and blood pH | 862.1120 | II | CHL |
| Sodium test system | 862.1665 | II | JGS |
| Potassium test system | 862.1600 | II | CEM |
| Calcium test system | 862.1145 | II | JFP |
| Chloride test system | 862.1170 | II | CGZ |
| Glucose test system | 862.1345 | II | CGA |
| Lactic acid test system | 862.1450 | I | KHP |
| Bilirubin (total or direct test system | 862.1110 | II | CIG |
| Bilirubin in the neonate test system | 862.1113 | I | MQM |
| Carboxyhemoglobin assay | 864.7425 | II | GHS |
| Automated hemoglobin system | 864.5620 | II | GKR |
| Fetal hemoglobin assay | 864.7455 | II | KQI |
# H. Intended Use:
1. Intended use(s):
See Indication(s) for use below.
2. Indication(s) for use:
The ABL800 FLEX with FLEXQ Module is intended for in vitro testing of samples of whole blood for the parameters pH, $\mathrm{pO}_2$ , $\mathrm{pCO}_2$ , potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions $\mathrm{FO}_2\mathrm{Hb}$ , FCOHb, FMetHb, FHHb and FHbF) as well as for in vitro testing of samples of expired air for the parameters $\mathrm{PO}_2$ and $\mathrm{PCO}_2$ .
Indications for use information for the analytes measured by the ABL800 FLEX:
$\mathrm{pH}$ : $\mathrm{pH}$ is the indispensable measure of academia or alkalemia and is therefore an essential part of the $\mathrm{pH}$ /blood gas measurement. The normal function of many metabolic processes requires a $\mathrm{pH}$ to be within a relatively narrow range.
$\mathrm{pO}_2$ : The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
$\mathrm{pCO}_2$ : $\mathrm{pCO}_2$ is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium $(c\mathrm{K}+)$ : The measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance.
Sodium $(c\mathrm{Na}+)$ : The measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
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Calcium (cCa₂+): The measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCl⁻): The measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measurements measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes, and hyper- and hypoglycemia.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): the bilirubin measurements measure the total concentration of bilirubin in plasma, ct Bil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO₂): sO₂ is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO₂ allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO₂Hb): FO₂Hb is a measure of the utilization of the potential oxygen transport capacity; that is the fraction of oxyhemoglobin in relation to all hemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consists of two α-chains and two β-chains, and has a higher oxygen affinity than adult Hb.
3. Special conditions for use statement(s):
For Prescription Use
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4. Special instrument requirements:
ABL800 FLEX Blood Gas Analyzer with FLEXQ module.
I. Device Description:
The ABL800 FLEX with FLEXQ Module is an ABL800 FLEX Analyzer with the added optional capability of automatic sampling of up to three blood samples. The analyzer part of the ABL800 FLEX with FLEXQ is identical to the analyzer part of the ABL800 FLEX. The ABL800 FLEX, the ABL800 FLEX with FLEXQ Module consists of several modules of the same analyzer for the measurement of blood gas, electrolyte, metabolite and co-oximetry.
The FLEXQ Module is designed to work with the vented arterial blood sampler, safe PICO (k043143) the safe PICO consists of a graduated plastic sample barrel coded with a unique barcode and a plunger. Within the sampler barrel is a soft, coated magnetic steel ball for mixing the sample before measurement and dry electrolyte-balanced lithium/sodium heparin. The sampler includes a vented tip cap that allows the sampler to be vented after the appliance of the tip cap to the male connector of the sampler. The safePICO may be delivered with a conventional PVC needle cube or with a transparent plastic needle shield device connected to the needle. The needle shield consists of two axially aligned plastic tubes, each with a slit where a tab from the other may slide. Activating the thumb grip on the inner tube causes the inner tube to slide along inside the outer tube and to cover the needle point by at least 8 mm.
Installing the FLEXQ module into an existing ABL800 FLEX Analyzer includes physically installing the module and loading upgraded software, which controls the functions of the FLEXQ module. The FLEXQ module comprises a sampler tray with three slots for holding up to three samplers simultaneously. Each slot has an optical switch detecting the presence of a sampler. The FLEXQ module has a barcode reader, which can read out the barcode of the samplers. The FLEXQ module includes a rotating magnet system located under the sampler tray, which interacts with the steel ball in the sampler barrel and automatically mixes the sample prior to measuring.
J. Substantial Equivalence Information:
1. Predicate device name(s):
The ABL800 FLEX with FLEXQ Module is substantially equivalent in features and characteristics to the predicate devices ABL800 FLEX (k041874) manufactured by Radiometer Medical ApS and AVL 9181 Electrolyte Analyzer (k972673) manufactured by AVL Scientific Corporation.
2. Predicate 510(k) number(s):
k041874
k972673
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3. Comparison with predicate:
See method comparison with predicate device below.
K. Standard/Guidance Document Referenced (if applicable):
Electrical Safety and EMC
Approvals: UL, CSA. In compliance with IEC 61010-1. Installation category II
EMC Emission: The equipment complies with the emission requirements for Class B equipment in EN 61326-1: Electrical equipment for measurement, control and laboratory use – EMC requirements part 1: General requirements.
EMC Immunity: The equipment complies with immunity requirements in EN 61326-1: Electrical equipment for measurement, control and laboratory use – EMC requirements part 1: General requirements.
L. Test Principle:
Potentiometric measuring principle
The potential of an electrode chain is recorded using a voltmeter, and related to the concentration of the sample (the Nernst equation).
An electrode chain describes an electrical circuit consisting of a sample, electrode, reference electrode, voltmeter, membranes, and electrolyte solutions. Every element in the electrode chain contributes a voltage to the total potential drop through the chain. Thus:
- When immersed in the appropriate electrolyte solution, both electrodes have separate potentials.
- The membrane junctions between the sample and electrolyte solutions also have separate potentials.
The potentiometric measuring principle is applied to pH, pCO₂, and electrolyte electrodes.
Amperometric measuring principle
The magnitude of an electrical current flowing through an electrode chain, which is in turn proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain.
The electrode chain in amperometric measurements consists of the sample, the two electrodes (anode and cathode), an amperometer, a voltage source, the membrane, and the electrolyte solution.
To simplify the description of the measuring process in an amperometric electrode, we make the following assumptions:
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- There is a species $\mathbf{A}$ in the sample which is reduced at the cathode to $\mathbf{A}^{-}$ .
- There is a species $\mathbf{X}$ in the electrolyte which is oxidized at the anode to $\mathbf{X}^{+}$ .
The membrane is selective to the species A, allowing no other species but it to pass through from the sample into the electrolyte solution.
As appropriate potential is applied across the electrodes, the species $\mathbf{A}$ is reduced as the cathode according to the following reaction:
$$
\mathrm {A} + \mathrm {e} ^ {-} \rightarrow \mathrm {A} ^ {-}
$$
The reduction of $\mathbf{A}$ produces a flow of electrons, i.e. an electrical current.
To complete the electrical circuit an oxidation reaction where electrons are released is necessary. Therefore species $\mathbf{X}$ is oxidized according to the following reaction:
$$
\mathrm {X} \rightarrow \mathrm {X} ^ {+} + \mathrm {e} ^ {-}
$$
The magnitude of the current flowing through the circuit is proportional to the concentration of the species being reduced, in this case species A. The analyzer thereby automatically calculates the concentration on A in the sample.
The amperometric measuring principle is applied in the $\mathrm{pO}_2$ , glucose, and lactate electrodes.
## Optical measuring principles
The optical system of the ABL800 FLEX analyzer is designed to measure the following parameters:
| Parameter | Description |
| --- | --- |
| ctHb | concentration of total hemoglobin |
| sO_{2} | oxygen saturation |
| FO_{2}Hb | fraction of oxyhemoglobin |
| FCOHb | fractionation of carboxyhemoglobin |
| FHHb | fractionation of deoxyhemoglobin |
| FMetHb | fraction of methemoglobin |
| FHbF | fraction of fetal hemoglobin |
| ctBil | concentration of total bilirubin (the sum of conjugated and conjugated bilirubin) in plasma |
Note: ctBil can be measured on a whole blood or plasma sample. Plasma samples provide the optimal measurement performance. To obtain optimal accuracy when following a patient trend in ctBil, use the same aspiration mode and same analyzer.
Hematocrit (Hct) is also available as a derived parameter.
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The optical system is based on a 128-wavelength spectrophotometer with a measuring range of $478 - 672\mathrm{nm}$ . The spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.
# M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
The precision (i.e. repeatability or within-run imprecision) and reproducibility (i.e. total imprecision) results for the parameters as well as the linearity/assay reportable ranges were established from a single large-sized study.
The variation parameters of the study appears from the table below
| Parameter | (n) |
| --- | --- |
| Observations | 2 |
| Days | 11 |
| Instruments | 11 |
| Operators | 3 |
| Sites | 1 |
| Runs | 16 |
The study was performed as a large comparative in-house study using 11 ABL8xx FLEX analyzers and 5 ABL735 analyzers. The study used the average of the 5 ABL735 analyzers (adjusted for drift of the parameters in the sample) as reference values. The study was designed to comprise all measuring modes of all the configurations of the ABL8xx FLEX analyzer on all parameters. All measurements on the ABL8xx FLEX analyzers were made as doubles. Three in-house operators located at one site performed the measurements during 11 working days - from March 22, 2004 to April 6, 2004.
Below are listed tables showing the $\% \mathrm{CV}$ for the parameters of the ABL800 FLEX analyzer:
| pH | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| | % | % |
| 6.80 | 0.121 | 0.089 |
| 6.90 | 0.115 | 0.083 |
| 7.00 | 0.111 | 0.081 |
| 7.10 | 0.110 | 0.080 |
| 7.20 | 0.109 | 0.082 |
| 7.25 | 0.110 | 0.083 |
| 7.30 | 0.111 | 0.085 |
| 7.40 | 0.115 | 0.091 |
| 7.50 | 0.123 | 0.101 |
| 7.60 | 0.133 | 0.112 |
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| pCO2 | CV-Macromode | CV-Macromode |
| --- | --- | --- |
| mmHg | % | % |
| 15.00 | 4.719 | 2.979 |
| 17.00 | 4.655 | 2.894 |
| 19.99 | 4.591 | 2.809 |
| 39.96 | 4.500 | 2.643 |
| 59.98 | 4.551 | 2.642 |
| 80.00 | 4.630 | 2.679 |
| 119.94 | 4.828 | 2.831 |
| 140.05 | 4.956 | 2.960 |
| 149.90 | 5.028 | 3.042 |
| 159.97 | 5.111 | 3.140 |
| pO2 | CV-Macromode | CV-Micromode |
| --- | --- | --- |
| mmHg | % | % |
| 14 | 1.866 | 4.018 |
| 15 | 1.848 | 4.005 |
| 20 | 1.796 | 3.958 |
| 25 | 1.771 | 3.929 |
| 35 | 1.750 | 3.899 |
| 45 | 1.743 | 3.897 |
| 50 | 1.741 | 3.904 |
| 65 | 1.742 | 3.961 |
| 75 | 1.745 | 4.025 |
| 80 | 1.748 | 4.064 |
| 85 | 1.368 | 3.406 |
| 120 | 1.360 | 3.343 |
| 150 | 1.356 | 3.305 |
| 180 | 1.354 | 3.281 |
| 210 | 1.354 | 3.273 |
| 250 | 1.356 | 3.285 |
| 280 | 1.361 | 3.312 |
| 310 | 1.367 | 3.354 |
| 340 | 1.375 | 3.409 |
| 390 | 1.393 | 3.532 |
| 410 | 1.816 | 4.675 |
| 420 | 1.799 | 4.576 |
| 430 | 1.783 | 4.484 |
| 440 | 1.769 | 4.401 |
| 450 | 1.757 | 4.325 |
| 460 | 1.747 | 4.259 |
| 480 | 1.732 | 4.153 |
| 510 | 1.724 | 4.069 |
| 530 | 1.730 | 4.066 |
| 550 | 1.742 | 4.104 |
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| cK+ | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| mmol/L | % | % |
| 1.65 | 4.294 | 4.009 |
| 2.01 | 3.672 | 3.330 |
| 2.46 | 3.190 | 2.784 |
| 3.00 | 2.824 | 2.348 |
| 3.32 | 2.677 | 2.165 |
| 3.67 | 2.551 | 2.004 |
| 4.48 | 2.365 | 1.752 |
| 5.47 | 2.241 | 1.569 |
| 6.69 | 2.156 | 1.432 |
| 8.17 | 2.102 | 1.334 |
| cNa+ | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| mmol/L | % | % |
| 119.10 | 1.210 | 0.926 |
| 127.74 | 1.188 | 0.897 |
| 134.29 | 1.174 | 0.879 |
| 141.17 | 1.165 | 0.868 |
| 148.41 | 1.170 | 0.874 |
| 156.02 | 1.175 | 0.881 |
| 164.02 | 1.180 | 0.888 |
| 172.43 | 1.187 | 0.897 |
| 181.27 | 1.194 | 0.907 |
| 200.34 | 1.211 | 0.931 |
| cCa2+ | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| Mmol/L | % | % |
| 0.50 | 8.778 | 3.771 |
| 0.75 | 5.865 | 2.550 |
| 0.95 | 4.641 | 2.039 |
| 1.15 | 3.843 | 1.707 |
| 1.35 | 3.284 | 1.476 |
| 1.55 | 2.870 | 1.307 |
| 1.75 | 2.553 | 1.178 |
| 1.95 | 2.301 | 1.078 |
| 2.10 | 2.145 | 1.017 |
| 2.21 | 2.045 | 0.979 |
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| cCl- | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| Mmol/L | % | % |
| 85.63 | 0.273 | 1.344 |
| 94.63 | 0.241 | 1.346 |
| 99.48 | 0.239 | 1.351 |
| 104.58 | 0.239 | 1.358 |
| 109.95 | 0.239 | 1.368 |
| 115.58 | 0.242 | 1.381 |
| 121.51 | 0.246 | 1.396 |
| 127.74 | 0.254 | 1.416 |
| 134.29 | 0.267 | 1.439 |
| 149.90 | 0.309 | 1.504 |
| cGlu | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| Mmol/L | % | % |
| 0.49 | 23.172 | 21.768 |
| 1.00 | 13.610 | 12.469 |
| 2.25 | 8.042 | 7.203 |
| 4.00 | 5.806 | 5.161 |
| 6.25 | 4.624 | 4.113 |
| 7.84 | 4.153 | 3.706 |
| 9.00 | 3.902 | 3.490 |
| 10.24 | 3.689 | 3.309 |
| 12.25 | 3.422 | 3.085 |
| 15.21 | 3.143 | 2.854 |
| cLac | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| Mmol/L | % | % |
| 0.15 | 35.878 | 34.841 |
| 0.37 | 18.083 | 15.707 |
| 1.00 | 13.181 | 9.233 |
| 2.72 | 12.899 | 8.329 |
| 4.48 | 13.143 | 8.450 |
| 5.75 | 13.297 | 8.563 |
| 7.39 | 13.463 | 8.697 |
| 9.49 | 13.639 | 8.848 |
| 12.18 | 13.824 | 9.015 |
| 15.64 | 14.016 | 9.196 |
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| ctHb | CV-Micromode | CV-Macromode |
| --- | --- | --- |
| Mmol/L | % | % |
| 2.00 | 3.297 | 2.241 |
| 4.00 | 3.293 | 2.224 |
| 6.00 | 3.290 | 2.211 |
| 8.00 | 3.288 | 2.201 |
| 10.00 | 3.287 | 2.193 |
| 12.00 | 3.286 | 2.188 |
| 14.00 | 3.286 | 2.187 |
| 17.00 | 3.287 | 2.190 |
| 20.00 | 3.290 | 2.200 |
| 24.00 | 3.295 | 2.223 |
# b. Linearity/assay reportable range:
The protocol used for the test of linearity is an integrated part of the experimental design for performance testing. The experimental design is basically a randomized experiment, where the measurements in the different modes of the analyzer are performed in a randomized sequence for each of the blood preparations.
Bias is defined as:
$\mathrm{Bias}_{\mathrm{Ref}} = \mathrm{X}_{\mathrm{ABL800Flex}} - \mathrm{X}_{\mathrm{Primary Reference method}}$
$\mathrm{Bias}_{\mathrm{ABL}} = \mathrm{X}_{\mathrm{ABL800Flex}} - \mathrm{X}_{\mathrm{ABL735}}$
# Where
$\mathrm{X_{ABL800Flex}}$ is the mean value of the measured value for a group of ABL800Flex analyzer. $\mathrm{X}_{\text {Primary Reference method }}$ is the mean value of the measured value obtained with the Primary Reference method.
$\mathrm{X_{ABL735}}$ is the mean value of the measured value for the ABL735 analyzers used as reference analyzers.
The acceptance criteria for linearity are the maximum bias values, specified at different values of the particular parameter. These values are chosen to cover the entire test range.
The maximum bias values were specified in the design specifications for the analyzer.
Requirements for the maximum bias values assure that the linearity is within acceptance criteria. The maximum bias values specified in the design specifications for the ABL800 series analyzers are given in Tables 1 and 2. The actual measured bias values from the data of the verification test are also presented in Tables 1 and 2.
From the Tables 1 and 2 it is seen that all acceptance criteria for bias, and thereby also for linearity, are met. The concept of using bias requirements for test of linearity is illustrated in Figure 1 below.
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Fig. 1
Micromode
| Parameter | Level | Unit | 95% Confidence Intervals (in specified units) | | | Accepted/ not accepted |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Lower Limit | Upper Limit | Acceptance criteria | |
| pH | 7.0 | | -0.009 | 0.006 | ±0.01 | accepted |
| pH | 7.4 | | 0.003 | 0.005 | ±0.005 | accepted |
| pH | 7.6 | | -0.008 | 0.006 | ±0.01 | accepted |
| pO2 | 15 | mmHg | -0.81 | 0.04 | ±2 | accepted |
| pO2 | 50 | mmHg | -0.39 | 1.71 | ±2 | accepted |
| pO2 | 150 | mmHg | -2.17 | 3.38 | ±4 | accepted |
| pO2 | 250 | mmHg | -5.32 | 2.68 | ±6 | accepted |
| pO2 | 530 | mmHg | -39.09 | 17.09 | ±40 | accepted |
| pCO2 | 15 | mmHg | -0.79 | 0.38 | ±0.8 | accepted |
| pCO2 | 40 | mmHg | -0.87 | 0.61 | ±1 | accepted |
| pCO2 | 60 | mmHg | -0.42 | 2.28 | ±3 | accepted |
| pCO2 | 80 | mmHg | -1.25 | 2.99 | ±3 | accepted |
| pCO2 | 150 | mmHg | -3.15 | 9.90 | ±10 | accepted |
| Cl | 85 | mmol/L | 0.15 | 1.00 | ±3.5 | accepted |
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| Cl | 105 | mmol/L | 1.66 | 2.50 | ±3.0 | accepted |
| --- | --- | --- | --- | --- | --- | --- |
| Cl | 140 | mmol/L | 2.81 | 1.83 | ±3.0 | accepted |
| Ca | 0.5 | mmol/L | 0.03 | 0.08 | ±0.08 | accepted |
| Ca | 1.25 | mmol/L | 0.03 | 0.06 | ±0.06 | accepted |
| K | 2 | mmol/L | -0.07 | -0.02 | ±0.08 | accepted |
| K | 4 | mmol/L | 0.20 | 0.24 | ±0.25 | accepted |
| K | 8 | mmol/L | 0.28 | 0.43 | ±0.45 | accepted |
| Na | 120 | mmol/L | 0.24 | 1.44 | ±1.5 | accepted |
| Na | 140 | mmol/L | 1.10 | 0.12 | ±1.5 | accepted |
| Na | 180 | mmol/L | 1.12 | 0.22 | ±1.5 | accepted |
| Glu | 2 | mmol/L | -0.07 | 0.04 | ±0.1 | accepted |
| Glu | 5 | mmol/L | -0.09 | 0.15 | ±0.2 | accepted |
| Glu | 15 | mmol/L | -0.26 | 0.49 | ±0.6 | accepted |
| Lac | 0.3 | mmol/L | -0.02 | 0.08 | ±0.1 | accepted |
| Lac | 2 | mmol/L | 0.06 | 0.27 | ±0.3 | accepted |
| Lac | 10 | mmol/L | -0.30 | -1.05 | ±1.1 | accepted |
| tHb | 7 | g/dL | 0.28 | -0.12 | ±0.3 | accepted |
| tHb | 15 | g/dL | 0.54 | 0.12 | ±0.6 | accepted |
| tHb | 25 | g/dL | 1.40 | 0.05 | ±1.5 | accepted |
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Table 1
Macromode
| Parameter | Level | Unit | 95% Confidence Intervals (in specified units) | | | Accepted/ not accepted |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Lower limit | Upper limit | Acceptance criteria | |
| pH | 7.0 | | -0.005 | -0.002 | ±0.005 | accepted |
| pH | 7.4 | | -0.003 | -0.001 | ±0.005 | accepted |
| pH | 7.6 | | -0.005 | 0.000 | ±0.005 | accepted |
| pO2 | 15 | mmHg | -0.03 | 0.12 | ±1.5 | accepted |
| pO2 | 50 | mmHg | 0.34 | 0.61 | ±1.5 | accepted |
| pO2 | 150 | mmHg | -1.87 | -0.97 | ±2 | accepted |
| pO2 | 250 | mmHg | -2.57 | -0.57 | ±3 | accepted |
| pO2 | 530 | mmHg | -12.59 | -6.23 | ±15 | accepted |
| pCO2 | 15 | mmHg | -0.49 | -0.30 | ±0.5 | accepted |
| pCO2 | 40 | mmHg | -0.59 | -0.03 | ±0.6 | accepted |
| pCO2 | 60 | mmHg | -0.12 | 1.02 | ±1.1 | accepted |
| pCO2 | 80 | mmHg | -1.05 | 0.83 | ±1.5 | accepted |
| pCO2 | 150 | mmHg | -0.75 | 4.28 | ±6 | accepted |
| Cl | 85 | mmol/L | 0.15 | 1.34 | ±3.5 | accepted |
| Cl | 105 | mmol/L | 1.66 | 2.81 | ±3 | accepted |
| Cl | 140 | mmol/L | 1.41 | 2.95 | ±3 | accepted |
| Ca | 0.5 | mmol/L | 0.03 | 0.05 | ±0.05 | accepted |
| Ca | 1.25 | mmol/L | 0.01 | 0.03 | ±0.03 | accepted |
| K | 2 | mmol/L | -0.04 | -0.01 | ±0.07 | accepted |
| K | 4 | mmol/L | 0.19 | 0.23 | ±0.25 | accepted |
| K | 8 | mmol/L | 0.18 | 0.32 | ±0.4 | accepted |
| Na | 120 | mmol/L | -0.36 | 1.08 | ±1.1 | accepted |
| Na | 140 | mmol/L | -0.44 | 0.75 | ±0.8 | accepted |
| Na | 180 | mmol/L | -0.05 | 0.58 | ±1 | accepted |
| Glu | 2 | mmol/L | -0.04 | 0.00 | ±0.1 | accepted |
| Glu | 5 | mmol/L | 0.00 | 0.10 | ±0.12 | accepted |
| Glu | 15 | mmol/L | 0.07 | 0.43 | ±0.5 | accepted |
| Lac | 0.3 | mmol/L | -0.03 | 0.01 | ±0.1 | accepted |
| Lac | 2 | mmol/L | -0.07 | 0.11 | ±0.12 | accepted |
| Lac | 10 | mmol/L | -0.80 | 0.20 | ±0.9 | accepted |
| tHb | 7 | g/dL | -0.01 | 0.11 | ±0.3 | accepted |
| tHb | 15 | g/dL | 0.29 | 0.44 | ±0.5 | accepted |
| tHb | 25 | g/dL | 0.90 | 1.23 | ±1.3 | accepted |
{14}
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
pH
Capillary-type glass pH electrode with a saturated calomel reference electrode and a liquid junction saturated with KCL (BMS™ Mk2) [1, 2].
pCO₂
Tonometry [3].
The gas used for tonometry is traceable to NIST certified Standard Reference Materials.
pO₂
Tonometry [3].
The gases used for tonometry are traceable to NIST certified Standard Reference Materials.
K⁺
NIST certified Standard Reference Material SRM 909b (human serum).
Na⁺
NIST certified Standard Reference Material SRM 909b (human serum) and Radiometer specified standard serum material (specified using flame photometry).
Cl⁻
NIST certified Standard Reference Material SRM 909b (human serum)
Ca²⁺
The calcium transfer standards were used. These are traceable to NIST SRM915 and have an ionic strength of 160.0 mmol per kg of water and pH 7.40 at 37 °C, using 1 mmol/L (37 °C) HEPES buffer. The standards were produced as indicated in [4].
Glu
Spectrophotometry, using the hexokinase (HK) method recommended by NCCLS [5], measured on serum.
Lac
Spectrophotometry using lactate dehydrogenase (LDH) method, measured on serum [10].
Hb
HiCN method recommended by NCCLS [6].
Oximetry
The optical system is unchanged in the ABL800 FLEX analyzers compared to the ABL700 Series. Tests of ctHb on the ABL800 FLEX analyzer have been conducted. As the other oximetry parameters (sO₂, FO₂Hb, FCOHb, FMetHb, FHHB, FHbF) are derived from ctHb, these parameters have not been re-tested; the information and results below are from the ABL700 Series.
The reference method established for the oximetry parameters used modified ABL520 analyzers
15
{15}
as the reference instruments. The ABL520 analyzers have been validated and their performance specifications determined according to primary reference methods.
The modified ABL520 analyzers are used in accordance with IFCC’s recommendations for traceability of reference methods.
## References
List of references
1. Kristensen HB, Salomon A, Kokholm G. International pH scales and certification of pH.
2. Definition of pH scales, standard reference values, measurement of pH and related terminology (Recommendations 1994). Pure and Appl Chem 1985; 57, 3: 531 - 42.
3. Burnett RW, Covington AK, Maas AHJ, Müller-Plathe O et al. J Clin Chem Clin Biochem 1989; 27: 403 - 08.
4. IFCC reference methods and materials for measurement pH, gases and electrolytes in blood. Scand J Clin Lab Invest 1993; 53, Suppl 214: 84 - 94.
5. Glucose. NCCLS Publication RS1-A. Villanova, Pa: NCCLS, 1989.
6. Reference and selected procedures for the quantitative determination of hemoglobin in blood. Approved Standard (3rd edition), NCCLS Publication H15-2A. Villanova, Pa: NCCLS, 2000.
7. Evelyn K, Malloy H. Microdetermination of oxyhemoglobin, methemoglobin and sulfhemoglobin in a single sample of blood. Biological Chem 1938; 126: 655 - 62.
8. Kristoffersen K. An improved method for the estimation of small quantities of alkali-resistant hemoglobin in blood. Scand J Clin Lab Invest 1961; 13: 402.
9. Quantitative measurement of fetal hemoglobin using the alkali denaturation method. Approved Guideline. NCCLS Publication H13-A 1989; 9, 18.
10. Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie Deerfield Beach 1984; 6: 582-88.
d. Detection limit:
16 different mixtures of heparinized whole blood samples were used in the test. The mixtures were prepared to have the parameter levels indicated in the table below:
16
{16}
# Target Concentrations of Test Sample Mixtures
| Mix No. | K+ mMol/L | Na+ mMol/L | Cl- mMol/L | Ca2+ mMol/L | Glu mMol/L | Lac mMol/L | tHb g/dL | pH pH | pO2 mmHg | pCO2 mmHg | Sat % | Bili μMol/L |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 8 | 120 | 98 | 1.99 | 3.15 | 5.04 | 15.598 | 7.538 | 493 | 10 | | 5 |
| 2 | | | | | | | 15 | 7.58 | 545 | 10 | 100 | |
| 3 | 3.44 | 187.5 | 138 | 0.56 | 1.01 | 6.24 | 9.656 | 7.061 | 31.8 | 80 | | 20 |
| 4 | 7 | | | | | | 15 | 7.13 | 130 | 80 | 98 | |
| 5 | 2.26 | 191.7 | 144 | 0.57 | 2.61 | 2.97 | 15.503 | 6.892 | 22.5 | 150 | | 0 |
| 6 | 7 | | | | | | 15 | 7 | 15 | 150 | 10 | |
| 7 | 5.6 | 154.7 | 121 | 1.32 | 1.5 | 2.89 | 14.626 | 7.223 | 37.7 | 55.7 | | 0 |
| 8 | 7 | | | | | | 15 | 7.22 | 40 | 60 | 70 | |
| 9 | 4 | 183.4 | 133 | 0.42 | 2.25 | 9.01 | 4.481 | 7.499 | 198 | 26.9 | | 48 |
| 10 | 7 | | | | | | 15 | 7.36 | 230 | 30 | 100 | |
| 11 | 4 | 177.5 | 134 | 0.56 | 0.95 | 0.29 | 2.446 | 7.32 | 211 | 44 | | 0 |
| 12 | 4 | 140 | 111 | 1.05 | 14.64 | 5.18 | 24.227 | 7.352 | 76.5 | 38.6 | | 645 |
| 13 | 7 | 133.7 | 109 | 1.47 | 7.02 | 3.66 | 19.046 | 7.454 | 54.8 | 20 | | 170 |
| 14 | 5.38 | 156.2 | 117 | 0.92 | 0.76 | 7.51 | 10.524 | 7.49 | 362 | 20 | | 19 |
| 15 | 4 | 166.7 | 123 | 0.59 | 6.67 | 7.1 | 14.172 | 7.375 | 90.6 | 35.7 | | 188 |
| 16 | 3.7 | 168.3 | 127 | 0.71 | 6.94 | 2.2 | 18.222 | 7.18 | 33.8 | 77.1 | | 159 |
During a day of test, the levels of the parameters of each mixture drifted somewhat away from the initial level. However, this did not influence the quality of the study as each double measurement on an ABL8xx FLEX analyzer was complemented by corresponding measurements on the five ABL 735 analyzers. The concentrations of the measured mixtures represent the entire test/reportable range of all the parameters.
# e. Analytical specificity:
pH/blood gas the following interference results are found for the pH and blood gas electrodes:
| Substance | Test Conc. | Interference on pO2 Electrode |
| --- | --- | --- |
| Halothane | 3% | 5 % increased sensitivity |
Intralipid (20 % solution) in a concentration greater than 4 % (the final Intralipid level being 0.8 %) will give interference on pH measurements.
{17}
Electrolytes The following interference results are found for the electrolyte electrodes:
| Substance Test Concentration | Interference on | | | | |
| --- | --- | --- | --- | --- | --- |
| | | cK+(4 mmol/L level) | cNa+(150 mmol/L level) | cCa2+(1.25 mmol/L level) | cCl-(110 mmol/L level) |
| Li+ | 4 mmol/L | 0 | 0 | 0 | |
| K+ | 12 mmol/L | | -1 | -0.01 | |
| Na+ | 100-180 mmol/L | 0.1 to -0.1 | | | |
| NH4 | 1 mmol/L | 0 | 0 | | |
| Ca2+ | 5 mmol/L | | 0 | | |
| Mg2+ | 5 mmol/L | 0 | 0 | 0.05 | |
| Br- | 10 mmol/L | | | | 41 |
| F- | 1 mmol/L | | | | 0 |
| Γ | 3.0 mmol/L | | | | 30-90 |
| ClO4- | 1.5 mmol/L | | | | 8-30 |
| HCO3- | 25-50 mmol/L | | | | 0.1 mmol/L Cl- per mmol/L HCO3- |
| Lactate | 10 mmol/L | | | | 0 |
| Acetyl-salicylic acid | 3.0 mmol/L | | | | 2 |
| Ascorbic acid | 1.0 mmol/L | | | | 0 |
| pH ≤ 7.2 | | 0 | 0 | 0.01 | -1 |
| pH≥ 7.6 | | 0 | 0 | -0.01 | 1 |
Sulphide will give erroneously high cCl results.
{18}
# Metabolites
The following interference results are found for the metabolite electrodes:
| Substance | Test Conc. (mmol/L) | Interference on | |
| --- | --- | --- | --- |
| | | cGlucose (4.0 mmol/L level) | cLactate (1.5 mmol/L level) |
| Acetylsalicylic acid | 3 | < 0.1 | < 0.1 |
| Ascorbic acid | 2 | < 0.1 | < 0.1 |
| Chlorpromazine HCl | 0.2 | < 0.1 | < 0.1 |
| Dopamine HCl | 1.0 | < 0.1 | < 0.1 |
| Ethanol | 79 | < 0.1 | < 0.1 |
| Salicylic acid | 4 | < 0.1 | < 0.1 |
| Ibuprofen | 2 | < 0.1 | < 0.1 |
| Thiocyanic acid | 24 | Interference | Interference |
| Paracentamol-4-acetamidopenol | 2 | < 0.1 | < 0.1 |
| Acetoacetic acid | 2 | < 0.1 | < 0.1 |
| Bilirubin (unconjugated) | 0.34 | < 0.1 | < 0.1 |
| Bilirubin (conjugated) | 0.46 | < 0.1 | < 0.1 |
| Creatinine | 3 | < 0.1 | < 0.1 |
| Urea | 84 | < 0.1 | < 0.1 |
| Uric acid | 1.5 | < 0.1 | < 0.1 |
| Lactic acid | 12 | < 0.1 | |
| Pyruvate | 2 | < 0.1 | < 0.1 |
| Glycolic acid | 1 | < 0.1 | Interference |
| D-glucose | 67 | | <0.1 |
| Citrate | 50 | -0.37 | 0.19 |
| Oxalate | 90 | -0.47 | 0.14 |
| Heparin | 8000 IU/dL | < 0.1 | < 0.1 |
| EDTA | 3 | < 0.1 | < 0.1 |
| Fluoride | 50 | -0.36 | <0.1 |
| Maltose | 13.3 | 0.75-4.2* | <0.1 |
cGlu level measure on Cal 1 (10 mmol/L) and Cal 2 (0 mmol/L)
| Hematocrit % | ΔcLactate % at: | |
| --- | --- | --- |
| | 5 mmol/L | 15 mmol/L |
| 0 | 0.7 % | 0.7 % |
| 45 | 0.0 % | 0.0 % |
| 60 | -0.5 % | -2.0 % |
| 75 | -2.2 % | -5.0 % |
{19}
# Oximetry Parameters
The substances against which the oximetry parameters (cHb, $\mathrm{sO}_2$ , $\mathrm{FO}_2\mathrm{Hb}$ , FCOHb, FMetHb, FHHb, FHbF) and ctBil were tested for interference given in the table below:
(SAT100 blood reference test sample: ctHb = 15 g/dL, sO₂ = 100 %, FO₂Hb = 0.7%, FMetHb = 0.5 %, ctBil = 0, pH = 7.4. Parameters sensitivity from the influence on the absorbance spectrum from various substances.)
| Substance | Test conc. | Change on | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | ctHb (g/dL) | sO2 (%) | FO2Hb (%) | FCOHb (%) | FMet Hb (%) | FHHb (%) | FHbF (%) | ctBil (μmol/L) |
| Intralipid | 4Vol % e) | -0.5 | 0.1 | -1.3 | 0.5 | 0.9 | -0.1 | 11 | 0 4 b) |
| Intralipid | 2 Vol % f) | -0.4 | 0.1 | -0.3 | 0.3 | 0.1 | -0.1 | 11 | 7 2 b) |
| HbF a), c) | 20 % | -0.02 | 1.17 | 0.04 | 0.73 | 0.37 | -1.14 | 0 | -14 |
| SHb | 10 % | 0 | -1.0 | 0.9 | -0.1 | 0.1 | -0.9 | Not Tested | |
| pH | 7.1 | -0.5 | -0.5 | -0.2 | -0.4 | 0.1 | 0.5 | -19 | 0 |
| | 7.9 | -0.6 | 0.6 | -0.5 | 1.0 | 0.1 | -0.6 | 13 | -5 |
| Cardio Green c) | 5 mg/L | -0.16 | 0.29 | 1.14 | 0.07 | -0.93 | -0.29 | -5 | -20 |
| Evans Blue c) | 5 mg/L | -0.04 | 0.14 | 0.28 | -0.20 | -0.20 | 0.14 | -5 | 5 |
| Betacarotene in plasma c) | 3.7 μmol/L | 0.0 | -0.02 | 0.03 | -0.01 | -0.04 | 0.02 | 0.1 | -0.2 |
| Patent Blue c) | 10 mg/L | -0.16 | 0.39 | 0.86 | -0.47 | 0.00 | -0.38 | -21 | 38 |
| Methylene Blue c) | 30 mg/L | -0.7 | -3.4 | 5.6 | -3.0 | -6.2 | 3.6 | -37 | -25 |
| HiCN c) | 0.11 mmol/L | 0.26 | -1.5 | -3.0 | -0.5 | 0.5 | 1.5 | 24 | 47 |
| MCHC c), d) newborn range | 320 g/L 350 g/L | No Interference | | | | | | | -12 17 |
| Sedimentation rate | 100 arb. Units | < ± 0.5 | No Interference | | | | | | Not Tested |
Notes: a) If function "Correction for HbF levels less than $20\%$ is activated, the change is 0 for all parameters.
b) Plasma sample.
c) Calculated value from mathematical superposition of measured pure interference spectrum on measured reference spectrum.
d) ctBil = 400 μmol/L
e) Intralipid (20% solution) at 4 Vol % gives final test level of 0.8%.
f) Intralipid (20% solution) at 2 Vol % gives final test level of 0.4%.
{20}
There is no interference from fetal hemoglobin (HbF when the analyzer applies HbF correction.
There is no interference from bilirubin (conjugated/unconjugated) up to $1000\mu \mathrm{mol} / \mathrm{L}$ .
# Known interfering substances
The following substances are known to affect or interfere with measurements on the ABL 800 FLEX analyzers.
| Substance | Interference |
| --- | --- |
| Halothane (anesthetic) | May give unreliable pO2results. |
| Liquid therapy, protamine sulphate treatment | In OXI measurements.After measurement on blood from a patient who has received liquid therapy of protamine sulphate it may be necessary to clan the analyzer using the Cleaning program. |
| Methylene Blue HiCN (medication) | In Oxi measurements. |
| Anions: Br-, I-, S2- and CIO4(drugs) | Erroneously high cCL results |
| Anticoagulant (sampling) | Anticoagulants that contain sodium salts will give erroneously high cNa+results.Sodium fluoride with or without EDTA and oxalate (di Na) influence cGlu results.Sodium fluoride gives erroneously high cNA+and low cCa2+,cGlucose, and cLactate results. Tri sodium citrate influences cNA+,cK+and cGlu results.Thus radiometer recommends the exclusive use of heparin as anticoagulant. Solutions containing organic preservatives may damage the ion-selective membranes of the K and Glu electrodes when introduced into the analyzer. |
| Thiocyanic Acid (degradation product from treatment with Nitroprusside. Also produced in thiosulphate treatment of cyanide poisoning) | Erroneously high cGlu and CLac measurements. |
| Glycolic Acid (ethylene glycol degradation product) | Erroneously high cLac measurements |
| Insufficiently stabilized blood. Caustic fluids (e.g. strong acids or bases, detergents, etc.). Fluids that precipitate. Fluids that affect the sensor enzymes. Fluids that form complexes with the | Other fluids mode allows you to measure on fluids other than heparinized human blood. Warning/Caution: Be aware that some substances, such as listed in the left column, measured in the Other fluids, |
{21}
| Substance | Interference |
| --- | --- |
| analyzer solutions (calcium). High viscosity fluids. Hydrophobic fluids. Reactive fluids. | mode may damage the instrument or the electrodes. This can affect the subsequent measurement on human blood or quality control solutions. |
| Carboxymethyl cellulose (CMC) | Some auto-venting arterial blood samplers contain carboxymethyl cellulose (CMC) in the porous vent. CMC can dissolve into the sample and give erroneously low cCa2+ results. Therefore we recommend Radiometer accessories together with our analyzers, e.g., PICO 70 arterial blood sampler which is specifically designed to minimize sample contamination with CMC. |
| Glucosamine | Interference on cGlu up to 1.06 mmol/L |
| Galactose, maltose, mannose, xylose | Interference – see Interference Tests in chapter 5 of the ABL800 FLEX Reference Manual. |
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
The sponsor completed a study to verify that the new analyzer ABL800 FLEX with FLEXQ Module performs substantially equivalent to the predicate device ABL800 FLEX. Several blood samples covering the entire measuring range of pH, $\mathsf{pO}_2$ , $\mathsf{pCO}_2$ , chloride, calcium, potassium, sodium, glucose, lactate, total hemoglobin, oxygen saturation and total bilirubin were prepared. The prepared blood samples were simultaneously measured on ABL800 FLEX analyzers with FLEXQ module using safe PICO samplers and on ABL800 FLEX using PICO70 samplers. The results of the study are shown below.
FLEXQ/safe PICO: ABL800 FLEX analyzer with FLEXQ module using safe PICO samplers.
ABL800 FLEX/PICO70: ABL800 FLEX using PICO70 samplers.
{22}
| Analyte | Range | n | Slope | Intercept | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- |
| pH | 6.8-7.6 | 62 | 1.00483 | -0.0337735 | 0.999867 |
| pO2(mmHg) | 0-600 | 56 | 0.973437 | 1.55976 | 0.999945 |
| pCO2(mmHg) | 0-180 | 63 | 0.987866 | 0.0132798 | 0.999095 |
| Cl-(mmol/L) | 99-149 | 63 | 0.993333 | 0.565056 | 0.999218 |
| Ca2+(mmol/L) | 0-2.4 | 63 | 0.974538 | 0.0261278 | 0.999881 |
| K+(mmol/L) | 2.5-8.5 | 55 | 1.00667 | 0.00350562 | 0.999316 |
| Na+(mmol/L) | 110-190 | 63 | 0.98835 | 0.850219 | 0.999893 |
| Glu (mmol/L) | 0-15 | 57 | 1.0098 | -0.135106 | 0.999299 |
| Lac (mmol/L) | 0-15 | 63 | 1.01218 | 0.0671328 | 0.997542 |
| tHb (g/dL) | 0-25 | 63 | 0.999705 | 0.0582917 | 0.999891 |
| sO2(%) | 0-120 | 57 | 1.00182 | -0.153404 | 0.999969 |
| tBil (μmol/L) | 0-500 | 44 | 1.02145 | -1.17612 | 0.998849 |
# b. Matrix comparison:
Not applicable. The ABL800 FLEX with FLEXQ modle is designed for use on undiluted whole human blood and expired air samples only.
# 3. Clinical studies:
a. Clinical Sensitivity:
Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a. and b. are not applicable):
# 4. Clinical cut-off:
Not applicable.
# 5. Expected values/Reference range:
The measuring range for a parameter is the range within which the analyzer is physically capable of measuring. The measuring range corresponds to the "range of indication" as defined in the "International vocabulary of basic and general terms in metrology" (VIM). The test range for a parameter is the range within which accuracy and precision of a measured parameter was specified and intended to lie within specified limits. The test range corresponds to the "measuring range" as defined in the "International vocabulary of basic and general terms in metrology (VIM).
The following measured parameters are available independent of analyzer configuration.
{23}
Expected values/Reference ranges cited from references. (see listed references below).
Blood
| Parameter | Unit | Measuring Range | Test Range |
| --- | --- | --- | --- |
| pH | pH scale | 6.300-8.000 | 7.0-7.7 |
| cH+ | Mmol/L | 10.0-501 | 20-100 |
| pCO2 | mmHg; | 5.0-250 | 15-150 |
| | torr kPa | 0.67-33.3 | 2.00-20.00 |
| pO2 | mmHg; | 0.0-800 | 15-530 |
| | torr kPa | 0.00-107 | 2-70 |
| ctHb | g/dL | 0.00-27.7 | 7-25 |
| | g/L | 0.0-277 | 70-250 |
| | mmol/L | 0.00-17.2 | 5-15 |
| sO2 | % | 0-100* | 0-100 |
| | fraction | 0.0-1.000* | 0-1 |
| FO2Hb | % | 0-100* | 0-100 |
| | fraction | 0.0-1.000* | 0-1 |
| FCOHb | % | 0-100* | 0-20 |
| | fraction | 0.0-1.000* | 0.0-0.2 |
| FMetHb | % | 0-100* | 0-20 |
| | fraction | 0.0-1.000* | 0.0-0.2 |
| FHHb | % | 0-100* | 0-100 |
| | fraction | 0.0-1.000* | 0-1 |
| FHbF | % | 0-100* | 0-80 |
| | fraction | 0.0-1.000* | 0.0-0.8 |
| cK+ | mmol/L; meq/L | 0.5-25.0 | 2-8 |
| cNa+ | mmol/L; meq/L | 7-350 | 120-180 |
| cCa2+ | mmol/L | 0.20-9.99 | 0.5-2.5 |
| | meq/L | 0.40-19.98 | 1.0-5.0 |
| | mg/dL | 0.8-40.04 | 2.0-10.0 |
| cCl- | mmol/L; meq/L | 7-350 | 85-140 |
| cGlucose | mmol/L | 0.0-60 | 2-15 |
| | mg/dL | 0-1081 | 36-270 |
| cLactate | mmol/L; meq/L | 0.0-30 | 0.3-10 |
| | mg/dL | 0-270 | 2.0-90 |
| ctBil | μmol/L | 1-1000* | 0-400 |
| | mg/dL | 0.0-60.0* | 0-23.5 |
| | mg/L | 0-600* | 0-235 |
*The values are for the analyzer with the activated "Out of range suppression" function. In case this function has not been activated, the measuring range will be as follows:
{24}
| Parameter | Unit | Measuring Range |
| --- | --- | --- |
| sO2, FO2Hb | % | -2.0 % to 102.0 % |
| FCOHb, FMetHb | fraction | -0.020- to 1.020 |
| FHbF | % | -15 % to 102 % |
| | fraction | -0.15 to 1.02 |
| ctBil | μmol/L | -20 to 1000 |
| | mg/dL | -1.2 to 58.5 |
| | mg/L | -12 to 585 |
Expired air
| Parameter | Unit | Measuring Range | Test Range |
| --- | --- | --- | --- |
| pCO2 | mmHg | 5.0-250 | 15-150 |
| | kPa | 0.67-33.3 | 2.00-20.00 |
| pO2 | mmHg | 0.0-800 | 15-530 |
| | kPa | 0.00-107 | 2-70 |
Baro
| Parameter | Unit | Measuring Range | Test Range |
| --- | --- | --- | --- |
| P(amb) | mmHg; Torr | 450-800 | 450-800 |
| | kPa | 60.0-106.7 | 60.0-106.7 |
# Other fluids
All parameters available on your ABL800 FLEX analyzer can be measured on fluids other than heparinized human whole blood.
NOTE: Before using this mode you must establish "user-defined corrections" specified for the fluid in question. The corrections assume a linear correlation between the measured value and the reference instrument. The data used for establishing "user-defined corrections" have to cover the desired measuring range; an evaluation of the linearity within the range is necessary as well. If no use-defined corrections are entered, you will measure in this mode as if on heparinized whole human blood.
# List of references
1. Kristensen HB, Salomon A, Kokholm G. International pH scales and certification of pH.
2. Definition of pH scales, standard reference values, measurement of pH and related terminology (Recommendations 1994). Pure and Appl Chem 1985; 57, 3: 531 - 42.
3. Burnett RW, Covington AK, Maas AHJ, Müller-Plathe O et al. J Clin Chem Clin Biochem 1989; 27: 403 - 08.
4. IFCC reference methods and materials for measurement pH, gases and electrolytes in blood.
{25}
Scand J Clin Lab Invest 1993; 53, Suppl 214: 84 - 94.
5. Glucose. NCCLS Publication RS1-A. Villanova, Pa: NCCLS, 1989.
6. Reference and selected procedures for the quantitative determination of hemoglobin in blood. Approved Standard (3rd edition), NCCLS Publication H15-2A. Villanova, Pa: NCCLS, 2000.
7. Evelyn K, Malloy H. Microdetermination of oxyhemoglobin, methemoglobin and sulfhemoglobin in a single sample of blood. Biological Chem 1938; 126: 655 - 62.
8. Kristoffersen K. An improved method for the estimation of small quantities of alkali-resistant hemoglobin in blood. Scand J Clin Lab Invest 1961; 13: 402.
9. Quantitative measurement of fetal hemoglobin using the alkali denaturation method. Approved Guideline. NCCLS Publication H13-A 1989; 9, 18.
10. Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie Deerfield Beach 1984; 6: 582-88.
N. Instrument Name:
ABL800 FLEX with FLEXQ Module
O. System Descriptions:
1. Modes of Operation:
The ABL800 FLEX with FLEXQ is identical to the analyzer part of the ABL800 FLEX Analyzer (k041874). The FLEXQ allows the capability of automatic sampling from up to three blood samplers. The FLEXQ module is designed to work with the vented arterial blood sampler, safe PICO (k043143). The upgraded software controls all steps of the FLEXQ module and the ABL800 FLEX Analyzer. If required, manual introduction of a blood sample may be performed as well. This may be relevant when having only small sample volumes e.g. in capillary tubes, or if it becomes necessary to perform an urgent measurement when all three slots of the FLEXQ sample tray are occupied.
2. Software:
The software is partly based on commercially available standard software such as Windows XP and SYBASE and partly on software developed in-house, the software interfaces via serial channel or Ethernet with TCP/IP to LIS HIS systems. The use of the XP platform provides the ABL800 FLEX with a user interface that is fully customizable.
In addition to the features of the ABL800 FLEX software, the software of the ABL800 FLEXQ also has the capacity of controlling the functioning of the FLEXQ module.
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# Electrical Safety and EMC
Approvals: UL, CSA. In compliance with IEC 61010-1. Installation category II
EMC Emission: the equipment complies with the emission requirements for Class B equipment in EN 61326-1: Electrical equipment for measurement, control and laboratory use – EMC requirements part 1: General requirements.
EMC Immunity: The equipment complies with immunity requirements in EN 61326-1: Electrical equipment for measurement, control and laboratory use – EMC requirements part 1: General requirements.
3. Specimen Identification:
See specimen sampling and handling below.
4. Specimen Sampling and Handling:
Once an arterial blood sample has been collected as prescribed with the safePICO sampler, the sampler is provided with the vented tip cap on the syringe luer tip and arranged in a free slot of the FLEXQ sampler tray. The presence of the sampler is detected and the barcode of the sampler is read out. The sampler is now put in queue to be analyzed. When the analyzer is ready to analyze the blood sample, the magnet system is activated to rotate and move the steel ball in the sampler for approximately 5 seconds to mix the sample. The sampler tray is then displaced to position the sampler in front of the inlet of the analyzer. The inlet probe of the analyzer penetrates the top of the tip cap and enters the sample barrel to aspirate the blood sample into the analyzer. The sampler is then analyzed and the sampler may be removed and discarded as prescribed.
5. Calibration:
The two calibration solutions, the rinse solution, the cleaning solution, the tHb calibrator and the calibration gases for the pO₂ and pCO₂ sensors are of the same formulations utilized in the ABL800 FLEX Analyzer 510(k) 041874.
6. Quality Control:
See Traceability, Stability, Expected values (controls, calibrators, or methods) indicated above.
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P. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above:
The following Software Review of this device was presented by the sponsor and reviewed:
- Level of Concern
- Software Description
- Device Hazard Analysis
- Software Requirements Specification (SRS)
- Architecture Design Chart
- Design Specification
- Traceability Analysis
- Development
- Validation, Verification and Testing (VV&T)
- Revision Level History
- Unresolved anomalies (bugs)
- Release Version Number
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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