Cleared Traditional

K201312 - VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K201312 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
504d
Days
Class 2
Risk

K201312 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 4, 2021 after a review of 504 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K201312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date October 04, 2021
Days to Decision 504 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
416d slower than avg
Panel avg: 88d · This submission: 504d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03548909 Completed Observational Industry-sponsored

VITROS Immunodiagnostic Products NT-proBNP II

3246
Patients (actual)
25
Sites
Condition studied Heart Failure
Eligibility All sexes · 22 Years+
Principal investigator Robert Christenson, PhD
Sponsor Ortho-Clinical Diagnostics, Inc. (industry)
Started 2018-06-06 → Primary completion 2019-10-17
Primary outcome
Sensitivity and Specificity of the VITROS NT-proBNP II assay
Secondary outcome
Heart Failure Severity Assessment
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NBC Test, Natriuretic Peptide

All 44
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K201312.
Access BNP II
K252169 · Beckman Coulter, Inc. · Mar 2026
Alere NT-proBNP for Alinity i
K253539 · Axis-Shield Diagnostics, Ltd. · Feb 2026
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · Axis-Shield Diagnostics, Ltd. · Jan 2025
Access NT-proBNP
K232164 · Beckman Coulter, Inc. · Apr 2024
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265 · Siemens Healthcare Diagnostics, Inc. · Sep 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · Roche Diagnostics · Jul 2023