(360 days)
Not Found
No
The device description details a standard immunoenzymometric assay and the analysis focuses on clinical performance metrics of the assay itself, not on any computational or algorithmic interpretation of the results using AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is for in vitro diagnostic use, meaning it measures a substance in a sample (like blood) to aid in diagnosis, rather than directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assay is "designed for IN VITRO DIAGNOSTIC USE ONLY" and is "used as an aid in the diagnosis of heart failure".
No
The device description clearly outlines a physical assay kit (ST AIA-PACK BNP test cups) and its interaction with a physical analyzer (Tosoh AIA System analyzers) to perform an immunoenzymometric assay. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "for IN VITRO DIAGNOSTIC USE ONLY".
- Device Description: The description details an assay performed on human plasma samples to measure a specific analyte (BNP) using laboratory techniques (immunoenzymometric assay). This is characteristic of an in vitro diagnostic test.
- Clinical Setting: The intended user is "Clinical and Hospital laboratories," which are settings where IVD tests are performed.
- Performance Data: The document provides performance metrics like sensitivity, specificity, PPV, and NPV, which are standard measures for evaluating the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" (SIEMENS ADVIA Centaur® BNP Assay) with a K number indicates that this device is being compared to a previously cleared IVD.
All of these points strongly indicate that the Tosoh ST AIA-PACK BNP assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human K2EDTA plasma on Tosoh AIA System analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.
Product codes (comma separated list FDA assigned to the subject device)
NBC
Device Description
The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.
ST AIA-PACK BNP (Cat. No. 025228)
The ST AIA-PACK BNP set consists of 5 trays x 20 test cups. Each kit contains plastic test cups containing twelve magnetic lyophilized beads coated with anti-BNP mouse monoclonal antibody and 100 µL of anti-BNP mouse monoclonal antibody conjugated to alkaline phosphatase with sodium azide as a preservative.
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
The study included patients from 22 to 97 years old. The mean age was 67 and the median age was 67.
Intended User / Care Setting
Clinical and Hospital laboratories, Emergency Department (ED)
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
The prospective study enrolled male and female patients from 8 clinical sites comprised of Emergency Departments (ED). The study included patients who were presented to the ED with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF, where a clinician would order a BNP test as part of a differential diagnosis. Patient samples were stored at -20°C or colder then sent to a central location for testing at a Tosoh Bioscience lab. A total of 825 samples were assayed for BNP using the Tosoh AIA 2000 Analyzer. Out of the 825 samples, a total number of 724 samples were used for the analysis. 101 samples were excluded from the analysis. Most of these exclusions were due to hemolysis and patients with severe renal insufficiency requiring dialysis (estimated glomerular filtration rate (eGFR)
§ 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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2020
Fujirebio Diagnostics, Inc. Stacey Dolan Sr. Manager, Regulatory Affairs 201 Great Valley Parkway Malvern, PA 19355
Re: K192380
Trade/Device Name: ST AIA-PACK BNP Regulation Number: 21 CFR 862.1117 Regulation Name: B-Type Natriuretic Peptide Test System Regulatory Class: Class II Product Code: NBC Dated: July 14, 2020 Received: July 15, 2020
Dear Stacey Dolan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192380
Device Name ST AIA-PACK BNP
Indications for Use (Describe)
The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human K2EDTA plasma on Tosoh AIA System analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized blue and white graphic on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc.", which is placed below it. The logo is clean and professional, with a focus on the company's name and brand.
Section 5 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
BNP
D. Type of Test:
Quantitative, Automated Immunoenzymometric assay on the Tosoh AIA System Analyzers
| E. Sponsor: | |
|---|---|
| Address: | Tosoh Bioscience, Inc. |
| 6000 Shoreline Court, Suite 101 | |
| South San Francisco, CA 94080 | |
| Contact person: | Dave Wurtz |
| Sr. Director Quality, Regulatory and Clinical | |
| (415) 635-4762 | |
| dave.wurtz@tosoh.com |
F. Application correspondent:
| Address: | Fujirebio Diagnostics, Inc. |
|---|---|
| 201 Great Valley Parkway | |
| Malvern, PA 19355 |
- Contact person: Stacey Dolan Sr. Manager, Regulatory Affairs (610) 240-3843 dolans@fdi.com
Summary preparation date: August 20, 2020
G. Proprietary/Established and Common Names:
-
- Proprietary/Established Names: ST AIA-PACK BNP
-
- Common Name: BNP
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Image /page/4/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized blue and green graphic on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
H. Regulatory Information:
-
- Requlation section: 21 CFR § 862.1117, Test, Natriuretic Peptide
-
- Classification: Class II
-
- Product code: NBC, B-Type natriuretic peptide test system
-
- Panel: 75, Chemistry
- l. Intended Use:
-
- Intended use(s): See indications for use below.
-
- Indication(s) for use:
The Tosoh ST AIA PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human (K2EDTA) plasma on Tosoh AIA System Analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.
-
- Special conditions for use statement(s): Prescription use only
-
- Special instrument requirements: Tosoh AIA System Analyzers
J. Device Description:
The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.
ST AIA-PACK BNP (Cat. No. 025228)
The ST AIA-PACK BNP set consists of 5 trays x 20 test cups. Each kit contains plastic test cups containing twelve magnetic lyophilized beads coated with anti-BNP mouse monoclonal antibody and 100 µL of anti-BNP mouse monoclonal antibody conjugated to alkaline phosphatase with sodium azide as a preservative.
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Image /page/5/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a combination of blue and green shapes, with a white teardrop shape in the center. The text "FUJIREBIO" is in blue, and "Diagnostics, Inc." is in black.
Other Materials/Equipment Required (not Provided):
AIA Systems: AIA-2000 ST AIA-2000 LA
AIA PACK
AIA-PACK Substrate Set II AIA-PACK Substrate Reagent II/ AIA-PACK Substrate Reconstituent II AIA-PACK Wash Concentrate AIA-PACK Diluent Concentrate Sample Cups AIA-PACK Detector Standardization Test Cups Pipette Tips (1000/pkg) Tip Rack (empty) Preloaded Pipette Tips (96 tips x 50 racks) Preloaded Pipette Tips (96 Tips x 5 Racks)
K. Substantial Equivalence Information:
-
- Predicate device name(s): SIEMENS ADVIA Centaur® BNP Assay
-
- Predicate 510(k) number(s): K031038
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| ST AIA-PACK BNP | ||
| (Proposed Device) | SIEMENS ADVIA Centaur® BNP | |
| (Predicate Device) | ||
| K031038 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class II | Class II |
| CFR section | 21 CFR 862.1117 | 21 CFR 862.1117 |
| Product Code | NBC | NBC |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | The Tosoh ST AIA PACK BNP | |
| assay is designed for IN VITRO | ||
| DIAGNOSTIC USE ONLY for the | ||
| quantitative measurement of BNP | ||
| in human (K₂EDTA) plasma on | ||
| Tosoh AIA System Analyzers. BNP | ||
| is used as an aid in the diagnosis of | ||
| heart failure in patients presenting | For in vitro diagnostic use in the | |
| quantitative determination of B- | ||
| type Natriuretic Peptide (BNP) in | ||
| human plasma using the ADVIA | ||
| Centaur and ADVIA Centaur XP | ||
| systems. This assay is indicated | ||
| for the measurement of plasma | ||
| BNP as an aid in the diagnosis |
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Image /page/6/Picture/1 description: The image is a logo for Fujirebio Diagnostics, Inc. The logo features a stylized graphic on the left, consisting of blue and green shapes. To the right of the graphic is the company name, "FUJIREBIO", in large, bold, blue letters. Below the company name is the text "Diagnostics, Inc.", in a smaller font size.
| Similarities | ||
|---|---|---|
| ST AIA-PACK BNP | ||
| (Proposed Device) | SIEMENS ADVIA Centaur® BNP | |
| (Predicate Device) | ||
| K031038 | ||
| to the emergency department (ED) | ||
| with symptoms suggestive of heart | ||
| failure. | and assessment of the severity of | |
| heart failure. | ||
| Type of Specimen | Human K₂EDTA plasma | Human EDTA Plasma |
| Specimen Collection | ||
| Method | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Analyte | Human B-type Natriuretic Peptide | |
| (BNP) | Human B-type Natriuretic Peptide | |
| (BNP) | ||
| Cut-off | 100 pg/mL | 100 pg/mL |
| Differences | ||
|---|---|---|
| ST AIA-PACK BNP | ||
| (Proposed Device) | SIEMENS ADVIA Centaur® BNP | |
| (Predicate Device) | ||
| K031038 | ||
| Instrument System | Tosoh AIA Analyzer 2000 | ADVIA Centaur and ADVIA |
| Centaur XP Systems | ||
| Principle of Operation | Immunoenzymometric Assay | Chemiluminescence immunoassay |
| Assay Range | 4.0 - 2000pg/mL |