The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial 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.

ABL90 FLEX PLUS:
The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial 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.

Device Description

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are two models of the same portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO-, pCO3, potassium, sodium, calcium, 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 and ABL90 FLEX PLUS is Radiometer Medical ApS.
The ABL90 FLEX and ABL90 FLEX PLUS consist 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.
Technology:
The ABL 90 FLEX and ABL90 FLEX PLUS electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX and ABL90 FLEX PLUS optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.
Clinical Utility ctBil:
For newborns up to an age of one month the method's reportable range covers the entire reference range. Neonatal Bilirubin test is intended for use to aid in assessing the risk of kernicterus in newborns.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA regarding the ABL90 FLEX and ABL90 FLEX PLUS devices for measuring neonatal bilirubin. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria as typically done for novel AI/ML medical devices.

Therefore, many of the requested points related to acceptance criteria, ground truth establishment, expert consensus, MRMC studies, and training sets are not applicable to this type of submission. This 510(k) is for an in-vitro diagnostic device that measures a chemical parameter (bilirubin) using established spectrophotometric technology, not an AI/ML-driven diagnostic or image analysis tool. The "performance" being evaluated is the analytical performance (accuracy, precision, linearity) of the device against a known predicate and reference methods, not the diagnostic performance of an algorithm.

However, I can extract the relevant information from the document that pertains to its performance evaluation.

Overview of Device Performance Evaluation (Not AI/ML focused)

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are in vitro diagnostic devices designed to quantitatively measure neonatal bilirubin in heparinized capillary, venous, and arterial whole blood. The submission aims to extend the indicated sample types for neonatal bilirubin measurement to include arterial and venous whole blood, leveraging performance data already established for capillary whole blood in a previous 510(k) (K132691).

The core of the performance study for this specific submission is demonstrating method comparison (correlation) against a predicate device (ABL800 FLEX or ABL835 FLEX, which is part of the ABL800 FLEX family) for the new sample types.

Relevant Performance Information and Analysis (from the provided document):

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the method comparison study. The goal is to demonstrate "substantial equivalence" based on the correlation characteristics (slope, intercept, R-squared) to the predicate device. The implicit acceptance is that the correlation is strong (R-squared close to 1) and the linear relationship is close to y=x (slope close to 1, intercept close to 0), indicating comparable performance to the predicate. The FDA's determination of substantial equivalence implies these criteria were met.

Reported Device Performance (from Table 1: Neonatal bilirubin linear regression data for ABL90 FLEX measurements compared to ABL835 FLEX measurements):

Parameter	Units	Slope	Intercept (mg/dL)	R²	Sy.x (mg/dL)
ctBil All (combined samples)	mg/dL	0.97	-0.38	1.00	0.60
ctBil Arterial All	mg/dL	0.98	-0.54	0.97	0.53
ctBil Venous All	mg/dL	0.98	-0.32	0.98	0.62
ctBil site 1	mg/dL	0.96	-0.18	1.00	0.57
ctBil site 2	mg/dL	0.98	-0.71	1.00	0.58

Interpretation: The R-squared values are very high (0.97 to 1.00), indicating a very strong linear correlation between the ABL90 FLEX and the predicate ABL835 FLEX. The slopes are close to 1 (0.96-0.98) and intercepts are close to 0 (-0.18 to -0.71 mg/dL), suggesting good agreement (i.e., minimal proportional or constant bias) between the new device and the predicate.

Sample size used for the test set and the data provenance:
- Test Set Sample Sizes:
  - 44 arterial blood samples
  - 42 venous blood samples
  - 17 spiked cord blood samples
  - Total N = 103 samples (44 arterial + 42 venous + 17 spiked)
- Data Provenance: The study was conducted at "two point-of-care sites." The document does not specify the country of origin of the data. It is a prospective method comparison study where new measurements were taken for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an AI/ML algorithm. For this in vitro diagnostic device, the "ground truth" for the method comparison is the measurement obtained from the predicate device (ABL835 FLEX), which is itself a validated diagnostic instrument. This is an analytical performance study, not a diagnostic performance study relying on expert interpretation.
Adjudication method for the test set:
- Not applicable. This study involves direct quantitative measurements of a chemical analyte, not qualitative assessments or interpretations that would require adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an in vitro diagnostic device measuring a chemical substance, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is inherently a "standalone" device in its measurement function. The device itself performs the measurement and provides a numerical output. Human involvement is in operating the device and interpreting the numerical result in a clinical context, but not in assisting an algorithm to produce the measurement.
The type of ground truth used:
- The "ground truth" (or reference method for comparison) was measurements obtained from another legally marketed device (predicate device, ABL835 FLEX), which is widely considered a reliable method for bilirubin measurement. For in vitro diagnostics, this is a standard approach to demonstrating substantial equivalence – showing comparable performance to an established method.
The sample size for the training set:
- Not applicable. This device uses established spectrophotometric technology and is not an AI/ML device that requires a training set in the conventional sense. The "training" here would be the design and calibration of the instrument based on chemical and optical principles.
How the ground truth for the training set was established:
- Not applicable. As above, no training set in the AI/ML sense.

Summary

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

April 28, 2017

RADIOMETER MEDICAL APS SOEREN BOEGESTRAND SENIOR REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21. BROENSHOEJ, DK DK-2700

Re: K170882

Trade/Device Name: ABL90 FLEX, ABL90 FLEX PLUS Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system. Regulatory Class: Class I, reserved Product Code: MOM Dated: March 17, 2017 Received: March 24, 2017

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. Isting 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

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Kellie B. Kelm -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) K170882

Device Name ABL90 FLEX and ABL90 FLEX PLUS

Indications for Use (Describe) ABL90 FLEX:

The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial 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.

ABL90 FLEX PLUS:

The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial 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.

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.

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510(k) Summary - K170882

1. Submitter and contact information

Submitter

Company Name:	Radiometer Medical ApS
ER Number:	3002807968
Address:	Aakandevej 212700 BroenshoejDenmark
Phone:	+45 3827 3827
Fax:	+45 3827 2727
Contact person:	Soeren Boegestrand
E-mail:	soren.bogestrand@radiometer.dk

Contact Person

Name:	Soeren Boegestrand
Function:	Senior Regulatory Affairs Specialist
E-mail:	soren.bogestrand@radiometer.dk
Phone:	+45 3827 3852
Fax:	+45 3827 2727
Date prepared
	Date:

2. Device Information

Device Name:	ABL90 FLEX and ABL90 FLEX PLUS
Common Name:	Bilirubin (total and unbound) in the neonate test system.

Classification:

Classification name	CFR Section	Device Class	Product Code
Bilirubin (total and unbound) in the neonate testsystem	862.1113	1, reserved	MQM

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3. Device Description

Instrument name, manufacturer, models and accessories

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

The ABL90 FLEX and ABL90 FLEX PLUS consist 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.

Technology

The ABL 90 FLEX and ABL90 FLEX PLUS electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX and ABL90 FLEX PLUS optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.

Clinical Utility ctBil

For newborns up to an age of one month the method's reportable range covers the entire reference range. Neonatal Bilirubin test is intended for use to aid in assessing the risk of kernicterus in newborns.

4. Intended Use/Indications for use

ABL90 FLEX:

The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole blood.

The ABL90 FLEX 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.

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ABL90 FLEX PLUS:

The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole blood.

The ABL90 FLEX PLUS 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.

5. Substantial Equivalence

The ABL90 FLEX and ABL90 FLEX PLUS analyzer with neonatal bilirubin on arterial and venous whole blood 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

Similarities
Item	Candidate Device	Predicate Device (K050869)
Product code	Same	MQM
Measuring method	Same	Spectrophotometrical
Calibration Method	Same	Two-point liquid calibration
Intended use	Same	In vitro testing of whole bloodsamples for total bilirubin

Item	Candidate Device	Predicate Device(K050869)
Sample types	Heparinized capillary, arterial and venous whole blood	Whole blood
Intended use site	Laboratory and point-of-care.	Laboratory.
Neonatal bilirubinmeasuring range	μmol/L: 28 – 648mg/dL: 1.6 – 37.9mg/L: 16 – 379	μmol/L: 0 - 1000mg/dL: 0.0 - 58.5mg/L: 0 - 585

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The ABL90 FLEX and ABL90 FLEX PLUS analyzers with neonatal bilirubin on arterial and venous whole blood described above are substantially equivalent in Intended Use, fundamental scientific technology, and characteristics to the predicate ABL800 FLEX (K050869) regarding the measurement of neonatal bilirubin.

6. Performance Characteristics

Substantial equivalence between the ABL90 FLEX PLUS analyzer and ABL90 FLEX analyzer has been demonstrated in K160153.

Verification of the ABL90 FLEX PLUS has demonstrated that the performance of the ABL90 FLEX PLUS is equivalent to the performance of ABL90 FLEX.

Since meaurements conducted on ABL90 FLEX PLUS and ABL90 FLEX are equivalent, the neonatal bilirubin testing on arterial and venous whole blood samples conducted on ABL90 FLEX represent both ABL90 FLEX and ABL90 FLEX PLUS.

The purpose of this submission is to include arterial and venous whole blood sample types to the neonatal bilirubin assay using the ABL90 FLEX and ABL90 FLEX PLUS Analyzers. Precision, linearity, detection limits and analytical specificity performance were previously established in K132691 in support of substantial equivalence for capillary whole blood, and are also applicable for arterial and venous whole blood. Consequently, only method comparison studies have been performed on arterial and venous neonatal whole blood to support substantial equivalence for these sample types.

6.1 Method Comparison

Method comparison study versus the predicate device has been conducted at two point-of-care sites, samples were analyzed by 4 to 5 operators per site. Bilirubin measurements were performed on 44 arterial. 42 venous and 17 spiked cord blood samples.

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Image /page/8/Figure/0 description: The image is a scatter plot comparing ABL90 FLEX and ABL835 FLEX measurements of arterial bilirubin. The x-axis represents ABL835 FLEX in mg/dl, and the y-axis represents ABL90 FLEX in mg/dl. The plot includes data points labeled as 'ART', a dashed line representing y=x, and a solid line representing a linear regression of all data points. The equation for the linear regression is y = 0.98x - 0.54, with an R-squared value of 0.97.

Figure 1: Scatter plot of ABL90 FLEX compared to ABL835 FLEX neonatal arterial bilirubin measurements performed at combined sites. The linear regression line is based on measurements made on arterial blood samples.

Image /page/8/Figure/2 description: The image is a scatter plot comparing Venous bilirubin ABL90 FLEX vs. ABL835 FLEX. The x-axis represents ABL835 FLEX in mg/dl, and the y-axis represents ABL90 FLEX in mg/dl. The plot includes data points labeled as 'VEN', a dashed line representing y=x, and a solid line representing a linear regression. The equation for the linear regression is y = 0.98x - 0.32, with an R-squared value of 0.98.

Figure 2: Scatter plot of ABL90 FLEX compared to ABL835 FLEX neonatal venous bilirubin measurements performed at combined sites. The linear regression line is based on measurements made on venous blood samples.

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Image /page/9/Figure/0 description: The image is a scatter plot comparing Bilirubin ABL90 FLEX and ABL835 FLEX measurements at Site 1. The plot includes data points for ART, VEN, and SPIKED samples, with ABL835 FLEX on the x-axis and ABL90 FLEX on the y-axis, both in mg/dl. A linear regression line, labeled "Linear (All)", is fitted to the data, with the equation y = 0.96x - 0.18 and an R-squared value of 1.00, indicating a strong positive correlation. A dashed green line representing y=x is also plotted for reference.

Figure 3: Scatter plot of ABL90 FLEX compared to ABL835 FLEX neonatal bilirubin measurements performed at site 1. The linear regression line is based on measurements made on arterial-, venous- and spiked cord blood samples.

Image /page/9/Figure/2 description: The image is a scatter plot titled "Site 2 All: Bilirubin ABL90 as function of ABL835". The x-axis represents ABL835 FLEX (mg/dl), and the y-axis represents ABL90 FLEX (mg/dl). The plot includes data points for ART, VEN, and SPIKED, along with a dashed line representing y=x and a solid line representing a linear fit for all data points. The equation for the linear fit is y = 0.98x - 0.71, with an R-squared value of 1.00.

Figure 4: Scatter plot of ABL90 FLEX compared to ABL835 FLEX neonatal bilirubin measurements performed at site 2. The linear regression line is based on measurements made on arterial-, venous- and spiked cord blood samples.

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Image /page/10/Figure/0 description: The image is a scatter plot comparing Bilirubin ABL90 FLEX and ABL835 FLEX measurements across combined sites. The plot includes data points for ART, VEN, and SPIKED samples, with ABL835 FLEX on the x-axis and ABL90 FLEX on the y-axis, both in mg/dl. A dashed green line represents y=x, and a solid black line represents a linear regression of all data, with the equation y = 0.97x - 0.38 and R^2 = 1.00.

Figure 5: Scatter plot of ABL90 FLEX compared to ABL835 FLEX neonatal bilirubin measurements performed at combined sites. The linear regression line is based on measurements made on arterial-, venous- and spiked cord blood samples.

Parameter	Units	RangeLow	RangeHigh	Totaln =	Spikedn =	Slope	Intercept	R2	Sy.x
ctBil All	mg/dLμM	1.627	37.3638	103	17	0.97	-0.38-6.50	1.00	0.6010.3
ctBil Arterial All	mg/dLμM	1.730	13.6232	44	N/A	0.98	-0.54-9.23	0.97	0.539.06
ctBil Venous All	mg/dLμM	1.627	28.1481	42	N/A	0.98	-0.32-5.47	0.98	0.6210.6
ctBil site 1	mg/dLμM	1.831	37.3638	66	11	0.96	-0.18-3.07	1.00	0.579.75
ctBil site 2	mg/dLμM	1.627	32.2551	37	6	0.98	-0.71-12.1	1.00	0.589.91

Table 1: Neonatal bilirubin linear regression data for ABL90 FLEX measurements compared to ABL835 FLEX measurements

7. Conclusion

Based on the substantial equivalence comparison and the results of the conducted performance evaluations it has been concluded that the ABL90 FLEX and ABL90 FLEX PLUS with neonatal bilirubin on arterial and venous whole blood are as safe and effective as the predicate device.

Regulation Number and Section

§ 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.