(48 days)
Not Found
No
The summary describes a standard immunoassay for measuring BNP levels and does not mention any AI or ML components. The performance studies focus on comparing the assay to a predicate device using traditional statistical methods.
No.
The device is used for in vitro diagnostic testing to aid in the diagnosis and assessment of heart failure, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section states: "BNP values are used as an aid in the diagnosis and assessment of severity of heart failure." This directly indicates a diagnostic purpose.
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) process involving reagents, microparticles, and a system (ARCHITECT i System) to measure light units. This indicates a hardware-based laboratory assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma." This involves testing a biological sample (plasma) outside of the body to gain information about a person's health status.
- Aid in Diagnosis: The intended use also states that BNP values are used as an "aid in the diagnosis and assessment of severity of heart failure." This directly aligns with the purpose of IVDs, which are used to provide information for diagnostic purposes.
- Device Description: The description details a "chemiluminescent microparticle immunoassay (CMIA)" which is a common technology used in IVD tests to measure specific substances in biological samples.
- Sample Type: The device analyzes "human EDTA plasma," which is a biological sample.
- Performance Studies: The document describes performance studies comparing the device to a predicate device using "EDTA plasma samples" from individuals with and without heart failure. This is typical for the validation of IVD devices.
- Predicate Device: The mention of a "Predicate Device" (ABBOTT AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Test) which is also an IVD, further supports the classification of this device as an IVD.
All of these points strongly indicate that the ARCHITECT BNP assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ARCHITECT BNP Reagent Kit: The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
ARCHITECT BNP Calibrator Kit: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.
ARCHITECT BNP Control Kit: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.
Product codes (comma separated list FDA assigned to the subject device)
NBC, JIT, JJX
Device Description
ARCHITECT BNP assay is a two-step immunoassay for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma using CMIA technology with flexible assay protocols, refereed to as Chemiflex®.
In the first step, sample and anti-BNP coated paramagnetic microparticles are combined. BNP present in the sample bind to the anti-BNP coated microparticles. After washing, anti-BNP acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of BNP in the sample and the RLUs detected by the ARCHITECT i System optics.
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
Clinical and Hospitals laboratories
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
A study was performed with guidance from NCCLS Protocol EP9-A2' to compare the ARCHITECT BNP assay to the AxSYM BNP assay. EDTA plasma samples form 171 individuals (128 heart failure patients, 43 non-heart failure individuals) were tested with both assays. These samples were collected from populations of individuals with and without heart failure.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison study. Sample size: 171. The results from the Passing-Bablok linear regression analysis showed a correlation coefficient of 0.96, an intercept (95% CI) of -38.32 (-48.26 to -28.50), and a slope (95% CI) of 1.03 (0.98 to 1.09). Sample Range (ARCHITECT): 0-3702 pg/mL Sample Range (AxSYM): 50 - 3103 pg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient: 0.96
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
510(k) SUMMARY
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: _
MAY 2 5 2006
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 | |
|---------------------------|------------------------------------------------------------------------------|--|
| Contact person: | Diana L. Wolaniuk, (610) 240-3917 | |
| Summary preparation date: | April 4, 2006 | |
| Name of Device | | |
| Trade/Proprietary Name: | ARCHITECT® BNP Assay | |
| Common/Usual Name: | BNP (B-Type Natriuretic Peptide) Test | |
Predicate Device
Classification Name:
ABBOTT AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Test
Test, Natriuretic Peptide
Device Description
ARCHITECT BNP assay is a two-step immunoassay for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma using CMIA technology with flexible assay protocols, refereed to as Chemiflex®.
In the first step, sample and anti-BNP coated paramagnetic microparticles are combined. BNP present in the sample bind to the anti-BNP coated microparticles. After washing, anti-BNP acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of BNP in the sample and the RLUs detected by the ARCHITECT i System optics.
For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.
1
Intended Use
Reagent Kit
The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
Calibrator Kit
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.
Control Kit
The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.
2
Statement of Substantial Equivalence
The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
The ARCHITECT BNP Assay kit is substantially equivalent to the AxSYM BNP Assay. Both of the devices are IVD products and are indicated for the quantitative determination of BNP assay values (human B-type natriuretic peptide) and used as an aid in the diagnosis and assessment of severity of heart failure.
A study was performed with guidance from NCCLS Protocol EP9-A2' to compare the ARCHITECT BNP assay to the AxSYM BNP assay. EDTA plasma samples form 171 individuals (128 heart failure patients, 43 non-heart failure individuals) were tested with both assays. These samples were collected from populations of individuals with and without heart failure. The results from the Passing-Bablok2 linear regression analysis is summarized in the following table. *
| ARCHITECT BNP vs. AxSYM BNP | |||||
|---|---|---|---|---|---|
| Regression | |||||
| Method | Specimen | ||||
| Type | N | Correlation | |||
| Coefficient | Intercept | ||||
| (95% CI) | Slope | ||||
| (95% CI) | |||||
| Passing- | |||||
| Bablok** | EDTA | ||||
| Plasma | 171 | 0.96 | -38.32 | ||
| (-48.26 to -28.50) | 1.03 | ||||
| (0.98 to 1.09) |
Sample Range (ARCHITECT): 0-3702 pg/mL Sample Range (AxSYM): 50 - 3103 pg/mL
- Representative data; variables such as differences in sampling size and population may impact the correlation of the assay. Therefore, results in individual laboratories may vary from these data. .
** A linear regression method with no special assumptions regarding the distribution of the samples and measurement errors.
1 National Committee for Clinical Laboratory Standards. Method comparison and bias estimation using patient samples; Approved Guideline-Second Edition. NCCLS Document EP9-A2, Wayne, PA: NCCLS, 2002.
2 Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21(11)709-20.
3
A comparison of the features of the ARCHITECT BNP assay device and the AxSYM BNP assay device are as follows:
| | ARCHITECT BNP
(Proposed Device) | AxSYM BNP
(Predicate Device)
K033606 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and
Product Code | Class II, NBC | Class II, NBC |
| Principle of Operation | Chemiluminscent Microparticle
Immunoassay (CMIA) | Microparticle Enzyme
Immunoassay (MEIA) |
| Product Usage | Clinical and Hospitals laboratories | Clinical and Hospitals laboratories |
| Intended Use | The ARCHITECT BNP assay is a
chemiluminescent microparticle
immunoassay (CMIA) for the
quantitative determination of
human B-type natriuretic peptide
(BNP) in human EDTA plasma on
the ARCHITECT i System. BNP
values are used as an aid in the
diagnosis and assessment of
severity of heart failure. | AxSYM BNP is a Microparticle
Enzyme Immunoassay (MEIA) for
the quantitative determination of
human B-type natriuretic peptide
(BNP) in human EDTA plasma on
the AxSYM System. BNP values
are used as an aid in the diagnosis
and assessment of severity of
heart failure. |
| Type of Specimen | EDTA Plasma | EDTA Plasma |
| Specimen Collection
Method | Plastic collection tubes | Plastic collection tubes |
| Capture Antibody | Anti-BNP (106.3) mouse
monoclonal | Anti-BNP (106.3) mouse
monoclonal |
| Conjugate Antibody | Anti-BNP (BC203) mouse
monoclonal | Anti-BNP (BC203) mouse
monoclonal |
| Calibrator | 6 levels (0 - 5000 pg/mL) | 6 levels (0 - 4000 pg/mL) |
| Controls | 3 levels (Low = 90 pg/mL,
Medium = 500 pg/mL, High =
3500 pg/mL) | 3 levels (Low = 100 pg/mL,
Medium = 440 pg/mL, High =
1500 pg/mL) |
| Interpretation of Results | Calibrator Curve
A direct relationship exists
between the amount of BNP in the
sample and the light detected by
the instrument system | Calibrator Curve
A direct relationship exists
between the amount of BNP in the
sample and the light detected by
the instrument system |
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Diana L. Wolaniuk Clinical and Regulatory Affairs Specialist Fujirebio Diagnostics, Inc. 201 Great Valley Parkway - Malvern, PA 19355
MAY 2 5 2006
Re: K060964
Trade/Device Name: ARCHITECT® BNP ARCHITECT BNP Reagent Kit ARCHITECT BNP Calibrator Kit ARCHITECT BNP Control Kit
Regulation Number: 21 CFR§862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class II Product Code: NBC, JIT, JJX Dated: April 5, 2006 Received: April 7, 2006
Dear Ms. Wolaniuk:
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).
5
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 G
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
6
Indications for Use
510(k) Number (if known):
Device Name: ARCHITECT® BNP
Indications For Use:
ARCHITECT BNP Reagent Kit
The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
ARCHITECT BNP Calibrator Kit
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.
ARCHITECT BNP Control Kit
The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.
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)
Carol C. Benson
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
s(k) K060964
349