ABL90 FLEX PLUS

K160153 · Radiometer Medical Aps · CHL · Nov 4, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160153
• Device Name: ABL90 FLEX PLUS
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ABL90 FLEX PLUS is intended for use by trained healthcare professionals in a clinical environment for the in vitro measurement of blood gases, electrolytes, metabolites, and co-oximetry parameters in whole blood samples.

Device Story

Portable, automated in vitro diagnostic analyzer for heparinized whole blood/capillary samples; measures pH, blood gases, electrolytes, glucose, lactate, and oximetry. Features a mechanized inlet module (AutoInlet) and 'Short Probe Mode' for reduced sample volume, replacing manual inlet clips. Operated by trained clinicians in lab or point-of-care settings. Provides quantitative results to aid clinical decision-making for acid-base, electrolyte, and metabolic conditions. Benefits include streamlined sample handling and reduced volume requirements for neonatal/point-of-care testing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of hardware and software modifications.

Technological Characteristics

Portable analyzer using potentiometry, amperometry, and spectrophotometry. Components: sensor cassette, solution pack, mechanized inlet module. Software-controlled inlet and measurement modes. No specific material standards cited.

Indications for Use

Indicated for use by healthcare professionals for in vitro diagnostic measurement of blood gases, electrolytes, metabolites, and co-oximetry parameters in whole blood samples.

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

• ABL90 FLEX (K132691)
• ABL90 FLEX (K131988)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

RADIOMETER MEDICAL APS SOEREN BØEGESTRAND SENIOR REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21 BROENSHOEJ DK-2700, DENMARK

November 4, 2016

Re: K160153

Trade/Device Name: ABL 90 FLEX PLUS Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, CEM, JGS, CGZ, CGA, KHP, GHS, GKR, KQI, JIX, JJY, MQM, JFP Dated: October 05, 2016 Received: October 07, 2016

Dear Soeren Boegestrand:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160153

Device Name ABL90 FLEX PLUS

#### Indications for Use (Describe)

The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.

The ABL90 FLEX PLUS analyzer 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.

Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

pH, pO2 and pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase disturbances.

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.

Chloride (cCl-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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 in plasma. 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.)

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

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FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

#### Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

# 1. Submitter and contact information

| Submitter | |
|-----------------|---------------------------------------------|
| Company Name: | Radiometer Medical ApS |
| ER Number: | 3002807968 |
| Address: | Aakandevej 21<br>2700 Broenshoej<br>Denmark |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact person: | Soeren Boegestrand |
| E-mail: | [e-mail] |

#### Contact Person

| Name: | Soeren Boegestrand |
|-----------|--------------------------------------|
| Function: | Senior Regulatory Affairs Specialist |
| E-mail: | [e-mail] |
| Phone: | [phone] |
| Fax: | [phone] |

| Date prepared | |
|---------------|------------------|
| Date: | November 4, 2021 |

## 2. a. Device Information

| Device Name: | ABL90 FLEX PLUS |
|--------------|---------------------------------------------------|
| Common Name: | Blood gases (pCO2, pO2) and blood pH test system. |

6

## Classification:

| Classification name | CFR Section | Device Class | Product Code |
|----------------------------------------------------------------|-------------|--------------|--------------|
| Electrode measurement, blood-gases<br>(pCO2, pO2) and blood pH | 862.1120 | II | CHL |
| Potassium test system | 862.1600 | II | CEM |
| Sodium test system | 862.1665 | II | JGS |
| Chloride test system | 862.1170 | II | CGZ |
| Glucose test system | 862.1345 | II | CGA |
| Carboxyhemoglobin assay | 864.7425 | II | GHS |
| Automated hemoglobin system | 864.5620 | II | GKR |
| Fetal hemoglobin assay | 864.7455 | II | KQI |
| Calibrator | 862.1150 | II | JIX |
| Calcium test system | 862.1145 | II | JFP |

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| Quality control material (assayed and<br>unassayed) | 862.1660 | I | JJY |
|-------------------------------------------------------------|----------|---|-----|
| Bilirubin (total and unbound) in the<br>neonate test system | 862.1113 | I | MQM |
| Lactic acid test system | 862.1450 | I | KHP |

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## 2. b. Device Description

### Instrument name, manufacturer, models and accessories

The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO-Hb, FCOHb, FMetHb, FHHb and FHbF).

The manufacturer of the ABL90 FLEX PLUS is Radiometer Medical ApS.

The ABL90 FLEX PLUS consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available.

The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in two models differing in the number of tests available.

### 2. c. Purpose of submission

The purpose of this submission is to seek clearance for a design change to the existing ABL90 FLEX analyzer. The design change will result in the introduction of an additional variant of the ABL90 FLEX analyzer called ABL90 FLEX PLUS. To accommodate this, the ABL90 FLEX analyzer has been changed as outlined below:

- . The inlet module on the ABL90 FLEX PLUS analyzer has been mechanized, the mechanized inlet module is in multiple places in this 510(k) referred to as the AutoInlet. The opening and closing of the inlet is either button activated using the touch screen or in certain cases automatic when appropriate. The mechanized inlet module subsequently calls for the following derived changes listed below.
- Addition of the Short Probe Mode measuring mode on the ABL90 FLEX PLUS. In ABL90 . FLEX, a little plastic clip (ABL90 FLEX Inlet Clip) component to be placed on the ABL90 FLEX inlet when using non-Radiometer samplers is incorporated. The purpose of the inlet clip is to shorten the maximum travel of the inlet into the sampler and thereby reduce the sample volume required. The use of an inlet clip for blood measurements is no longer relevant with the introduction of the Short Probe Mode. On the ABL90 FLEX PLUS, the short probe position has been built directly into the analyzer to replace the use of the inlet clip allowing the user the option of the standard syringe mode or the Short Probe Mode.
- . Modifications to software to support both ABL90 FLEX and ABL90 FLEX PLUS. The modifications in the software relevant to this application are the support of the mechanized inlet module in ABL90 FLEX PLUS (including the Short Probe Mode), as well as the ability to distinquish and detect the type of inlet (manual or mechanized) an analyzer is fitted with.
- Instructions for Use for ABL90 FLEX PLUS have been established. .

Except for the above identified modifications and minor differences in visual appearance the ABL90 FLEX and ABL90 FLEX PLUS analyzers are identical. Both analyzers use the same software version and have the same accessories.

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## 3. Intended Use/Indications for use

The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood qases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.

The ABL90 FLEX PLUS analyzer 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.

Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

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.

Chloride (cCl-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Glucose (cGlu): qlucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoqlycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. 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.)

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoqlobin and oxyhemoglobin plus reduced hemoqlobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoqlobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

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## 4. Predicate device: ABL90 FLEX (K132691) Substantial Equivalence

The ABL90 FLEX PLUS analyzer is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate devices:

Predicate Device: 510(k) Number, Name, Device Manufacturer:

K132691, ABL90 FLEX, Radiometer Medical ApS K131988, ABL90 FLEX, Radiometer Medical ApS

| Similarities | | |
|--------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Issue | SE Device | Predicate Devices (K132691, K131988) |
| Parameters | Same | pH, pO2, pCO2, sodium, potassium, calcium, chloride, glucose, lactate, sO2, FO2Hb, FCOHb, FMetHb, FHHB, FHbF, neonatal bilirubin. |
| Measuring method | Same | Potentiometry, Amperometry, Optical pO2 ,Spectrophotometry |
| Calibration Method | Same | Two-point liquid calibration |
| Intended Use | Same | The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.<br>The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists.<br>It is intended for use in a laboratory environment, near patient or point-of-care setting.<br>These tests are only performed under a physician's order.<br>Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates. |
| Intended use site | Same | Laboratory and point-of-care. |

| Differences | | |
|------------------|------------------|--------------------------------------|
| Issue | SE Device | Predicate Devices (K132691, K131988) |
| Inlet | Mechanized inlet | Manual inlet |
| Short probe mode | Yes | No |

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## 5. Performance Characteristics

No performance data are affected by the change. The existing performance data still apply.

Verification of the ABL90 FLEX PLUS showed that the precision performance of all three modes of the ABL90 FLEX PLUS is equivalent to the precision performance of ABL90 FLEX for the 17 parameters available on the analyzers: pH, pCO2, pO2, cCa2+, cCli, cK*, cGlu, cLac, ctHb, sO3, FO3Hb, FHHb, FMetHb, FCOHb, FHbF, and neonatal bilirubin.

The existing clinical precision performance claims in the manual for ABL90 FLEX are also applicable to ABL90 FLEX PLUS.

Verification of the ABL90 FLEX PLUS Short Probe mode showed that measurements performed with ABL90 FLEX PLUS in Short Probe mode are equivalent to measurements performed with ABL90 FLEX in syringe mode with inlet clip for the 17 parameters available on the analyzers: pH, pCO₂, pO₂, cCa²†, cCl˙, cK†, cNa†, cGlu, cLac, ctHb, sO₂, FO₂Hb, FHHb, FMetHb, FCOHb, FHbF, and neonatal bilirubin.

The existing clinical method comparison claims in the manual for ABL90 FLEX syringe mode are applicable to ABL90 FLEX PLUS Short Probe mode.

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## 6. Summary of Design Control activities

#### Risk Assessment:

We conducted an FMEA risk analysis and mitigated all identified hazards to As Low As Reasonably Practicable (ALARP) per ISO 14971, and verified mitigations by using test protocols. Results met predefined acceptance criteria

#### Performance testing:

| Issue | Acceptance<br>criteria | Verification<br>method | Result and Pass/Fail | Comments |
|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Method<br>comparison of<br>ABL90 FLEX<br>PLUS Short<br>Probe mode<br>versus ABL90<br>FLEX syringe<br>mode with inlet<br>clip | Data analysis by linear<br>regression must result in:<br>Slope between 0.95<br>and 1.05 Coefficient of<br>determination<br>R2>0.97 Intercepts: pH:<br>±0.75<br>pO2:<br>±11 mmHg<br>pCO2:<br>±4.5 mmHg<br>Cl-:<br>±11 mM<br>Na+:<br>±15 mM<br>K+:<br>±0.5 mM<br>Ca2+:<br>±0.5 mM<br>Glucose: ±0.6 mmol/L<br>Lactate: ±0.4 mmol/L<br>tHb:<br>±1.5 g/dL<br>sO2:<br>±10%<br>FO2Hb:<br>±10%<br>FCOHb:<br>±1%<br>FMetHb:<br>±1%<br>FHHb:<br>±2.4%<br>FHbF:<br>±21%<br>Neonatal<br>bilirubin: ±28 μmol/L | In-house method comparison<br>study of ABL90 FLEX PLUS<br>Short Probe mode versus<br>ABL90 FLEX syringe mode with<br>inlet clip with more than 40<br>samples (N) per parameter<br>spanning the measuring range.<br>Each sample was analyzed in<br>singlicate. For each parameter,<br>less than 20% of the samples<br>were spiked.<br><br>Samples were heparinized,<br>leftover whole blood samples<br>(analyzed 2-3 hours post<br>draw). | Data analysis by linear<br>regression showed:<br>Slopes were<br>between 0.95 and<br>1.05. Coefficients of<br>determination R2<br>were >0.97. Intercepts were<br>within acceptance<br>criteria. Pass. | Existing method<br>comparison<br>claims for ABL90<br>FLEX syringe<br>mode apply to<br>ABL90 FLEX<br>PLUS Short<br>Probe mode. |
| Issue | Acceptance<br>criteria | Verification<br>method | Result and Pass/Fail | Comments |
| Imprecision | The same or better<br>clinical precision than<br>originally determined for<br>ABL90 FLEX (K092686<br>and K132691).<br>The within-run ( $S_r$ ) and<br>total imprecision ( $S_T$ )<br>pooled across sites must<br>be the same or better<br>than originally determined<br>for ABL90 FLEX (K092686<br>and K132691) at a 95%<br>confidence level using a<br>Chi-square test.<br>The acceptance criteria<br>have been itemized in the<br>below table. | Point-of-care precision studies<br>on ABL90 FLEX PLUS syringe,<br>short probe, and capillary<br>mode were performed at 3<br>point-of care sites over at least<br>20 days, with 2 runs per day<br>and 2 replicates per run.<br>Samples were spiked whole<br>blood except for neonatal<br>bilirubin for which samples<br>were aqueous solutions. For<br>FHbF, the sample material was<br>cord blood.<br>Fresh whole blood samples<br>were prepared each test day.<br>To eliminate the sample-to-<br>sample imprecision<br>contribution, the total<br>imprecision for all parameters<br>except neonatal bilirubin was<br>calculated as the imprecision of<br>the bias towards a reference<br>value determined for each<br>sample on an ABL90 FLEX<br>reference instrument. | All within-run and total<br>imprecisions were<br>within the acceptance<br>criteria.<br>Pass | Existing clinical<br>precision claims<br>for ABL90 FLEX<br>apply to ABL90<br>FLEX PLUS. |

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## Imprecision acceptance criteria

| Analyte | Level | Sr (within-run) | %CV (within-run) | St (total) | %CV (total) |
|--------------------------------|-------|-----------------|------------------|------------|-------------|
| Capillary mode | | | | | |
| | 7.27 | 0.0030 | 0.04 | 0.0056 | 0.08 |
| pH | 7.38 | 0.0028 | 0.04 | 0.0065 | 0.09 |
| | 7.47 | 0.0032 | 0.04 | 0.0067 | 0.09 |
| | 28 | 0.71 | 2.54 | 0.86 | 3.07 |
| pCO₂ (mmHg) | 42 | 0.76 | 1.81 | 1.13 | 2.69 |
| | 61 | 1.04 | 1.70 | 1.51 | 2.48 |
| | 45 | 0.56 | 1.24 | 1.21 | 2.69 |
| pO₂ (mmHg) | 77 | 0.94 | 1.22 | 1.86 | 2.42 |
| | 205 | 2.45 | 1.20 | 4.82 | 2.35 |
| | 0.58 | 0.021 | 3.62 | 0.032 | 5.52 |
| cCa²⁺ (mmol/L) | 1.21 | 0.009 | 0.74 | 0.029 | 2.40 |
| | 1.89 | 0.036 | 1.90 | 0.070 | 3.70 |
| | 94 | 0.38 | 0.40 | 1.41 | 1.50 |
| cCl⁻ (mmol/L) | 108 | 0.43 | 0.40 | 1.83 | 1.69 |
| | 122 | 0.37 | 0.30 | 1.69 | 1.39 |
| | 4.8 | 0.05 | 1.04 | 0.12 | 2.50 |
| cK⁺ (mmol/L) | 6.6 | 0.04 | 0.61 | 0.09 | 1.36 |
| | 120 | 0.36 | 0.30 | 0.90 | 0.75 |
| cNa⁺ (mmol/L) | 141 | 0.48 | 0.34 | 1.15 | 0.82 |
| | 151 | 0.48 | 0.32 | 1.15 | 0.76 |
| | 0.78 | 0.04 | 5.13 | 0.11 | 14.10 |
| cGlu (mmol/L) | 5.5 | 0.09 | 1.64 | 0.23 | 4.18 |
| | 15.1 | 0.23 | 1.52 | 0.77 | 5.10 |
| | 2.1 | 0.09 | 4.29 | 0.17 | 8.10 |
| cLac (mmol/L) | 16.1 | 0.44 | 2.73 | 1.56 | 9.69 |
| | 3.7 | 0.07 | 1.89 | 0.09 | 2.43 |
| ctHb (g/dL) | 15 | 0.15 | 1.00 | 0.33 | 2.20 |
| | 21.6 | 0.20 | 0.93 | 0.28 | 1.30 |
| | 76 | 0.30 | 0.39 | 0.61 | 0.80 |
| sO₂ (%) | 93 | 0.20 | 0.22 | 0.45 | 0.48 |
| | 100 | 0.11 | 0.11 | 0.20 | 0.20 |
| | 3.2 | 0.04 | 1.25 | 0.29 | 9.06 |
| FCOHb (%) | 37.3 | 0.04 | 0.11 | 0.32 | 0.86 |
| | 3.4 | 0.11 | 3.24 | 0.33 | 9.71 |
| FMetHb (%) | 10.0 | 0.13 | 1.30 | 0.29 | 2.90 |
| | 6.6 | 0.26 | 3.94 | 0.50 | 7.58 |
| FHHb (%) | 23.8 | 0.26 | 1.09 | 0.60 | 2.52 |
| FO₂Hb (%) | 74 | 0.30 | 0.41 | 0.67 | 0.91 |
| | 89 | 0.28 | 0.31 | 0.44 | 0.49 |
| | 97 | 0.20 | 0.21 | 0.29 | 0.30 |
| FHbF (%) | 42 | 2.86 | 6.81 | 7.07 | 16.83 |
| | 64 | 2.89 | 4.52 | 7.08 | 11.06 |
| | 36 | 0.92 | 2.56 | 1.77 | 4.92 |
| Neonatal bilirubin<br>(µmol/L) | 127 | 1.85 | 1.46 | 2.55 | 2.01 |
| | 523 | 7.07 | 1.35 | 9.41 | 1.80 |
| Analyte | Level | Sr (within-run) | %CV (within-run) | ST (total) | %CV (total) |
| Syringe mode | | | | | |
| pH | 7.27 | 0.0023 | 0.03 | 0.0047 | 0.06 |
| | 7.37 | 0.0015 | 0.02 | 0.0045 | 0.06 |
| | 7.47 | 0.0013 | 0.02 | 0.0060 | 0.08 |
| pCO2 (mmHg) | 28 | 0.66 | 2.36 | 0.86 | 3.07 |
| | 42 | 0.77 | 1.83 | 1.10 | 2.62 |
| | 60 | 1.15 | 1.92 | 1.83 | 3.05 |
| pO2 (mmHg) | 45 | 0.27 | 0.60 | 0.90 | 2.00 |
| | 76 | 0.84 | 1.11 | 1.43 | 1.88 |
| | 204 | 1.82 | 0.89 | 3.54 | 1.74 |
| cCa2+ (mmol/L) | 0.58 | 0.003 | 0.52 | 0.022 | 3.79 |
| | 1.21 | 0.009 | 0.74 | 0.026 | 2.15 |
| | 1.89 | 0.009 | 0.48 | 0.042 | 2.22 |
| cCl (mmol/L) | 94 | 0.25 | 0.27 | 1.38 | 1.47 |
| | 108 | 0.42 | 0.39 | 1.82 | 1.69 |
| | 122 | 0.24 | 0.20 | 1.32 | 1.08 |
| cK+ (mmol/L) | 4.8 | 0.04 | 0.83 | 0.08 | 1.67 |
| | 6.6 | 0.03 | 0.45 | 0.08 | 1.21 |
| | 119 | 0.36 | 0.30 | 0.77 | 0.65 |
| cNa+ (mmol/L) | 141 | 0.48 | 0.34 | 0.90 | 0.64 |
| | 151 | 0.36 | 0.24 | 0.90 | 0.60 |
| | 0.73 | 0.04 | 5.48 | 0.09 | 12.33 |
| cGlu (mmol/L) | 5.5 | 0.05 | 0.91 | 0.23 | 4.18 |
| | 14.7 | 0.18 | 1.22 | 0.64 | 4.35 |
| | 2.2 | 0.07 | 3.18 | 0.18 | 8.18 |
| cLac (mmol/L) | 16.2 | 0.51 | 3.15 | 1.94 | 11.98 |
| | 3.8 | 0.07 | 1.84 | 0.12 | 3.16 |
| ctHb (g/dL) | 15 | 0.11 | 0.73 | 0.17 | 1.13 |
| | 21.7 | 0.14 | 0.65 | 0.20 | 0.92 |
| | 75 | 0.29 | 0.39 | 0.49 | 0.65 |
| sO2 (%) | 93 | 0.17 | 0.18 | 0.44 | 0.47 |
| | 100 | 0.11 | 0.11 | 0.22 | 0.22 |
| | 3.2 | 0.06 | 1.88 | 0.28 | 8.75 |
| FCOHb (%) | 38.0 | 0.08 | 0.21 | 0.32 | 0.84 |
| | 3.4 | 0.09 | 2.65 | 0.23 | 6.76 |
| FMetHb (%) | 10.1 | 0.08 | 0.79 | 0.30 | 2.97 |
| | 6.7 | 0.17 | 2.54 | 0.40 | 5.97 |
| FHHb (%) | 24.3 | 0.25 | 1.03 | 0.41 | 1.69 |
| | 72 | 0.28 | 0.39 | 0.59 | 0.82 |
| FO2Hb (%) | 91 | 0.32 | 0.35 | 0.45 | 0.49 |
| | 97 | 0.18 | 0.19 | 0.26 | 0.27 |
| FHbF (%) | 41 | 2.32 | 5.66 | 6.37 | 15.54 |
| | 64 | 4.56 | 7.13 | 8.76 | 13.69 |
| Neonatal bilirubin<br>(µmol/L) | 36 | 1.19 | 3.31 | 2.12 | 5.89 |
| | 127 | 1.35 | 1.06 | 2.48 | 1.95 |
| | 525 | 4.46 | 0.85 | 9.15 | 1.74 |
| Analyte | Level | Sr (within-run) | %CV (within-run) | ST (total) | %CV (total) |
| Short probe mode | | | | | |
| pH | 7.27 | 0.002 | 0.03 | 0.005 | 0.06 |
| | 7.37 | 0.002 | 0.02 | 0.005 | 0.06 |
| | 7.47 | 0.001 | 0.02 | 0.006 | 0.08 |
| pCO2 (mmHg) | 28 | 0.66 | 2.36 | 0.86 | 3.07 |
| | 42 | 0.77 | 1.83 | 1.10 | 2.62 |
| | 60 | 1.15 | 1.92 | 1.83 | 3.05 |
| pO2 (mmHg) | 45 | 0.27 | 0.60 | 0.90 | 2.00 |
| | 76 | 0.84 | 1.11 | 1.43 | 1.88 |
| | 204 | 1.82 | 0.89 | 3.53 | 1.73 |
| cCa²+ (mmol/L) | 0.58 | 0.003 | 0.52 | 0.02 | 3.79 |
| | 1.21 | 0.009 | 0.74 | 0.03 | 2.15 |
| | 1.89 | 0.009 | 0.48 | 0.04 | 2.22 |
| cCl⁻ (mmol/L) | 94 | 0.25 | 0.27 | 1.38 | 1.47 |
| | 108 | 0.42 | 0.39 | 1.82 | 1.69 |
| | 122 | 0.24 | 0.20 | 1.32 | 1.08 |
| cK⁺ (mmol/L) | 4.8 | 0.04 | 0.83 | 0.08 | 1.67 |
| | 6.6 | 0.03 | 0.45 | 0.08 | 1.21 |
| cNa⁺ (mmol/L) | 119 | 0.36 | 0.30 | 0.77 | 0.65 |
| | 141 | 0.48 | 0.34 | 0.90 | 0.64 |
| | 151 | 0.36 | 0.24 | 0.90 | 0.60 |
| cGlu (mmol/L) | 0.73 | 0.04 | 5.48 | 0.09 | 12.33 |
| | 5.5 | 0.05 | 0.91 | 0.23 | 4.18 |
| | 14.7 | 0.18 | 1.22 | 0.65 | 4.42 |
| cLac (mmol/L) | 2.2 | 0.07 | 3.18 | 0.18 | 8.18 |
| | 16.2 | 0.51 | 3.15 | 1.94 | 11.98 |
| ctHb (g/dL) | 3.8 | 0.07 | 1.84 | 0.12 | 3.16 |
| | 15 | 0.11 | 0.73 | 0.17 | 1.13 |
| | 21.7 | 0.14 | 0.65 | 0.20 | 0.92 |
| sO2 (%) | 75 | 0.29 | 0.39 | 0.49 | 0.65 |
| | 93 | 0.17 | 0.18 | 0.44 | 0.47 |
| | 100 | 0.11 | 0.11 | 0.22 | 0.22 |
| FCOHb (%) | 3.2 | 0.06 | 1.88 | 0.28 | 8.75 |
| | 38.0 | 0.08 | 0.21 | 0.32 | 0.84 |
| FMetHb (%) | 3.4 | 0.09 | 2.65 | 0.22 | 6.47 |
| | 10.1 | 0.08 | 0.79 | 0.30 | 2.97 |
| FHHb (%) | 6.7 | 0.17 | 2.54 | 0.40 | 5.97 |
| | 24.3 | 0.25 | 1.03 | 0.41 | 1.69 |
| FO₂Hb (%) | 72 | 0.28 | 0.39 | 0.59 | 0.82 |
| | 91 | 0.32 | 0.35 | 0.45 | 0.49 |
| | 97 | 0.18 | 0.19 | 0.26 | 0.27 |
| FHbF (%) | 41 | 2.32 | 5.66 | 6.37 | 15.54 |
| | 64 | 4.56 | 7.13 | 8.76 | 13.69 |
| Neonatal bilirubin<br>(µmol/L) | 36 | 1.19 | 3.31 | 2.12 | 5.89 |
| | 127 | 1.35 | 1.06 | 2.48 | 1.95 |
| | 525 | 4.46 | 0.85 | 0.14 | 1.74 |

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

## 7. Conclusion

Based on the substantial equivalence comparison and the results of the conducted performance evaluations it has been concluded that the ABL90 FLEX PLUS is as safe and effective as the predicate device.