(384 days)
Not Found
No
The device is a standard colorimetric in vitro diagnostic assay for measuring albumin concentration. The description focuses on chemical reactions and absorbance measurements, with no mention of AI/ML techniques for data analysis, interpretation, or decision-making. The performance studies are based on traditional analytical validation methods.
No
This device is an in vitro diagnostic assay used for quantitation of albumin in human serum or plasma to aid in diagnosis and treatment of diseases, not to directly treat a disease.
Yes
The device is described as an "aid in the diagnosis and treatment of numerous diseases" and measures biomarkers (albumin concentration) to provide information relevant to diagnoses.
No
The device is an in vitro diagnostic assay that relies on chemical reactions and absorbance measurements performed on a specific hardware system (ARCHITECT c System), not solely on 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." This indicates it's used to analyze biological samples in vitro (outside the body).
- Device Description: The description details a "clinical chemistry assay" that uses a chemical reaction (binding of bromocresol green to albumin) to produce a measurable result (colored complex). This is characteristic of an in vitro diagnostic test.
- Methodology: The methodology is listed as "Colorimetric (Bromocresol Green)," which is a common technique used in clinical chemistry for analyzing samples in a laboratory setting.
- Performance Studies: The performance studies described (precision, accuracy, linearity, interference, method comparison) are all typical evaluations performed on in vitro diagnostic assays to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" with a K number (K981758) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process for medical devices, including IVDs.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
CIX
Device Description
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)
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reportable Interval: Determined by the range of values that demonstrated acceptable performance for linearity, imprecision, and bias. Analytical Measuring Interval (AMI) and Reportable Interval for albumin were found to be 0.3 – 9.4 g/dL.
Within-Laboratory Precision: A study based on CLSI EP05-A3 was performed using 3 lots of reagent, 3 lots of calibrator, 1 lot of controls, and 3 instruments. Two controls and 3 human serum panels were tested in duplicate, twice per day on 20 days.
Results for a representative combination:
- Control Level 1 (mean 4.1 g/dL): SD 0.05, %CV 1.2 (Within-Run); SD 0.06, %CV 1.5 (Within-Laboratory)
- Control Level 2 (mean 2.6 g/dL): SD 0.03, %CV 1.3 (Within-Run); SD 0.04, %CV 1.4 (Within-Laboratory)
- Panel 1 (mean 0.4 g/dL): SD 0.00, %CV 0.0 (Within-Run); SD 0.00, %CV 0.0 (Within-Laboratory)
- Panel 2 (mean 5.7 g/dL): SD 0.06, %CV 1.0 (Within-Run); SD 0.06, %CV 1.0 (Within-Laboratory)
- Panel 3 (mean 9.4 g/dL): SD 0.07, %CV 0.8 (Within-Run); SD 0.07, %CV 0.8 (Within-Laboratory)
Accuracy: A study was performed using 2 reagent lots, 2 calibrator lots, and 1 instrument to estimate bias relative to ERM-DA470k/IFCC. The bias was within ± 2.4%.
Lower Limits of Measurement: A study based on CLSI EP17-A2 was performed using 3 reagent lots on 2 instruments over a minimum of 3 days.
- Limit of Blank (LoB): 0.0 g/dL
- Limit of Detection (LoD): 0.3 g/dL
- Limit of Quantitation (LoQ): 0.3 g/dL
Linearity: A study based on CLSI EP06-A was performed. The assay was demonstrated to be linear across the analytical measuring interval of 0.3 to 9.4 g/dL.
Potentially Interfering Endogenous and Exogenous Substances: A study based on CLSI EP07-A2 was performed. No significant interference (within ± 10%, based on 95% confidence intervals) was observed at specified concentrations for various endogenous substances (e.g., Bilirubin, Hemoglobin, Triglycerides) and exogenous substances (e.g., Acetaminophen, Ibuprofen, Penicillin, Sodium Heparin).
Method Comparison: A study based on CLSI EP09-A3 using the Passing-Bablok regression method compared the Albumin BCG2 assay to the Albumin BCG assay (List Number 7D53) on the ARCHITECT c System.
- Sample size: 128 serum samples
- Units: g/dL
- Correlation Coefficient: 1.00
- Intercept: 0.03
- Slope: 1.03
- Concentration Range: 0.4 - 8.1 g/dL
Tube Type: A study was performed using samples from a minimum of 40 donors. The following tube types were determined acceptable: Serum tubes, Serum separator tubes, Dipotassium EDTA tubes, Lithium heparin tubes, Lithium heparin separator tubes, Sodium heparin tubes.
Conclusion: The performance of the subject device, Albumin BCG2, is substantially equivalent to the predicate device, Albumin BCG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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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) | ☑ |
|---|---|
| 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: November 15, 2021
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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.
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| Characteristics | Subject Device
Albumin BCG2 (List No. 04T34) | Predicate Device
Albumin BCG (K981758; List No. 7D53) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | ARCHITECT c System | Same |
| Intended Use
and Indications
for 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. | The Albumin BCG assay is used for the
quantitation of albumin in human serum or
plasma. |
| Methodology | Colorimetric (Bromocresol Green) | Same |
| Specimen Type | Human serum or plasma | Same |
| Assay Principle
/ Principle of
Procedure | 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. | The Albumin BCG procedure is based on
the binding of bromocresol green
specifically with albumin to produce a
colored complex. The absorbance of the
complex at 628 nm is directly proportional
to the albumin concentration in the sample. |
| Standardization | ERM-DA470/IFCC | Same |
| Use of
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
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| Characteristics | Subject Device
Albumin BCG2 (List No. 04T34) | Predicate Device
Albumin BCG (K981758; List No. 7D53) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Range | Analytical Measuring Interval:
0.3 – 9.4 g/dL
Reportable Interval: 0.3 – 9.4 g/dL | Measuring Interval: 0.4 – 10.5 g/dL |
| Precision | Samples with albumin
concentrations between 0.4 g/dL
and 9.4 g/dL demonstrated
standard deviations ranging from
0.00 g/dL to 0.07 g/dL and
% Coefficient of Variation (%CV)
values ranging from 0.0% to 1.9%. | Samples with albumin concentrations
between 2.7 g/dL and 4.1 g/dL
demonstrated %CV values ranging from
1.4% to 1.5% |
| 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 BCG2 to Predicate Device Albumin BCG (Continued)
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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 – 9.4 |
| 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.
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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 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
(Repeatability) | | Within-Laboratorya | |
|-----------------|----|----------------|-------------------------------|-----|-----------------------|--------------------|
| Sample | n | Mean
(g/dL) | SD | %CV | SD
(Rangeb) | %CV
(Rangeb) |
| Control Level 1 | 80 | 4.1 | 0.05 | 1.2 | 0.06
(0.05 - 0.06) | 1.5
(1.3 - 1.6) |
| Control Level 2 | 80 | 2.6 | 0.03 | 1.3 | 0.04
(0.04 - 0.05) | 1.4
(1.4-1.9) |
| Panel 1 | 80 | 0.4 | 0.00 | 0.0 | 0.00
(0.00 - 0.00) | 0.0
(0.0-0.0) |
| Panel 2 | 80 | 5.7 | 0.06 | 1.0 | 0.06
(0.05 - 0.06) | 1.0
(0.9 - 1.0) |
| Panel 3 | 80 | 9.4 | 0.07 | 0.8 | 0.07
(0.06-0.07) | 0.8
(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.
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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.
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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).
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.
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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 | ||||
| Coefficient | Intercept | Slope | Concentration | |||
| 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.
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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
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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) 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.