(89 days)
No
The summary describes a standard immunoassay system for measuring NT-proBNP levels, with no mention of AI or ML in the intended use, device description, or other sections.
No
This device is for in vitro diagnostic (IVD) use to aid in the diagnosis and risk stratification of heart failure, and for assessment of heart failure severity. It measures a biomarker, but does not treat or alleviate a disease, nor does it affect the structure or function of the body.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids "in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure." This directly indicates a diagnostic purpose.
No
The device description clearly outlines a system comprised of physical components: reagent packs, calibrators, range verifiers, and instrumentation. This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the VITROS Immunodiagnostics NT-proBNP Reagent Pack is "For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma..." The term "in vitro" means "in glass" or "in a test tube," indicating that the test is performed outside of the living body, which is a key characteristic of IVDs.
- Device Description: The description details a system that uses reagents and calibrators to measure analytes in human body fluids (serum and plasma). This process of analyzing biological samples outside the body is the core function of an IVD.
- Components: The components listed (reagent pack, calibrators, range verifiers) are typical components of an IVD assay kit used to perform a diagnostic test on a biological sample.
Therefore, based on the provided information, the VITROS Immunodiagnostic System and its associated components are clearly intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
VITROS Immunodiagnostics NT-proBNP Reagent Pack:
For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).
Product codes (comma separated list FDA assigned to the subject device)
NBC, JIT, JJX
Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of there main elements:
- . The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, the VITROS Immunodiagnostic Products NT-proBNP Calibrators, and the VITROS Immunodiagnostic Products NT-proBNP Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS NTproBNP assay) and VITROS Immunodiagnostic Products High Sample Diluent B.
- . The VITROS Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- . Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
JUN -6 2006
Image /page/0/Picture/2 description: The image shows the logo for Ortho-Clinical Diagnostics, which is identified as a Johnson & Johnson company. Below the logo is the address "100 Indigo Creek Drive, Rochester, New York 14626-5101". The logo is in black and white.
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.
The assigned 510(k) number is:
1 Submitter Name, Address and Contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-4131
Contact Person: Leah Van De Water
2 Preparation Date
Date 510(k) prepared: March 8, 2006
3 Device Name
- VITROS Immunodiagnostic Products NT-proBNP Reagent Pack Common Name: NT-proBNP Reagent Pack Classification Name: B-Type natriuretic peptide test system (862.1117), Class II
- VITROS Immunodiagnostic Products NT-proBNP Calibrators Common Name: NT-proBNP Calibrators Classification Name: Calibrator (862.1150), Class II
- VITROS Immunodiagnostic Products NT-proBNP Range Verifiers Common Name: NT-proBNP Range Verifiers Classification: Quality control material (862.1660), Class I
1
4 Predicate Device
The VITROS Immunodiagnostic Products NT-proBNP Reagent Pack . VITROS Immunodiagnostic Product NT-proBNP Calibrators are substantially equivalent to the Roche Elecsys® proBNP Immunoassay K051382.
The VITROS Immunodiagnostic Products NT-proBNP Range Verifiers are substantially equivalent to the VITROS Immunodiagnostic Product CEA Range Verifiers previously cleared under K990984.
5 Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of there main elements:
- . The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, the VITROS Immunodiagnostic Products NT-proBNP Calibrators, and the VITROS Immunodiagnostic Products NT-proBNP Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS NTproBNP assay) and VITROS Immunodiagnostic Products High Sample Diluent B.
- . The VITROS Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- . Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
2
4.0: 510(k) Summary
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
б Device Intended Use
VITROS Immunodiagnostics NT-proBNP Reagent Pack:
For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).
7 Comparison to Predicate Device
The VITROS Immunodiagnostic Products NT-proBNP Reagent Pack and Calibrators is substantially equivalent to the Roche Elecsys proBNP Immunoassay K051382. The VITROS Immunodiagnostic Products NT-proBNP Range Verifiers are substantially equivalent to the VITROS Immunodiagnostic Products CEA Range Verifiers K990984.
Tables 1 through 3 compare the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, Calibrator and Range Verifier to the Roche Elecsys proBNP Immunoassay K051382 and VITROS Immunodiagnostic Products CEA Range Verifiers K990984.
3
| Table 1 | Comparison of the VITROS Immunodiagnostic
Products NT-proBNP Reagent Pack to the Elecsys
proBNP Reagent Pack |
| --------- | -------------------------------------------------------------------------------------------------------------------- |
|---|
| Comparison
Device
Characteristic | VITROS
(new device) | Elecsys
(predicate device) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro
quantitative
measurement of N-
terminal pro Brain
Natriuretic Peptide
(NT-proBNP) in
human serum and
plasma (EDTA or
heparin) to aid in the
diagnosis of
congestive heart
failure and for the risk
stratification of acute
coronary syndrome
and congestive heart
failure. The test is
further indicated as an
aid in the assessment
of increased risk of
cardiovascular events
and mortality in
patients at risk for
heart failure who have
stable coronary artery
disease. The test can
also be used in the
assessment of heart
failure severity in
patients diagnosed
with congestive heart
failure. | For the in vitro quantitative
determination of N-terminal pro-
Brain natriuretic peptide in human
serum and plasma. The Elecsys
proBNP assay is used as an aid in
the diagnosis of individuals
suspected of have congestive heart
failure. The test is further
indicated for the risk stratifications
of patients with acute coronary
syndrome and congestive heart
failure. The test may also serve as
an aid in the assessment of
increased risk of cardiovascular
events and mortality in patients at
risk for heart failure who have
stable coronary artery disease. |
| Basic principle | Chemiluminescence
Immunoassay | Electrochemiluminescence
Immunoassay |
| Antibody | Biotinylated polyclonal
anti-NT-proBNP
(sheep) | Biotinylated polyclonal anti-NT-
proBNP (sheep) |
| Instrumentation | ECI/ECIQ
Immunodiagnostic
System: Automated
analyzer | Elecsys family of analyzers
(Elecsys 1010, Elecsys 2010 and
Elecsys Modular Analytics
Immunassay Analyzers |
| Sample type | Human serum and
plasma (EDTA and
heparin) | Human serum and plasma |
| Expected Values | Age and sex-related statistics Cut-offs of 125 pg/mL for patients
younger than 75 years and 450
pg/mL for patients
75 years and older | Age and sex-related statistics Cut-offs of 125 pg/ml for
patients younger than 75 years
and 450 pg/mL for patients 75
years and older |
| Measuring Range | 5.00-35,000 pg/mL | 5-35,000 pg/mL |
| Hook Effect | No high dose hook
effect up to 500,000
pg/mL | No high dose hook effect up to
300,000 pg/mL |
| Analytical Sensitivity | Trade/Device Name: VITROS Immunodiagnostic Products NT-proBNP Reagent Pack VITROS Immunodiagnostic Products NT-proBNP Calibrator VITROS Immunodiagnostic Products NT-proBNP Range Verifier Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC, JIT, JJX Dated: May 5, 2006 Received: May 8, 2006
Dear Ms. Water:
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 (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,
Alberto Garcia
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
VITROS Immunodiagnostic Products NT-proBNP Reagent Pack VITROS Immunodiagnostic Products NT-proBNP Calibrator VITROS Immunodiagnostic Products NT-proBNP Range Verifier
Indications for Use:
VITROS Immunodiagnostics NT-proBNP Reagent Pack:
For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).
ﺮ ﺍ Prescription Use (Per 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 | Page __ of __ |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| (510(k)) K060632 |