(246 days)
Not Found
No
The summary describes a standard in vitro diagnostic analyzer and its components, focusing on analytical performance testing according to CLSI guidelines. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
Explanation: The device is an in vitro diagnostic (IVD) analyzer used for quantitative measurements of various blood parameters to aid in diagnosis and treatment monitoring, not to directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer," and further details how its measurements are "used in the diagnosis and treatment of life-threatening acid-base disturbances" and as "an aid in the diagnosis of carbon monoxide poisoning." These statements directly indicate its role in diagnosing medical conditions.
No
The device description explicitly states that the system consists of an analyzer, sensor cassette, solution pack consumables, and related accessories, indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The very first sentence of the "Intended Use / Indications for Use" section explicitly states: "The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer..."
Furthermore, the description of the device's function (measuring pH, blood gas, and Oximetry in whole blood) and the intended use of these measurements in the diagnosis and treatment of various conditions (acid-base disturbances, carbon monoxide poisoning, anemia) clearly align with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FCOHb, FMetHb, and FHHb), 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.
pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin.
ctHb (Total Hemoglobin): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin.
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.
Product codes (comma separated list FDA assigned to the subject device)
CHL, GKR, GHS
Device Description
The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The sensor cassettes, solution packs and related accessories are compatible with both analyzers. Multiple versions of the sensor cassettes are available. The sensor cassette versions vary in the maximum number of tests and availability of sensors for use. The solution pack is available in two versions, differing in the number of activities available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Testing Summary
The ABL90 FLEX PLUS System has been tested for analytical performance, including tests for linearity, limit of blank, detection and quantification, precision, bias, interference, stability. The tests were conducted in general accordance with Clinical Laboratory Standards Institute (CLSI) guidelines, all of which are FDA-recognized consensus standards.
Linearity
Linearity testing was conducted in general accordance with CLSI EP06, Evaluation of the Linearity of Quantitative Measurement Procedures, 2nd Edition and EP39, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition.
Detection
Detection capability testing in terms of limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ) was conducted. in general accordance with CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, and EP39, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition.
Precision
Two precision studies were performed; both were in general accordance with CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures.
-
Precision using stable, aqueous ampoule-based QC material
The primary endpoints of the study were repeatability and within laboratory precision for pooled across several sites. The secondary endpoint was reproducibility between sites. The sample material was Radiometer QUALICHECK5+ QC ampoules, a QC material that comes in four "levels". Testing occurred at three external sites. Sample size (N) for each quality control level per parameter was 243 or 244.
Key results are presented in Table 3 and 9: "Precision results using QC materials". -
Precision using blood
The primary endpoint of the study was repeatability, designated SD, pooled across sites. Two levels of concentration were covered for all parameters. Testing was conducted in both samples collection modes: syringe/S65 mode and short probe/SP65 mode. Sample size (N) ranges from 4 to 184 for S65 Mode and 4 to 188 for SP65 Mode across different parameters and test intervals.
Key results are presented in Table 4: "Precision results using whole blood".
Method comparison
Bias was determined by conducting a method comparison study in general accordance with CLSI EP09c, 3rd Edition, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. The comparator device was the ABL90 FLEX PLUS analyzer as it was designed at the time of the clearance of K160153, in terms of its characteristics related to analytical performance. Testing was conducted using both arterial and venous blood, and in both samples collection modes: syringe/S65 mode and short probe/SP65 mode. Analysis was performed by linear regression over the reportable range.
Sample size (n) for method comparison studies (Tables 5 and 6) ranges from 26 to 442 depending on the parameter, blood type, and mode.
Key results include intercept, slope, R2, medical decision point, and bias at medical decision point, presented in Table 5: "Method comparison results using reportable ranges specified in the protocol" and Table 6: "Method comparison results, arterial and venous combined, additional medical decision levels".
Interference
Interfering substances were evaluated based on testing conducted in general accordance with CLSI, EP07, Interference Testing in Clinical Chemistry, 3rd Edition, and CLSI EP37, Supplemental Tables for Interference Testing in Clinical Chemistry, 1st Edition. The interference testing consists of two parts: paired-difference and dose-response studies. The paired-difference study was conducted on a large panel of likely interferents, using clinically significant amount of the interferents. Dose-response studies were only conducted in cases where a clinically significant interferent effect was noted during the paired different study.
Table 7: "Interference testing" summarizes the substances tested for interference. Table 8: "Interference values" provides specific values for level of interference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include:
- Linearity interval
- Limit of blank (LoB)
- Limit of detection (LoD)
- Limit of quantitation (LoQ)
- Repeatability (SD, CV%)
- Within Lab Precision (SD, CV%)
- Reproducibility (SD, CV%)
- Bias at Medical Decision Point
- Intercept, Slope, and R2 from linear regression for method comparison results.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.
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December 13, 2024
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name reads "U.S. Food & Drug Administration" with the word "Administration" on the second line.
Radiometer Medicals ApS Andrea Swingle Senior Specialist, Regulatory Affairs Aakandevej 21 2700 Broenshoej Denmark
Re: K240998
Trade/Device Name: ABL90 FLEX PLUS System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (PCO2, PO2) and Blood pH Test System Regulatory Class: Class II Product Code: CHL, GKR, GHS Dated: November 15, 2024 Received: November 15, 2024
Dear Andrea Swingle:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
approvals in the device master record (21 CFR 820.181).
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240998
Device Name ABL90 FLEX PLUS System
Indications for Use (Describe)
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FCOHb, FMetHb, and FHHb), 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.
pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin.
ctHb (Total Hemoglobin): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin.
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K240998
The information provided in this 510(k) summary are in accordance with 21 CFR 807.92
Submitter Information:
| Company Name: | Radiometer Medical ApS |
|---|---|
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denmark | |
| Contact Person: | Hsiao-Qing Chow |
| Phone: | +45 31401578 |
Application Correspondent:
| Name: | Andrea Swingle |
|---|---|
| Function: | Senior Specialist, Regulatory Affairs |
| Email: | andrea.swingle@radiometeramerica.com |
| Phone: | +1 510 246 2559 |
Date prepared: December 13, 2024
Device Information
| Device Trade Name: | ABL90 FLEX PLUS System |
|---|---|
| Common Name: | Blood Gas Analyzer |
| Regulations: | - 21 CFR 862.1120, Blood gases (pCO2, pO2) and blood pH test system |
- 21 CFR 864.5620, Automated hemoglobin system
- 21 CFR 864.7425, Carboxyhemoglobin assay |
| Product Codes: | CHL, GKR, GHS |
| Device Class: | Class II |
| Predicate Device | |
| Device Trade Name: | ABL90 FLEX PLUS |
| Common Name: | Blood Gas Analyzer |
| 510(k) | K160153 |
| Regulations: | - 21 CFR 862.1120, Blood gases (pCO2, pO2) and blood pH test system - 21 CFR 864.5620, Automated hemoglobin system
- 21 CFR 864.7425, Carboxyhemoglobin assay |
| Product Codes: | CHL, GKR, GHS |
| Device Class: | Class II |
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Image /page/5/Picture/0 description: The image shows the word "RADIOMETER" in gray, with a gray circle containing the letter "R" to the right of the word. The font is sans-serif and the letters are all capitalized. The logo is simple and modern.
Device Description
The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The sensor cassettes, solution packs and related accessories are compatible with both analyzers. Multiple versions of the sensor cassettes are available. The sensor cassette versions vary in the maximum number of tests and availability of sensors for use. The solution pack is available in two versions, differing in the number of activities available.
Intended Use
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FMetHb, and FHHb), 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.
pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of lifethreatening acid-base disturbances.
s02: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
ctHb (Total Hemoglobin): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
FO2Hb: Oxyhemoqlobin as a fraction of total hemoglobin.
FCOHb: Carboxyhemoqlobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: Methemoqlobin as a fraction of total hemoglobin.
FHHb: Reduced hemoglobin as a fraction of total hemoglobin.
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Substantial Equivalence Comparison
Substantial equivalence comparison table
| | ABL90 FLEX PLUS System
(This 510(k)) | ABL90 FLEX PLUS
(510(k) K160153) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Radiometer Medical | Radiometer Medical |
| Indications for Use | The ABL90 FLEX PLUS System is an
In Vitro diagnostic, portable,
automated analyzer that
quantitatively measures, pH, blood
gases ( $pO_2$ ), Oximetry ( $sO_2$ , ctHb,
$FO_2Hb$ , FCOHb, FMetHb, and FHHb),
in heparinized arterial and venous
whole blood. | The ABL90 FLEX analyzer is an In
Vitro diagnostic, portable, automated
analyzer that quantitatively
measures, pH, blood gases,
electrolytes, glucose, lactate and
oximetry in heparinized whole blood,
and neonatal bilirubin in heparinized
capillary, venous and arterial whole
blood.
Bilirubin measurements on the ABL90
FLEX PLUS analyzer are intended to
aid in assessing the risk of
kernicterus in neonates. |
| Intended Use | Measurement of pH, $pO_2$ , $sO_2$ , ctHb,
$FO_2Hb$ , FCOHb, FMetHb, and FHHb | Measurement of pH, $pO_2$ , $sO_2$ , ctHb,
$FO_2Hb$ , FCOHb, FMetHb, and FHHb |
| Intended use
environment | Laboratory environment, near patient
or point-of-care setting | Laboratory environment, near patient
or point-of-care setting |
| Prescription/OTC
Use | Prescription | Prescription |
| Sample requirements | | |
| Sample type | Heparinized whole blood (arterial,
venous) | Heparinized whole blood (arterial,
venous, capillary) |
| Compatible
sampling devices | Radiometer samplers (in S65 mode)
and non-Radiometer samplers (in S65
mode) | Radiometer samplers (in S65 mode)
and non-Radiometer samplers (in S65
mode) |
| Sample volume | 65 μL | 65 μL |
| Sample
preparation | With balanced heparin anticoagulant | With balanced heparin anticoagulant |
| Device design | | |
| Operating
principles | Potentiometry: pH
Optical: $pO_2$
Spectrophotometry: $sO_2$ , ctHb,
$FO_2Hb$ , FCOHb, FMetHb, and FHHb | Potentiometry: pH
Optical: $pO_2$
Spectrophotometry: $sO_2$ , ctHb,
$FO_2Hb$ , FCOHb, FMetHb, and FHHb |
| Major
components | Touch screen Barcode reader Sample mixer Inlet module Fluid transport system Oximetry module Electronics Software Printer Optional battery pack Communication ports | Touch screen Barcode reader Sample mixer Inlet module Fluid transport system Oximetry module Electronics Software Printer Optional battery pack Communication ports |
| | ABL90 FLEX PLUS System
(This 510(k)) | ABL90 FLEX PLUS
(510(k) K160153) |
| Consumables | Sensor cassette Solution pack | Sensor cassette Solution pack |
| Performance characteristics | | |
| Reportable
ranges | pH: 6.818 - 7.797
pO2: 30.1 - 488 mmHg
sO2: 3.3 - 100.0%
ctHb: 0.1 - 24.0 g/dL
FO2Hb: 3.3 - 98.5%
FCOHb: 1.00 - 92.2%
FMetHb: 0.5 - 91%
FHHb: 1.5 - 98.3% | pH: 6.818 - 7.797
pO2: 30.1 - 488 mmHg
sO2: 3.3 - 100.0%
ctHb: 0.1 - 24.0 g/dL
FO2Hb: 3.3 - 98.5%
FCOHb: 1.00 - 92.2%
FMetHb: 1.0 - 91%
FHHb: 2.4 - 98.5% |
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Analytical Performance Testing Summary
The ABL90 FLEX PLUS System has been tested for analytical performance, including tests for linearity, limit of blank, detection and quantification, precision, bias, interference, stability. The tests were conducted in general accordance with Clinical Laboratory Standards Institute (CLSI) guidelines, all of which are FDA-recognized consensus standards.
Linearity
Linearity testing was conducted in general accordance with CLSI EP06, Evaluation of the Linearity of Quantitative Measurement Procedures, 2nd Edition and EP39, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition. The resulting linearity intervals are listed in Table 1.
| Parameter | Linearity interval |
|---|---|
| Ph | 6.605-7.997 |
| pO2 | 0.81-75.41 kPa |
| ctHb | 0.068-27.660 g/dL |
| sO2 | 2.18-100.22 % |
| FO2Hb | 2.18-98.96 % |
| FCOHb | 0.54-95.79 % |
| FMetHb | 0.49-95.61 % |
| FHHb | 0.53-98.37 % |
Table 1: I inearity results
Detection
Detection capability testing in terms of limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ) was conducted. in general accordance with CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, and EP39, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition. Table 2 shows the results of the detection testing.
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| Parameter | Unit | Lower LoQ | Upper LoQ | |
|---|---|---|---|---|
| pH | - | 6.754 | 7.843 | |
| Parameter | Unit | LoB | LoD | LoQ |
| $pO_2$ | mmHg | N/A | N/A | 7.7 |
| kPa | 1.02 | |||
| ctHb | g/dL | 0.03 | 0.09 | 0.09 |
| FHHb | % | 0.2 | 0.6 | 1.4 |
| Fraction | 0.002 | 0.006 | 0.014 | |
| $sO_2$ | % | N/A | N/A | 1.4 |
| Fraction | 0.014 | |||
| $FO_2$ Hb | % | N/A | N/A | 1.4 |
| Fraction | 0.014 | |||
| FCOHb | % | N/A | N/A | 0.7 |
| Fraction | 0.007 | |||
| FMetHb | % | N/A | N/A | 0.3 |
| Fraction | 0.003 |
Table 2: Detection results
N/A: Not applicable
Precision
Two precision studies were performed; both were in general accordance with CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures.
Precision using stable, aqueous ampoule-based QC material
The primary endpoints of the study were repeatability and within laboratory precision for pooled across several sites. The secondary endpoint was reproducibility between sites. The sample material was Radiometer QUALICHECK5+ QC ampoules, a QC material that comes in four "levels". Testing occurred at three external sites. Table 3 presents the data on the primary and secondary endpoints.
| Parameter | QC ampoule | N | Mean | Repeatability | Within Lab Precision | Reproducibility | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV% | SD | CV% | SD | CV% | |||||
| FCOHb | ||||||||||
| (%) | QC5+ L 1 | 243 | 5.9 | 0.03 | 0.6 | 0.06 | 1.0 | 0.11 | 1.8 | |
| QC5+ L 2 | 244 | 2.8 | 0.03 | 1.1 | 0.08 | 2.9 | 0.13 | 4.7 | ||
| QC5+ L 3 | 244 | 20.0 | 0.02 | 0.1 | 0.05 | 0.3 | 0.05 | 0.3 | ||
| QC5+ L 4 | 244 | 10.1 | 0.02 | 0.2 | 0.03 | 0.3 | 0.06 | 0.6 | ||
| FMetHb | ||||||||||
| (%) | QC5+ L 1 | 243 | 5.0 | 0.01 | 0.3 | 0.03 | 0.6 | 0.05 | 0.9 | |
| QC5+ L 2 | 244 | 2.0 | 0.02 | 0.8 | 0.04 | 2.1 | 0.05 | 2.3 | ||
| QC5+ L 3 | 244 | 10.0 | 0.02 | 0.2 | 0.02 | 0.2 | 0.03 | 0.3 | ||
| QC5+ L 4 | 244 | 20.1 | 0.04 | 0.2 | 0.06 | 0.3 | 0.09 | 0.4 |
Table 3: Precision results using QC materials
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RADIOME
| Parameter | QC ampoule | N | Mean | Repeatability | | Within Lab
Precision | | Reproducibility | |
|----------------|------------|-----|-------|---------------|-----|-------------------------|-----|-----------------|-----|
| | | | | SD | CV% | SD | CV% | SD | CV% |
| FHHb
(%) | QC5+ L 1 | 243 | 44.6 | 0.03 | 0.1 | 0.05 | 0.1 | 0.13 | 0.3 |
| | QC5+ L 2 | 244 | 3.0 | 0.02 | 0.7 | 0.06 | 2.0 | 0.09 | 3.2 |
| | QC5+ L 3 | 244 | 21.0 | 0.01 | 0.1 | 0.03 | 0.1 | 0.03 | 0.1 |
| | QC5+ L 4 | 244 | 66.3 | 0.05 | 0.1 | 0.07 | 0.1 | 0.13 | 0.2 |
| FO2Hb
(%) | QC5+ L 1 | 243 | 44.6 | 0.03 | 0.1 | 0.05 | 0.1 | 0.05 | 0.1 |
| | QC5+ L 2 | 244 | 92.2 | 0.04 | 0.0 | 0.06 | 0.1 | 0.06 | 0.1 |
| | QC5+ L 3 | 244 | 49.0 | 0.02 | 0.1 | 0.05 | 0.1 | 0.05 | 0.1 |
| | QC5+ L 4 | 244 | 3.5 | 0.01 | 0.3 | 0.03 | 0.7 | 0.03 | 0.8 |
| pH | QC5+ L 1 | 243 | 7.066 | 0.0034 | 0.0 | 0.0034 | 0.0 | 0.0038 | 0.1 |
| | QC5+ L 2 | 244 | 7.390 | 0.0018 | 0.0 | 0.0018 | 0.0 | 0.0019 | 0.0 |
| | QC5+ L 3 | 244 | 7.582 | 0.0018 | 0.0 | 0.0018 | 0.0 | 0.0018 | 0.0 |
| | QC5+ L 4 | 244 | 6.784 | 0.0037 | 0.1 | 0.0037 | 0.1 | 0.0041 | 0.1 |
| pO2
(mmHg) | QC5+ L 1 | 243 | 154.3 | 1.91 | 1.2 | 2.87 | 1.9 | 3.13 | 2.0 |
| | QC5+ L 2 | 244 | 100.3 | 1.13 | 1.1 | 2.01 | 2.0 | 2.01 | 2.0 |
| | QC5+ L 3 | 244 | 56.1 | 0.95 | 1.7 | 1.33 | 2.4 | 1.33 | 2.4 |
| | QC5+ L 4 | 244 | 310.0 | 3.00 | 1.0 | 5.51 | 1.8 | 6.95 | 2.2 |
| sO2
(%) | QC5+ L 1 | 243 | 50.0 | 0.01 | 0.0 | 0.02 | 0.0 | 0.06 | 0.1 |
| | QC5+ L 2 | 244 | 96.9 | 0.03 | 0.0 | 0.07 | 0.1 | 0.12 | 0.1 |
| | QC5+ L 3 | 244 | 70.0 | 0.01 | 0.0 | 0.03 | 0.0 | 0.03 | 0.0 |
| | QC5+ L 4 | 244 | 5.0 | 0.01 | 0.2 | 0.03 | 0.5 | 0.03 | 0.5 |
| ctHb
(g/dL) | QC5+ L 1 | 243 | 8.1 | 0.02 | 0.2 | 0.03 | 0.4 | 0.04 | 0.6 |
| | QC5+ L 2 | 244 | 12.9 | 0.03 | 0.2 | 0.04 | 0.3 | 0.06 | 0.5 |
| | QC5+ L 3 | 244 | 19.3 | 0.03 | 0.2 | 0.06 | 0.3 | 0.09 | 0.5 |
| | QC5+ L 4 | 244 | 2.7 | 0.01 | 0.4 | 0.02 | 0.6 | 0.02 | 0.6 |
N: Number of data points for analysis SD: Standard Deviation CV%: %Coefficient of Variation QC5+ L X: QUALICHECK5+ Level X
Precision using blood
The primary endpoint of the study was repeatability, designated SD, pooled across sites. Two levels of concentration were covered for all parameters. Testing was conducted in both samples collection modes: syringe/S65 mode and short probe/SP65 mode. Table 4 summarize the results of the study.
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| Parameter (unit) | N | Test interval | Mean | Repeatability
SD | CV% |
|------------------|-----|-----------------|--------|---------------------|------|
| S65 Mode | | | | | |
| pH (pH unit) | 18 | 6.9 -