Cleared Special

TPSA FLEX REAGENT CARTRIDGE (K031343) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031343 · Dade Behring, Inc. · Immunology device
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May 2003
Decision
16d
Days
Class 2
Risk

K031343 is an FDA 510(k) clearance for the TPSA FLEX REAGENT CARTRIDGE. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 15, 2003 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.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K031343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2003
Decision Date May 15, 2003
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
88d faster than avg
Panel avg: 104d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K031343.
Atellica IM Total PSA II (tPSAII)
K251630 · Siemens Healthcare Diagnostics, Inc. · Jan 2026
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · Dade Behring, Inc. · Feb 2001
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · Boehringer Mannheim Corp. · Oct 1998
ELECSYS PSA, MODEL 2010
K982949 · Boehringer Mannheim Corp. · Oct 1998