Cleared Special

K994145 - VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS

K994145 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIS cleared through the Special 510(k) pathway after a 14-day FDA review.

K994145 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
14d
Days
Class 2
Risk

K994145 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTI.... Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 22, 1999 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 - K994145

510(k) Number K994145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date December 22, 1999
Days to Decision 14 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
75d faster than avg
Panel avg: 89d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 129
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K994145.
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K983640 · Beckman Coulter, Inc. · Dec 1998
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K970933 · Pointe Scientific, Inc., · May 1997
K994145 · VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
Download PDF FDA Summary Ortho-Clinical Diagno…