(471 days)
Not Found
No
The device description and performance studies focus on a standard colorimetric chemical assay, with no mention of AI or ML techniques.
No.
The device is an in vitro diagnostic assay used to quantitate albumin levels, which serves as an aid in diagnosis and treatment, but it does not directly deliver a therapeutic effect to a patient.
Yes
The "Intended Use / Indications for Use" section states: "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." This directly indicates its diagnostic purpose.
No
The device is an in vitro diagnostic assay that relies on chemical reactions and absorbance measurements performed on a physical instrument (ARCHITECT c System) to determine albumin concentration. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitation of albumin in human serum or plasma" and is used "as an aid in the diagnosis and treatment of numerous diseases." This clearly indicates it's used to test samples taken from the human body to provide information for medical diagnosis.
- Device Description: The description details a "clinical chemistry assay" that analyzes a biological sample (serum or plasma) using a chemical reaction (binding of bromocresol purple) to produce a result (absorbance at 604 nm) that is proportional to the analyte concentration. This is a hallmark of an in vitro diagnostic test.
- Input Imaging Modality and Anatomical Site: The "Not Applicable (In vitro diagnostic assay)" entries for these sections further confirm its nature as an IVD, as it doesn't involve imaging or direct interaction with an anatomical site.
- Performance Studies: The detailed performance studies (precision, accuracy, lower limits, linearity, interference, method comparison, tube type, dilution) are typical evaluations performed for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K981814) and name ("Albumin BCP") is a strong indicator that this device is being submitted for regulatory clearance as an IVD, often compared to a previously cleared IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
CJW
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
c 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 "
§ 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.
0
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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
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
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)
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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 Device
Albumin BCP2 (List No. 04U45) | Predicate Device
Albumin BCP (K981814; List No. 7D54) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
and Indications
for Use | 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 andinvolving primarily the liver or
kidneys. | The Albumin BCP assay is used for the
quantitation of albumin in human serum or
plasma. |
| Platform | ARCHITECT c System | Samea |
| Methodology | Colorimetric (Bromocresol Purple) | Same |
| Specimen Type | Human serum or plasma | Same |
| Assay Principle
/ Principle of
Procedure | 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. | Same |
| Standardization | ERM-DA470/IFCC | Same |
| Use of
Calibrators | Yes | Same |
| Use of Controls | Yes | Same |
| Assay Range | 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 | Measuring Interval: 0.31 to 11.0 g/dL |
| Characteristics | Subject Device
Albumin BCP2 (List No. 04U45) | Predicate Device
Albumin BCP (K981814; List No. 7D54) |
| Precision | Samples with albumin
concentrations between 0.4 and
8.2 g/dL were evaluated. The
samples demonstrated
% coefficients of variation
(%CV) ≤ 1.7% and standard
deviations (SD) ≤ 0.04 g/dL. | Samples with albumin concentrations
between 2.4 and 3.7 g/dL demonstrated
%CVs ranging from 1.2% to 1.4%. |
| Lower Limits of
Measurement | Limit of Blank: 0.0 g/dL
Limit of Detection: 0.3 g/dL
Limit of Quantitation: 0.3 g/dL | Limit of Detection: 0.3 g/dL
Limit of Quantitation: 0.31 g/dL |
| Tube Types | Serum:
- Serum tubes
- Serum separator tubes
Plasma:
- Dipotassium EDTA tubes
- Lithium heparin tubes
- Lithium heparin separator tubes
- Sodium heparin tubes | Serum:
- Glass or plastic tubes with or without gel
barrier
Plasma:
- 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 "" 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 | Correlation | ||||
| Coefficient | Intercept | Slope | Concentration | |||
| Range | ||||||
| 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.