Albumin BCG2

K203248 · Abbott Ireland Diagnostics Division · CIX · Nov 23, 2021 · Clinical Chemistry

Device Facts

• Record ID: K203248
• Device Name: Albumin BCG2
• Applicant: Abbott Ireland Diagnostics Division
• Product Code: CIX · Clinical Chemistry
• Decision Date: Nov 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System. The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Story

Automated, colorimetric clinical chemistry assay for human serum or plasma; utilizes bromocresol green reagent (R1) to bind albumin; forms colored complex measured via absorbance at 604 nm; absorbance directly proportional to albumin concentration. Used on ARCHITECT c8000 system in clinical laboratory settings; operated by trained laboratory personnel. Output provides quantitative albumin concentration (g/dL) to assist healthcare providers in diagnosing and monitoring liver or kidney disease; facilitates clinical decision-making regarding patient treatment plans.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A3 (n=80 per sample). Linearity confirmed across 0.3–9.4 g/dL. Interference testing performed per CLSI EP07-A2 for 24 substances. Method comparison against predicate (n=128) showed Passing-Bablok slope 1.03, intercept 0.03, r=1.00. Matrix comparison validated serum and various plasma types (K2EDTA, lithium/sodium heparin). No clinical studies performed.

Technological Characteristics

Colorimetric assay; active ingredient bromocresol green (0.320 g/L) in sodium hydroxide/succinic acid buffer (pH 4.2). Automated system (ARCHITECT c8000). Traceable to ERM-DA470/IFCC. Analytical measuring interval 0.3–9.4 g/dL. Preservative: ProClin 300. Standards: CLSI EP05-A3, EP17-A2, EP07-A2.

Indications for Use

Indicated for the quantitative measurement of albumin in human serum or plasma to aid in the diagnosis and treatment of liver or kidney diseases.

Regulatory Classification

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.

Predicate Devices

• Albumin BCG (k981758)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

November 23, 2021

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

Re: K203248

Trade/Device Name: Albumin BCG2 Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CIX Dated: August 30, 2021 Received: August 31, 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.

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

{1}------------------------------------------------

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K203248

Device Name Albumin BCG2

Indications for Use (Describe)

The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCG2 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) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| 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."

EF

{3}------------------------------------------------

### 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

k203248

## 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 [phone] Fax [phone]

Secondary contact person for all communications:

Magdalena Suszko, Manager, Regulatory Affairs Abbott Diagnostics Division Phone [phone] Fax [phone]

Date Summary Prepared: November 15, 2021

{4}------------------------------------------------

#### III. Device Name

Albumin BCG2

Reagents

Trade Name: Albumin BCG2 Device Classification: Class II Classification Name: Albumin test system Governing Regulation Number: 21 CFR 862.1035 Product Code: CIX

## IV. Predicate Device

Albumin BCG (k981758)

## V. Description of Device

## A. Principles of the Procedure

The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample 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 Green)

{5}------------------------------------------------

## B. Reagents

The configurations of the Albumin BCG2 reagent kit are described below.

| | List Number | |
|------------------------------|-------------|---------|
| | 04T3420 | 04T3430 |
| Tests per cartridge | 261 | 1000 |
| Number of cartridges per kit | 4 | 4 |
| Tests per kit | 1044 | 4000 |
| Reagent 1 (R1) | 25.5 mL | 86.0 mL |

Reagent 1 Active ingredient: bromocresol green 0.320 g/L. Inactive ingredients: Sodium hydroxide/succinic acid buffer (pH 4.2) and detergents/surfactants (1.6%). Preservative: ProClin 300.

## VI. Intended Use of the Device

The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCG2 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 BCG2 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.

{6}------------------------------------------------

| Characteristics | Subject Device<br>Albumin BCG2 (List No. 04T34) | Predicate Device<br>Albumin BCG (k981758; List No. 7D53) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | ARCHITECT c System | Same |
| Intended Use<br>and Indications<br>for Use | The Albumin BCG2 assay is used<br>for the quantitation of albumin in<br>human serum or plasma on the<br>ARCHITECT c System.<br>The Albumin BCG2 assay is to be<br>used as an aid in the diagnosis and<br>treatment of numerous diseases<br>involving primarily the liver or<br>kidneys. | The Albumin BCG assay is used for the<br>quantitation of albumin in human serum or<br>plasma. |
| Methodology | Colorimetric (Bromocresol Green) | Same |
| Specimen Type | Human serum or plasma | Same |
| Assay Principle<br>/ Principle of<br>Procedure | The Albumin BCG2 procedure is<br>based on the binding of<br>bromocresol green in the assay<br>reagent specifically with albumin<br>in the patient sample to produce a<br>colored complex. The absorbance<br>of the complex at 604 nm is<br>directly proportional to the<br>albumin concentration in the<br>sample. | The Albumin BCG procedure is based on<br>the binding of bromocresol green<br>specifically with albumin to produce a<br>colored complex. The absorbance of the<br>complex at 628 nm is directly proportional<br>to the albumin concentration in the sample. |
| Standardization | ERM-DA470/IFCC | Same |
| Use of<br>Calibrators | Yes | Same |
| Use of Controls | Yes | Same |

Comparison of Subject Device Albumin BCG2 to Predicate Device Albumin BCG

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/A004 in May 2002.

ERM = European Reference Materials Standard Reference Material

IFCC - International Federation of Clinical Chemistry and Laboratory Medicine

{7}------------------------------------------------

| Characteristics | Subject Device<br>Albumin BCG2 (List No. 04T34) | Predicate Device<br>Albumin BCG (k981758; List No. 7D53) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Range | Analytical Measuring Interval:<br>0.3 – 9.4 g/dL<br>Reportable Interval: 0.3 – 9.4 g/dL | Measuring Interval: 0.4 – 10.5 g/dL |
| Precision | Samples with albumin<br>concentrations between 0.4 g/dL<br>and 9.4 g/dL demonstrated<br>standard deviations ranging from<br>0.00 g/dL to 0.07 g/dL and<br>% Coefficient of Variation (%CV)<br>values ranging from 0.0% to 1.9%. | Samples with albumin concentrations<br>between 2.7 g/dL and 4.1 g/dL<br>demonstrated %CV values ranging from<br>1.4% to 1.5% |
| Lower Limits of<br>Measurement | Limit of Blank: 0.0 g/dL<br>Limit of Detection: 0.3 g/dL<br>Limit of Quantitation: 0.3 g/dL | Limit of Detection: 0.3 g/dL<br>Limit of Quantitation: 0.31 g/dL |
| Tube Types | Serum:<br>- Serum tubes<br>- Serum separator tubes<br><br>Plasma:<br>- Dipotassium EDTA tubes<br>- Lithium heparin tubes<br>- Lithium heparin separator tubes<br>- Sodium heparin tubes | Serum:<br>- Glass or plastic tubes with or without gel<br>barrier<br><br>Plasma:<br>- Glass or plastic lithium heparin tubes<br>(with or without gel barrier)<br>- Glass or plastic sodium heparin tubes |

Comparison of Subject Device Albumin BCG2 to Predicate Device Albumin BCG (Continued)

{8}------------------------------------------------

## 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 – 9.4 |
| Reportable Intervalb | 0.3 – 9.4 |

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 reportable interval extends from the LoD to the upper limit of the AMI.

NOTE: The default Low Linearity value of the assay file corresponds to the Analytical Measuring Interval (AMI).

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

{9}------------------------------------------------

## B. Within-Laboratory Precision

A study was performed based on guidance from CLSI EP05-A3. Testing was conducted using 3 lots of the Albumin BCG2 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<br>(Repeatability) | | Within-Laboratorya | |
|-----------------|----|----------------|-------------------------------|-----|-----------------------|--------------------|
| Sample | n | Mean<br>(g/dL) | SD | %CV | SD<br>(Rangeb) | %CV<br>(Rangeb) |
| Control Level 1 | 80 | 4.1 | 0.05 | 1.2 | 0.06<br>(0.05 - 0.06) | 1.5<br>(1.3 - 1.6) |
| Control Level 2 | 80 | 2.6 | 0.03 | 1.3 | 0.04<br>(0.04 - 0.05) | 1.4<br>(1.4-1.9) |
| Panel 1 | 80 | 0.4 | 0.00 | 0.0 | 0.00<br>(0.00 - 0.00) | 0.0<br>(0.0-0.0) |
| Panel 2 | 80 | 5.7 | 0.06 | 1.0 | 0.06<br>(0.05 - 0.06) | 1.0<br>(0.9 - 1.0) |
| Panel 3 | 80 | 9.4 | 0.07 | 0.8 | 0.07<br>(0.06-0.07) | 0.8<br>(0.7 - 0.8) |

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

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

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

{10}------------------------------------------------

## C. Accuracy

A study was performed to estimate the bias of the Albumin BCG2 assay relative to a standard reference material European Reference Materials Standard Reference Material - DA470k/ International Federation of Clinical Chemistry and Laboratory Medicine [ERM - DA470k/IFCC]). Testing was conducted using 2 lots of the Albumin BCG2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument. The bias was within ± 2.4%.

## 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 BCG2 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 |

4 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.

C 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. Linearitv

A study was performed based on guidance from CLSI EP06-A. 1 The assay was demonstrated to be linear across the analytical measuring interval of 0.3 to 9.4 g/dL.

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

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

{11}------------------------------------------------

## 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).

## Potentially Interfering Endogenous Substances

# No significant interference (interference within ± 10%, based on 95% confidence

intervals) was observed at the following concentrations.

| Potentially Interfering Substance | Interferent Level |
|-------------------------------------|-------------------|
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Hemoglobin | 750 mg/dL |
| Triglycerides | 3000 mg/dL |
| Potentially Interfering Substance | Interferent Level |
| 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 |
| Calcium 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 |
| Penicillin | 18,000 mg/L |
| Phenylbutazone | 400 mg/L |
| Rifampicin | 60 mg/L |
| Sodium Heparin | 10 U/mL |
| Theophylline (1,3-dimethylxanthine) | 100 mg/L |

^* CLSI Document EP07-A2. Wayne, PA: CLSI; 2005.

{12}------------------------------------------------

## Potentially Interfering Exogenous Substances

## No significant interference (interference within ± 10%, based on 95% confidence

intervals) was observed at the following concentrations.

{13}------------------------------------------------

## G. Method Comparison

A study was performed based on guidance from CLSI EP09-A3* using the Passing-Bablok regression method. The study compared the Albumin BCG2 assay to the Albumin BCG assay (List Number 7D53).

| Albumin BCG2 vs Albumin BCG on the ARCHITECT c System | | | | | | |
|-------------------------------------------------------|-----|-------|----------------------------|-----------|-------|------------------------|
| | n | Units | Correlation<br>Coefficient | Intercept | Slope | Concentration<br>Range |
| Serum | 128 | g/dL | 1.00 | 0.03 | 1.03 | 0.4 - 8.1 |

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

{14}------------------------------------------------

## H. Tube Type

A study was performed to evaluate the suitability of specific blood collection tube types for use with the Albumin BCG2 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 BCG2 assay:

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

{15}------------------------------------------------

## IX. Summary of Clinical Performance

This section does not apply.

## X. Conclusion Drawn from Nonclinical Laboratory Studies

The results presented in this 510(k) premarket notification demonstrate that the performance of the subject device, Albumin BCG2 (List No. 04T34), is substantially equivalent to the predicate device, Albumin BCG (List No. 7D53, k981758).

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 BCG2 reagent package insert instructions.