For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.

This in vitro diagnostic device is intended for prescription use only.

Device Description

The Total Bilirubin kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: BR8307

R1. Total Bilirubin R1 4 x 20 mL
R2. Total Bilirubin R2 4 x 8 mL

REAGENT COMPOSITION

Contents Initial Concentration of Solutions
R1. Total Bilirubin R1
Citrate buffer, pH2.9 0.1 mol/L
Detergent 0.9%
Antimicrobial
R2. Total Bilirubin R2
Phosphate buffer, pH 7.0 10 mmol/L
Sodium Metavanadate 4 mmol/L

MATERIALS REQUIRED BUT NOT PROVIDED

Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458 Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153 RX series Saline (Cat. No. SA 8396)

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the studies conducted to meet them for the Total Bilirubin (T BIL) device.

Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Linearity/Reportable Range	Deviation from linearity less than 5% across the analytical range.	Linear regression correlation (r) = 0.9999 for the range 0.21 – 26.3 mg/dL. The reported range is 0.21 – 26.3 mg/dL. (Implies linearity within this range was met).
Limit of Detection (LoD)	Not explicitly stated as an acceptance criterion for the study, but determined.	LoD = 0.08 mg/dL (based on 240 determinations, 4 low-level samples).
Limit of Blank (LoB)	Not explicitly stated as an acceptance criterion for the study, but determined.	LoB = 0.06 mg/dL.
Limit of Quantitation (LoQ)	Not explicitly stated as an acceptance criterion for the study, but determined.	LoQ = 0.21 mg/dL (lowest concentration at which precision is still met).
Analytical Specificity (Interference)	Recovery within ±10% of the initial value of Total Bilirubin concentration (0.99 mg/dL and 15.03 mg/dL) for specified interferents.	Haemoglobin: No significant interference up to 1000 mg/dL. Triglycerides: No significant interference up to 2000 mg/dL. Intralipid®: No significant interference up to 1000 mg/dL. Ascorbic Acid: No significant interference up to 25.0 mg/dL. (All met the ±10% recovery implicitly).
Method Comparison (with predicate device)	Not explicitly stated as an acceptance criterion (e.g., a specific agreement or bias limit), but "substantial equivalence" is the overall goal.	Linear regression equation: Y = 1.02x - 0.02. Correlation coefficient (r) = 0.9999. (This high correlation supports substantial equivalence).
Matrix Comparison (Serum vs. Plasma)	Not explicitly stated as an acceptance criterion, but the goal is for method accuracy with plasma to be equivalent to serum and no interference.	Linear regression equation: Y = 0.99x + 0.04. Correlation coefficient (r) = 0.9999. (This high correlation suggests equivalence).
Expected/Reference Values	Verified using NCCLS C28-A3 guidelines; all values from 30 normal donors fall within the quoted range for healthy individuals (0.3 – 1.2 mg/dL).	All values from the 30 normal donors tested on the RX Daytona plus fell within the quoted ranges for Healthy Individuals (0.3 – 1.2 mg/dL).
Precision/Reproducibility	Not explicitly stated as an acceptance criterion (e.g., a maximum CV%), but detailed results are provided.	See Table 2 (page 6) for detailed SD and CV values across different concentrations for Within Run, Among Run, Among Day, and Total precision. For example, for a mean of 25.0 mg/dL, Total CV was 1.7%; for 0.3 mg/dL, Total CV was 7.4%. These values are typically considered acceptable for clinical assays.

Study Details

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision/Reproducibility: 80 determinations per sample type (LIN Pool, LOQ Pool, QC 1, QC 2, Serum Pool 1-4) across two lots, two RX Daytona plus systems, over 20 non-consecutive days with 2 replicates per run. Data provenance is not specified, but the study design suggests prospective testing of control materials and human serum samples (spiked or diluted).
- Linearity/Assay Reportable Range: 11 levels, each run in replicates of five across two lots of reagent on one RX Daytona plus system. Data provenance is not specified.
- Detection Limit: 240 determinations (for LoD) using 4 low-level samples. Data provenance is not specified.
- Analytical Specificity (Interference): Not explicitly stated how many samples or replicates per interferent. Samples were spiked with interferents and compared to control samples. Data provenance is not specified.
- Method Comparison: 106 serum patient samples spanning 0.21 to 26.9 mg/dL. Data provenance is not specified, but these are "patient samples," suggesting retrospective or prospective clinical samples.
- Matrix Comparison: A minimum of 40 matched patient sample pairs (serum and lithium heparin plasma). Data provenance is not specified, but these are "patient samples," suggesting retrospective or prospective clinical samples.
- Expected values/Reference range: Human serum from 30 normal donors. Data provenance is not specified. The study was prospective in nature, testing new samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is an in vitro diagnostic device for quantitative chemical analysis. The "ground truth" is established by the analytical reference methods or established values of control materials, or comparison to a predicate device. There is no mention of human experts defining ground truth through consensus in the way a radiological study might. For the method comparison, the predicate device (Siemens Healthcare Diagnostic Inc, Total Bilirubin 2 reagent, K063845) serves as the reference, which itself would have undergone rigorous analytical validation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is an analytical chemistry device, not an imaging device requiring human adjudicated interpretations. The performance is assessed by quantitative analytical metrics.
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 analytical chemistry device, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is an in vitro diagnostic assay, which by nature operates "standalone" in terms of measurement. The results are then interpreted by a clinician, but the device itself generates a quantitative result without human-in-the-loop performance influencing the measurement. Performance studies like precision, linearity, and analytical specificity are inherently "standalone" evaluations of the device's analytical function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Reference Methods/Materials: For linearity and precision, the ground truth is based on gravimetrically prepared samples, known concentrations of control materials, or dilutions with expected values.
- Predicate Device: For method comparison, the results from the legally marketed predicate device (Siemens Healthcare Diagnostic Inc, Total Bilirubin 2 reagent, K063845) serve as the comparative ground truth.
- Literature/Guidelines: For reference range verification, established normal ranges from scientific literature (e.g., "Tietz Clinical Guide to laboratory Tests") and guidelines (NCCLS C28-A3) are used.
The sample size for the training set
- Not applicable. This is an analytical chemistry device, not a machine learning model that requires a training set.
How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.

Summary

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

RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG, QA/RA MANAGER 55 DIAMOND ROAD, ARDMORE CRUMLIN, COUNTY ANTRIM BT29 4OY, GREAT BRITAIN

January 28, 2016

Re: K152344

Trade/Device Name: Total Bilirubin (T BIL) Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: II Product Code: JFM Dated: December 15, 2015 Received: December 17, 2015

Dear Pauline Armstrong:

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 (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" (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.

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) K152344

Device Name Total Bilirubin (TBIL)

Indications for Use (Describe)

This in vitro diagnostic device is intended for prescription use only.

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, TOTAL BILIRUBIN ASSAY

1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.

2. SUBMITTER NAME AND ADDRESS

Name: Dr Pauline Armstrong

Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.

Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com

Date of Summary Preparation: December 7, 2015

3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER

510k No: K152344

Device Proprietary Name: Total Bilirubin (T BIL)

Common Name: Total Bilirubin

Purpose for Submission: New Device

ProductCode	Regulation Name	Classification	Regulation Section	Panel
JFM	Bilirubin (Total orDirect) Test System	Class II	21 CFR 862.1110	ClinicalChemistry(75)

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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS

Predicate Device Proprietary Name:

Siemens Healthcare Diagnostic Inc (formerly Bayer Healthcare), Total Bilirubin 2 reagent

510 (k) Number: K063845

5. INTENDED USE

For the quantitative in vitro determination of Total Bilirubin in serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.

This in vitro diagnostic device is intended for prescription use only.

6. DEVICE DESCRIPTION

The Total Bilirubin kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: BR8307

R1. Total Bilirubin R1	4 x 20 mL
R2. Total Bilirubin R2	4 x 8 mL

REAGENT COMPOSITION

Contents	Initial Concentrationof Solutions
R1. Total Bilirubin R1Citrate buffer, pH2.9DetergentAntimicrobial	0.1 mol/L0.9%
R2. Total Bilirubin R2Phosphate buffer, pH 7.0Sodium Metavanadate	10 mmol/L4 mmol/L

MATERIALS REQUIRED BUT NOT PROVIDED

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7. PREDICATE DEVICE COMPARISON TABLE

Table 1 Comparison of Total Bilirubin test system for the RX Daytona plus to predicate device

CHARACTERISTICS	Total Bilirubin Assay forRX daytona plus (NewDevice)	Siemens Healthcare Diagnostic Inc,Total Bilirubin_2 reagent(K063845)(Predicate Device)
	Similarities
INTENDED USE	For the quantitative in vitro determination ofTotal Bilirubin in serum and plasma. TotalBilirubin measurements are used in thediagnosis and treatment of hemolytic, biliaryand liver disorders, including hepatitis andcirrhosis.	Same
ASSAY PROTOCOL	Vanadate Oxidation Method	Same
CONTROLFREQUENCY	Randox assayed human multisera Level 2 & 3Two levels of control should be assayed atleast once a day	Same
SAMPLE TYPE	Serum, heparinized plasma samples aresuitable.	Same
REAGENTCOMPOSITION	ContentsInitial Concentrationof SolutionsR1.Total Bilirubin R1Citrate buffer, pH2.9DetergentAntimicrobialR2.Total Bilirubin R2Phosphate buffer, pH 7.0Sodium Metavanadate	Same

Differences
TEST RANGE	0.21 - 26.3 mg/dL	0.1 - 35 mg/dL
STORAGE(UNOPENED)	Reagents are stable up to the expiry datewhen stored unopened at +2 to +8°C	Reagents are stable up to the expiry datewhen stored unopened at +2 to +35°C
CALIBRATIONFREQUENCY	Every 28 days, with a change of reagent lotor as indicated by quality controlprocedures.	Every 60 days.

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8. TEST PRINCIPLE (1)

The bilirubin is oxidised by vanadate at about pH 2.9 to produce biliverdin. In the presence of detergent and vanadate, both coniugate (direct) and unconiuqated bilirubin are oxidised. This oxidation reaction causes a decrease in the optical density of the yellow colour, which is specific to bilirubin. The decrease in optical density at 450/546 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.

Bilirubin + Surfactant + VO3- Biliverdin

I . Tokuda K, Tanimoto K. New method of measuring serum bilirubin using vanadic acid. |pn | Clin Chem. 1993:22:116-122.2.

9. PERFORMANCE CHARACTERISTICS

Analytical performance:

a. Precision/Reproducibility:

Precision was evaluated consistent with C.L.S.I documents EP5-A2 Precision studies were performed by two operators on two RX Daytona plus systems using serum based control material and unaltered human serum samples that were spiked with unconjugated Bilirubin or diluted to achieve Total Bilirubin concentrations based on normal ranges 0.3 - 1.2 mg/dL. Testing was conducted for two reagent lots of Total Bilirubin, one lot on each RX Daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run were performed for each sample. The assay was calibrated initially with no further calibration required. The results are summarized in the following tables.

Lot 2			MEAN	Within Run			Among Run		Among Day	Total
Method	Product	N	(mg/dl)	SD	CV	SD	CV	SD	CV	SD	CV
TBIL	LIN Pool	80	25.0	0.23	0.9	0.14	0.6	0.32	1.3	0.41	1.7
TBIL	LOQ Pool	80	0.3	0.02	6.9	0.01	2.6	0.00	0.0	0.02	7.4
TBIL	QC 1	80	1.5	0.04	2.9	0.02	1.6	0.01	0.7	0.05	3.4
TBIL	QC 2	80	5.3	0.08	1.5	0.03	0.5	0.13	2.5	0.16	3.0
TBIL	Serum Pool 1	80	1.1	0.05	4.0	0.03	2.4	0.03	2.8	0.06	5.4
TBIL	Serum Pool 2	80	6.7	0.11	1.6	0.08	1.1	0.09	1.4	0.16	2.4
TBIL	Serum Pool 3	80	12.0	0.12	1.0	0.07	0.6	0.24	2.0	0.28	2.3
TBIL	Serum Pool 4	80	16.2	0.15	0.9	0.21	1.3	0.24	1.5	0.35	2.2

Table 2 Precision Summary

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b. Linearity/assay reportable range:

Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 5%).

The linearity samples were prepared at 11 levels. The sponsor set a range from 0.21 mg/dl analyte concentration up to a high concentration approximately 26.3 mg/dl using low and high serum pools. The low and high pools were mixed to make nine intermediate levels. Each level was run in replicates of five on two lots of Total Bilirubin reagent on one RX Daytona plus system. The observed values were compared to the expected values; the linear regression correlation between the expected values and the observed values are summarized in the following table:

Table 3 Linearity Summary including Regression equation and correlation co-
efficient.

Analyte Tested	Total Bilirubin(mg/dL)
Linear Regression	$Y = 1.02 + 0.01$
r	0.9999

Analyte	Linearity	Reportable Range
TBIL	26.3 mg/dl	0.21 – 26.3 mg/dl

The low end of the reportable assay range is based on the Limit of Quantitation. The high end of the reportable assay range is based on the linearity. The Rx Davtona Plus analyzer has an auto-dilution feature that is automatically activated when measuring samples >26.3 mg/dL, which are diluted and remeasured to obtain values within the measuring range.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Refer to K942458 Randox Assayed Multisera Level 2 and Level 3.

Refer to K053153 Randox Calibration Serum Level 3.

Randox Calibration Serum Level 3 for Total Bilirubin is traceable to an internal master reference material.

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d. Detection limit:

Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Evaluation of detection capability for clinical laboratory measurement procedures: Approved Guideline Second Edition'. A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.

The Limit of Detection (LoD) for Total Bilirubin on the RX Daytona Plus is 0.08 mg/dL based on 240 determinations, with 4 low level samples.

The Limit of Blank (LoB) is 0.06 mg/dL.

The Limit of Quantitation (LoQ) is 0.21 mg/dL as determined by the lowest concentration at which precision is still met.

e. Analytical Specificity:

Interference studies have been carried out in accordance with C.L.S.I. guideline EP7-A2 'Interference testing in clinical chemistry; Approved Guideline Second Edition' The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents.

Acceptance Criteria:

The criteria for no significant interference is recovery within ±10% of the initial value of Total Bilirubin concentration of 0.99 mg/dL and 15.03 mg/dL

Haemoglobin	No significant interference up to 1000mg/dL
Triglycerides	No significant interference up to 2000mg/dL
Intralipid®	No significant interference up to 1000mg/dL
Ascorbic Acid	No significant interference up to 25.0mg/dL

f. Method comparison with predicate device:

Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'.

106 serum patient samples spanning the range 0.21 to 26.9 mg/dL were tested by two operators on two lots of Total Bilirubin reagent on one RX Daytona plus analyzer and the predicate device tested on one ADVIA 1650 system across 3 working days with each sample tested in singlicate.

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The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.02x - 0.02 Correlation coefficient of r = 0.9999

q. Matrix comparison:

Matrix method comparisons for Total Bilirubin assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of reagents. Both serum and lithium heparin plasma were tested to determine whether method accuracy with plasma specimens are equivalent to serum results and that lithium heparin plasma does not interfere with either the method or the system.

Total Bilirubin matrix comparison on the RX Daytona plus (Lithium Heparin)

Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A minimum of 40 matched patient sample pairs were analyzed spanning the 0.23 to 23.5 mg/dl and the following linear regression equation was obtained:

Y = 0.99x + 0.04

Correlation coefficient of r = 0.9999

Expected values/Reference range:

Referenced from literature

A reference interval for Total Bilirubin was verified using NCCLS C28-A3 guidelines. In a study, human serum from 30 normal donors were tested in singlicate on the RX daytona plus. The results obtained were ordered from lowest to highest before being examined for outliers using the Dixon test.

Upon confirmation there were no outliers; the values were compared to the quoted ranges for Total Bilirubin. Results of the study indicate that all values reported in the range for Healthy Individuals.

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Table 4 Reference Ranges

Analyte	Expected Values
Total Bilirubin (2)	0.3 – 1.2 mg/dL

WuAHB. Tietz Clinical Guide to laboratory Tests, 4th edition, Saunders Elsevier, St. Louis, MO: 2006:316.

10. CONCLUSION

Testing results indicate that the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.