Cleared Special

K000566 - MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

K000566 is an FDA 510(k) clearance for MODOFICATION TO VITRO IMMUNODIAGNOSTIC ..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LTJ cleared through the Special 510(k) pathway after a 16-day FDA review.

K000566 · Ortho-Clinical Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
16d
Days
Class 2
Risk

K000566 is an FDA 510(k) clearance for the MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUN.... Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 9, 2000 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device 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 - K000566

510(k) Number K000566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date March 09, 2000
Days to Decision 16 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 105d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

LTJ Device Classification - Class 2, Special Controls

Product Code LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 Immunology devices follow this clearance model.

Regulatory Peers - LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers

All 33
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K000566.
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QUALISYS PSA IMMUNOASSAY
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VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
K984289 · Ortho-Clinical Diagnostics, Inc. · Mar 1999
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · Boehringer Mannheim Corp. · Oct 1998
K000566 · MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
Download PDF FDA Summary Ortho-Clinical Diagno…