(601 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring a specific biomarker (NT-proBNP). There is no mention of AI, ML, image processing, or any other technology that would indicate the use of these methods for data analysis or interpretation. The performance studies focus on analytical and clinical validation of the assay itself, not on the performance of an AI/ML algorithm.
No.
This device is an in vitro diagnostic (IVD) assay used to measure NT-proBNP levels to aid in the diagnosis of heart failure. It provides information for diagnosis but does not directly treat or mitigate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use" and is "used as an aid in the diagnosis of heart failure".
No
The device description explicitly states it is an "assay kit" which includes physical reagents (Primary Reagent ReadyPack and Calibrator) for in vitro diagnostic use. This is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA Centaur® NT-proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma..."
This statement directly identifies the device as being intended for use outside of the body to diagnose a condition (heart failure) by analyzing a biological sample (serum and plasma).
N/A
Intended Use / Indications for Use
The ADVIA Centaur® NT-proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system.
In the Emergency Department (ED) and Outpatient (OP) populations, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
Product codes
NBC
Device Description
The ADVIA Centaur® NT-proBNPII (PBNPII) assay kit includes:
- ADVIA Centaur PBNPII Primary Reagent ReadyPack:
- Lite Reagent (7.5 mL/pack): Monoclonal sheep anti-human NT-proBNP F(ab')2 fragment antibody (~0.36 µg/mL) labeled with acridinium ester in buffer; bovine serum albumin (BSA); bovine gamma globulin; preservatives.
- Solid Phase Reagent (20.0 mL/pack): Monoclonal sheep anti-human NT-proBNP antibody (~2 µg/mL) labeled with biotin bound to streptavidin magnetic particles (~220 mg/L) in buffer; BSA; bovine gamma globulin; sheep gamma globulin; preservatives.
- Ancillary Well Reagent (7.5 mL/pack): Buffer; BSA; bovine gamma globulin; sheep gamma globulin; preservatives.
- ADVIA Centaur PBNPII Calibrator (included in assay kit):
- ADVIA Centaur PBNPII Low and High Calibrators (2.0 mL/vial Lyophilized): After reconstitution, low or high levels of NT-proBNP antigen; buffer; BSA; preservatives.
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
Patient age ranges are specified for the ED and OP populations in clinical performance studies:
ED Population: 75 years
OP Population: ≤ 75 years, > 75 years
Intended User / Care Setting
Emergency Department (ED) and Outpatient (OP) populations.
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
ED Population:
- Sample Size: A total of 3128 subjects with signs and symptoms of acute HF who presented to the ED. 1148 subjects were adjudicated as acute HF and 1980 subjects were adjudicated as without HF.
- Data Source: Prospectively enrolled in a multi-site clinical evaluation of the ADVIA Centaur PBNPII assay.
- Annotation Protocol: Diagnosis and severity of HF were determined by an independent central adjudication panel of expert clinicians (Cardiologists).
OP Population:
- Sample Size: A total of 1033 OP subjects with signs and symptoms of new onset HF. 185 subjects were adjudicated as new onset HF and 848 subjects were adjudicated as without HF.
- Data Source: Prospectively enrolled in a multi-site clinical evaluation of the ADVIA Centaur PBNPII assay.
- Annotation Protocol: Diagnosis and severity of HF were determined by an independent central adjudication panel of expert clinicians (Cardiologists).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (9.1)
- Study Type: Determined in accordance with CLSI Document EP05-A3. Samples assayed in duplicate in 2 runs per day for 20 days.
- Sample Size: Not explicitly stated for each serum/QC, but 80 reps for mean.
- Key Results:
- Serum 1 (116 pg/mL): Repeatability %CV 5.3, Within-Lab %CV 6.7
- Serum 2 (271 pg/mL): Repeatability %CV 3.5, Within-Lab %CV 4.0
- Serum 3 (380 pg/mL): Repeatability %CV 1.4, Within-Lab %CV 2.3
- Serum 4 (806 pg/mL): Repeatability %CV 1.9, Within-Lab %CV 2.1
- Serum 5 (1597 pg/mL): Repeatability %CV 1.6, Within-Lab %CV 2.0
- Serum 6 (25,073 pg/mL): Repeatability %CV 1.7, Within-Lab %CV 2.8
- QC 1 (144 pg/mL): Repeatability %CV 3.9, Within-Lab %CV 4.2
- QC 2 (418 pg/mL): Repeatability %CV 2.1, Within-Lab %CV 2.9
- QC 3 (4778 pg/mL): Repeatability %CV 1.9, Within-Lab %CV 2.8
Reproducibility (9.2)
- Study Type: Determined in accordance with CLSI Document EP05-A3. Samples assayed in duplicate in 2 runs per day for 5 days at 3 sites.
- Sample Size: 90 for each sample ID.
- Key Results:
- Serum A (141 pg/mL): Reproducibility %CV 5.0%
- Serum B (324 pg/mL): Reproducibility %CV 3.2%
- Serum C (489 pg/mL): Reproducibility %CV 3.7%
- Serum D (824 pg/mL): Reproducibility %CV 3.1%
- Serum E (1641 pg/mL): Reproducibility %CV 3.0%
- Serum F (10428 pg/mL): Reproducibility %CV 4.1%
- Serum G (19469 pg/mL): Reproducibility %CV 3.8%
- Serum H (28860 pg/mL): Reproducibility %CV 3.5%
- Control 1 (146 pg/mL): Reproducibility %CV 4.5%
- Control 2 (430 pg/mL): Reproducibility %CV 3.8%
- Control 3 (4965 pg/mL): Reproducibility %CV 3.3%
Linearity (9.3)
- Study Type: Performed in accordance with CLSI Document EP06-Ed2.
- Key Results: Linear for the measuring interval of 35-35,000 pg/mL (4.13-4130 pmol/L).
Detection Limit (9.4)
- Study Type: Determined as described in CLSI protocol EP17-A2.
- Key Results: LoB of 13 pg/mL (1.53 pmol/L), LoD of 20 pg/mL (2.36 (pmol/L), and LoQ of 35 pg/mL (4.13 pmol/L).
Interference (9.5)
- Study Type: Performed in accordance with CLSI Document EP07-ed3 for Hemolysis, Icterus, Lipemia (HIL) and other substances.
- Key Results: No interference from various substances including Hemoglobin, Bilirubin, Lipemia, and other common medications/substances at indicated concentrations (bias does not exceed 10%).
Cross-Reactivity (9.6)
- Study Type: Determined in accordance with CLSI Document EP07-ed3. Tested at NT-proBNP concentrations of 0 pg/mL (0 pmol/L) and 126–158 pg/mL (14.9–18.6 pmol/L).
- Key Results: Most cross-reactants showed "Not Detectable" or " 300 pg/mL for 75 years was 98.4%.
- OP Population (9.8.2.2):
- Sample Size: 185 patients (102 females and 83 males) adjudicated with new onset of HF.
- Key Results: Mean NT-proBNP levels were 1313 pg/mL for ≤75 years and 2418 pg/mL for >75 years. For combined male and female, % > 125 pg/mL was 82.1% for ≤75 years and 96.1% for >75 years.
- NYHA Functional Class: p = 35,000 pg/mL.
- OP Population (9.8.2.2):
Stability (9.11)
- Key Results: Reagents and calibrators stable until printed date at 2-8°C. Onboard stability and calibration interval of reagents is 36 days. Calibrators stable for 48 hours at 2-8°C, 31 days at 450), 2.4% for negative (900), 4.8% for negative ( 75: Post-test Risk 68.3% for positive (>1800), 5.4% for negative ( 75 years: Sensitivity 90.5%, Specificity 37.2%, PPV 41.3%, NPV 88.9%
- Females > 75 years: Sensitivity 100%, Specificity 20.8%, PPV 34.5%, NPV 100%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
OP Population (at 125 pg/mL cutoff):
- Sensitivity: 86.0% (159/185) (80.1%, 90.6%)
- Specificity: 64.3% (545/848) (60.9%, 67.5%)
- PPV: 34.4% (159/462) (30.1%, 39.0%)
- NPV: 95.5% (545/571) (93.4%, 97.0%)
OP Population by Sex and Age Group (at 125 pg/mL cutoff):
- Males ≤ 75 years:
- Sensitivity: 85.5% (53/62) (74.2%, 93.1%)
- Specificity: 68.9% (179/260) (62.8%, 74.4%)
- PPV: 39.6% (53/134) (31.2%, 48.4%)
- NPV: 95.2% (179/188) (91.1%, 97.8%)
- Females ≤ 75 years:
- Sensitivity: 79.2% (57/72) (67.5%, 87.8%)
- Specificity: 70.8% (335/473) (67.0%, 74.9%)
- PPV: 29.2% (57/195) (23.0%, 36.2%)
- NPV: 95.7% (335/350) (93.0%, 97.6%)
- Males > 75 years:
- Sensitivity: 90.5% (19/21) (69.6%, 98.8%)
- Specificity: 37.2% (16/43) (22.8%, 51.7%)
- PPV: 41.3% (19/46) (27.0%, 56.8%)
- NPV: 88.9% (16/18) (65.3%, 98.6%)
- Females > 75 years:
- Sensitivity: 100% (30/30) (88.4%,100%)
- Specificity: 20.8% (15/72) (2.2%, 32.0%)
- PPV: 34.5% (30/87) (24.6%, 45.4%)
- NPV: 100% (15/15) (78.2%, 100%)
ED Population:
- Age 450): 63.0% (209/332) (57.5%,68.2%)
- Indeterminate (300 - ≤450): 29.6% (8/27) (13.8%,50.2%)
- Negative ( 450): 5.01 (4.25, 5.91)
- Indeterminate (300 - ≤450): 1.24 (0.55, 2.80)- LR-:
- Negative ( 900): 68.5% (403/588) (64.6%,72.3%)
- Indeterminate (300 - ≤900): 25.2% (54/214) (19.6%,31,6%)
- Negative ( 900): 3.71 (3.25, 4.24)
- Indeterminate (300 - ≤900): 0.58 (0.43, 0.77)
- LR-:
- Negative ( 75:
- Post-test Risk:
- Positive (> 1800): 68.3% (375/549) (64.2%,72.2%)
- Indeterminate (300-≤1800): 22.8% (55/241) (17.7%,27.7%)
- Negative ( 1800): 2.38 (2.10, 2.69)
- Indeterminate (300-≤1800): 0.33 (0.25, 0.43)
- LR-:
- Negative (
- LR-:
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
0
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September 24, 2023
Siemens Healthcare Diagnostics Inc. Asha Gartland Regulatory Affairs Specialist 511 Benedict Ave Tarrytown, NY 10591
Re: K220265
Trade/Device Name: ADVIA Centaur® NT-proBNPII (PBNPII) Regulation Number: 21 CFR 862.1117 Regulation Name: B-Type Natriuretic Peptide Test System Regulatory Class: Class II Product Code: NBC Dated: November 18, 2022 Received: November 18, 2022
Dear Asha Gartland:
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.
1
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 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 -S
Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220265
Device Name ADVIA Centaur® NT-proBNPII (PBNPII)
Indications for Use (Describe)
The ADVIA Centaur® NT-proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system.
In the Emergency Department (ED) and Outpatient (OP) populations, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
| 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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3
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K220265 1. Date Prepared September 22nd , 2023 Applicant Information 2. Asha Gartland Contact: Regulatory Affairs Specialist Address: Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5097 845-327-8296 Phone: Email asha.gartland@siemens-healthineers.com
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur® NT-proBNPII (PBNPII) Assay
| Trade Name | ADVIA Centaur® NT-proBNPII (PBNPII) |
|---|---|
| Common Name | Test, Natriuretic Peptide |
| Classification Name | B-type natriuretic peptide test system |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry (75) |
| Product Code | NBC |
| Regulation Number | 21 CFR 862.1117 |
Predicate Device Information 4.
Predicate Device Name: Roche Elecsys proBNP II assay
510(k) Number: K072437
4
Intended Use / Indications for Use 5.
The ADVIA Centaur® NT-proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system.
In the Emergency Department (ED) and Outpatient (OP) populations, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
Special Conditions for Use Statement 6.
For Prescription Use
7. Device Description
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur PBNPII Primary Reagent ReadyPack (included in assay kit) | ||
| Lite Reagent | 7.5 mL/pack | Monoclonal sheep anti-human NT-proBNP F(ab')2 |
| fragment antibody (~0.36 µg/mL) labeled with acridinium | ||
| ester in buffer; bovine serum albumin (BSA); bovine | ||
| gamma globulin; preservatives | ||
| Solid Phase Reagent | 20.0 mL/pack | Monoclonal sheep anti-human NT-proBNP antibody (~2 |
| µg/mL) labeled with biotin bound to streptavidin magnetic | ||
| particles (~220 mg/L) in buffer; BSA; bovine gamma | ||
| globulin; sheep gamma globulin; preservatives | ||
| Ancillary Well Reagent | 7.5 mL/pack | Buffer; BSA; bovine gamma globulin; sheep gamma |
| globulin; preservatives | ||
| ADVIA Centaur PBNPII Calibrator (included in assay kit) | ||
| ADVIA Centaur PBNPII Low | ||
| and High Calibrators | 2.0 mL/vial | |
| Lyophilized | After reconstitution, low or high levels of NT-proBNP | |
| antigen; buffer; BSA; preservatives |
5
| Candidate Device | Predicate | |
|---|---|---|
| Item | ADVIA Centaur | |
| NT-proBNP (PBNPII) assay | Roche Elecsys proBNP II assay | |
| (K072437) | ||
| Intended Use | The ADVIA Centaur® NT-proBNPII (PBNPII) | |
| assay is for in vitro diagnostic use in the | ||
| quantitative determination of N-terminal | ||
| pro-brain natriuretic peptide (NT-proBNP) in | ||
| human serum and plasma (EDTA and lithium | ||
| heparin) using the ADVIA Centaur® XP | ||
| system. | ||
| In the Emergency Department (ED) and | ||
| Outpatient (OP) populations, measurements | ||
| of NT-proBNP are used as an aid in the | ||
| diagnosis of heart failure (HF) in patients | ||
| with clinical suspicion of new onset or | ||
| worsening HF. | Immunoassay for the in vitro | |
| quantitative determination of | ||
| N-terminal pro-Brain natriuretic | ||
| peptide in human serum and plasma. | ||
| This assay is used as an aid in the | ||
| diagnosis of individuals suspected of | ||
| having congestive heart failure. | ||
| The test is further indicated for the | ||
| risk stratification of patients with | ||
| acute coronary syndrome and | ||
| congestive heart failure. The test may | ||
| also serve as an aid in the assessment | ||
| of increased risk of cardiovascular | ||
| events and mortality in patients at risk | ||
| for heart failure who have stable | ||
| coronary artery disease. | ||
| Indications for Use | Same as Intended Use (Candidate) | Same (for Predicate) |
| Similarities | ||
| Measurement | Quantitative | Same |
| Technology | Chemiluminescence | Same |
| Sample type | Plasma and Serum | Same |
| Standardization | Traceable to synthetic human NT-proBNP | |
| (1-76) through internal standard | Same | |
| Calibration | 2 levels | Same |
| Calibrators | Lyophilized | Same |
| Hook Effect | No hook effect up to 300,000 pg/mL | Same |
| Differences | ||
| Operating Principle | 1-Step Sandwich immunoassay | 2-Step Sandwich immunoassay |
| Assay Range | 35-35,000 pg/mL | 5-35,000 pg/mL |
| Candidate Device | Predicate | |
| Item | ADVIA Centaur | |
| NT-proBNP (PBNPII) assay | Roche Elecsys proBNP II assay | |
| (K072437) | ||
| Sample Volume | 20 μL | 15 μL |
| LoB | 13 pg/mL | LoB75 years ≥ 300 to ≤ 1800 pg/mL |
| Rule-in HF | ||
| 450 pg/mL | ||
| 50–75 years > 900 pg/mL |
75 years > 1800 pg/mL
OP Population
Rule out HF
All ages 75
years and sex | Sensitivity and Specificity vs age (75 | 120 | 56 (6.61) | 50.6 (5.97) | 75 | 120 | 89 (10.5) | 216.4 (25.5) | 43 (5.07) | 178 (21.0) | N/Aa | 97.5 |
| Overall | Overall | 723 | 69 (8.14) | 124.9 (14.7) | 75 years.
The data for the ED population with acute HF for combined male and female (All) is presented in this summary.
| ED Population – All Subjects with Acute HF | |||
|---|---|---|---|
| Age Group | 75 years | ||
| Mean pg/mL (pmol/L) | 6004 (708) | 6820 (805) | 8591 (1014) |
| SD pg/mL (pmol/L) | 7601 (897) | 8182 (965) | 8984 (1060) |
| Median pg/mL (pmol/L) | 3552 (419) | 3677 (434) | 5295 (625) |
| 95th Percentile pg/mL (pmol/L) | 25,401 (2997) | 26,473 (3124) | 34,451 (4065) |
| % > 300 pg/mL | 94.3 | 95.0 | 98.4 |
| % > 450 pg/mL | 90.9 | N/A* | N/A* |
| % > 900 pg/mL | N/A* | 83.8 | N/A* |
| % > 1800 pg/mL | N/A* | N/A* | 85.8 |
| N | 230 | 481 | 437 |
- The cut-off value is not applicable for the age group indicated.
9.8.2.2 OP Population
Samples were obtained from 185 patients (102 females and 83 males) adjudicated with new onset of HF.
The data for the OP population with new onset of HF for combined male and female (All) is presented in this summary.
| OP Population – All Subjects with Adjudicated New Onset HF | ||
|---|---|---|
| Age Group | ≤ 75 years | > 75 years |
| Mean pg/mL (pmol/L) | 1313 (155) | 2418 (285) |
| SD pg/mL (pmol/L) | 3756 (443) | 5536 (653) |
| Median pg/mL (pmol/L) | 449 (53.0) | 661 (78.0) |
| 95th Percentile pg/mL (pmol/L) | 4547 (537) | 13,518 (1595) |
| % > 125 pg/mL | 82.1 | 96.1 |
| N | 134 | 51 |
15
| NYHA Functional Classa | NYHA I | NYHA II | NYHA III | NYHA IV | |
|---|---|---|---|---|---|
| Mean pg/mL (pmol/L)b | 880 (104) | 3340 (394) | 7139 (842) | 7466 (881) | |
| SD pg/mL (pmol/L) | 1161 (137) | 6262 (739) | 8480 (1001) | 8277 (977) | |
| Median pg/mL (pmol/L) | 387 (46) | 996 (118) | 4018 (474) | 4409 (520) | |
| 5th Percentile pg/mL | |||||
| (pmol/L) | 135 (15.9) | 73 (8.6) | 261 (30.8) | 449 (52.9) | |
| 95th Percentile pg/mL | |||||
| (pmol/L) | 2612 (308) | 17357 (2048) | 29643 (3498) | 30,824 (3637) | |
| N | 4c | 265 | 573 | 474 |
The NYHA classifications for the ED and OP population with acute HF for combined male and female (All) is presented in this summary.
a Unable to determine NYHA classification for 16 subjects.
b p = 35,000pg/mL (4130 pmol/L).
9.11 Stability
The ADVIA Centaur NT-proBNP (PBNPII) reagents and calibrators are stable until the date printed on the box label when stored at 2-8°C.
The onboard stability and calibration interval of the ADVIA Centaur NT-proBNP (PBNPII) reagents is 36 days. The ADVIA Centaur PBNPII Calibrators are stable for 48 hours at 2-8°C and 31 days at 450 | 209 | 123 | 332 | 63.0% (209/332) | (57.5%,68.2%) | 5.01 | (4.25, 5.91) |
| | Indeterminate | 300 - ≤450 | 8 | 19 | 27 | 29.6% (8/27) | (13.8%,50.2%) | 1.24 | (0.55, 2.80) |
| | Negative | 900 | 403 | 185 | 588 | 68.5% (403/588) | (64.6%,72.3%) | 3.71 | (3.25, 4.24) |
| | Indeterminate | 300 - ≤900 | 54 | 160 | 214 | 25.2% (54/214) | (19.6%,31,6%) | 0.58 | (0.43, 0.77) |
| | Negative | 75 | Positive | > 1800 | 375 | 174 | 549 | 68.3% (375/549) | (64.2%,72.2%) | 2.38 | (2.10, 2.69) |
| | Indeterminate | 300-≤1800 | 55 | 186 | 241 | 22.8% (55/241) | (17.7%,27.7%) | 0.33 | (0.25, 0.43) |
| | Negative | 75 years | Estimate | 90.5% (19/21) | 37.2% (16/43) | 41.3% (19/46) | 88.9% (16/18) |
| | 95% CI* | 69.6%, 98.8% | 22.8%, 51.7% | 27.0%, 56.8% | 65.3%, 98.6% |
| Females
75 years | Estimate | 100% (30/30) | 20.8% (15/72) | 34.5% (30/87) | 100% (15/15) |
| | 95% CI* | 88.4%,100% | (2.2%, 32.0% | 24.6%, 45.4% | 78.2%, 100% |
*CI=Confidence Interval
10. Conclusions
ADVIA Centaur NT-proBNP II (PBNPII) assay is substantially equivalent in analytical performance to the currently marketed predicate device, the Roche Elecsys proBNP II assay cleared under 510(k) Number: K072437.