(28 days)
The Bayer ADVIA IMS BNP method is for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA IMS® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
The ADVIA IMS BNP Assay is an in vitro immunoassay intended for the quantitative measurement of b-type natriuretic peptide (BNP) in human EDTA plasma covering the analytical range of 10 to approximately 6,000 pg/mL. The assay is a heterogeneous sandwich immunoassay using magnetic separation. Reagony a a freel genedus monoclonal antibody to BNP labeled with FITC and Reagent 2 (R2) contains the second monoclonal antibody to BNP (F(ab)2) conjugated to the enzyme /kaline phosphatase (ALP). The monoclonal antibodies used in the ADVIA IMS BNP assay are identical to those used in the ADVIA Centaur assay. The sandwich complex formed by the modite and the antibody conjugates is captured by the magnetic particles so that the BNP concentration in the sample can be measured in terms of enzyme activity. The substrate used for this assay is a dioxetane phosphate derivative, which is dephosphorylated by ALP resulting in photon emission. Luminescence is measured by a photomultiplier tube. The dose response curve is proportional to the analyte concentration in sample.
The provided text describes the 510(k) Summary of Safety and Effectiveness for the BNP Assay for Bayer ADVIA® Integrated Modular System (IMS). This is a diagnostic device, and the acceptance criteria and study detailed are centered on its analytical performance and equivalence to a predicate device, not on clinical effectiveness in human readers or pathology.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of values that the new device must meet to be considered effective. Instead, it presents performance characteristics of the new device (ADVIA IMS BNP assay) and compares them directly to the predicate device (ADVIA Centaur BNP assay) to demonstrate substantial equivalence. The implication is that performance comparable to the predicate device is the de-facto acceptance criterion.
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (ADVIA IMS) | Predicate Device Performance (ADVIA Centaur) |
|---|---|---|---|
| Imprecision (CV%) | Comparable to Predicate device | Level 71 pg/mL: 4.1%Level 716 pg/mL: 1.9%Level 2660 pg/mL: 1.8% | Level 48.5 pg/mL: 3.5%Level 458 pg/mL: 2.8%Level 1736 pg/mL: 2.9% |
| Correlation (Spearman R) | Close to 1 (indicating high correlation) | 0.992 | Not directly stated for comparison, but the new device is correlated against it. |
| Correlation (Regression Equation Y=ADVIA IMS, X=ADVIA Centaur) | Y ≈ X | $0.990 * X + 4.37$ | N/A (It is the comparison system) |
| Interfering Substances (% Deviation in Recovery) | Generally within acceptable biological variation (e.g., < +/-10%) | Most deviations < +/-10% (e.g., Albumin: -9.46%; Hemoglobin: -9.68%; IgG: 9.30%) | Not explicitly stated for specific comparison, but the study implies it is within acceptable limits for a clinical assay. |
| Analytical Range | Comparable to predicate device | 4 pg/mL to ~6,000 pg/mL | Not explicitly stated for comparison, but implied to be similar. |
| Minimum Detectable Concentration | Comparable to predicate device | 4 pg/mL | 2 pg/mL |
| Expected Results (Reference Group: % < 100 pg/mL) | Comparable to predicate device clinical studies results | 97.4% (All), 99.7% (<45 years), 97.0% (65-74 years), 85.5% (75+ years) | The expected values were determined from clinical studies performed for the predicate and included in the labeling for the ADVIA IMS BNP assay. So the acceptance is that the values generated by the IMS are consistent with reference ranges established by the Centaur. |
| Expected Results (Heart Failure Group: % > 100 pg/mL) | Comparable to predicate device clinical studies results | 72.6% (All), 43.1% (NYHA I), 95.8% (NYHA IV) | Same as above. The acceptance is consistency with established ranges. |
2. Sample sized used for the test set and the data provenance
- Imprecision Study: Not explicitly stated, but typically involves repeated measurements of control samples or patient pools across multiple runs and days. The levels (71 pg/mL, 716 pg/mL, 2660 pg/mL) indicate different concentrations of BNP tested.
- Correlation Study:
- Sample Size: N = 360 EDTA Plasma specimens.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a comparison of the new device (ADVIA IMS) against the predicate device (ADVIA Centaur) using patient samples, implying it is retrospective or a prospective collection for analytical validation.
- Interfering Substances Study: Not explicitly stated, but involves testing samples spiked with various interfering substances at different BNP concentrations (e.g., 145.3 pg/mL and 407.5 pg/mL for Albumin).
- Expected Results (Reference Group):
- Sample Size: 1521 individuals without heart failure (785 women and 736 men).
- Data Provenance: Not explicitly stated. The text notes these values are "representative of the results obtained from clinical studies" and were derived from the predicate device's clinical studies. This suggests the data is retrospective and likely US-based, though not explicitly stated.
- Expected Results (Heart Failure Group):
- Sample Size: 722 patients diagnosed with heart failure (264 women and 458 men).
- Data Provenance: Not explicitly stated. Similar to the reference group, these values are "representative of the results obtained from clinical studies" for the predicate device. This suggests the data is retrospective and likely US-based, though not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes the analytical performance and clinical utility of an in vitro diagnostic assay, not the performance of human experts interpreting images or complex data. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) does not directly apply here.
The "ground truth" for the analytical performance studies (imprecision, correlation, interfering substances, analytical range, MDC) is the actual measured concentration of BNP in the samples, as determined by a well-controlled laboratory method (often the predicate device itself or a reference method).
For the "Expected Results" sections, the ground truth for patient classification (heart failure vs. no heart failure, and NYHA functional class) would have been established by clinical diagnosis. This would involve qualified medical professionals (e.g., cardiologists, physicians) using a combination of patient history, physical examination, imaging (e.g., echocardiography), and other clinical tests to make these diagnoses. The number and specific qualifications of these clinicians are not provided in this summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is an analytical performance study for an in vitro diagnostic device, not a study involving human reader agreement or adjudication of results.
5. 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 analytical comparison of two automated IVD assays, not an MRMC study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (imprecision, correlation, interfering substances, analytical range, minimum detectable concentration) are all standalone performance evaluations of the ADVIA IMS BNP assay device itself. The "Expected Results" sections describe how the device performs in clinically defined patient populations, again, as a standalone measurement device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Analytical Ground Truth: For the analytical performance characteristics (imprecision, correlation, interfering substances, analytical range, MDC), the ground truth is based on the quantified concentration of BNP in the samples. In the correlation study, the predicate device (ADVIA Centaur BNP assay) served as the comparator or reference method for the new device.
- Clinical Ground Truth (for Expected Results): For the reference and heart failure population data, the ground truth for classifying patients as "without heart failure" or "with heart failure" (and their NYHA functional class) was based on clinical diagnosis, which would typically include outcomes data, physical examinations, and other diagnostic tests, as determined by qualified medical professionals.
8. The sample size for the training set
This document does not describe a "training set" in the context of machine learning or AI. It describes the validation of a new in vitro diagnostic assay. The equivalent concept would be the development of the assay itself and the establishment of its calibration curves and internal parameters. The text indicates that the ADVIA IMS assay uses identical monoclonal antibodies to the predicate ADVIA Centaur assay and uses the Centaur BNP Master Curve Material (MCM) as calibrators. This implies that the underlying "training" for the assay's fundamental chemistry and measurement principles was established during the development of the predicate device and is being adapted or confirmed for the new platform. No specific "training set" sample size for this development is provided.
9. How the ground truth for the training set was established
As noted above, the concept of a "training set" in this context is primarily related to the development and calibration of the assay. The ground truth for developing and calibrating such an immunoassay typically involves:
- Known concentrations of BNP: Precisely quantified BNP standards are used to establish the dose-response relationship and build the master curve.
- Replicate measurements: Numerous measurements of these standards and various patient samples are performed to optimize assay parameters, ensure linearity, and define the analytical range.
The document indicates that the calibrators used for the ADVIA IMS BNP assay are the same as those used for the ADVIA Centaur assay (Centaur BNP Master Curve Material). This means the "ground truth" for the calibration of this new assay directly relies on the established and validated calibration from the predicate device. Details of how the predicate device's master curve ground truth was established are not provided here.
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JUN 1 3 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BNP Assay for Bayer ADVIA® Integrated Modular System (IMS)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K051265
June 6, 2005
1. Submitter's name, address and telephone number:
Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC A subsidiary of Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591 TEL: 914-524-2531 FAX: 914-524-2500 Email: andres holle b@bayer.com
2. Name of the device:
| a) | Classification Names: B-type natriuretic peptide test systems, §862.1117 |
|---|---|
| Classification: | Class II |
| Product Code: | NBC |
- b) Common name: BNP assays
- c) Proprietary name: ADVIA Immuno Modular System (IMS)® B-Type Natriuretic Peptide (BNP) Assay
d) The device:
| Product Name | Reagent Part# / BAN Number | Calibrator Part# / BAN Number |
|---|---|---|
| ADVIA IMS BNP Assay | 0154537(100 tests) | 00155177 |
3. Predicate Device:
| Product Name | Reagent Part # | Master CurveMaterial Part # |
|---|---|---|
| ADVIA Centaur BNP Assay | REF 02816634(500 tests)REF 02816138(100 tests) | REF 02815905 |
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4. Description of the device:
The ADVIA IMS BNP Assay is an in vitro immunoassay intended for the quantitative measurement of b-type natriuretic peptide (BNP) in human EDTA plasma covering the analytical range of 10 to approximately 6,000 pg/mL. The assay is a heterogeneous sandwich immunoassay using magnetic separation. Reagony a a freel genedus monoclonal antibody to BNP labeled with FITC and Reagent 2 (R2) contains the second monoclonal antibody to BNP (F(ab)2) conjugated to the enzyme /kaline phosphatase (ALP). The monoclonal antibodies used in the ADVIA IMS BNP assay are identical to those used in the ADVIA Centaur assay. The sandwich complex formed by the modite and the antibody conjugates is captured by the magnetic particles so that the BNP concentration in the sample can be measured in terms of enzyme activity. The substrate used for this assay is a dioxetane phosphate derivative, which is dephosphorylated by ALP resulting in photon emission. Luminescence is measured by a photomultiplier tube. The dose response curve is proportional to the analyte concentration in sample
The Centaur BNP Master Curve Material (MCM) (part number 02815905) will be used as the calibrators (six levels) for the ADVIA IMS BNP assay. The controls used in the ADVIA IMS BNP assay, QC BNP 1, 2, 3 (REF 02817045), are existing Bayer Centair products consisting of three levels of lyophilized controls. The controls contain various concentrations of BNP in buffered sodium caseinate with preservative.
5. Intended Use
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA IMS® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
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| ADVIA IMS BNP assay | ADVIA Centaur BNP assay(predicate device) | |
|---|---|---|
| Intended Use | Same | Same |
| Summary | Same | Same |
| Principle | Heterogeneous SandwichMagnetic Separation Assay | Heterogeneous SandwichMagnetic Separation Assay |
| Reagents | Two liquid reagents containedin system specific packaging | Two liquid reagents containedin system specific packaging |
| Storage | 2-8 °C | 2-8 °C |
| Stability | Same | Same |
| Precautions | Same | Similar |
| Indications ofDeterioration | Same | Same |
| PerformanceCharacteristics | Same | Same |
| Limitations | Same | Same |
| Parameters | Multi-point calibration,sandwich immunoassay andsystem specific parameters | Multi-point calibration,sandwich immunoassay andsystem specific parameters |
6. Similarities and Differences between ADVIA® IMS™ BNP assay and Bayer Centaur® BNP assay:
7. Performance summary:
a) Imprecision:
| ADVIA IMS | ADVIA Centaur | |||
|---|---|---|---|---|
| LevelTotal(pg/mL) CV(%) | Level(pg/mL) | TotalCV(%) | ||
| 71 | 4.1 | 48.5 | 3.5 | |
| 716 | 1.9 | 458 | 2.8 | |
| 2660 | 1.8 | 1736 | 2.9 |
b) Correlation:
| Specimen type | ComparisonSystem (X) | N | RegressionEquation | Syx(pg/mL) | R | SampleRange(pg/mL) |
|---|---|---|---|---|---|---|
| EDTA Plasma | ADVIACentaur | 360 | $0.990 * X + 4.37$ | 111.7 | 0.992 | 4 to 4531 |
(Y= ADVIA IMS, X= comparison system)
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c) Interfering substances:
| Interference | Interference Conc.mg/dL | Recovery (pg/mL) | %Deviation | |
|---|---|---|---|---|
| Expected | Observed | |||
| Albumin | 7,000 | 145.3 | 131.5 | -9.46 |
| 407.5 | 377.9 | -7.27 | ||
| Bilirubin | 25 | 79.4 | 80.6 | 1.50 |
| 366.1 | 356.4 | -2.65 | ||
| Cholesterol | 1,000 | 133.8 | 139.5 | 4.26 |
| 352.8 | 383.6 | 8.73 | ||
| Creatinine | 2.5 | 99.2 | 100.0 | 0.76 |
| 427.0 | 419.0 | -1.87 | ||
| Hemoglobin | 750 | 86.7 | 78.3 | -9.68 |
| 402.3 | 366.7 | -8.86 | ||
| Triglyceride | 800 | 86.2 | 83.4 | -3.19 |
| 389.4 | 384.3 | -1.32 | ||
| Urea Nitrogen | 200 | 87.7 | 88.9 | 1.34 |
| 380.2 | 382.0 | 0.48 | ||
| IgG | 4,600 | 129.3 | 141.2 | 9.15 |
| 398.7 | 435.8 | 9.30 |
d). Analytical Range:
4 pg/mL (1.1 pmol/L) to calibrator level 6 concentration (about 6000 pg/mL or 1728 pmol/L)
e) Minimum Detectable Concentration:
| ADVIA IMS BNP (pg/mL) | ADVIA Centaur BNP (pg/mL) |
|---|---|
| 4 | 2 |
f) Expected Results:
.
The expected values were determined from clinical studies performed for the predicate ADVIA Centaur BNP Test and results of the studies are included in the labeling for the ADVIA IMS BNP assay.
BNP concentrations in the Reference Group are shown in the tables below. The decision threshold was determined by the 95% confidence limit of BNP in the Reference population. The most appropriate decision threshold apparent from these distributions is 100 pg/mL. This BNP value translates into a general specificity of the test of greater than 97 %.
Reference Group
To establish the expected results, the circulating BNP concentration was determined from 1521 individuals without heart failure (785 women and 736 men). This population included apparently healthy individuals and individuals with hypertension, diabetes, renal insufficiency, and chronic obstructive pulmonary disease. The
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descriptive statistics for BNP concentrations in the population without heart failure are shown in the following tables. These values are representative of the results obtained from clinical studies.
| All | Age Group | |||||
|---|---|---|---|---|---|---|
| All | <45 years | 45-54 years | 55-64 years | 65-74 years | 75 + years | |
| Mean, pg/mL | 23.2 | 11.9 | 15.6 | 19.5 | 28.3 | 60.3 |
| SD, pg/mL | 32.5 | 12.9 | 15.9 | 22.6 | 25.4 | 73.0 |
| Median, pg/mL | 14.5 | 8.6 | 10.4 | 13.8 | 22.1 | 43.7 |
| 95th Percentile, pg/mL | 70.8 | 33.3 | 46.7 | 53.2 | 72.3 | 176 |
| % < 100 pg/mL | 97.4 | 99.7 | 99.7 | 98.8 | 97.0 | 85.5 |
| Minimum, pg/mL | <2 | <2 | <2 | <2 | <2 | <2 |
| Maximum, pg/mL | 576 | 128 | 119 | 286 | 164 | 576 |
| N | 1521 | 317 | 291 | 403 | 365 | 145 |
| Males | Age Group | ||||||
|---|---|---|---|---|---|---|---|
| All | <45years | 45-54years | 55-64years | 65-74years | 75 +years | ||
| Mean, pg/mL | 17.9 | 9.1 | 11.2 | 14.5 | 25.8 | 41.9 | |
| SD, pg/mL | 22.9 | 9.4 | 11.8 | 13.9 | 25.1 | 48.8 | |
| Median, pg/mL | 11.3 | 5.9 | 7.6 | 11.9 | 17.8 | 26.1 | |
| 95th Percentile, pg/mL | 54.3 | 29.4 | 32.8 | 38.8 | 67.6 | 121 | |
| % < 100 pg/mL | 98.6 | 100 | 100 | 99.5 | 96.8 | 94.6 | |
| Minimum, pg/mL | <2 | <2 | <2 | <2 | <2 | <2 | |
| Maximum, pg/mL | 250 | 56.6 | 88.9 | 132 | 151 | 250 | |
| N | 736 | 129 | 140 | 223 | 188 | 56 | |
| Females | Age Group | ||||||
| All | <45years | 45-54years | 55-64years | 65-74years | 75 +years | ||
| Mean, pg/mL | 28.1 | 13.8 | 19.8 | 25.6 | 31.0 | 71.9 | |
| SD, pg/mL | 38.8 | 14.6 | 18.0 | 29.0 | 25.5 | 82.9 | |
| Median, pg/mL | 18.5 | 10.4 | 14.8 | 19.4 | 25.7 | 54.3 | |
| 95th Percentile, pg/mL | 86.1 | 35.9 | 56.7 | 75.5 | 72.9 | 167 | |
| % < 100 pg/mL | 96.3 | 99.5 | 99.3 | 97.8 | 97.1 | 79.8 | |
| Minimum, pg/mL | <2 | <2 | <2 | <2 | <2 | <2 | |
| Maximum, pg/mL | 576 | 128 | 119 | 286 | 164 | 576 | |
| N | 785 | 188 | 151 | 180 | 177 | 89 |
Patients with Heart Failure
To establish the expected results for the ADVIA Centaur BNP assay in individuals with heart failure, plasma samples were obtained from 722 patients diagnosed with heart failure (264 women and 458 men). The descriptive statistics
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for BNP concentrations in patients with heart failure are presented in the following tables. These values are representative of the results obtained from clinical studies. Each laboratory should establish a reference range representing the patient population being evaluated. In addition, laboratories should be aware of the propertive institution's current practice for the evaluation of heart failure.
| NYHA Functional Class | |||||
|---|---|---|---|---|---|
| All | NYHA I | NYHA II | NYHA III | NYHA IV | |
| Mean, pg/mL | 505 | 178 | 270 | 525 | 1134 |
| SD, pg/mL | 711 | 347 | 402 | 576 | 1141 |
| Median, pg/mL | 262 | 64.3 | 130 | 355 | 843 |
| 5th percentile, pg/mL | 10.8 | 1.6 | 5.4 | 21.1 | 109 |
| 95th percentile, pg/mL | 1873 | 772 | 999 | 1696 | 3157 |
| % > 100 pg/mL | 72.6 | 43.1 | 58.7 | 82.0 | 95.8 |
| Minimum, pg/mL | <2 | <2 | <2 | <2 | 4.0 |
| Maximum, pg/mL | 6989 | 2310 | 3107 | 4052 | 6989 |
| N | 722 | 72 | 242 | 289 | 119 |
Heart Failure Population – All
Heart Failure Population – Males
| NYHA Functional Class | |||||
|---|---|---|---|---|---|
| All | NYHA I | NYHA II | NYHA III | NYHA IV | |
| Mean, pg/mL | 518 | 121 | 308 | 542 | 1214 |
| SD, pg/mL | 726 | 135 | 475 | 588 | 1200 |
| Median, pg/mL | 245 | 77.7 | 135 | 339 | 950 |
| 5th percentile, pg/mL | 10.7 | 3.9 | 4.4 | 23.2 | 71.5 |
| 95th percentile, pg/mL | 1946 | 400 | 1280 | 1852 | 3157 |
| % > 100 pg/mL | 72.9 | 44.7 | 61.3 | 81.4 | 93.9 |
| Minimum, pg/mL | <2 | <2 | <2 | <2 | 33.7 |
| Maximum, pg/mL | 6989 | 552 | 3107 | 3503 | 6989 |
| N | 458 | 47 | 150 | 194 | 66 |
Heart Failure Population - Females
| NYHA Functional Class | |||||
|---|---|---|---|---|---|
| All | NYHA I | NYHA II | NYHA III | NYHA IV | |
| Mean, pg/mL | 482 | 285 | 207 | 492 | 1034 |
| SD, pg/mL | 687 | 551 | 228 | 556 | 1068 |
| Median, pg/mL | 291 | 62.5 | 117 | 355 | 779 |
| 5th percentile, pg/mL | 11.0 | 0 | 9.5 | 15.9 | 115 |
| 95th percentile, pg/mL | 1575 | 1447 | 552 | 1518 | 2970 |
| % > 100 pg/mL | 72.0 | 40.0 | 54.3 | 83.2 | 98.1 |
| Minimum, pg/mL | <2 | <2 | <2 | 4.8 | 4.0 |
| Maximum, pg/mL | 5845 | 2310 | 1231 | 4052 | 5845 |
| N | 264 | 25 | 92 | 94 | 53 |
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These results show that there is a relationship between the severity of the clinical signs and symptoms of heart failure and the median BNP concentrations, demonstrating that the assay can be used as an aid in the diagnosis of all degrees of heart failure severity, including asymptomatic patients.
Andres Holle Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
.
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/7/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
JUN 1 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manger, Regulatory Affairs Bayer HealthCare LLC 511 Benedict Avenue Tarrytown, NY 10591
K051265 Re:
Trade/Device Name: B-type Natriuretic Peptide (BNP) Assay for the ADVIA IMS Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: May 12, 2005 Received: May 17, 2005
Dear Mr. Holle:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may of cable of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051265
Device Name: B-type Natriuretic Peptide (BNP) Assay for the ADVIA IMS
Indications for Use:
The Bayer ADVIA IMS BNP method is for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA IMS® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruth Chesler
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051265
§ 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.”