Cleared Traditional

K013900 - VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMI...

K013900 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMI... by Ortho-Clinical Diagnostics. It is a Class 1 Toxicology device (product code JJX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K013900 · Ortho-Clinical Diagnostics · Toxicology device
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Dec 2001
Decision
28d
Days
Class 1
Risk

K013900 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K013900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date December 21, 2001
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K013900.
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K020369 · Roche Diagnostics Corp. · Mar 2002
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · Bionostics, Inc. · Oct 2001
N LP(A) CONTROL SY
K013130 · Dade Behring, Inc. · Oct 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561 · Ortho-Clinical Diagnostics · Aug 2001