← Product Code [NBC](/productcode/NBC) · K262597 # Access BNP II (K262597) _Beckman Coulter, Inc. · NBC · Oct 20, 2026 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K262597 ## Device Facts - **Applicant:** Beckman Coulter, Inc. - **Product Code:** [NBC](/productcode/NBC.md) - **Decision Date:** Oct 20, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1117 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: - as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure - for the risk stratification of patients with acute coronary syndromes - for the risk stratification of patients with heart failure ## Device Story Access BNP II is a chemiluminescent immunoassay for quantitative measurement of B-type natriuretic peptide (BNP) in EDTA plasma. The device is used on the Access 2 Immunoassay Analyzer. It functions by measuring BNP levels to aid in heart failure diagnosis and risk stratification for heart failure and acute coronary syndromes. The assay is performed in clinical laboratory settings by trained personnel. Results are provided to clinicians to assist in the clinical assessment of patients presenting with dyspnea or other symptoms of heart failure. The device modification involves the use of Access Substrate to enable compatibility with the Access 2 Immunoassay Analyzer, maintaining the same analytical performance and clinical utility as the predicate. ## Clinical Evidence Prospective study of 333 subjects (age 22+) presenting with suspected acute heart failure. Subjects were evaluated using both the candidate and predicate devices. Concordance analysis at the 100 pg/mL cutoff showed 100% agreement for confirmed AHF (n=105) and 97.8% agreement for non-AHF (n=228). Passing-Bablok regression showed a slope of 0.99 (95% CI: 0.98-1.00) and correlation coefficient R=1.00. Subgroup analyses across age, sex, race, BMI, and kidney function confirmed analytical equivalence. ## Technological Characteristics Chemiluminescent immunoassay for EDTA plasma. Measuring range: 5.0-5,000 pg/mL (up to 10,000 pg/mL with manual dilution). Instrument: Access 2 Immunoassay Analyzer. Substrate: Access Substrate. Analytical performance follows CLSI guidelines (EP05-A3, EP06-2, EP17-A2, EP09c). ## Regulatory 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. ## Special Controls *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.” ## Predicate Devices - Access BNP II on DxI 9000 Immunoassay Analyzer ([K252169](/device/K252169.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION ### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ### I Background Information: A 510(k) Number K262597 B Applicant Beckman Coulter, Inc. C Proprietary and Established Names Access BNP II D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | NBC | Class II | 21 CFR 862.1117 – B-Type Natriuretic Peptide Test System | Clinical Chemistry | ### II Submission/Device Overview: A Purpose for Submission: Modified device B Measurand: B-type natriuretic peptide (BNP) C Type of Test: Chemiluminescent Assay Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} ### III Intended Use/Indications for Use: #### A Intended Use(s): See Indications for Use below. #### B Indication(s) for Use: The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: - as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure - for the risk stratification of patients with acute coronary syndromes - for the risk stratification of patients with heart failure #### C Special Conditions for Use Statement(s): Rx - For Prescription Use Only #### D Special Instrument Requirements: Access 2 Immunoassay Analyzer ### IV Device/System Characteristics: #### A Device Description: The candidate device is the same as described in K252169 except for the chemiluminescent substrate, which was changed from Lumi-Phos PRO Substrate to the Access Substrate to support use on the Access 2 Immunoassay Analyzer. #### B Principle of Operation: The principle of operation is unchanged from the previous clearance described in K252169. The device has been modified to now use the Access Substrate to support use on the Access 2 Immunoassay Analyzer. ### V Substantial Equivalence Information: #### A Predicate Device Name(s): Access BNP II on DxI 9000 Immunoassay Analyzer #### B Predicate 510(k) Number(s): K252169 K262109- Page 2 of 9 {2} ### C Comparison with Predicate(s): | Device & Predicate Device(s): | K262597 | K252169 | | --- | --- | --- | | Device Trade Name | Access BNP II | Access BNP II | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | For the quantitative determination of B-type natriuretic peptide (BNP) levels in plasma | Same | | General Device Characteristic Differences | | | | Instrument Required | Access 2 Immunoassay Analyzer | Dxl 9000 Access Immunoassay Analyzer | | Substrate | Access Substrate | Lumi-Phos PRO Substrate | ### VI Standards/Guidance Documents Referenced: Clinical & Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; 3 \( ^{rd} \) Edition. CLSI EP06-2 \( ^{nd} \) Edition: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach. CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; 2 \( ^{nd} \) Edition. CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation using Patient Samples. Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers (November 30, 2000). ### VII Performance Characteristics (if/when applicable): ### A Analytical Performance: #### 1. Precision/Reproducibility: The sponsor evaluated the precision of the Access BNP II assay on the Access 2 Immunoassay Analyzer following the CLSI guideline EP05-A3. #### Single Site Precision The study was conducted at a single internal site using three Access 2 Immunoassay Analyzers, each paired with a unique reagent lot and calibrator lot. K262109- Page 3 of 9 {3} A panel of seven EDTA plasma samples with concentrations of BNP spanning the measuring range were used in the study. Sample 1 to Sample 5 were pooled native human plasma samples. Sample 6 and Sample 7 were pooled native plasma samples supplemented with BNP antigen. Each sample was measured in 2 replicates per run, 2 runs per day over 20 days across the three instruments, yielding a total of 240 measurements per sample. The overall imprecision includes repeatability (within-run), between-run, between-day, and between-reagent-lot variance component. Results for combined lots are shown below. Precision Combined Lots (n=240) | Sample | N | Mean (pg/mL) | Repeatability | | Between-Run | | Between-Day | | Between-Lot | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD (pg/mL) | %CV | SD (pg/mL) | %CV | SD (pg/mL) | %CV | SD (pg/mL) | %CV | | S1 | 240 | 4.8 | 0.3 | 6.3 | 0.0 | 0.0 | 0.2 | 3.6 | 0.2 | 4.2 | | S2 | 240 | 129 | 2.2 | 1.7 | 2.2 | 1.7 | 1.1 | 0.9 | 0.4 | 0.3 | | S3 | 240 | 318 | 5.8 | 1.8 | 5.3 | 1.7 | 5.2 | 1.7 | 2.5 | 0.8 | | S4 | 240 | 554 | 9.5 | 1.7 | 11.9 | 2.1 | 4.6 | 0.8 | 6.1 | 1.1 | | S5 | 240 | 1331 | 22.3 | 1.7 | 25.6 | 1.9 | 8.7 | 0.7 | 9.0 | 0.7 | | S6 | 240 | 2543 | 48.9 | 1.9 | 44.7 | 1.8 | 23.6 | 0.9 | 58.5 | 2.3 | | S7 | 240 | 4109 | 61.3 | 1.5 | 150.9 | 3.7 | 27.4 | 0.7 | 75.7 | 1.8 | | Sample | N | Mean (pg/mL) | Overall | | | | | | | | | | | | SD (pg/mL) | %CV | | | | | | | | S1 | 240 | 4.8 | 0.4 | 8.1 | | | | | | | | S2 | 240 | 129 | 3.4 | 2.6 | | | | | | | | S3 | 240 | 318 | 9.8 | 3.1 | | | | | | | | S4 | 240 | 554 | 17.0 | 3.1 | | | | | | | | S5 | 240 | 1331 | 36.1 | 2.7 | | | | | | | | S6 | 240 | 2543 | 91.5 | 3.6 | | | | | | | | S7 | 240 | 4109 | 181.7 | 4.4 | | | | | | | The sponsor provided information to support the device's multi-site reproducibility performance. ### 2. Linearity: The linearity performance of the Access BNP II assay run on the Access 2 Immunoassay Analyzer was established for EDTA plasma in a study following the recommendations of the CLSI EP06-2 \( ^{nd} \) Edition guideline. Three Access 2 Immunoassay Analyzers, each paired with a unique reagent lot and calibrator lot, were used in this study. A low sample was obtained by pooling low concentration (< 5 pg/mL) native EDTA plasma samples. A high sample was prepared by pooling high concentration (> 5000 pg/mL) native EDTA plasma samples. The low and high pool samples were mixed in pre-defined ratios to create an additional seven samples. K262109- Page 4 of 9 {4} Each sample was measured on each Access 2 Immunoassay analyzer. The low sample was run in replicates of eight, and all other samples were run in replicates of four. The linearity was analyzed separately for each reagent lot/instrument combination. Using a weighted linear regression model, the difference between the mean observed value and the value predicted by the weighted linear regression model was derived. The maximum deviation from linearity was 8%. Additionally, the sponsor provided a sub-range linearity study and the results obtained with native samples were shown to be similar to the full range studies. These data support the sponsor's measuring range claim of 5 to 5,000 pg/mL. # Hook Effect The sponsor provided information to support that the hook effect claim is the same as described in K252169. # 3. Analytical Specificity/Interference: The Analytical Specificity/Interference performance was evaluated in K252169. The sponsor provided information to support that the analytical specificity/interference claims are the same as described in K252169. # 4. Detection Limit and Assay Reportable Range # Detection Limit The detection capability of the Access BNP II assay run on the Access 2 Immunoassay Analyzer was evaluated. The limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ) were established following the recommendations in the CLSI EP17-A2 guideline. # Limit of Blank (LoB) The LoB study was performed on five blank samples with three Access 2 Immunoassay Analyzers, three reagent lots, and one calibrator lot, with each analyzer paired with a unique reagent lot. Each sample was tested across three days with one run per day and five replicates per run on each analyzer. A total of 75 measurements were obtained per analyzer-reagent lot combination. The LoB was determined non-parametrically for each combination separately, and the highest value obtained across three lots was taken as the LoB value for the assay. - The LoB for the Access BNP II assay on the Access 2 Immunoassay Analyzer is estimated to be 0.3 pg/mL. K262109- Page 5 of 9 {5} ## Limit of Detection (LoD) The LoD study was performed using nine native EDTA plasma samples containing low levels of BNP analyte with three Access 2 Immunoassay Analyzers, three reagent lots, and one calibrator lot, with each analyzer paired with a unique reagent lot. Each sample was tested across five days with one run per day and nine replicates per run on each analyzer. A total of 45 measurements were obtained per sample on each analyzer-reagent lot combination. The parametric approach described in EP17-A2 was followed to determine the LoD. The highest observed LoD across three lots was the reported LoD for the assay. - The LoD for the Access BNP II assay on the Access 2 Immunoassay Analyzer is estimated to be 2 pg/mL. ## Limit of Quantification (LoQ) The LoQ study was performed using thirteen EDTA plasma samples containing low levels of BNP analyte with three Access 2 Immunoassay Analyzers, three reagent lots and one calibrator lot, with each analyzer paired with a unique reagent lot. Each sample was tested across five days with one run per day and nine replicates per run on each analyzer. A total of 45 measurements were obtained for each sample per analyzer-reagent lot combination. The LoQ was determined independently for each analyzer-reagent lot using a precision profile approach as the concentration where the %CV was less than or equal to 20%. The highest LoQ values obtained across three lots were taken as the LoQ value of the assay. - The LoQ for the Access BNP II assay on the Access 2 Immunoassay Analyzer is estimated to be 2 pg/mL. These studies support the following detection capability claims in the labeling: Limit of Blank (LoB): 0.3 pg/mL Limit of Detection (LoD): 2 pg/mL Limit of Quantitation (LoQ) (≤ 20% within-lab CV): 2 pg/mL Assay Reportable Range 5.0-5,000 pg/mL The candidate device only has a manual dilution claim. The sponsor provided information to support an extended measuring range up to 10,000 pg/mL: - For manual dilutions, dilute one volume of sample with one volume of wash buffer. The sponsor performed studies to demonstrate that the Access BNP II assay is not susceptible to carryover on the Access 2 Immunoassay Analyzer. 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Traceability, and sample stability are the same as described in K252169. K262109- Page 6 of 9 {6} The sponsor provided data to support: - Opened reagent onboard stability of 21 days at 2 to 10°C - Calibration stability of 28 days # 6. Assay Cut-Off: Not applicable. # B Comparison Studies: # 1. Method Comparison with Predicate Device: The sponsor performed a method comparison study to demonstrate the equivalence between the candidate device and the predicate device (K252169). This method comparison study was conducted following the recommendation from the CLSI EP09c 3rd Edition guideline. In this study, a total of 333 subjects age 22 years and older presenting with clinical suspicion of acute heart failure across five geographically diverse clinical sites were prospectively enrolled. Subjects on dialysis and subjects with dyspnea clearly not secondary to HF (e.g., primary lung disease or chest trauma) were excluded from the study. The study cohort consisted of 43.2% (144/333) female subjects and 56.8% (189/333) male subjects. Individuals in the population were 39.9% (133/333) Black or African American, 58.0% (193/333) White, and 1.2% (4/333) Asian. In addition, the study cohort represented key demographic and clinical subgroups, with diverse representation across age, BMI, kidney function (eGFR), history of heart failure, and comorbidities. For each subject, an EDTA plasma sample was collected to determine the BNP concentration on both the candidate device and the predicate device. All samples were stored and handled within validated conditions. Samples were tested on 3 DxI 9000 Analyzers using 3 reagent lots and 3 calibrator lots of the predicate device and 3 Access 2 Immunoassay Analyzers using 3 reagent lots and 3 calibrator lots of the candidate device. Results of this method comparison study were analyzed using Passing-Bablok regression and are summarized below: | N | Concentration Range (pg/mL) by Comparator | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient R | | --- | --- | --- | --- | --- | | 333 | 5.1 – 5003 | 0.99 (0.98 – 1.00) | -0.84 (-1.15 – -0.46) | 1.00 | Estimated bias at cutoff of 100 pg/mL | MDL (pg/mL) | Bias (pg/mL) (95%CI) | %Bias (95%CI) | | --- | --- | --- | | 100 | -2.2 (-2.9, -1.5) | -2.2% (-2.9% – -1.5%) | Additional subgroup Passing-Bablok regression analyses were performed by stratifying subjects such as age (<50, 50-75, >75 years), sex (male and female), race (White and non-White), BMI (< 30 and ≥30 kg/m², kidney function (eGFR <60 and ≥60 mL/min/1.73m²), K262109- Page 7 of 9 {7} history of heart failure, and comorbidity status. Across all evaluated subgroups, slope and intercept estimates demonstrated minimal deviation from the predicate device, with confidence intervals consistently supporting analytical accuracy in each subgroup. The results of this method comparison study demonstrate analytical equivalence between the candidate device and the predicate device (K252169). These findings support the conclusion that the modification to the candidate device did not impact the clinical performance characteristics and clinical claims described in K252169. 2. Matrix Comparison: K₂-EDTA plasma is the only sample type. # C Clinical Studies: 1. Clinical Sensitivity: The sponsor provided information to support that the modification to the candidate device did not impact the clinical performance claims described in K252169. 2. Clinical Specificity: See Clinical Sensitivity above. 3. Clinical Cut-Off: For patients in the Emergency Department (ED) settings, the cut-offs are the same as described in K252169. 4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): In addition to the analytical accuracy evaluation, all enrolled subjects were adjudicated for an acute heart failure (AHF) diagnosis by an independent clinical event committee (CEC), yielding 105 subjects with a confirmed AHF diagnosis and 228 subjects with a confirmed non-AHF diagnosis. The concordance analysis between the candidate device and predicate device were performed using the age-independent (< 100 pg/mL) cutoff. Among the subjects with a confirmed AHF diagnosis (N=105 with New York Heart Association (NYHA) functional class from I to IV), total exact agreement between the candidate device and the predicate device was 100% (105/105). Among the subjects with a confirmed non-AHF diagnosis (N=228), 97.8% (223/228) showed exact agreement between results, and 2.2% (5/228) of the results were discordant. The 5 discordant results were near the cutoff value, and the discordance is consistent with the normal variation of the assays. # D Expected Values/Reference Range: The sponsor provided information to support that the modification to the candidate device did not impact the expected values of BNP in healthy adults established in K252169/K033383. K262109- Page 8 of 9 {8} ### VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. ### IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K262109- Page 9 of 9 --- **Source:** [https://fda.innolitics.com/device/K262597](https://fda.innolitics.com/device/K262597) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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