(200 days)
Not Found
No
The device description details a standard immunoenzymometric assay based on chemical reactions and standard curve calculations, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an in vitro diagnostic (IVD) assay designed to measure BNP levels to aid in the diagnosis of heart failure. It is not used to treat or prevent a disease.
Yes
The device is explicitly stated to be "designed for IN VITRO DIAGNOSTIC USE ONLY" and "used as an aid in the diagnosis of heart failure".
No
The device is an in vitro diagnostic assay kit, which is a physical reagent and consumable product used with a specific hardware analyzer. It is 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 "designed for IN VITRO DIAGNOSTIC USE ONLY".
- Measurement of Analytes: The device measures BNP in human plasma, which is a biological sample.
- Diagnostic Aid: The assay is used "as an aid in the diagnosis of heart failure". This indicates its role in providing information for a medical diagnosis.
- Laboratory Setting: The description of the assay process (immunoenzymometric assay, magnetic beads, fluorogenic substrate) points to a laboratory-based test.
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 microL of anti-BNP mouse monoclonal antibody conjugated to alkaline phosphatase with sodium azide as a preservative.
Other Materials/Equipment Required (not Provided):
Tosoh AIA Analyzer 2000
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
AIA-PACK Sample Treatment Cups
Pipette Tips (1000/pkg)
Tip Rack (empty)
Preloaded Pipette Tips (96 tips x 50 racks)
Preloaded Pipette Tips (96 Tips x 5 Racks)
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
For use on patients presenting to the Emergency Department (ED).
The Tosoh ST AIA PACK BNP assay is intended for prescription use only, on Tosoh AIA Analyzer 2000.
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)
Manual dilution study had a recovery value of 102% for 1:5 and 100% for 1:10 dilution.
On-board (automated) dilution study had a recovery value of 95% for 1:5 and 95% for 1:10 dilution.
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.
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2021
Tosoh Bioscience, Inc. Louise Musante Regulatory Compliance Consultant 6000 Shoreline Court. Suite 101 South San Francisco, CA 94080
Re: K211199
Trade/Device Name: ST AIA-PACK BNP Assay Regulation Number: 21 CFR 862.1117 Regulation Name: B-Type Natriuretic Peptide Test System Regulatory Class: Class II Product Code: NBC Dated: April 20, 2021 Received: April 22, 2021
Dear Louise Musante:
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
1
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 803) 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 mediation-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,
Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ST AIA-PACK BNP Assay
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/0 description: The image shows the logo for Tosoh Bioscience. The logo consists of a red cross-like symbol with a white square in the center, followed by the text "TOSOH BIOSCIENCE" in bold black letters. Below the symbol, the text "TOSOH" is written in a smaller font size.
510(k) Summary Tosoh Bioscience, Inc.'s ST AIA-PACK BNP Assay
DATE PREPARED: April 20, 2021
-
- COMPANY NAME/CONTACT Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080
-
- CONTACT: Louise Musante Regulatory Compliance Consultant Email: louise.musante@tosoh.com Cell Phone: (650) 242-5563
3. DEVICE INFORMATION
Device Trade Name: ST AIA-PACK BNP Assay Regulation Number: 21 CFR Part 862.1117 Regulation Name: Test, Natriuretic Peptide Product Code: NBC, B-Type natriuretic peptide test system Device Class: Class II 510(k) Review Panel: Clinical Chemistry
Assigned Special 510(k) number: K211199
4. PREDICATE DEVICE
Trade name: ST AIA-PACK BNP Assay
| 510(k) submitter/holder: | Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Francisco, CA 94080 |
| -------------------------- | -------------------------------------------------------------------------------------------- |
|---|
510(k) Number:
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Image /page/4/Picture/0 description: The image shows the logo for Tosoh Bioscience. The logo consists of a red cross-like symbol with a white square in the center, followed by the text "TOSOH BIOSCIENCE" in bold, black letters. Below the cross symbol, the text "TOSOH" is written in smaller, black letters.
5. 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.
Other Materials/Equipment Required (not Provided):
Tosoh AIA Analyzer 2000
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 AIA-PACK Sample Treatment Cups Pipette Tips (1000/pkg) Tip Rack (empty) Preloaded Pipette Tips (96 tips x 50 racks) Preloaded Pipette Tips (96 Tips x 5 Racks)
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Image /page/5/Picture/0 description: The image shows the logo for Tosoh Bioscience. The logo consists of a red cross-like symbol with a white square in the center, followed by the text "TOSOH" in a smaller font size. To the right of the logo, the words "TOSOH BIOSCIENCE" are written in a larger, bold font.
6. INDICATION FOR USE STATEMENT
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.
7. INTENDED USE STATEMENTS:
(See above Indications For Use Statement).
The Tosoh ST AIA PACK BNP assay is intended for prescription use only, on Tosoh AIA Analyzer 2000.
8. REASON FOR SUBMISSION
This Special 510(k) is being filed to seek FDA clearance for the ST AIA-PACK BNP assay, a modified version of the existing ST AIA-PACK BNP assay, which is currently cleared (K192380, FDA cleared on August 24, 2020).
9. DESCRIPTION OF DEVICE MODIFICATION
The ST AIA-PACK BNP device is being modified to add a manual and automated dilution claim to the existing ST AIA-PACK BNP assay 510(k) clearance (K192380).This modification does not change the Intended Use/Indications for Use. the fundamental scientific technology, reagent formulation, assay configuration, manufacturing procedures, principle of operation, or safety and effectiveness of the device.
A summary of the modifications and the rationale for the changes between the current cleared Device: ST AIA-PACK BNP assay (K192380) and the ST AIA-PACK BNP assay with the dilution claims (modified device) are provided in Table 1 below.
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Table 1 - Summary of Modifications to Subject Device Compared to Predicate Device
| Cleared Device (K192380) | Candidate Device
(Modification) | Rationale |
|--------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No sample dilution claim | Addition of a 1:5 and 1:10
manual & automated
dilution claim for the ST
AIA-PACK BNP Assay | To allow a clinician to extend the measuring interval
of the ST AIA-PACK BNP assay (above the
analytical measurement interval of 2,000pg/mL)
through specimen dilution, prepared both manually
or onboard (automated) by the analyzer, for higher
concentration BNP specimens. |
10. SUBSTANTIAL EQUIVALENCE COMPARISON
The Tosoh ST AIA PACK BNP assay is substantially equivalent to the claimed predicate device; the Tosoh ST AIA PACK BNP (K192380), based on comparisons of the intended use and technological characteristics.
| Attributes | ST AIA-PACK BNP
Candidate | ST AIA-PACK BNP
Predicate
(K192380) | Differences | Differences
raise any
additional
safety
issues? |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------|
| General Information | | | | |
| Regulation # | 21 CFR 862.1117 | 21 CFR 862.1117 | Same | N/A |
| Regulation
Name | B-type natriuretic peptide test
system | B-type natriuretic peptide test
system | Same | N/A |
| Regulatory
Class | Class II | Class II | Same | N/A |
| Product Code | NBC | NBC | Same | N/A |
| 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. | 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. | Same | N/A |
Table 2 - Comparison Table of Subject Device to Predicate Device
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| Attributes | ST AIA-PACK BNP
Candidate | ST AIA-PACK BNP
Predicate
(K192380) | Differences | Differences
raise any
additional
safety
issues? |
|-------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-------------|-------------------------------------------------------------|
| Intended Use
Setting | For use on patients presenting to
the Emergency Department (ED). | For use on patients presenting to
the Emergency Department (ED). | Same | N/A |
Table 3 – Comparison Table of Technological Characteristics: Subject Device to Predicate Device
| Attributes | ST AIA-PACK BNP
Candidate | ST AIA-PACK BNP
Predicate
(K192380) | Differences | Differences
raise any
additional
safety issues? |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------|----------------------------------------------------------|
| Product Specifications | | | | |
| Instrument
Platform | Tosoh AIA Analyzer 2000 | Tosoh AIA Analyzer 2000 | Same | N/A |
| Detection
Method | Fluorescence | Fluorescence | Same | N/A |
| Assay
Principle | Immunoenzymometric Assay | Immunoenzymometric Assay | Same | N/A |
| Test
Principle | On-step sandwich assay | On-step sandwich assay | Same | N/A |
| Specimen
Types | Human EDTA plasma | Human EDTA plasma | Same | N/A |
| Specimen
Collection
Methodology | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques | Same | N/A |
| Analyte | Human B-type Natriuretic Peptide
(BNP) | Human B-type Natriuretic Peptide
(BNP) | Same | N/A |
| Measuring
Range | 4.0 – 2000 pg/mL | 4.0 – 2000 pg/mL | Same | N/A |
| Cut-off | 100 pg/mL | 100 pg/mL | Same | N/A |
| Manual &
Automated
Dilution | Manual dilution study had a
recovery value of 102% for 1:5
and 100% for 1:10 dilution.
On-board (automated) dilution
study had a recovery value of 95%
for 1:5 and 95% for 1:10 dilution. | Not previously cleared | Different | No |
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Image /page/8/Picture/0 description: The image shows the logo for Tosoh Bioscience. The logo consists of a red cross-like symbol with a white square in the center, followed by the text "TOSOH BIOSCIENCE" in black, sans-serif font. Below the cross symbol, the text "TOSOH" is written in a smaller font size. The logo is simple and modern, with a focus on the company name.
11. RISK MANAGEMENT
The Risk Management was performed in compliance with EN ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices. The Failure Modes Effects Analysis (FMEA) methodology was used to systematically identify, estimate, evaluate, control and report risks to ensure the development and maintenance of a safe and effective product that meets its intended use.
12. VERIFICATION AND VALIDATION SUMMARY
All verification and validation activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures, Testing verified all acceptance criteria were met. Verification of the changes did not raise any new items of safety and effectiveness.
13. SUMMARY OF PERFORMANCE DATA
Refer to Table 3 - Comparison Table of Technological Characteristics: Subject Device to Predicate Device for the summary results of the verification and validation testing.
14. SUBSTANTIAL EQUIVALENCE STATEMENT
All verification and validation testing conducted with the ST AIA-PACK BNP assay demonstrate that the modified device met the predetermined acceptance criteria, supporting the determination of substantial equivalence to the predicate device.
The modifications to the predicate device to provide a manual and automated dilution claim do not substantially change the device. The validation and verification data demonstrate that the performance of the ST AIA-PACK BNP assay to detect BNP is substantially equivalent to the predicate device.
15. CONCLUSION
Tosoh Bioscience, Inc. believes that the ST AIA-PACK BNP, is substantially equivalent in intended use and technological characteristics to the previously cleared ST AIA-PACK BNP (K192083). The ST AIA-PACK BNP, therefore, meets the Federal Food, Drug and Cosmetic Act criteria for 510(k) clearance of this device.