(442 days)
No
The summary describes a standard automated analyzer using electrochemical and optical sensors and a spectrophotometer. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) analyzer used for measuring neonatal bilirubin to aid in assessing the risk of kernicterus, not for treating or preventing a disease.
Yes
The device is described as an "in vitro diagnostic, portable, automated analyzer" and is intended to "aid in assessing the risk of kernicterus in neonates" by quantitatively measuring neonatal bilirubin. These phrases explicitly state its diagnostic purpose.
No
The device description clearly states it is a portable, automated system consisting of an instrument with a sensor cassette and a solution pack, indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer..."
N/A
Intended Use / Indications for Use
The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX 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 analyzer are intended to aid in assessing the risk of kernicterus in neonates.
Product codes (comma separated list FDA assigned to the subject device)
MQM
Device Description
The name of the device is the ABL90 FLEX. The device is manufactured by Radiometer Medical ApS, Brønshøj, Denmark.
The ABL90 FLEX 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 FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
The ABL90 FLEX 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 one model.
The ABL 90 FLEX electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.
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
neonates
Intended User / Care Setting
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)
Precision:
Repeatability and Device/Method Precision was evaluated according to CLSI guideline "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition", EP05-A2. The study was conducted at three point-of-care (POC) sites and on two instruments in Radiometer's laboratory facility on aqueous samples. In addition, a one-day study was conducted using spiked adult whole blood samples adjusted to mimic neonatal whole blood.
The test verified that neonatal bilirubin can be measured with acceptable precision in both POC and laboratory settings and in both capillary and syringe mode.
Method Comparison:
Method comparison study versus the predicate has been conducted according to NCCLS guideline "Method Comparison and Bias Estimation Using Patient Samples", EP09-A2. The study was conducted for both capillary (224 samples) and syringe (210 samples) mode at three point-of-care sites and included samples spanning the entire measuring range.
Linear regression of the pooled data gives a slope of 0.9903/0.9760 and an R2 of 0.99/0.99 for syringe and capillary mode respectively showing good correlation with the predicate device and very good agreement between the two modes.
Linearity:
Linearity study has been conducted according to CLSI guideline "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline", EP6-A.
The method is linear (first order) over the entire measuring range and fulfils the requirements for allowable error due to non-linearity established by Radiometer. R-squared value of 0.9996.
Interference:
Interference study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition", EP07-A2.
Significant interference was observed from Fluorescein, Beta-carotene, Methylene Blue, Patent Blue V, Cardio Green, HiCN, Hydroxycobalamin, Cyanocobalamin, and SHb. No clinically significant interference was observed from Evans Blue, HbF, Hemolysis, Intralipid or Triglyceride.
LoB, LoD, LoQ:
Study has been conducted according to CLSI guideline "Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline", EP17-A2.
LoB was determined to be 1.1 mg/dL (18 µmol/L). LoD was determined to be 1.60 mg/dL (27.4 umol/L). LoQ was determined to be 1.60 mg/dL (27.4 µmol/L).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Summary of Performance Studies for precision, linearity, and interference data.
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.
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
§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
RADIOMETER MEDICAL APS SOREN BOGESTRAND REGULATORY AFFAIRS SPECIALIST AKANDEVEJ 21 BRONSHOJ DK-2700
Re: K132691
Trade/Device Name: ABL90 Flex Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: I. reserved Product Code: MQM Dated: October 24, 2014 Received: October 31, 2014
Dear Mr. Bogestrand:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
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
2
Indications for Use
510(k) Number (if known) K132691
Device Name ABL90 FLEX
Indications for Use (Describe)
Intended Use:
The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX 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 analyzer are intended to aid in assessing the risk of kernicterus in neonates.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
1. Submitter and contact information
| Submitter | |
|---|---|
| Company Name: | Radiometer Medical ApS |
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denmark | |
| Phone: | +45 3827 3827 |
| Fax: | +45 3827 2727 |
Contact Person
| Name: | Søren Bøgestrand |
|---|---|
| Function: | Senior RA Specialist |
| E-mail: | soren.bogestrand@radiometer.dk |
| Phone: | +45 3827 3852 |
| Fax: | +45 3827 2727 |
Date prepared
| Date: | November 11, 2014 | |
|---|---|---|
2. a. Device Information
| Device Name: | ABL90 FLEX analyzer |
|---|---|
| Common Name: | Blood gases, Cooximetry, and Metabolite analyzer |
Classification:
| Classification name | CFR Section | Device Class Product Code | |
|---|---|---|---|
| Bilirubin in the neonate test system | 862.1113 | 1,reserved | MOM |
4
2. b. Device Description
Instrument name, manufacturer, models and accessories
The name of the device is the ABL90 FLEX. The device is manufactured by Radiometer Medical ApS, Brønshøj, Denmark.
The ABL90 FLEX 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 FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
The ABL90 FLEX 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 one model.
The ABL 90 FLEX electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.
2. c. Purpose of submission
Addition of neonatal bilirubin measurement to previously cleared ABL90 FLEX analyzer (K092686)
Clinical Utility neonatal Bilirubin
Neonatal Bilirubin test is intended for use to aid in assessing the risk of kernicterus in neonates.
3. Intended Use/Indications for use
The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX 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 analyzer are intended to aid in assessing the risk of kernicterus in neonates.
4. Predicate device: ABL800 FLEX analyzer (K050869)
Substantial Equivalence
The ABL90 FLEX analyzer with neonatal bilirubin is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:
510(k) Number/Device Manufacturer:
K050869 ABL800 FLEX, Radiometer Medical ApS
5
| Similarities | ||
|---|---|---|
| Issue | SE Device | Predicate Device (K050869) |
| Intended use | The ABL90 FLEX analyzer is an in vitro | |
| diagnostic, portable, automated analyzer | ||
| that quantitatively measures neonatal | ||
| bilirubin in heparinised capillary whole | ||
| blood. The ABL90 FLEX 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 analyzer are intended to aid in | ||
| assessing the risk of kernicterus in | ||
| neonates. | Same | |
| Measuring method | ||
| for neonate bilirubin | ||
| test | Using spectrophotometric multi-component | |
| analysis through the instrument's existing | ||
| CO-Oximetry module on a hemolyzed part | ||
| of the sample. | Same | |
| Calibration Method | ||
| for neonate bilirubin | ||
| test | Two-point liquid calibration. | Same |
| Differences | |||||||
|---|---|---|---|---|---|---|---|
| l ssue | SE Device | Predicate Device | |||||
| (K050869) | |||||||
| Intended use site | Clinical laboratory and point-of-care. | Clinical laboratory. | |||||
| Neonatal bilirubin | |||||||
| reportable range | μmol/L: | ||||||
| mg/dL: | |||||||
| mg/L: | 28 - 648 | ||||||
| 1.6 - 37.9 | |||||||
| 16 - 379 | umol/L: | ||||||
| mg/dL: | |||||||
| mg/L: | 1 - 1000 | ||||||
| 0.0 - 58.5 | |||||||
| 0 - 585 |
5. Performance Characteristics
Precision
Repeatability and Device/Method Precision was evaluated according to CLSI guideline "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition", EP05-A2. The study was conducted at three point-of-care (POC) sites and on two instruments in Radiometer's laboratory facility on aqueous samples. In addition, a one-day study was conducted using spiked adult whole blood samples adjusted to mimic neonatal whole blood.
The test verified that neonatal bilirubin can be measured with acceptable precision in both POC and laboratory settings and in both capillary and syringe mode.
6
Point-of-care studies
20 day precision performance on aqueous solutions, all sites pooled:
| Capillary mode: | ||||||
|---|---|---|---|---|---|---|
| Sample | N | Mean | ||||
| (mg/dL) | Within run, Sr | Total, ST | ||||
| SD (Sr) | %CV | SD (ST) | %CV | |||
| Sample 1 | 240 | 2.1 | 0.04 | 2.1 | 0.08 | 3.8 |
| Sample 2 | 240 | 7.4 | 0.09 | 1.2 | 0.11 | 1.5 |
| Sample 3 | 240 | 30.6 | 0.32 | 1.1 | 0.42 | 1.4 |
Syringe mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|-----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 240 | 2.1 | 0.06 | 2.7 | 0.10 | 4.6 |
| Sample 2 | 240 | 7.4 | 0.06 | 0.8 | 0.11 | 1.5 |
| Sample 3 | 240 | 30.7 | 0.20 | 0.7 | 0.40 | 1.3 |
20 day precision performance on aqueous solutions, site 1:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.1 | 0.04 | 1.8 | 0.08 | 3.7 |
| Sample 2 | 80 | 7.3 | 0.06 | 0.8 | 0.10 | 1.3 |
| Sample 3 | 80 | 30.2 | 0.19 | 0.6 | 0.49 | 1.6 |
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.1 | 0.05 | 2.4 | 0.08 | 4.1 |
| Sample 2 | 80 | 7.3 | 0.05 | 0.7 | 0.09 | 1.3 |
| Sample 3 | 80 | 30.3 | 0.09 | 0.3 | 0.50 | 1.6 |
7
20 day precision performance on aqueous solutions, site 2:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.2 | 0.05 | 2.3 | 0.08 | 3.6 |
| Sample 2 | 80 | 7.5 | 0.10 | 1.4 | 0.13 | 1.7 |
| Sample 3 | 80 | 31.3 | 0.38 | 1.2 | 0.40 | 1.3 |
Syringe mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.2 | 0.06 | 2.9 | 0.11 | 4.9 |
| Sample 2 | 80 | 7.6 | 0.07 | 0.9 | 0.13 | 1.6 |
| Sample 3 | 80 | 31.6 | 0.28 | 0.9 | 0.41 | 1.3 |
20 day precision performance on aqueous solutions, site 3:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.1 | 0.05 | 2.3 | 0.09 | 4.2 |
| Sample 2 | 80 | 7.3 | 0.09 | 1.2 | 0.11 | 1.5 |
| Sample 3 | 80 | 30.3 | 0.37 | 1.2 | 0.34 | 1.1 |
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.1 | 0.06 | 2.8 | 0.10 | 4.8 |
| Sample 2 | 80 | 7.3 | 0.06 | 0.9 | 0.11 | 1.5 |
| Sample 3 | 80 | 30.4 | 0.20 | 0.7 | 0.27 | 0.9 |
8
1 day precision performance on spiked adult whole blood, all sites pooled:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|------|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 75 | 2.1 | 0.12 | 5.7 | 0.30 | 14.0 |
| Sample 2 | 75 | 7.1 | 0.16 | 2.3 | 0.44 | 6.3 |
| Sample 3 | 75 | 30.0 | 0.28 | 0.9 | 0.49 | 1.6 |
Syringe mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|-----|-----------------|----------------|-----|-----------|-----|
| SD (Sr) | %CV | SD (ST) | %CV | | | |
| Sample 1 | 75 | 2.5 | 0.13 | 5.0 | 0.22 | 8.7 |
| Sample 2 | 75 | 7.2 | 0.14 | 2.0 | 0.21 | 2.9 |
| Sample 3 | 75 | 30.8 | 0.27 | 0.9 | 0.31 | 1.0 |
1 day precision performance on spiked adult whole blood, site 1:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|------|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 25 | 2.3 | 0.14 | 6.1 | 0.31 | 13.4 |
| Sample 2 | 25 | 7.1 | 0.15 | 2.1 | 0.61 | 8.5 |
| Sample 3 | 25 | 30.4 | 0.16 | 0.5 | 0.37 | 1.2 |
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 25 | 2.5 | 0.12 | 4.8 | 0.12 | 4.9 |
| Sample 2 | 25 | 7.2 | 0.14 | 1.9 | 0.14 | 1.9 |
| Sample 3 | 25 | 31.1 | 0.21 | 0.7 | 0.19 | 0.6 |
9
1 day precision performance on spiked adult whole blood, site 2:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 25 | 1.8 | 0.11 | 5.7 | 0.14 | 7.3 |
| Sample 2 | 25 | 7.2 | 0.19 | 2.6 | 0.20 | 2.8 |
| Sample 3 | 25 | 29.5 | 0.22 | 0.7 | 0.41 | 1.4 |
Syringe mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 25 | 2.6 | 0.11 | 4.2 | 0.12 | 4.5 |
| Sample 2 | 25 | 7.5 | 0.16 | 2.1 | 0.15 | 2.0 |
| Sample 3 | 25 | 30.9 | 0.21 | 0.7 | 0.20 | 0.6 |
1 day precision performance on spiked adult whole blood, site 3:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|------|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 25 | 2.2 | 0.11 | 5.2 | 0.39 | 17.7 |
| Sample 2 | 25 | 6.9 | 0.14 | 2.1 | 0.42 | 6.2 |
| Sample 3 | 25 | 30.0 | 0.40 | 1.3 | 0.65 | 2.2 |
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|------|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 25 | 2.4 | 0.15 | 6.1 | 0.34 | 13.9 |
| Sample 2 | 25 | 6.8 | 0.13 | 1.9 | 0.30 | 4.5 |
| Sample 3 | 25 | 30.5 | 0.36 | 1.2 | 0.46 | 1.5 |
10
Laboratory studies
Precision study on aqueous solutions, 20 days:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.1 | 0.05 | 2.3 | 0.07 | 3.4 |
| Sample 2 | 80 | 7.4 | 0.12 | 1.6 | 0.13 | 1.7 |
| Sample 3 | 80 | 30.7 | 0.48 | 1.6 | 0.46 | 1.5 |
Syringe mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|----------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1 | 80 | 2.1 | 0.05 | 2.4 | 0.07 | 3.2 |
| Sample 2 | 80 | 7.4 | 0.11 | 1.5 | 0.14 | 1.9 |
| Sample 3 | 80 | 30.9 | 0.45 | 1.4 | 0.57 | 1.8 |
1 day precision performance on spiked adult whole blood and cord blood:
Capillary mode:
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|-----------------------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1, Adult blood | 25 | 2.3 | 0.15 | 6.7 | 0.18 | 7.7 |
| Sample 2, Adult blood | 25 | 7.8 | 0.22 | 2.8 | 0.34 | 4.4 |
| Sample 3, Adult blood | 25 | 30.2 | 0.73 | 2.4 | 0.80 | 2.6 |
| Sample 1, Cord blood | 25 | 2.0 | 0.10 | 4.9 | 0.13 | 6.7 |
| Sample 2, Cord blood | 25 | 7.0 | 0.19 | 2.7 | 0.24 | 3.4 |
| Sample 3, Cord blood | 25 | 30.6 | 0.32 | 1.1 | 0.34 | 1.1 |
| Sample | N | Mean
(mg/dL) | Within run, Sr | | Total, ST | |
|-----------------------|----|-----------------|----------------|-----|-----------|-----|
| | | | SD (Sr) | %CV | SD (ST) | %CV |
| Sample 1, Adult blood | 25 | 2.6 | 0.13 | 5.0 | 0.21 | 8.3 |
| Sample 2, Adult blood | 25 | 7.4 | 0.09 | 1.2 | 0.15 | 2.1 |
| Sample 3, Adult blood | 25 | 29.4 | 0.51 | 1.7 | 0.52 | 1.8 |
| Sample 1, Cord blood | 25 | 2.4 | 0.12 | 4.9 | 0.18 | 7.4 |
| Sample 2, Cord blood | 25 | 7.1 | 0.24 | 3.4 | 0.28 | 4.0 |
| Sample 3, Cord blood | 25 | 29.9 | 0.21 | 0.7 | 0.26 | 0.9 |
11
Method Comparison
Method comparison study versus the predicate has been conducted according to NCCLS guideline "Method Comparison and Bias Estimation Using Patient Samples", EP09-A2. The study was conducted for both capillary and syringe mode at three point-of-care sites and included a total of 224 samples for capillary mode and 210 samples for syringe mode spanning the entire measuring range.
Linear regression of the pooled data qives a slope of 0.9903/0.9760 and an R2 of 0.99/0.99 for syringe and capillary mode respectively showing good correlation with the predicate device and very good agreement between the two modes.
| Site | N | ABL 90 FLEX
range tested,
mg/dL | Slope
(95% CI) | Intercept
(95% CI)
mg/dL | R2 |
|--------------------|-----|---------------------------------------|---------------------------|--------------------------------|--------|
| Site 1 | 74 | 1.8 - 35.9 | 0.9922
(0.964 - 1.020) | 1.0207
(0.64 - 1.40) | 0.9857 |
| Site 2 | 51 | 2.0 - 37.9 | 1.0054
(0.980 - 1.031) | 0.3744
(0.00 - 0.75) | 0.9924 |
| Site 3 | 85 | 2.7 - 37.1 | 0.9917
(0.969 - 1.014) | 0.3623
(0.01 - 0.71) | 0.9895 |
| All sites combined | 210 | 1.8 - 37.9 | 0.9903
(0.975 - 1.005) | 0.6574
(0.44 - 0.88) | 0.9878 |
Syringe mode:
Capillary mode:
| Site | N | ABL 90 FLEX
range tested,
mg/dL | Slope
(95% CI) | Intercept
(95% CI)
mg/dL | R2 |
|--------------------|-----|---------------------------------------|---------------------------|--------------------------------|--------|
| Site 1 | 77 | 1.8 - 35.5 | 0.9774
(0.950 - 1.005) | 1.1199
(0.76 - 1.48) | 0.9853 |
| Site 2 | 56 | 2.1 - 37.3 | 0.9977
(0.974 - 1.021) | 0.5385
(0.19 - 0.88) | 0.9927 |
| Site 3 | 91 | 3.0 - 36.7 | 0.9737
(0.948 - 0.999) | 0.4862
(0.09 - 0.88) | 0.9845 |
| All sites combined | 224 | 1.8 - 37.3 | 0.9760
(0.961 - 0.991) | 0.7741
(0.55 - 1.00) | 0.9861 |
12
Linearity
Linearity study has been conducted according to CLSI guideline "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline", EP6-A.
The method is linear (first order) over the entire measuring range and fulfils the requirements for allowable error due to non-linearity established by Radiometer.
Image /page/12/Figure/3 description: The image is a scatter plot titled "Bilirubin: ABL90 vs Sample Conc." The x-axis is labeled "Bilirubin, mg/dL, Target value" and ranges from 0.0 to 50.0. The y-axis is labeled "Bilirubin, mg/dL, ABL90" and ranges from 0.0 to 50.0. A line of best fit is plotted on the scatter plot, and the equation of the line is y = 0.968x + 0.2984, with an R-squared value of 0.9996.
Interference
Interference study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition", EP07-A2.
Significant interference was observed from Fluorescein, Beta-carotene, Methylene Blue, Patent Blue V, Cardio Green, HiCN, Hydroxycobalamin, Cyanocobalamin, and SHb.
No clinically significant interference was observed from Evans Blue, HbF, Hemolysis, Intralipid or Triglyceride. Interference specifications are tabulated below.
13
There was non-significant interference with Evans Blue, Intralipid, HbF, Hemolysis, and Triglyceride at the highest concentration indicated below: (Sponsor defines non-significant interference as