Cleared Traditional

K984289 - VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CA...

K984289 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CA... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Immunology device (product code LTJ) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K984289 · Ortho-Clinical Diagnostics, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
101d
Days
Class 2
Risk

K984289 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRO.... 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 12, 1999 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K984289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1998
Decision Date March 12, 1999
Days to Decision 101 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 104d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K984289.
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · Bayer Corp. · Oct 2000
BAYER PSA ASSAY
K994221 · Bayer Corp. · Apr 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
K000566 · Ortho-Clinical Diagnostics, Inc. · Mar 2000
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · Boehringer Mannheim Corp. · Oct 1998
ELECSYS PSA, MODEL 2010
K982949 · Boehringer Mannheim Corp. · Oct 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · Diagnostic Systems Laboratories, Inc. · Aug 1998