(61 days)
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in buman plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
The NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the NT-proBNP method on the Stratus® CS analyzer.
The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product intended to be used for dilution of the NT-proBNP Method on the Stratus® CS analyzer.
The Stratus® CS Acute Care™ NT-proBNP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassav (RPIA) technology. In this procedure, dendrimer linked polyclonal antibody is added to the center portion of a square piece of glass fiber paper in the pBNP TestPak. This antibody recognizes a distinct antigenic site on the NT-proBNP molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled polvclonal antibody directed against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP , forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of NT-proBNP in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Here's a summary of the acceptance criteria and study details for the Dade Behring Stratus® CS Acute Care™ NT-proBNP TestPak assay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was deemed "substantially equivalent" to the predicate device (Roche Diagnostics Elecsys® proBNP immunoassay). The acceptance criteria are implicitly defined by demonstrating comparable performance across various analytical and clinical metrics.
| Feature / Acceptance Criteria (Implicit) | Reported Device Performance (Stratus® CS Acute Care™ pBNP) | Comparison to Predicate (Roche Elecsys® proBNP) |
|---|---|---|
| Intended Use | For the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human plasma as an aid in the diagnosis and assessment of severity of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. | Similar intended use, with slight wording differences. The key clinical applications of diagnosis, severity assessment, and risk stratification are consistent. |
| Reportable Range | 15- 20,000 pg/mL | Predicate: 5 - 35,000 pg/mL. The Stratus® CS range is slightly narrower, but still overlaps significantly for clinical utility. |
| Analytical Sensitivity | 15 pg/mL | Predicate: 5 pg/mL. Stratus® CS has a slightly higher lower detection limit, but still within a clinically relevant range. |
| Functional Sensitivity | < 50 pg/mL | Predicate: < 50 pg/mL. Performance is equivalent. |
| Cut-off Values (for clinical use) | 125 pg/mL for patients < 75 years; 450 pg/mL for patients ≥ 75 years | Predicate: 125 pg/mL for patients < 75 years; 450 pg/mL for patients ≥ 75 years. Performance is equivalent; the document states, "The high level of equivalence... justifies using the same cutoffs." |
| Clinical Performance (Sensitivity, Males < 75 yrs) | 90% (84 – 95 CI) | Predicate: 91% (86 – 96 CI). Very similar. |
| Clinical Performance (Specificity, Males < 75 yrs) | 92% (86 – 98 CI) | Predicate: 93% (87 – 98 CI). Very similar. |
| Clinical Performance (Sensitivity, Females < 75 yrs) | 84% (74-94 CI) | Predicate: 84% (74-94 CI). Identical. |
| Clinical Performance (Specificity, Females < 75 yrs) | 92% (87-97 CI) | Predicate: 94% (90-99 CI). Very similar. |
| Method Comparison (Slope vs. Predicate) | 0.96 | Indicating good agreement (close to 1). |
| Method Comparison (Correlation Coefficient vs. Predicate) | 0.99 | Indicating very strong linear correlation. |
| Reproducibility (Within-Run Precision, %CV) | Pool 1: 4.2%; Pool 2: 3.2%; Pool 3: 2.6%; Level 1: 4.9%; Level 2: 2.1% | Not directly compared to a specific predicate value in the document, but these values are generally considered good for diagnostic assays. |
| Reproducibility (Total Precision, %CV) | Pool 1: 5.1%; Pool 2: 3.2%; Pool 3: 2.6%; Level 1: 4.9%; Level 2: 3.0% | Not directly compared to a specific predicate value in the document, but these values are generally considered good for diagnostic assays. |
| Lithium Heparin vs. Sodium Heparin Agreement (Slope) | 1.00 | Demonstrates excellent agreement between different heparin types, indicating flexibility in sample collection. |
| Lithium Heparin vs. Sodium Heparin Agreement (Correlation Coefficient) | 0.999 | Demonstrates excellent agreement. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Performance Test Set:
- Reference Study Group (without CHF): 308 individuals (163 Women, 145 Men).
- Disease Study Group (with CHF): 234 patients (70 women, 164 men).
- Provenance: Data used for clinical values were generated at the University of Maryland Medical Center. The document does not explicitly state if the data was retrospective or prospective, but clinical studies for such assays are typically prospective or involve collecting new samples from a defined population.
- Method Comparison Test Set:
- Sample Size: 481 heparinized plasma patient samples.
- Provenance: Not explicitly stated, but likely from the same clinical study background as the clinical performance data, given the reference to "method comparison and reference interval data sets generated at the University of Maryland Medical Center."
- Lithium Heparin vs. Sodium Heparin Test Set:
- Sample Size: 19 samples.
- Provenance: Not explicitly stated.
- Reproducibility Test Set:
- Sample Size: Multiple human plasma pools (n=3) and commercial controls (n=2). Each level was analyzed in duplicate once per day for 20 days (total of 40 measurements per level).
- Provenance: Laboratory testing according to NCCLS guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Clinical Performance: The ground truth for "congestive heart failure (CHF)" and "without congestive heart failure" was established by diagnosis. The document does not specify the number or qualifications of medical experts who made these diagnoses. However, it states that the "Disease Study Group" consisted of "patients diagnosed with congestive heart failure," implying physician diagnosis as the ground truth.
- Analytical Performance: Analytical ground truth for NT-proBNP concentrations in the test samples was established by the predicate device (Roche Elecsys® proBNP immunoassay) and verified against known standards for reproducibility and linearity studies.
4. Adjudication Method for the Test Set
- Clinical Performance: Not explicitly mentioned, but the ground truth (diagnosis of CHF) would typically be established by clinical consensus or accepted diagnostic criteria by treating physicians. There is no mention of a separate adjudication panel for the diagnostic status of the patients.
- Analytical Performance: Not applicable, as it involves comparison to an existing, validated method and instrument readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay that automates the measurement of a biomarker from a biological sample. It does not involve human readers interpreting images or data in a way that an MRMC study would be applicable. The comparison is between the performance of two automated assay systems.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, this was a standalone performance study of the algorithm (the immunoassay method) as a diagnostic test. The device provides quantitative measurements of NT-proBNP directly. The performance metrics (sensitivity, specificity, method comparison, reproducibility) are measures of the assay's performance on its own. Human clinicians then use these quantitative results for diagnosis and risk stratification, but the measurement itself is automated.
7. The Type of Ground Truth Used
- Clinical Performance: Clinical diagnosis (presence or absence of congestive heart failure) was used as the ground truth for patients in the clinical study groups.
- Analytical Performance: The measurements from the predicate device (Roche Elecsys® proBNP immunoassay) served as the comparative analytical ground truth for method comparison studies. Known concentrations in control materials were used as ground truth for reproducibility.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/machine learning model, as this is an immunoassay, not an AI-driven image analysis or prediction model. The "training" in this context refers to the development and optimization of the assay itself and its calibration. The calibration process uses specific calibrator materials.
- Calibration: The assay uses a "pBNP Calibrator" which is a frozen liquid product containing synthetic human NT-proBNP. The kit consists of five CalPaks, each with three wells of calibrator reagent (a single calibrator level). The calibration curve is updated for each lot, using one level, and every 30 days thereafter.
9. How the Ground Truth for the Training Set was Established
For the immunoassay, the "ground truth" for calibration (analogous to training) is established by known concentrations of synthetic NT-proBNP in the calibrator materials. These calibrators are traceable to a reference standard (Roche purified synthetic NT-proBNP (1-76)). The specific concentrations of NT-proBNP in the calibrator solution are precisely manufactured and assigned to ensure accurate quantitative measurement by the assay.
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FEB 1 5 2005
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: | George M. PlummerDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | December 14, 2004 |
| Name of Product(s): | Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak assayStratus® CS pBNP CalPak (the assay calibrator)Stratus® CS pBNP DilPak (the assay diluent) |
| FDA Classification Name(s): | B-type natriuretic peptide test system and calibrator (all 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 Stratus® CS Acute Care™ NT-proBNP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassav (RPIA) technology. In this procedure, dendrimer linked polyclonal antibody is added to the center portion of a square piece of glass fiber paper in the pBNP TestPak. This antibody recognizes a distinct antigenic site on the NT-proBNP molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled polvclonal antibody directed against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP , forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of NT-proBNP in the sample. The reaction rate can then be measured by an optical system that monitors the
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reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Calibrator
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 five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells.
Diluent
The Dade Behring pBNP Diluent is a refrigerated product containing a buffered bovine protein matrix with stabilizers and preservative. The kit consists of 5 DilPaks with diluent in one well.
Intended Use:
Method
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparanized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
Calibrator
The NT-proBNP (pBNP) Calibrator (CalPak), REF CPBNP-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ NT-proBNP method (pBNP).
Diluent
The NT-proBNP Dilution Pak (DilPak), REF CPBNP-D, is an in vitro diagnostic product intended to be used in conjunction with the pBNP TestPak, REF CPBNP, on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP.
Comparison to Predicate Device:
Method
A summary of the features of the Dade Behring Stratus® CS Acute Care™ pBNP TestPak and the predicate Roche Diagnostics Elecsys® proBNP immunoassay (K032646/K022516) is provided in the following charts. The Dade Behring pBNP TestPak utilizes the Roche polyclonal (sheep) antibody/antigen set.
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Method:
:
·
| Feature | Stratus® CS Acute Care™ pBNP | Roche Elecsys® proBNP |
|---|---|---|
| Intended Use | For the in vitro quantitativedetermination of N-terminalpro-brain natriuretic peptide inhuman plasma as an aid in thediagnosis and assessment ofseverity of individuals suspected ofhaving congestive heart failure.The test is further indicated for therisk stratification of patients withacute coronary syndrome and heartfailure. | 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(fluorometric) | immunoassay(electrochemiluminescent) |
| Reportable Range | 15- 20,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Roche Diagnostics'polyclonal (sheep) antibody | polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL for patients less than 75years and 450 pg/mL for patients 75years and older | 125 pg/mL for patients less than 75years and 450 pg/mL for patients 75years and older |
| AnalyticalSensitivity | 15 pg/mL | 5 pg/mL |
| FunctionalSensitivity | < 50 pg/mL | < 50 pg/mL |
| AnalyticalSpecificity | The pharmaceutical Natrecor®shows no significant cross reactivityat 0 and 125 pg/mL NT-proBNP;sixteen other substances also showno significant cross reactivity | The pharmaceutical Natrecor® showsno significant cross reactivity at 300pg/mL and 3000 pg/mL NT-proBNP;sixteen other substances also show nosignificant cross reactivity |
| Interferences | No significant interference from: bilirubin, conj. up to 60 mg/dLbilirubin, unconjugated up to 60 mg/dL hemoglobin up to 1000 mg/dL triglycerides up to 3000 mg/dL rheumatoid factors up to 750 IU/mL | No significant interference from: bilirubin up to 35 mg/dLhemoglobin up to 1.4 g/dL triglycerides up to 4000 mg/dL rheumatoid factors up to 1500 IU/mL |
| Reference | Roche purified synthetic NT-proBNP (1-76) | Roche purified synthetic NT-proBNP (1-76) |
| Hook Effect | No high dose effect ( up to 1,400,000 pg/mL) | No high dose effect ( up to 300,000 pg/mL) |
| Calibration Interval | Calibration curve updated for each lot, using one level and every 30 days, thereafter with the same reagent lot. After calibration update at completion of each test, recovered values are calculated from stored calibration coefficients. | Calibration curve updated for each lot, using two levels every 30 days with the same reagent lot. |
| Sample Volume | 50 uL | 20 uL |
:
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Calibrator:
| Feature | Stratus® CS Acute Care™ pBNP | Roche Elecsys® proBNP |
|---|---|---|
| Intended Use | pBNP method calibration | proBNP method calibration |
| Analyte | Synthetic NT-proBNP | Synthetic NT-proBNP |
| Matrix | Bovine albumin | Horse serum |
| Form | Liquid | Lyophilyzed |
| Volume | 150 uL in each of three wells | 1 mL for each level |
| Levels | 1 level | 2 levels (140 and 2700 pg/mL) |
Method performance Summary:
Clinical Results
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 healthy individuals and individuals with diabetes, hypertension, and pulmonary disease. For the Disease Study Group, blood samples were obtained from 234 patients diagnosed with congestive heart failure (CHF); this population included 70 women and 164 men.
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The high level of equivalence between the two assays on clinical performance measures justifies using the same cutoffs for the Stratus® CS Acute Care™ pBNP assay as the Elecsys® proBNP 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 presented in the tables below 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-DroBNP assay versus predicate device on Male patients. | ||
|---|---|---|
| LE SALES CONSULTION CONSULTION COLLECTION COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION |
| Males | <75 yrs (95% CI) | ≥ 75 yrs (95% CI) | |
|---|---|---|---|
| Sensitivity (%) | Stratus® CS pBNP | 90% (84 – 95) | 92% (84 – 99) |
| Elecsys® proBNP | 91% (86 – 96) | 92% (84 – 99) | |
| Specificity (%) | Stratus® CS pBNP | 92% (86 – 98) | 73% (61 – 84) |
| Elecsys® proBNP | 93% (87 – 98) | 73% (61 – 84) | |
| NPV | Stratus® CS pBNP | 86% (79 – 94) | 92% (84 – 100) |
| Elecsys® proBNP | 89% (82 – 95) | 92% (84 – 100) |
Clinical Performance of Dade Behring NT-proBNP assay versus predicate device on Female Patients
| Females | <75 yrs (95% CI) | ≥75 yrs (95% CI) | |
|---|---|---|---|
| Sensitivity (%) | Stratus® CS pBNP | 84% (74-94) | 95% (85-100) |
| Elecsys® proBNP | 84% (74-94) | 95% (85-100) | |
| Specificity (%) | Stratus® CS pBNP | 92% (87-97) | 85% (76-94) |
| Elecsys® proBNP | 94% (90-99) | 87% (78-95) | |
| NPV | Stratus® CS pBNP | 92% (87-97) | 98% (94-100) |
| Elecsys® proBNP | 92% (87-97) | 98% (94-100) |
Analytical Results
Method Comparison
A split sample method comparison demonstrated good agreement between the Dade Behring Stratus® CS Acute Care™ NT-proBNP TestPak method and the predicate Roche Elecsys® proBNP immunoassay with heparinized plasma patient samples.
| ComparativeMethod | Slope | Intercept(pg/mL) | CorrelationCoefficient | n |
|---|---|---|---|---|
| Roche Elecsys® proBNP | 0.96 | 5.5 | 0.99 | 481 |
The model equation for Passing-Bablok linear regression statistics is: [results for Stratus = slope x [comparative method results] + intercept. The range of NT-proBNP values in the correlation study was: 16.1 - 17691.9 pg/mL.
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Lithium Heparin versus Sodium Heparin
Comparison of lithium heparin versus sodium heparin samples on the Stratus® CS system showed very good agreement. Lithium heparin samples (n=19) ranging from < 15 to 15,810 pg/mL when compared to sodium heparin samples gave a slope of 1.00, correlation coefficient of 0.999, and intercept of 28 pg/mL using Passing-Bablok regression statistics.
Reproducibility
Typical precision observed for the Stratus® CS NT-proBNP TestPak method is summarized below:
| Within-Run Precision | Total Precision | |||||
|---|---|---|---|---|---|---|
| Sample | Mean (pg/mL) | SD (pg/mL) | %CV | SD (pg/mL) | %CV | |
| Human Plasma Pool | ||||||
| Pool 1 | 153 | 6.5 | 4.2 | 7.8 | 5.1 | |
| Pool 2 | 463 | 15.0 | 3.2 | 15.0 | 3.2 | |
| Pool 3 | 6726 | 177.3 | 2.6 | 177.3 | 2.6 | |
| MAS® CardioImmune® proBNP Control | ||||||
| Level 1 | 156 | 7.7 | 4.9 | 7.7 | 4.9 | |
| Level 2 | 5371 | 115.5 | 2.1 | 158.6 | 3.0 |
- MAS® and CardioImmune® are registered trademarks of Medical Analysis Systems, Inc., Camarillo, CA
The reproducibility testing was conducted 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.
Calibrator
The Stratus® CS pBNP CalPak is similar to other calibrator products associated with their assays, such as the Roche Elecsys® proBNP CalSet calibrator.
Diluent
The Stratus® CS pBNP DilPak is similar to other diluent products associated with their assays, such as the Roche Elecys® proBNP CalSet diluent.
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Comments on Substantial Equivalence:
Both the Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak 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 ® CS Acute Care™ NT-proBNP (pBNP) TestPak 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 and diluent products are also equivalent in their design and intended use with their respective assay systems.
George M. Plummer Regulatory Affairs and Compliance Manager December 14, 2004
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wave-like lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 5 2005
Mr. George M. Plummer Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community Building 500, MS 514 PO Box 6101 Newark, DE 19714
Re: K043476
K043470
Trade/Device Name: Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak assay Stratus® CS pBNP CalPak Stratus® CS pBNP DilPak Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT Dated: December 14, 2004 Received: December 16, 2004
Dear Mr. Plummer:
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, do floos that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may attress, 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 caojoer of the 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 r houre of action and 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 or any 1 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,
Sean M. Cooper MS, DUM
Jean 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
Ko43476 510(k) Number (If Known):
Device(s) Name(s):
Stratus® CS Acute Care™ NT-proBNP (pBNP) TestPak assay Stratus® CS pBNP CalPak Stratus® CS pBNP DilPak
Indications for Use:
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in buman plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
The NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the NT-proBNP method on the Stratus® CS analyzer.
The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product intended to be used for dilution of the NT-proBNP Method on the Stratus® CS analyzer.
✓
510(k) Numbe
Prescription Use (Part 21 CFR 801 Subpart D)
and/or
Over-the-counter Use (21 CFR 801 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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
§ 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.”