Cleared Special

K011463 - VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS

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

K011463 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K011463

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
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

JJX Device Classification - Class 1, General Controls

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 492
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K011463.
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430 · Bionostics, Inc. · Aug 2001
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
K012122 · Maine Standards Co. · 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
K011463 · VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
Download PDF FDA Summary Ortho-Clinical Diagno…