Cleared Special

K011463 - VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE...

K011463 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE... by Ortho-Clinical Diagnostics. It is a Class 1 Chemistry device (product code JJX) cleared through the Special 510(k) pathway after a 30-day FDA review.

K011463 · Ortho-Clinical Diagnostics · Chemistry device
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Jun 2001
Decision
30d
Days
Class 1
Risk

K011463 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE 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 June 13, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K011463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date June 13, 2001
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K011463.
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561 · Ortho-Clinical Diagnostics · Aug 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430 · Bionostics, Inc. · Aug 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · Ortho-Clinical Diagnostics, Inc. · Jun 2001
VIGIL DNASE B CONTROL
K010693 · Beckman Coulter, Inc. · Apr 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · Beckman Coulter, Inc. · Mar 2001
ELECSYS HCG+B CALCHECK
K010237 · Roche Diagnostics Corp. · Feb 2001