ST AIA-PACK BNP Assay

K211199 · Tosoh Bioscience, Inc. · NBC · Nov 8, 2021 · Clinical Chemistry

Device Facts

• Record ID: K211199
• Device Name: ST AIA-PACK BNP Assay
• Applicant: Tosoh Bioscience, Inc.
• Product Code: NBC · Clinical Chemistry
• Decision Date: Nov 8, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

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.

Device Story

Two-site immunoenzymometric assay for quantitative measurement of BNP in human K2EDTA plasma. Input: plasma sample in test cup. Process: BNP binds to monoclonal antibody on magnetic beads and enzyme-labeled monoclonal antibody; magnetic beads washed; incubated with fluorogenic substrate (4-methylumbelliferyl phosphate). Output: fluorescence signal proportional to BNP concentration. Used on Tosoh AIA System Analyzers in clinical settings. Healthcare providers use results as aid in heart failure diagnosis. Modification adds manual and automated 1:5 and 1:10 dilution claims to extend measuring interval for high-concentration specimens.

Clinical Evidence

Bench testing only; verification and validation activities performed to support the addition of a dilution claim; no clinical data required as fundamental technology is unchanged.

Technological Characteristics

In vitro diagnostic immunoassay; quantitative measurement of BNP; utilizes Tosoh AIA System analyzers; modification limited to dilution claim; fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative measurement of B-type natriuretic peptide (BNP) in human plasma to aid in diagnosis of congestive heart failure and risk stratification of patients with acute coronary syndromes and congestive heart failure.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• ST AIA-PACK BNP Assay (K192380)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K211199

B Applicant

Tosoh Bioscience, Inc.

C Proprietary and Established Names

ST AIA-PACK BNP Assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBC | Class II | 21 CFR 862.1117 - B-Type Natriuretic Peptide Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: The ST AIA-PACK BNP, K192380.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

- The change was for the addition of a dilution claim for the device.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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