The Albumin BCP2 assay is an automated clinical chemistry assay. The Albumin BCP2 procedure is based on the binding of bromocresol purple specifically with human albumin to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.

Methodology: Colorimetric (Bromocresol Purple)

AI/ML Overview

This document is a 510(k) premarket notification for a new in vitro diagnostic device, the Albumin BCP2 assay, which measures albumin in human serum or plasma. It seeks to prove substantial equivalence to a predicate device, Albumin BCP.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds for each performance characteristic. Instead, it describes various studies conducted and reports the results, implying that meeting standard analytical performance metrics demonstrates acceptable performance and substantial equivalence.

However, we can infer the acceptance criteria from the reported performance and the context of typical FDA 510(k) submissions for in vitro diagnostic assays. The studies are designed to demonstrate the new device performs comparably to established standards and the predicate device.

Performance Characteristic	Inferred Acceptance Criteria (General)	Reported Device Performance (Albumin BCP2)
Reportable Interval (Range)	Clinically relevant and accurate measurement across a broad range commensurate with predicate/clinical needs.	Analytical Measuring Interval: 0.3 – 9.0 g/dL. Extended Measuring Interval: 9.0 – 22.4 g/dL. Reportable Interval: 0.3 – 22.4 g/dL.
Within-Laboratory Precision	Low Coefficients of Variation (CV%) and Standard Deviations (SD) across different levels, indicating consistent and reproducible results. Specific numeric thresholds would be defined internally by Abbott based on regulatory/clinical expectations (e.g., %CV < 10-15%).	Control Level 1 (3.7 g/dL): SD=0.04 g/dL, %CV=1.1% (Within-Run); SD=0.05 g/dL, %CV=1.4% (Within-Lab).Control Level 2 (2.5 g/dL): SD=0.04 g/dL, %CV=1.6% (Within-Run); SD=0.04 g/dL, %CV=1.6% (Within-Lab).Panel 1 (0.4 g/dL): SD=0.02 g/dL, %CV=5.3% (Within-Run); SD=0.04 g/dL, %CV=10.4% (Within-Lab).Panel 2 (5.3 g/dL): SD=0.05 g/dL, %CV=1.0% (Within-Run); SD=0.05 g/dL, %CV=1.0% (Within-Lab).Panel 3 (8.2 g/dL): SD=0.03 g/dL, %CV=0.3% (Within-Run); SD=0.05 g/dL, %CV=0.7% (Within-Lab).All values consistently meet or exceed typical precision expectations for clinical chemistry assays.
Accuracy (Bias)	Bias relative to a standard reference material should be within an acceptable clinical or analytical range (e.g., ±5% or less). The document states "within ± 2.8%."	Bias was within ± 2.8% relative to ERM-DA470k/IFCC.
Lower Limits of Measurement (LoB, LoD, LoQ)	Low Blank, Detection, and Quantitation limits, indicating sensitivity. Specific numeric values would be internally determined.	LoB = 0.0 g/dL, LoD = 0.3 g/dL, LoQ = 0.3 g/dL.
Linearity	Demonstrated linearity across the stated analytical measuring interval, indicating proportional response over the working range.	Demonstrated linearity across the analytical measuring interval of 0.3 to 9.0 g/dL.
Interference	No significant interference (e.g., within ±10%) from common endogenous substances and exogenous medications at specified concentrations.	No significant interference (within ±10%) observed at specified concentrations of endogenous substances (e.g., bilirubin, hemoglobin, triglycerides) and exogenous substances (various drugs).
Method Comparison	High correlation (e.g., R > 0.95 or 0.98) and acceptable agreement (slope near 1.0, intercept near 0) with the predicate device, demonstrating substantial equivalence.	Correlation Coefficient = 1.00; Intercept = -0.20; Slope = 1.00; Concentration Range = 0.6 - 9.6 g/dL (Serum, n=127).
Tube Type Suitability	Acceptable performance across various specified blood collection tube types.	Deemed acceptable for use with Serum tubes, Serum separator tubes, Dipotassium EDTA tubes, Lithium heparin tubes, Lithium heparin separator tubes, and Sodium heparin tubes.
Dilution Verification	Acceptable agreement between automated and manual dilution methods (e.g., % difference within a specified tolerance like ±5-10%).	% difference values for automated vs. manual dilution ranged from -2.9% to -1.5%, demonstrating acceptable performance.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes test methods rather than specific "test sets" in the context of an AI/ML algorithm that might have a dedicated validation dataset. Instead, for an in-vitro diagnostic device, studies are conducted across various analytical performance characteristics.

Precision Study: "2 controls and 3 human serum panels were tested in duplicate, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations." This means 80 data points for each control/panel (2 tests/day * 20 days * 2 replicates).
Accuracy Study: "2 lots of the Albumin BCP2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument." (No specific sample count for patient samples, but implied to be sufficient for bias estimation against a reference material).
Lower Limits of Measurement: "n ≥ 60 replicates of zero-analyte samples" for LoB, and "n ≥ 60 replicates of low-analyte level samples" for LoD and LoQ.
Linearity: No specific sample size mentioned, but typically involves preparing multiple dilutions.
Interference Study: "Each substance was tested at 2 levels of the analyte (approximately 3.5 g/dL and 5.0 g/dL)."
Method Comparison: 127 serum samples.
Tube Type: "Samples were collected from a minimum of 40 donors".
Dilution Verification: 5 human serum samples prepared by spiking.

Data Provenance: The document doesn't explicitly state the country of origin for the human samples used in the studies. Given that Abbott Ireland Diagnostics Division submitted the application, the studies were likely conducted in a setting compliant with international standards, possibly in Ireland or the US given the FDA submission. The studies described are nonclinical laboratory studies, not human clinical trials. They are retrospective or prospective in the sense of laboratory-controlled experiments designed to evaluate performance characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable as this is an in-vitro diagnostic (IVD) device, specifically a clinical chemistry assay, not an AI/ML diagnostic software. The "ground truth" for an IVD device is established through:

Reference Methods: Using highly accurate and precise laboratory methods (e.g., mass spectrometry, enzymatic methods, or other established validated assays) or certified reference materials (like ERM-DA470k/IFCC for accuracy testing).
Standardization: Traceability to international standards (like IFCC).
Analytical Performance: Rigorous testing against defined analytical parameters (precision, linearity, limits of detection/quantitation).

There is no "ground truth" derived from human expert consensus for this type of device.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1, 3+1) are common in AI/ML studies where human readers are establishing ground truth for image interpretation or similar tasks. For an IVD assay, performance is judged against analytical accuracy and precision, not human consensus on results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. MRMC studies are specific to AI/ML software that assists human readers (e.g., radiologists, pathologists) in interpreting medical images or data. This device is a quantitative laboratory assay. There is no human "reader" assisted by this device in the same way. The device directly measures a biochemical analyte.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This isn't an "algorithm" in the AI/ML sense but rather a chemical assay method run on an automated analyzer. The entire performance data presented (precision, accuracy, linearity, interference, method comparison) represents the "standalone" analytical performance of the assay without human intervention influencing the measurement itself. Human involvement is in the operation of the instrument, quality control, and interpretation of the results, but not in the measurement process being evaluated here.

7. Type of Ground Truth Used:

The ground truth for this chemical assay is primarily established by:

Standard Reference Materials (SRMs): For accuracy, the device's results are compared against ERM-DA470k/IFCC, which are certified reference materials with highly accurate assigned values.
Reference Measurement Procedures: Implied by the use of standard methods and CLSI (Clinical and Laboratory Standards Institute) guidance, which dictates how analytical performance (e.g., LoB, LoD, LoQ, linearity, precision) should be determined using robust statistical methods and replicates.
Predicate Device Comparison: For method comparison, the "ground truth" (or comparative truth) is the performance of the legally marketed predicate device (Albumin BCP) on patient samples.

8. Sample Size for the Training Set:

This concept of a "training set" is specific to AI/ML models. For an IVD assay, calibration and internal method development (which could be analogous to "training") would involve various reagent lots, calibrators, and QC materials provided by the manufacturer. The document does not specify a "training set size" in the AI/ML context because the development of a chemical assay follows different principles.

9. How the Ground Truth for the Training Set Was Established:

Again, this is not applicable in the AI/ML sense. For chemical assays, the establishment of the assay (analogous to "training") involves:

Reagent Formulation and Optimization: Developing the chemical reagents (Bromocresol Purple, buffers, etc.) to ensure proper reaction kinetics, stability, and specificity.
Calibrator Assignment: Assigning accurate values to calibrator materials used by the assay, often traceable to international standards (like ERM-DA470/IFCC).
Method Development on Platform: Optimizing the assay parameters (volumes, incubation times, temperatures, wavelength) on the specific ARCHITECT c System to achieve optimal performance.
Internal Validation: Initial testing during development to ensure the assay performs as expected before formal verification and validation studies are conducted for regulatory submission. This internal validation would use similar principles of analytical testing as described in Section 8 (e.g., accuracy, precision, linearity using reference materials and pooled human samples).

Summary

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March 18, 2022

Abbott Ireland Diagnostics Division Suzanne Cheang Regulatory Affairs Manager Lisnamuck Longford, Ireland

Re: K203530

Trade/Device Name: Albumin BCP2 Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CJW Dated: December 17, 2021 Received: December 20, 2021

Dear Suzanne Cheang:

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. 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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203530

Device Name Albumin BCP2

Indications for Use (Describe)

The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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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Section 5: 510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I. 510(k) Number

K203530

II. Applicant Name

Abbott Ireland Diagnostics Division Lisnamuck, Longford Longford, IE

Primary contact person for all communications:

Suzanne Cheang, Manager, Regulatory Affairs Abbott Diagnostics Division Phone (972) 518-6617 Fax (972) 518-7498

Secondary contact person for all communications:

Magdalena Suszko, Manager, Regulatory Affairs Abbott Diagnostics Division Phone (224) 667-9025 Fax (224) 667-4836

Date Summary Prepared: December 16, 2021

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III. Device Name

Albumin BCP2

Reagents

Trade Name: Albumin BCP2 Device Classification: Class II Classification Name: Albumin test system Governing Regulation Number: 21 CFR 862.1035 Product Code: CJW

IV. Predicate Device

Albumin BCP (K981814)

V. Description of Device

A. Principles of the Procedure

Methodology: Colorimetric (Bromocresol Purple)

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B. Reagents

The various kit configurations of the Albumin BCP2 reagent kits are described below.

	List Number
	04U4520	04U4530
Tests per cartridge	150	550
Number of cartridges per kit	4	4
Tests per kit	600	2200
Reagent 1 (R1)	15.8 mL	49.9 mL

Active ingredient: Bromocresol Purple 0.154 g/L. Inactive ingredients: Reagent 1 sodium hydroxide/acetic acid (pH 5.4) and detergent/surfactant (0.8%). Preservatives: ProClin 300 and ProClin 950.

VI. Intended Use of the Device

The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

VII. Comparison of Technological Characteristics

The Albumin BCP2 assay (subject device) is an automated clinical chemistry assay for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The similarities and differences between the subject device and the predicate device are presented in the following table.

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Characteristics	Subject DeviceAlbumin BCP2 (List No. 04U45)	Predicate DeviceAlbumin BCP (K981814; List No. 7D54)
Intended Useand Indicationsfor Use	The Albumin BCP2 assay is usedfor the quantitation of albumin inhuman serum or plasma on theARCHITECT c System.The Albumin BCP2 assay is to beused as an aid in the diagnosis andinvolving primarily the liver orkidneys.	The Albumin BCP assay is used for thequantitation of albumin in human serum orplasma.
Platform	ARCHITECT c System	Samea
Methodology	Colorimetric (Bromocresol Purple)	Same
Specimen Type	Human serum or plasma	Same
Assay Principle/ Principle ofProcedure	The Albumin BCP2 procedure isbased on the binding ofbromocresol purple specificallywith human albumin to produce acolored complex. The absorbanceof the complex at 604 nm isdirectly proportional to thealbumin concentration in thesample.	Same
Standardization	ERM-DA470/IFCC	Same
Use ofCalibrators	Yes	Same
Use of Controls	Yes	Same
Assay Range	Analytical Measuring Interval:0.3 – 9.0 g/dLExtended Measuring Interval:9.0 – 22.4 g/dLReportable Interval:0.3 – 22.4 g/dL	Measuring Interval: 0.31 to 11.0 g/dL
Characteristics	Subject DeviceAlbumin BCP2 (List No. 04U45)	Predicate DeviceAlbumin BCP (K981814; List No. 7D54)
Precision	Samples with albuminconcentrations between 0.4 and8.2 g/dL were evaluated. Thesamples demonstrated% coefficients of variation(%CV) ≤ 1.7% and standarddeviations (SD) ≤ 0.04 g/dL.	Samples with albumin concentrationsbetween 2.4 and 3.7 g/dL demonstrated%CVs ranging from 1.2% to 1.4%.
Lower Limits ofMeasurement	Limit of Blank: 0.0 g/dLLimit of Detection: 0.3 g/dLLimit of Quantitation: 0.3 g/dL	Limit of Detection: 0.3 g/dLLimit of Quantitation: 0.31 g/dL
Tube Types	Serum:- Serum tubes- Serum separator tubesPlasma:- Dipotassium EDTA tubes- Lithium heparin tubes- Lithium heparin separator tubes- Sodium heparin tubes	Serum:- Glass or plastic tubes with or without gelbarrierPlasma:- Glass or plastic lithium heparin tubes(with or without gel barrier)- Glass or plastic sodium heparin tubes

Comparison of Subject Device (Albumin BCP2) to Predicate Device (Albumin BCP)

ª In accordance with FDA Guidance Document "Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagent for Automated Analyzers", issued June 10, 1996, the assay equivalency study on ARCHITECT c System vs. the original platform, AEROSET, was performed and submitted under K980367/A005 in May 2002.

ERM = European Reference Materials Standard Reference Material

IFCC - International Federation of Clinical Chemistry and Laboratory Medicine

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VIII. Summary of Nonclinical Performance

A. Reportable Interval

Based on the limit of detection (LoD), limit of quantitation (LoQ), precision, and linearity, the ranges over which results can be reported are provided below according to the definitions from Clinical and Laboratory Standards Institute (CLSI) EP34, 1st ed. *

	g/dL
Analytical Measuring Interval (AMI)a	0.3 - 9.0
Extended Measuring Interval (EMI)b	9.0 - 22.4
Reportable Intervalc	0.3 - 22.4

a AMI: The AMI extends from the LoQ to the upper limit of quantitation (ULoQ). This is determined by the range of values in g/dL that demonstrated acceptable performance for linearity, imprecision, and bias.

b The EMI extends from the ULoQ to the ULoQ × dilution factor.

6 The reportable interval extends from the LoD to the upper limit of the EMI.

NOTE: The default Low Linearity value of the assay file corresponds to the lower limit of the Analytical Measuring Interval (AMI), and result values below 0.3 g/dL are reported as "<0.3 g/dL".

Clinical and Laboratory Standards Institute (CLS). Establishing and Verifying an Extended Measuring Interval Through Speciment Dilution and Spiking. 1st ed. CLSI Document EP34. Wayne, PA: CLSI; 2018.

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B. Within-Laboratory Precision

A study was performed based on guidance from CLSI EP05-A3. * Testing was conducted using 3 lots of the Albumin BCP2 reagent, 3 lots of the Consolidated Chemistry Calibrator, 1 lot of commercially available controls, and 3 instruments. Two controls and 3 human serum panels were tested in duplicate, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations, where a unique reagent lot and a unique calibrator lot is paired with 1 instrument. The performance from a representative combination is shown in the following table.

			Within-Run(Repeatability)		Within-Laboratorya
Sample	n	Mean(g/dL)	SD	%CV	SD(Rangeb)	%CV(Rangeb)
Control Level 1	80	3.7	0.04	1.1	0.05(0.05 - 0.05)	1.4(1.3 - 1.4)
Control Level 2	80	2.5	0.04	1.6	0.04(0.04 - 0.04)	1.6(1.4-1.7)
Panel 1	80	0.4	0.02	5.3	0.04(0.02 - 0.04)	10.4(5.5 - 10.4)
Panel 2	80	5.3	0.05	1.0	0.05(0.03 - 0.06)	1.0(0.6-1.0)
Panel 3	80	8.2	0.03	0.3	0.05(0.05 - 0.07)	0.7(0.7 - 0.9)

a Includes within-run, between-run, and between-day variability.

b Minimum and maximum SD or %CV across all reagent lot and instrument combinations.

C. Accuracy

A study was performed to estimate the bias of the Albumin BCP2 assay relative to a standard reference material (ERM - DA470k/IFCC). Testing was conducted using 2 lots of the Albumin BCP2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument. The bias was within ± 2.8%.

" Clinical and Laboratory Standards Institute (CLSI). Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.

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D. Lower Limits of Measurement

A study was performed based on guidance from CLSI EP17-A2. * Testing was conducted using 3 lots of the Albumin BCP2 reagent kit on each of 2 instruments over a minimum of 3 days. The maximum observed limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) values are summarized below.

	g/dL
LoBa	0.0
LoDb	0.3
LoQc	0.3

a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.

b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.

6 The LoQ is defined as the lowest concentration at which a maximum allowable precision of 20% CV was met and was determined from n ≥ 60 replicates of low-analyte level samples.

E. Linearity

A study was performed based on guidance from CLSI EP06-A. $ The assay was demonstrated to be linear across the analytical measuring interval of 0.3 to 9.0 g/dL.

+ Clinical and Laboratory Standards Institute (CLS). Evaluation of Detection Capability for Clinical Laboratory Measurent Procedures; Approved Guideline-Second Edition. CLSI Document EP17-A2. Wayne, PA: CLSI; 2012.

S Clinical and Laboratory Standards Institute (CLS). Evaluation of the Linearity of Quanitiative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI Document EP06-A. Wayne, PA: CLSI; 2003.

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F. Potentially Interfering Endogenous and Exogenous Substances

A study was performed based on guidance from CLSI EP07-A2. ** Each substance was tested at 2 levels of the analyte (approximately 3.5 g/dL and 5.0 g/dL).

No significant interference (interference within ± 10%) was observed at the following concentrations.

Potentially Interfering Endogenous Substances

	Interferent Level
Potentially Interfering Substance	Default Units
Conjugated Bilirubin	60 mg/dL
Unconjugated Bilirubin	60 mg/dL
Hemoglobin	2000 mg/dL
Triglycerides	3025 mg/dL
	Interferent Level
Potentially Interfering Substance	Default Units
Acetaminophen	250 mg/L
Acetylcysteine	1663 mg/L
Acetylsalicylic Acid	1000 mg/L
Aminosalicylic Acid	80 mg/dL
Ampicillin-Na	1000 mg/L
Ascorbic Acid	300 mg/L
Ca-dobesilate	200 mg/L
Cefotaxime	31 mg/dL
Cefoxitin	2500 mg/L
Cyclosporine	5 mg/L
Desacetylcefotaxime	6 mg/dL
Doxycycline	50 mg/L
Ibuprofen	500 mg/L
Levodopa	20 mg/L
Methyldopa	20 mg/L
Metronidazole	200 mg/L
Phenylbutazone	400 mg/L
Rifampicin	60 mg/L
Sodium Heparin	10 U/mL
Theophylline (1,3-dimethylxanthine)	100 mg/L

** Clinical and Laboratory Standards Institute (CLS). Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI Document EP07-A2. Wayne, PA: CLSI; 2005.

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Potentially Interfering Exogenous Substances

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G. Method Comparison

A study was performed based on guidance from CLSI EP09-A3** using the Passing-Bablok regression method.

Albumin BCP2 vs Albumin BCP on the ARCHITECT c System
	n	Units	CorrelationCoefficient	Intercept	Slope	ConcentrationRange
Serum	127	g/dL	1.00	-0.20	1.00	0.6 - 9.6

H. Tube Type

A study was performed to evaluate the suitability of specific blood collection tube types for use with the Albumin BCP2 assay. Samples were collected from a minimum of 40 donors and evaluated across tube types. The following blood collection tube types were determined to be acceptable for use with the Albumin BCP2 assay:

Serum tubes .
Serum separator tubes .
Dipotassium EDTA tubes •
Lithium heparin tubes .
Lithium heparin separator tubes .
Sodium heparin tubes .

** Clinical and Laboratory Standards Institute (CLS). Measurement Procedure Comparison and Bias Patient Samples; Approved Guideline-Third Edition. CLSI Document EP09-A3. Wayne, PA: CLSI; 2013.

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I. Dilution Verification

A study was performed to evaluate the performance of the Albumin BCP2 automated dilution protocol relative to the manual dilution procedure on the ARCHITECT c System. Five human serum samples were prepared by spiking human serum albumin (HSA) stock solution into reagent grade water to obtain the target concentration values of 10.0 g/dL, 12.5 g/dL, 17.5 g/dL, and 20.0 g/dL. Each sample was divided into multiple aliquots. An aliquot of each sample was tested using the 1:2.5 automated dilution protocol on the ARCHITECT c System. The additional aliquots were used to prepare 6 sets of manual dilutions (1:2.5 dilution with saline) of each sample and the manually diluted samples were tested.

The % difference values for the automated dilution protocol versus the manual dilution procedure ranged from of -2.9% to -1.5% and therefore, demonstrated acceptable performance.

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IX. Summary of Clinical Performance

This section does not apply.

X. Conclusion Drawn from Nonclinical Laboratory Studies

The results presented in this 510(k) pre-market notification demonstrate that the performance of the subject device, Albumin BCP2 (List No. 04U45), is substantially equivalent to the predicate device, Albumin BCP (List No. 7D54, K981814).

The similarities and differences between the subject device and predicate device are presented in Section 5-VII.

There is no known potential adverse effect to the operator when using this in vitro device according to the Albumin BCP2 reagent package insert instructions.

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.