(52 days)
The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The assay is intended for professional use only.
For In Vitro Diagnostic use only.
Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.
Here's the breakdown of the acceptance criteria and study information for the Albumin BCP device, based on the provided text:
Acceptance Criteria and Device Performance
| Study | Acceptance Criteria (Required Performance) | Reported Device Performance (Achieved) |
|---|---|---|
| Limit of Blank (LoB) | ≤ 1 g/L | 0.3 g/L (highest observed) |
| Limit of Detection (LoD) | ≤ 3 g/L | 0.8 g/L (highest observed) |
| Limit of Quantitation (LoQ) | ≤ 5 g/L | 1.5 g/L (claimed) |
| Precision | ≤ 2.5% CV (across all tested concentrations) | Highest %CV: 2.2% |
| Intra Assay Precision | ≤ 1.5% CV (across all tested concentrations) | All samples gave %CV lower than 1.5% (e.g., 0.40% to 0.95%) |
| Linearity (Measuring Range) | Absolute bias: - 2 g/L to + 2 g/L OR Relative bias: -6% to + 6% | Linear up to 70 g/L (e.g., y = 0.00 + 1.000x, r = 0.999) |
| Endogenous Interferences | % bias: ±10% for Hemoglobin (2000 mg/dL), Unconjugated bilirubin (66 mg/dL), Conjugated bilirubin (66 mg/dL), Lipids (as Triglycerides) (2000 mg/dL) | Met acceptance criteria for all tested substances at specified concentrations (Lipids up to 1200 mg/dL) |
| Reagent Stability | % Bias: within ± 10% vs initial measurement | Min %bias: -1.3%, Max %bias: 10.0% |
| Method Comparison | Regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975 | Passing & Bablok: y = 0.94x + 1.01, r = 0.992; Linear fit: y = 0.95x + 0.78, r = 0.992 |
| Matrix Comparison (Serum vs. Lithium-Heparin plasma) | Regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975 | Passing & Bablok: y = 1.01x - 0.34, r = 0.995; Linear fit: y = 1.00x + 0.01, r = 0.995 |
| Matrix Comparison (Serum vs. Potassium EDTA plasma) | Regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975 | Passing & Bablok: y = 1.00x - 0.20, r = 0.996; Linear fit: y = 0.995x - 0.05, r = 0.996 |
Note regarding "Test Set" and "Training Set" terminology: For in vitro diagnostic assays measuring specific analytes, the concepts of "test set" and "training set" (as typically used in machine learning or image analysis) are not directly applicable in the same way. Instead, performance studies use different sample types (e.g., control materials, patient samples, spiked samples) to validate the analytical performance characteristics. The following answers reflect this distinction.
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Limit of Blank (LoB): Not explicitly stated, but performed with three different reagent lots (F0390, F0391, F0480) and one calibrator lot (E0179). LoB is typically determined using replicate measurements of blank samples.
- Limit of Detection (LoD): Not explicitly stated, but inferred to be similar to LoB determination as it also uses reagent and calibrator lots.
- Limit of Quantitation (LoQ): Not explicitly stated, inferred to be similar to LoB/LoD determination.
- Precision Study: 80 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (26.26-26.62 g/L, 40.53-40.67 g/L, 49.96-50.47 g/L) using human serum. An additional lot (90228) used 88 replicates per level (19.10 g/L, 40.18 g/L, 51.33 g/L).
- Intra Assay Precision Study: 20 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (21.4-21.5 g/L, 35.6-35.8 g/L, 50.2-50.3 g/L) using human serum.
- Linearity (Measuring Range): Three different reagent lots (F0390, F0391, F0480) were tested across specified ranges (e.g., 4.17 to 78.30 g/L). Number of distinct samples within these ranges not explicitly stated.
- Endogenous Interferences Study: "2 aliquots of serum pool were prepared (Base and Test pool)" for two albumin concentrations (~35 g/L and ~50 g/L), with the test pool divided into 4 sub-aliquots and diluted. Specific number of interference samples not stated, but covered a range of dilution levels (100% down to 0%).
- Reagent Stability: Four different lots (F0390, F0391, F0480, 90228) were evaluated across three different concentration levels.
- Method Comparison: 128 serum samples, including 8 altered samples, covering the measuring interval 6.0 - 70 g/L.
- Matrix Comparison: 77 paired plasma/serum samples, including 7 altered samples, covering the assay's range, for both Lithium-Heparin plasma and Potassium EDTA plasma.
Data Provenance: The studies used human serum and plasma samples. The document does not explicitly state the country of origin of the data or whether the samples were collected retrospectively or prospectively. Given the context of a medical device submission, these would typically be from clinical laboratory settings.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is an in vitro diagnostic (IVD) assay for measuring a biochemical analyte (albumin). The "ground truth" for such assays is established by the reference methods or highly characterized materials used to calibrate and validate the assay. It does not involve human experts interpreting images or diagnosing conditions, but rather relies on established analytical standards and predicate devices.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts might arise. For quantitative IVD assays, performance is assessed against defined analytical criteria and reference values.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance studies described are for the standalone functioning of the Albumin BCP assay on the AU680 Automatic Analyzer. This is inherent to the nature of an in vitro diagnostic test, where the device performs the measurement independently.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this IVD device is established through:
- Reference materials and calibrators: Used to ensure accuracy and traceability of measurements (e.g., ERM-DA 470k/IFCC for standardization).
- Predicate device measurements: The method comparison study used a legally marketed predicate device (Siemens ADVIA 2400, ADVIA® Chemistry Albumin BCP assay) as a comparative standard.
- Analytical standards: Performance is measured against accepted analytical performance guidelines (e.g., CLSI documents EP17-A2, EP05-A3, EP15-A3, EP6-A, EP07-A2, EP09-A3) which define acceptable limits for various performance characteristics.
- Known concentrations: For studies like LoB, LoD, LoQ, Precision, and Intra-Assay Precision, samples with known or characterized concentrations (e.g., control materials, spiked samples, serum pools) are used to assess the device's accuracy and reproducibility.
-
The sample size for the training set:
Not applicable in the machine learning sense. The device is a chemical assay, not an algorithm trained on a dataset. Its analytical characteristics are inherently designed and validated through laboratory studies.
-
How the ground truth for the training set was established:
Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning. The analytical methods and performance targets are established through scientific principles of chemistry and validated using established laboratory practices and reference standards.
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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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2019
Sentinel CH. SpA Patricia Dupe Head of Quality System Via Robert Koch, 2 Milano, IT 20152
Re: K193001
Trade/Device Name: Albumin BCP Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CJW Dated: October 23, 2019 Received: October 28, 2019
Dear Patricia Dupe:
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
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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. Acting Deputy Director Division of Chemistry and Toxicology Devices | OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193001
Device Name Albumin BCP
Indications for Use (Describe)
The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The assay is intended for professional use only.
For In Vitro Diagnostic use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY (SUMMARY OF SAFETY AND EFFECTIVENESS) ട്.
for the Albumin BCP (6x20mL), Albumin BCP (6x50 mL)
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.
5.1. 510 (k) Number: K193001
5.2. Applicant Name
SENTINEL CH. S.p.A. Via Robert Koch, 2 Milano (MI) 20152, Italy +39 02 345 514 1
Primary contact person for all communications:
Patricia Dupé Head of Quality System Phone: +39 02 34 551 496 Fax: +39 02 34 551 464 Email: patriciadupe@sentinel.it
Date Summary Prepared: October 23th, 2019
Date Summary Revised: December 13th, 2019
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5.3. Device Name
Albumin BCP
Device Classification: Class II Classification Name: Bromcresol purple dye-binding, albumin Governing Regulation: 21CFR862.1035 Product Code: CJW Panel: Clinical Chemistry (75)
5.4. Predicate Device
ADVIA Chemistry BCP assay (ALBP) (K132664)
5.5. Intended Use of the Device
The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma.
Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The assay is intended for professional use only. For In Vitro Diagnostic use only.
5.6. Description of Device
Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.
| Test per kit calculation (based on the minimumreagent fill volume) | |
|---|---|
| Albumin BCP (6x20 mL) | 2700 |
| Albumin BCP (6x50 mL) | 6000 |
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| Reactive Ingredients | Concentration |
|---|---|
| Acetate Buffer | 6.8 % |
| Stabilizer | 4.38 % |
| Bromcresol purple | 0.028 % |
| Detergent | 0.045 % |
| Sodium azide | <0.1 %. |
5.7. Principles of the Procedure
Albumin at pH 5.0 – 5.5 reacts with bromocresol purple (BCP) forming a colored complex. The color intensity of this complex is proportional to the concentration of albumin present in the sample measurement as an endpoint reaction at 600/700 nm. Methodology: Colorimetric
5.8. Comparison of Technological Characteristics
The Albumin BCP assay is intended for the quantitative measurement of albumin in human serum and plasma.
For In Vitro Diagnostic use only.
A comparison of the candidate device (Albumin BCP) and the predicate device [ADVIA Chemistry BCP assay (ALBP)] is presented in Table 5.1
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| Predicate Assay (K132664) | ||
|---|---|---|
| Characteristics | ADVIA Chemistry Albumin BCP assay (ALBP) | Candidate AssayAlbumin BCP |
| Technical Characteristics | ||
| Classification | Regulation name: Albumin BCP assay | Same |
| Method Principle | Bromcresol purple (BCP) dye-binding method | Same |
| IntendedUse/Indicationsfor Use | For in Vitro diagnostic use in the quantitativemeasurement of albumin in human serum or plasma onADVIA Chemistry Systems.Albumin measurements are used in the diagnosis andtreatment of numerous diseases primarily involving theliver or kidneys | The Albumin BCP assay is an in vitro diagnostic test usedfor the determination of albumin in human serum or plasma.Albumin measurements are used in the diagnosis andtreatment of numerous diseases primarily involving theliver or kidneys.The assay is intended for professional use only.For In Vitro Diagnostic use only. |
| Analyte Measured | Albumin | Same |
| Instrument to beused | Advia 1650 Chemistry System | AU680 Automatic Analyzer |
| Measurement | quantitative | Same |
| Specimen type | Serum, plasma | Same |
| Reference Value | 34 - 50 g/L | 35 - 52 g/L |
| Reagents | Single reagent | Same |
| Format | Liquid | Same |
| Analyticalmeasuringinterval | 6.0 - 80 g/L | 6.0 - 70 g/L |
| Standardization | ERM-DA 470k Reference Material | Same (ERM-DA 470k/IFCC) |
| Predicate Assay (K132664) | ||
| Characteristics | ADVIA Chemistry Albumin BCP assay (ALBP) | Candidate AssayAlbumin BCP |
| Performance Characteristics | ||
| Reagent storagetemperature | 2-8 °C | 15-30 °C |
| Use of Calibrators | Yes | Same |
| Use of Controls | Yes | Same |
Table 5.1: Comparison of Albumin BCP to Predicate (K132664) ADVIA Chemistry Albumin BCP assay (ALBP)
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5.9. Summary of Performance Testing
All performance were established using the AU680 analyzer.
5.9.1. Limit of Blank (LoB) Study
The Limit of Blank (LoB) Study was performed to determine the highest measurement result that is likely to be observed (with a stated probability) for a blank sample.
The LoB, study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2.
Acceptance criteria: the Limit of Blank (LoB) should be ≤ 1 g/L
A summary of the results is presented below:
| Reagent | Calibrator | Limit ofBlank (LoB)g/L | Acceptancecriteriag/L |
|---|---|---|---|
| Lot F0390 | 0.2 | ||
| Lot F0391 | Lot E0179 | 0.3 | $ \leq 1 $ g/L |
| Lot F0480 | 0.3 |
The observed Limit of Blank supports the LoB claim of 0.3 g/L.
Limit of Detection (LoD) Study 5.9.2.
LoD is the lowest analyte concentration likely to be reliably distinguished from the LoB and at which detection is feasible.
The Limit of Detection (LoD) was determined on the basis of CLSI EP17-A2 Guideline (Evaluation of detection capability for clinical laboratory measurement procedures).
Acceptance criteria: the Limit of Detection (LoD) should be ≤ 3 g/L. A summary of the results is presented below:
| Reagent | Calibrator | Limit ofDetection(LoD)g/L | Acceptancecriteriag/L |
|---|---|---|---|
| Lot F0390 | 0.6 | ||
| Lot F0391 | Lot E0179 | 0.8 | ≤ 3.0 g/L |
| Lot F0480 | 0.8 |
The results meet the acceptance criteria. The Limit of Detection is chosen to be the highest of the values obtained. The LoD observed supports the claim of 0.8 g/L.
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Limit of Quantitation (LoQ) Study 5.9.3.
LoQ is the lowest amount of a measured in a material that can be quantitatively determined with stated accuracy (as total error or as independent for bias and precision), under stated experimental conditions.
The results of the LoQ study are provided for completeness in conjunction with the LoB and LoD studies.
The LoQ, study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2.
Acceptance criteria: the Limit of Quantitation (LoQ) should be ≤ 5 g/L
A summary of the results is presented below:
| Reagent | Calibrator | Limit ofQuantification(LoQ)g/L | Acceptancecriteriag/L |
|---|---|---|---|
| Lot F0390 | 1.3 | ||
| Lot F0391 | Lot E0179 | 1.3 | ≤ 5.0 g/L |
| Lot F0480 | 1.3 |
The results meet the acceptance criteria. The LoQ observed supports the claim of 1.5 g/L.
5.9.4. Precision Study
The Precision study verifies the agreement between indications or measured quantity values obtained by replicates measurements on the same or similar objects under specified conditions. One human serum sample pool and two human serum based controls were used. After calibration at Time zero (0), 2 replicates of each sample were performed on 2 different runs per day. The precision was determined on the basis of CLSI EP05-A3 Guideline (Evaluation of Precision of Quantitative Measurement Procedures).
Acceptance Criteria: The Precision should be ≤ 2.5% across all tested concentrations
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| Reagent | Material | N | Concentration | Total | Acceptance |
|---|---|---|---|---|---|
| g/L | %CV | criteria | |||
| Lot | Level 1 | 80 | 26.26 | 2.2% | |
| F0390 | Level 2 | 80 | 40.53 | 2.0% | |
| Level 3 | 80 | 49.96 | 1.8% | ||
| LotF0391 | Level 1 | 80 | 26.50 | 2.1% | |
| Level 2 | 80 | 40.64 | 1.8% | ||
| Level 3 | 80 | 50.30 | 1.9% | < 2.5% | |
| LotF0480 | Level 1 | 80 | 26.62 | 2.2% | |
| Level 2 | 80 | 40.67 | 2.1% | ||
| Level 3 | 80 | 50.47 | 1.6% | ||
| Lot 90228 | Level 1 | 88 | 19.10 | 1.9% | |
| Level 2 | 88 | 40.18 | 1.2% | ||
| Level 3 | 88 | 51.33 | 1.3% |
A summary of the results is presented below:
All calculated CV's were well within the acceptance criteria of ≤ 2.5%. The highest %CV was 2.2%. The data show good precision across the concentration range from 18 to 55 g/L.
5.9.5 Intra Assay Precision Study
The Intra Assay Precision Study was performed to verify the precision and the trueness of the method relative to the assigned values of materials with known concentrations.
One human serum sample pool and two human serum based controls were used. After calibration, 20 replicates of each sample were run on 3 different runs (each run with a new calibration).
The Intra Assay Precision was determined on the basis of CLSI EP15-A3 Guideline (User Verification of Precision and Estimation of Bias).
Acceptance Criteria:
The Intra Assay Precision should be ≤ 1.5 % across all tested concentrations
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| Reagent | Material | Concentration | Total | SD | Acceptance criteria |
|---|---|---|---|---|---|
| g/L | %CV | g/L | % CV | ||
| Lot F0390 | Level 1 | 21.4 | 0.75% | 0.2 | $ \u2264 $ 1.5% |
| Level 2 | 35.7 | 0.79% | 0.3 | ||
| Level 3 | 50.2 | 0.40% | 0.2 | ||
| Lot F0391 | Level 1 | 21.5 | 0.74% | 0.2 | |
| Level 2 | 35.8 | 0.61% | 0.2 | ||
| Level 3 | 50.3 | 0.49% | 0.2 | ||
| Lot F0480 | Level 1 | 21.5 | 0.95% | 0.2 | |
| Level 2 | 35.6 | 0.74% | 0.3 | ||
| Level 3 | 50.3 | 0.44% | 0.2 |
A summary of the results is presented below:
The results meet the acceptance criteria. All the samples gave %CV lower than 1.5%
5.9.6. Linearity (Measuring Range)
The Study was performed to establish the Upper Limit of Measuring Range (MR) based upon the linearity of the Albumin BCP assay on the AU680 System.
Linearity was evaluated using guideline CLSI EP6-A Guideline (Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach).
Acceptance Criteria: the absolute bias should be between - 2 g/L and + 2 g/L or The relative bias should be between -6% and + 6%
A summary of the results is presented below:
| Reagent | Tested range (g/L) | Linear regression equations |
|---|---|---|
| Lot F0390 | 4.17 to 78.30 | y = 0.00 + 1.000x, r = 0.999 |
| Lot F0391 | 4.30 to 78.67 | y = 0.00 + 1.000x. r = 0.999 |
| Lot F0480 | 4.20 to 78.03 | y = 0.00 + 1.000x, r = 0.999 |
The results meet the acceptance criteria, demonstrating that the assay is linear up to 70 g/L. The upper limit of the MR is 70 g/L.
The MR is claimed as 6.0 to 70 g/L.
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Endogenous Interferences Study 5.9.7
The Endogenous Interferences study was performed to evaluate the effect of some substances on the performances of the product.
The interference was evaluated at the following Albumin concentrations:
Low: ~ 35 g/L (±10%)
High: ~ 50 g/L (±10%)
For each concentration 2 aliquots of serum pool were prepared (Base and Test pool) Test pool was divided into 4 sub-aliquots, then spiked using the interfering substances under evaluation. The 4 Test Pool aliquots were diluted using the Base Pool to obtain additional dilution levels in the ratio: 100%, 90%, 80%, 70%, 60%, 30%, 20%, 10%, 0%.
Potential interferences study was performed on the basis of CLSI document EP07-A2 -Interference Testing in Clinical Chemistry
Acceptance Criteria:
| Interfering substance | Testedconcentration up to | Acceptance criteria |
|---|---|---|
| Hemoglobin | 2000 mg/dL | |
| Unconjugated bilirubin | 66 mg/dL | % bias: ±10% |
| Conjugated bilirubin | 66 mg/dL | |
| Lipids (as Triglycerides) | 2000 mg/dL |
A summary of the results is presented below:
| Interferingsubstance | Tested concentrationup to | Found concentrationwithoutInterferences | Acceptancecriteria |
|---|---|---|---|
| Hemoglobin | 2000 mg/dL | 2000 mg/dL | |
| Unconjugatedbilirubin | 66 mg/dL | 66 mg/dL | |
| Conjugatedbilirubin | 66 mg/dL | 66 mg/dL | % bias: ±10% |
| Lipids (asTriglycerides) | 2000 mg/dL | 1200 mg/dL |
The results meet the acceptance criteria.
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5.9.8 Reagent stability
The Stability study was performed to determine, both open on-board and calibration stability of the Albumin BCP assay on the AU680 System.
The Stability study was determined following: European Standard EN 23640:2015 - Stability Testing of In Vitro Diagnostics Reagents
Acceptance Criteria
% Bias: within ± 10% vs initial measurement
| Reagent | Material | %bias | % bias | Acceptance criteria |
|---|---|---|---|---|
| Min | Max | % bias vs Time 0 | ||
| LotF0390 | Level 1 | 0.0% | 8.5% | |
| Level 2 | 1.2% | 7.9% | ||
| Level 3 | 0.65% | 7.3% | ||
| LotF0391 | Level 1 | 0.0% | 9.8% | |
| Level 2 | 1.0% | 9.9% | ||
| Level 3 | 0.1% | 9.6% | ±10% | |
| LotF0480 | Level 1 | 1.6% | 10.0% | |
| Level 2 | 0.6% | 9.8% | ||
| Level 3 | 0.3% | 8.8% | ||
| Lot90228 | Level 1 | -1.3% | 7.3% | |
| Level 2 | 0.0% | 5.9% | ||
| Level 3 | 0.5% | 5.2% |
A summary of the results is presented below:
The results meet the acceptance criteria.
The on-board reagent stability claimed is 28 days on the AU680 analyzer. The calibration stability claimed is 14 days on the AU680 analyzer.
5.9.9 Method Comparison
Method Comparison study was performed to demonstrate correlation to the predicate device (Siemens ADVIA® 2400). 128 serum samples with concentrations spanning the measuring interval 6.0 - 70 g/L were tested in duplicate on the AU680 System and on Siemens Advia 2400. 8 samples were altered samples, prepared for a better coverage of the measuring range.
The method comparison study was performed based on guidance from the CLSI document EP09-A3.
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Acceptance Criteria:
The method comparison study results were considered acceptable if the assay had a regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975.
A Passing-Bablok linear regression and a linear fit regression were performed, regressing the 1st replicate of the SCH Albumin BCP assay (y-axis) versus the mean of 2 replicates of each corresponding sample of the predicate (ADVIA® Chemistry Albumin BCP) assay (x-axis).
A summary of the results is presented below:
Passing & Bablok regression method: N = 128; y (g/L) = 0.94x + 1.01; r = 0.992
Linear fit regression method: N = 128; y (g/L) = 0.95x + 0.78; r = 0.992
SCH Albumin BCP assay on the AU680 demonstrated acceptable correlation to the predicate device (Siemens ADVIA 2400, ADVIA® Chemistry Albumin BCP) by meeting the evaluation criteria.
5.9.10 Matrix Comparison Study
Matrix Comparison study was performed to demonstrate correlation between:
- serum and Lithium-Heparin plasma samples A
- ア serum and Potassium EDTA plasma samples
77 paired plasma/serum samples with albumin concentrations throughout the range of the assay were tested.
7 samples were altered samples, prepared for a better coverage of the measuring range.
The matrix comparison study was performed based on guidance from the CLSI document EP09-A3.
The matrix comparison study results were considered acceptable if the assay had a regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975.
A Passing-Bablok linear regression and a linear fit regression were performed, regressing the 1st replicate of the SCH Albumin BCP plasma, Li-Heparin (y-axis) versus the 1st replicate of each corresponding sample of the SCH Albumin BCP Serum (x-axis).
A Passing-Bablok linear regression and a linear fit regression were performed, regressing the 1st replicate of the SCH Albumin BCP plasma, potassium EDTA (y-axis) versus the 1st replicate of each corresponding sample of the SCH Albumin BCP Serum (x-axis).
{15}------------------------------------------------
A summary of the results, Serum vs Lithium-Heparin plasma samples is presented below: Passing & Bablok regression method: N = 77; y (g/L) = 1.01x - 0.34; r = 0.995 Linear fit regression method: N = 77; y (g/L) = 1.00x + 0.01; r = 0.995
A summary of the results, Serum vs Potassium EDTA plasma samples is presented below: Passing & Bablok regression method: N = 77; y (g/L) = 1.00x - 0.20; r = 0.996
Linear fit regression method: N = 77; y (g/L) = 0.995x − 0.05; r = 0.996
The results meet the acceptance criteria.
5.10. Conclusion
Testing results indicate that the Candidate device (Albumin BCP) is safe and effective for the stated intended use and is substantially equivalent to the predicate device.
§ 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.