(54 days)
The Dade Behring Dimension® PBNP Flex® reagent cartridge method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure.
The Dade Behring Dimension® PBNP Calibrator is intended to be used to calibrate the N-terminal pro-brain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system.
The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The PBNP method is a one step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with polyclonal antibodies which recognize an epitope located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)] labeled polyclonal antibody specific for a second independent epitope on NT-proBNP, to form a particle/NT-proBNP/conjugate sandwich. Unbound conjugate is removed by magnetic separation and washing. After separation and washing, the particle/NT-proBNP/coniugate sandwich is transferred to the cuvette where the sandwich-bound ALP triggers an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to produce FAD. FAD binds to apo D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase produces multiple molecules of hydrogen peroxide (H2O2). H2O2 in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510 nm. The color change measured is directly proportional to the concentration of proBNP present in the patient sample.
The Dade Behring PBNP Calibrator is a frozen liquid product containing synthetic human NT-proBNP in a bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials at each of five levels, 1.0 mL in each vial.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method, based on the provided text:
Acceptance Criteria and Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device (Roche Diagnostics Elecsys® proBNP immunoassay) rather than explicitly stating pre-defined "acceptance criteria" for novel device performance. The performance metrics presented are comparative against the predicate.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Dade Behring Dimension® PBNP) | Comparison to Predicate (Roche Elecsys® proBNP) |
|---|---|---|
| Clinical Performance: | ||
| Sensitivity for <75 years (Male) | 84% (77 - 91% CI) | Predicate: 90% (85 - 96% CI) |
| Sensitivity for ≥75 years (Male) | 91% (84 - 99% CI) | Predicate: 91% (84 - 99% CI) |
| Specificity for <75 years (Male) | 94% (90- 99% CI) | Predicate: 92% (87 - 98% CI) |
| Specificity for ≥75 years (Male) | 77% (67-88% CI) | Predicate: 73% (61 - 84% CI) |
| NPV (Male) | 82 (<75 yrs), 92 (≥75 yrs) | Predicate: 88 (<75 yrs), 92 (≥75 yrs) |
| Sensitivity for <75 years (Female) | 77% (64 – 89% CI) | Predicate: 81% (70–92% CI) |
| Sensitivity for ≥75 years (Female) | 91% (79 – 100% CI) | Predicate: 95% (87 – 104% CI) |
| Specificity for <75 years (Female) | 93% (89–98% CI) | Predicate: 91% (85–96% CI) |
| Specificity for ≥75 years (Female) | 88% (80–96% CI) | Predicate: 87% (78–95% CI) |
| NPV (Female) | 91 (<75 yrs), 96 (≥75 yrs) | Predicate: 92 (<75 yrs), 98 (≥75 yrs) |
| Analytical Performance: | ||
| Correlation Coefficient (vs. predicate) | 0.985 (n=352) | Not applicable (comparison metric) |
| Slope (vs. predicate) | 0.90 | Not applicable (comparison metric) |
| Intercept (vs. predicate) | -15.4 pg/mL | Not applicable (comparison metric) |
| Reportable Range | 10 - 30,000 pg/mL | Predicate: 5 - 35,000 pg/mL |
| Analytical Sensitivity | ≤ 10 pg/mL | Predicate: 5 pg/mL |
| Functional Sensitivity | ≤ 30 pg/mL | Predicate: < 50 pg/mL |
| Cut-off for < 75 years | 125 pg/mL | Predicate: 125 pg/mL |
| Cut-off for ≥ 75 years | 450 pg/mL | Predicate: 450 pg/mL |
| Within-Run Precision (Pool 1) | 2.2% CV (159.0 pg/mL mean) | Not directly compared, shown to be low |
| Total Precision (Pool 1) | 5.7% CV (159.0 pg/mL mean) | Not directly compared, shown to be low |
| Within-Run Precision (QC Pool 1) | 1.8% CV (449.5 pg/mL mean) | Not directly compared, shown to be low |
| Total Precision (QC Pool 1) | 3.7% CV (449.5 pg/mL mean) | Not directly compared, shown to be low |
| Within-Run Precision (QC Pool 2) | 1.6% CV (956.7 pg/mL mean) | Not directly compared, shown to be low |
| Total Precision (QC Pool 2) | 3.6% CV (956.7 pg/mL mean) | Not directly compared, shown to be low |
| Within-Run Precision (Audit™ Level 1) | 1.1% CV (175.5 pg/mL mean) | Not directly compared, shown to be low |
| Total Precision (Audit™ Level 1) | 3.8% CV (175.5 pg/mL mean) | Not directly compared, shown to be low |
| Within-Run Precision (Audit™ Level 2) | 1.9% CV (3733.8 pg/mL mean) | Not directly compared, shown to be low |
| Total Precision (Audit™ Level 2) | 3.1% CV (3733.8 pg/mL mean) | Not directly compared, shown to be low |
Study Information
The study primarily supporting this 510(k) submission is a comparative study demonstrating substantial equivalence between the new Dimension® PBNP Flex® method and the predicate Roche Elecsys® proBNP immunoassay.
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Sample size used for the test set and the data provenance:
- Clinical Performance Study:
- Reference Study Group (without CHF): 308 individuals (163 women, 145 men).
- Disease Study Group (with CHF): 227 patients (69 women, 158 men).
- Data Provenance: The text states, "Data used to calculate the values are from the method comparison and reference interval data sets generated at the University of Maryland Medical Center." This implies prospective collection or a well-defined retrospective cohort from a specific medical center in the USA.
- Analytical Performance (Method Correlation):
- Sample Size: 352 split patient heparinized plasma samples.
- Data Provenance: Not explicitly stated, but likely from the same source as the clinical performance data (University of Maryland Medical Center).
- Reproducibility: Involved human plasma pools, internal QC pools, and commercial control materials. The number of individual patient samples in these pools is not specified, but the testing involved 20 days of duplicate analysis.
- Clinical Performance Study:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the clinical study was based on diagnosis of congestive heart failure (CHF). The document does not specify the number or qualifications of experts who established these diagnoses. It refers to individuals "without congestive heart failure" and "patients diagnosed with congestive heart failure (CHF)," implying standard clinical diagnostic procedures, likely by physicians, determined the CHF status.
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Adjudication method for the test set:
- No information on a specific adjudication method (e.g., 2+1, 3+1) is provided for the clinical diagnoses of CHF or for resolving discrepancies. The diagnoses are assumed to be a clinical standard.
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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:
- No, a MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, directly measuring a biomarker. It's not an image-based or interpretive AI device that involves human readers or their interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is a standalone algorithm (an automated immunoassay method) without "human-in-the-loop performance" in the sense of human interpretation being required for each result. The device generates quantitative NT-proBNP values independently. Clinical interpretation of these values as an "aid in diagnosis" is then performed by a healthcare professional.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical performance evaluation was the clinical diagnosis of congestive heart failure (CHF). This would typically be based on a combination of patient symptoms, physical examination, imaging (e.g., echocardiography), and other clinical findings, representing an "outcomes data" or "clinical diagnosis" type of ground truth.
- For the analytical performance (method correlation study), the ground truth was the measurements obtained from the predicate device (Roche Elecsys® proBNP immunoassay). This is a common approach for demonstrating substantial equivalence for new diagnostic assays.
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The sample size for the training set:
- The document does not explicitly mention a separate "training set" in the context of device development. This type of immunoassay development typically involves calibration and verification steps rather than machine learning training. The information provided focuses on the validation (test) set for demonstrating performance against the predicate.
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How the ground truth for the training set was established:
- As no explicit "training set" is described for this immunoassay (which is not an AI/ML device), this question is not applicable. The device's calibration is performed using the provided PBNP Calibrator, which contains synthetic human NT-proBNP at known concentrations.
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JUL 2 0 2004
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Richard M. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | May 26, 2004 |
| Name of Product(s): | Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method,and Dimension® PBNP Calibrator |
| FDA Classification Name(s): | B-type natriuretic peptide test system and calibrator (both Class II) |
| FDA Guidance Documents: | "Class II Special Control Guidance Document for B-Type NatriureticPeptide Premarket Notifications; Final Guidance for Industry andFDA Reviewers" - 11/30/2000 |
| Predicate Device(s): | Roche Diagnostics Elecsys® proBNP immunoassay and CalSetcalibrator (K032646/K022516) |
Device Description(s):
Method
The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The PBNP method is a one step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with polyclonal antibodies which recognize an epitope located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)] labeled polyclonal antibody specific for a second independent epitope on NT-proBNP, to form a particle/NT-proBNP/conjugate sandwich. Unbound conjugate is removed by magnetic separation and washing. After separation and washing, the particle/NT-proBNP/coniugate sandwich is transferred to the cuvette where the sandwich-bound ALP triggers an amplification cascade. * ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to produce FAD. FAD binds to apo D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase produces multiple molecules of hydrogen peroxide (H2O2). H2O2 in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510 nm. The color change measured is directly proportional to the concentration of proBNP present in the patient sample.
- Technology licensed from London Biotechnology, Ltd., London, U.K.
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Calibrator
Cantorator
The Dade Behring PBNP Calibrator is a frozen liquid product containing synthetic human NT-proBNP in a bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials at each of five levels, 1.0 mL in each vial.
Intended Use:
Method
The Dimension® PBNP Flex® method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure (CHF).
Calibrator
The PBNP Calibrator is an in vitro diagnostic product intended to be used to calibrate the N-terminal probrain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system with the heterogeneous immunoassay module.
Comparison to Predicate Device:
A summary of the features of the Dade Behring Dimension® PBNP Flex® method and the predicate Roche Diagnostics Elecsys® proBNP immunoassay (K032646/K022516) is provided in the following chart. The Dade Behring Dimension® PBNP assay utilizes the same antibody/antigen set as the predicate, Roche Diagnostics Elecsys® proBNP immunoassay.
| Feature | Dimension® PBNP | Roche Elecsys® proBNP |
|---|---|---|
| Intended Use | For the in vitro quantitativedetermination of N-terminalpro-brain natriuretic peptide inhuman plasma as an aid in thediagnosis of individuals suspectedof having congestive heart failure. | For the in vitro quantitativedetermination of N-terminal pro-brainnatriuretic peptide in human serumand plasma as an aid in the diagnosisof individuals suspected of havingcongestive heart failure.The test is further indicated for therisk stratification of patients withacute coronary syndrome andcongestive heart failure. |
| Assay Type(detection) | immunoassay(photometric) | immunoassay(electrochemiluminescent) |
| Reportable Range | 10 - 30,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Roche Diagnostics'polyclonal (sheep) antibody | polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL for patients < 75 years;450 pg/mL for patients ≥ 75 years | 125 pg/mL for patients < 75 years;450 pg/mL for patients ≥ 75 years |
| AnalyticalSensitivity | ≤ 10 pg/mL | 5 pg/mL |
| FunctionalSensitivity | ≤ 30 pg/mL | < 50 pg/mL |
| AnalyticalSpecificity | The pharmaceutical Natrecor®shows no significant cross reactivityat 0 and 125 pg/mL NT-proBNP;sixteen other substances show nosignificant cross reactivity | The pharmaceutical Natrecor® showsno significant cross reactivity at300 pg/mL and 3000 pg/mLNT-proBNP; sixteen othersubstances show no significant crossreactivity |
| Interferences | No significant interference from:bilirubin, conj. up to 60 mg/dLbilirubin, unconj. up to 20 mg/dLhemoglobin up to 1000 mg/dLtriglycerides up to 3000 mg/dLrheumatoid factors up to 500 IU/mL | No significant interference from:bilirubin up to 35 mg/dLhemoglobin up to 1.4 g/dLtriglycerides up to 4000 mg/dLrheumatoid factors up to 1500 IU/mL |
| Reference | Roche purified syntheticNT-proBNP (1-76) | Roche purified syntheticNT-proBNP (1-76) |
| Hook Effect | No high dose effect( up to 300,000 pg/mL) | No high dose effect( up to 300,000 pg/mL) |
| Calibration Interval | 30 days - same reagent lot | 30 days - same reagent lot |
| Sample Volume | 50 uL | 20 uL |
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Method Performance Summary
CLINICAL
For the Reference Study Group, NT-proBNP concentrations were determined in 308 individuals without congestive heart failure (163 women and 145 men); this population included apparently health individuals and individuals with diabetes, hypertension, and pulmonary disease. For the Disease Study Group, blood
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samples were obtained from 227 patients diagnosed with congestive heart failure (CHF); this population included 69 women and 158 men.
The high level of equivalence on clinical performance measures justifies using the cutoffs recommended for the predicate device, as shown below:
| Patients < 75 years: | 125 pg/mL [14.8 pmol/L] |
|---|---|
| Patients ≥75 years: | 450 pg/mL [53.2 pmol/L] |
The clinical performance of the Dade Behring assay was substantially equivalent to that of the predicate device. Data used to calculate the values are from the method comparison and reference interval data sets generated at the University of Maryland Medical Center.
Clinical Performance of Dade Behring NT-proBNP assay vs. predicate device on Male patients.
| Males | <75 yrs (95% CI) | ≥75 yrs (95% CI) | |
|---|---|---|---|
| Sensitivity (%) | Dimension® PBNP | 84 (77 - 91) | 91 (84 - 99) |
| Elecsys® proBNP | 90 (85 - 96) | 91 (84 - 99) | |
| Specificity (%) | Dimension® PBNP | 94 (90- 99) | 77 (67-88) |
| Elecsys® proBNP | 92 (87 - 98) | 73 (61 - 84) | |
| NPV | Dimension® PBNP | 82 | 92 |
| Elecsys® proBNP | 88 | 92 |
Clinical Performance of Dade Behring NT-proBNP assay vs. predicate device on Female patients.
| Females | <75 yrs (95% CI) | ≥75 yrs (95% CI) | |
|---|---|---|---|
| Sensitivity (%) | Dimension® PBNP | 77 (64 – 89) | 91 (79 – 100) |
| Elecsys® proBNP | 81 (70–92) | 95 (87 – 104) | |
| Specificity (%) | Dimension® PBNP | 93 (89–98) | 88 (80–96) |
| Elecsys® proBNP | 91 (85–96) | 87 (78–95) | |
| NPV | Dimension® PBNP | 91 | 96 |
| Elecsys® proBNP | 92 | 98 |
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ANALYTICAL
Comparison using split patient heparinized plasma samples between the Dade Behring Dimension® PBNP Flex® method and the predicate Roche Elecsys® proBNP immunoassay demonstrated good agreement between the methods as summarized below:
| Method Correlation | ||||
|---|---|---|---|---|
| Comparative Method | Slope | Intercept(pg/mL) | CorrelationCoefficient | n |
| Roche Elecsys® proBNP | 0.90 | -15.4 | 0.985 | 352 |
Model equation by Passing-Bablok linear regression statistics is: [results for Dimension = slope x [comparative method results] + intercept. The range of NT-proBNP values in the correlation study was: 16.1 to 29,893.1 pg/mL.
In addition, comparison of lithium heparin versus sodium heparin and EDTA plasma samples on the Dimension® system showed very good agreement. Lithium heparin samples ranging from 13 to 29,221 pg/mL when compared to sodium heparin and EDTA samples gave slopes of 0.95 and 0.96, correlation coefficients of 0.998 and 0.998, and intercepts of 0.9 and 10.9 respectively, using Passing-Bablok regression statistics.
Reproducibility
| Mean (pg/mL) | Within-Run Precision | Total Precision | |||
|---|---|---|---|---|---|
| SD (pg/mL) | %CV | SD (pg/mL) | %CV | ||
| Human Plasma Pool | |||||
| Pool 1 | 159.0 | 3.4 | 2.2 | 9.1 | 5.7 |
| Internal QC Pools | |||||
| Pool 1 | 449.5 | 8.1 | 1.8 | 16.6 | 3.7 |
| Pool 2 | 956.7 | 15.3 | 1.6 | 34.9 | 3.6 |
| AuditTM MicroFDTM BNP Control * | |||||
| Level 1 | 175.5 | 2.0 | 1.1 | 6.8 | 3.8 |
| Level 2 | 3733.8 | 71.8 | 1.9 | 115.9 | 3.1 |
Typical precision observed for the Dimension® PBNP Flex® method is summarized below:
The reproducibility testing was done in accordance with the NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A, 1999. Specimens at each level were analyzed in duplicate once per day for 20 days. The within-run and total standard deviations were calculated by the analysis of variance method.
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- Audit™ and MicroFD™ are registered trademarks of Audit™ MicroControls, Inc., Las Vegas, NV
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Comments on Substantial Equivalence:
Both the Dade Behring Dimension® PBNP and the Roche Elecsys® proBNP immunoassays are intended for the quantitative determination of NT-proBNP. Comparative data for human plasma samples demonstrate good analytical and clinical agreement between the methods.
Conclusion:
The Dade Behring Dimension® PBNP Flex® method and the predicate Roche Elecsys® proBNP immunoassay (K032646/K022516) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products are also equivalent in their design and intended use with their respective assay systems.
Richard M. Vaught Regulatory Affairs and Compliance Manager May 26, 2004
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
JUL 2 0 2004
Re: K041417
Trade/Device Name: Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method Dimension® PBNP Calibrator Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC, JIT Dated: May 26, 2004 Received: May 27, 2004
Dear Mr. Vaught:
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 can be found in Title 21, Code 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 (OS) 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Tean M. Cooper, MS, D.V.M. 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 STATEMENT
Device(s) Name(s):
Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method, and Dimension® PBNP Calibrator
Indications for Use:
The Dade Behring Dimension® PBNP Flex® reagent cartridge method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure.
The Dade Behring Dimension® PBNP Calibrator is intended to be used to calibrate the N-terminal pro-brain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system.
RmVaught
Richard M. Vaught
Richard M. Vaught Regulatory Affairs and Compliance Manager
May 26, 2004
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)
Aleat Catz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041117
Page 1 of
§ 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.”