Cleared Special

K211199 - ST AIA-PACK BNP Assay

K211199 is an FDA 510(k) clearance for ST AIA-PACK BNP Assay, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code NBC cleared through the Special 510(k) pathway after a 200-day FDA review.

K211199 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
200d
Days
Class 2
Risk

K211199 is an FDA 510(k) clearance for the ST AIA-PACK BNP Assay. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on November 8, 2021 after a review of 200 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K211199

510(k) Number K211199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2021
Decision Date November 08, 2021
Days to Decision 200 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 89d · This submission: 200d
Pathway characteristics
Modification to existing cleared device.

NBC Device Classification - Class 2, Special Controls

Product Code NBC Test, Natriuretic Peptide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1117
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBC Test, Natriuretic Peptide

All 46
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K211199.
ADVIA Centaur® NT-proBNPII (PBNPII)
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Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · Roche Diagnostics · Jul 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · Roche Diagnostics · Mar 2022
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312 · Ortho-Clinical Diagnostics · Oct 2021
ST AIA-PACK BNP
K192380 · Fujirebio Diagnostics,Inc. · Aug 2020
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
K092649 · Roche Diagnostics Corp. · Feb 2010
K211199 · ST AIA-PACK BNP Assay
Download PDF FDA Summary Tosoh Bioscience, Inc.