(112 days)
Not Found
No
The summary describes a standard immunoassay for measuring a specific biomarker and does not mention any AI or ML components in its description, intended use, or performance studies.
No
This device is an in vitro diagnostic immunoassay used to aid in the diagnosis of congestive heart failure by measuring proBNP levels, rather than providing treatment.
Yes
The device is described as "an aid in the diagnosis of individuals suspected of having congestive heart failure," which directly indicates a diagnostic purpose.
No
The device is an immunoassay, which is a laboratory test that uses antibodies to detect and measure specific substances in a sample. This involves physical reagents and a laboratory analyzer (the Roche Elecsys family of analyzers), indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description states "A device for the measurement of human proBNP in serum or plasma." This describes a test performed on biological samples outside of the body, which is characteristic of an IVD.
- Purpose: The device is intended "for use as an aid in the diagnosis of individuals suspected of having congestive heart failure." This diagnostic purpose, performed on biological samples, aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
Intended Use: For the quantitative determination of N-terminal pro-Brain natriuretic peptide.
Indications for Use: An aid in the diagnosis of individuals suspected of having congestive heart failure.
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure.
Product codes (comma separated list FDA assigned to the subject device)
NBC; JIT; JJX
Device Description
A device for the measurement of human proBNP in serum or plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document provides a comparison of performance characteristics between the Elecsys proBNP Immunoassay and the predicate device, Biosite Triage BNP Test.
Precision:
- Elecsys proBNP Immunoassay:
- E170: Within-run 0.8-1.1 %CV from 208-13,682 pg/mL; Total 3.6-5.8% CV from 200-13143 pg/mL
- E101/2010: Within-run 1.8-2.7 %CV from 175-4962 pg/mL; Total 2.2-3.2 %CV from 175-4962 pg/mL
- Biosite Triage BNP Test (predicate): Average within-run 9.4-15.2 %CV from 28.8-1080.4 pg/mL; Average total 10.1-16.2 %CV
Hook Effect:
- Elecsys proBNP Immunoassay: No high dose hook effect up to 300,000 pg/mL
- Biosite Triage BNP Test (predicate): NA
Analytical sensitivity (LDL):
- Elecsys proBNP Immunoassay: 5 pg/mL
- Biosite Triage BNP Test (predicate): 5 pg/mL
Measuring Range:
- Elecsys proBNP Immunoassay: 5-35,000 pg/mL
- Biosite Triage BNP Test (predicate): 5-1300 pg/mL
Limitations/Warnings/Precautions:
- Elecsys proBNP Immunoassay: No interference from bilirubin up to 35 mg/dL; No interference from hemoglobin up to 1.4 g/dL; No interference from triglycerides up to 4000 mg/dL; No interference with biotin up to 30 ng/mL; No interference from rheumatoid factor up to 1500 IU/mL; In patients receiving high biotin doses > 5 mg/dL, sample should not be taken until 8 hours after administration; Rare occurrence of interference from high titers of anti-streptavidin and ruthenium; Use in conjunction with patient medical history, clinical exam and other findings.
- Biosite Triage BNP Test (predicate): No interference from bilirubin up to 20 mg/dL; No interference from hemoglobin up to 10000 mg/dL (severely hemolyzed specimens should be avoided); No interference from triglycerides up to 1000 mg/dL; No interference from cholesterol up to 1000 mg/dL; Blood concentrations of natriuretic peptides may be elevated in patients with acute myocardial infarction, patients that are candidates for renal dialysis, and patients that have undergone renal dialysis; Results should be evaluated in the context of all the clinical and laboratory data available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics in the format of sensitivity, specificity, PPV, NPV are not explicitly provided. The document focuses on analytical performance characteristics such as precision and analytical sensitivity (LDL).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
0
Roche Diagnostic Corporations 11/12/02
K022516- Elecsys ProBNP
510(k) Summary
NOV 1 9 2002
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
(317) 521 - 3544
Contact Person: Kay A. Taylor
Date Prepared: September 12, 2002 |
| Device Name | Proprietary name: Elecsys® proBNP Immunoassay
Common name: proBNP test
Classification name: Test, Natriuretic Peptide |
| Device
Description | A device for the measurement of human proBNP in serum or plasma. |
| Intended use | For the quantitative determination of N-terminal pro-Brain natriuretic peptide. |
| Indications for
Use | An aid in the diagnosis of individuals suspected of having congestive heart
failure. |
1
Roche Diagnostic Corporations 11/12/02
510(k) Summary, Continued
The Elecsys proBNP Immunoassay is substantially equivalent to other Substantial devices legally marketed in the United States. We claim equivalence to the equivalence Biosite Triage BNP Test cleared under K003475. Both products are intended for use in the quantitative determination of brain natriuretic peptides.
The following table compares the Roche Elecsys proBNP Immunoassay with Substantial equivalence the predicate device. comparison
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| Feature | Elecsys proBNP
Immunoassay | Biosite Triage BNP Test
(predicate) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | For the quantitative
determination of N-terminal
pro-Brain natriuretic peptide. | Measurement of B-Type
Natriuretic Peptide (BNP). |
| Indication for Use | An aid in the diagnosis of
individuals suspected of
having congestive heart
failure. | An aid in the diagnosis of
congestive heart failure in
patients age 55 and older |
| Assay Protocol | Electrochemiluminescent
immunoassay | Fluorescence Immunoassay |
| Traceability / Standardization | Reference standard - purified
synthetic NTG-proBNP (1-
76) in human serum matrix | Purified BNP preparation
based on mass of analyte
present in EDTA plasma |
| Calibration Interval | E170/E2010
After 1 month when using
the same reagent lot After 7 days when using
the same reagent kit
E1010 With every reagent kit After 7 days (20-25°C) After 3 days (25-32°C) | Each kit |
| Sample Type | Human serum and plasma | Human whole blood and
EDTA plasma |
| Calibrator | Elecsys proBNP CalSet | Electronic code chip |
| Controls | Elecsys PreciControl proBNP | Triage® BNP Controls |
ំ ដោ
Continued on next page
2
510(k) Summary, Continued, Continued
| Feature | Elecsys proBNP
Immunoassay | Biosite Triage BNP Test
(predicate) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent Stability | Unopened
• Up to stated expiration
date stored at 2-8°C
Opened
• 12 weeks at 2-8°
• 8 weeks on E170
• 8 weeks on E2010
• 4 weeks on E1010 (20-25°
ambient temp - up to 20
hours opened in total) | • Up to stated expiration
date when stored at 2-8°C.
• 14 days at ambient
temperature |
| Expected Values | • Age and sex-related
descriptive statistics
provided
• Cut-offs of 125 pg/ml for
patients younger than 75
years and 450 pg/ml for
patients 75 years and
older are recommended. | • Age and sex-related
descriptive statistics
provided
• Cut-off 100 pg/mL
recommended |
| Instrument | Elecsys family of analyzers
(Elecsys 1010, Elecsys 2010
and Elecsys E170
MODULAR Analytics
Immunoassay Analyzers) | Triage® Meter |
| Measuring Range | 5-35,000 pg/mL | 5-1300 pg/mL |
| Feature | Elecsys proBNP Immunoassay | Biosite Triage BNP Test
(predicate) |
| Precision | E170
Within-run 0.8-1.1 %CV from 208-13,682 pg/mL Total 3.6-5.8% CV from 200-13143 pg/mL
E101/2010 Within-run 1.8-2.7 %CV from 175-4962 pg/mL Total 2.2-3.2 %CV from 175-4962 pg/mL | Average within-run 9.4-15.2 %CV from 28.8-1080.4 pg/mL Average total 10.1-16.2 %CV |
| Hook Effect | No high dose hook effect up to
300,000 pg/mL | NA |
| Analytical
sensitivity (LDL) | 5 pg/mL | 5 pg/mL |
| Limitations/Warnings/Precautions | No interference from bilirubin up to 35 mg/dL No interference from hemoglobin up to 1.4 g/dL No interference from triglycerides up to 4000 mg/dL No interference with biotin up to 30 ng/mL No interference from rheumatoid factor up to 1500 IU/mL In patients receiving high biotin doses > 5 mg/dL, sample should not be taken until 8 hours after administration Rare occurrence of interference from high titers of anti-streptavidin and ruthenium Use in conjunction with patient medical history, clinical exam and other findings | No interference from bilirubin up to 20 mg/dL. No interference from hemoglobin up to 10000 mg/dL
Severely hemolyzed specimens should be avoided. No interference from triglycerides up to 1000 mg/dL No interference from cholesterol up to 1000 mg/dL Blood concentrations of natriuretic peptides may be elevated in patients with acute myocardial infarction, patients that are candidates for renal dialysis, and patients that have undergone renal dialysis Results should be evaluated in the context of all the clinical and laboratory data available |
Continued on next page
3
Roche Diagnostic Corporations 11/12/02
100 - 100 - 100 -
510(k) Summary, Continued
The performance characteristics of the Elecsys proBNP Immunoassay and the Substantial equivalence predicate device are compared in the table below. performance characteristics
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kay A. Taylor Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
NOV 1 9 200
Re: K022516
Trade/Device Name: Elecsys® proBNP Immunoassay Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; JIT; JJX Dated: October 23, 2002 Received: October 24, 2002
Dear Ms. Taylor:
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.
5
Page 2 -
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). 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). Other general information on your responsibilities under the Act may be obtained 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,
Daniel H. L.
Steven 1. Gutman, M.D., M.B.A. Director
Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
k 022
510(k) Number (if known): Nes
Device Name:
Elecsys® proBNP Immunoassay
Indications For Use:
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K022516