Cleared Traditional

K192380 - ST AIA-PACK BNP

K192380 is an FDA 510(k) clearance for ST AIA-PACK BNP, manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 2 Chemistry device with product code NBC cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K192380 · Fujirebio Diagnostics,Inc. · Chemistry device
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Aug 2020
Decision
360d
Days
Class 2
Risk

K192380 is an FDA 510(k) clearance for the ST AIA-PACK BNP. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 24, 2020 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujirebio Diagnostics,Inc. devices

FDA 510(k) Submission Details - K192380

510(k) Number K192380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date August 24, 2020
Days to Decision 360 days
Submission Type Traditional
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
272d slower than avg
Panel avg: 88d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 40
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K192380.
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · Roche Diagnostics · Mar 2022
ST AIA-PACK BNP Assay
K211199 · Tosoh Bioscience, Inc. · Nov 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312 · Ortho-Clinical Diagnostics · Oct 2021
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
K092649 · Roche Diagnostics Corp. · Feb 2010
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
K082645 · Siemens Healthcare Diagnostics · Sep 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · Biosite Incorporated · Jun 2008