Cleared Special

K022901 - VITROS IMMUNODIAGNOSTIC PRODUCTS PROGES...

K022901 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS PROGES... by Ortho-Clinical Diagnostics. It is a Class 2 Chemistry device (product code JIS) cleared through the Special 510(k) pathway after a 24-day FDA review.

K022901 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
24d
Days
Class 2
Risk

K022901 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 27, 2002 after a review of 24 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.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K022901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date September 27, 2002
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K022901.
CALIBRATION PLASMA LMW HEPARIN
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WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
K030320 · Wako Chemicals USA, Inc. · Apr 2003
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K022682 · Randox Laboratories, Ltd. · Nov 2002
N LP(A) STANDARD SY
K013126 · Dade Behring, Inc. · Nov 2001
RANDOX LIPOPROTEIN
K011568 · Randox Laboratories, Ltd. · Sep 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · Beckman Coulter, Inc. · May 2001