Cleared Abbreviated

K112603 - ACCESS HYBRITECH P2PSA QC ON THE ACCESS...

K112603 is the FDA 510(k) clearance for ACCESS HYBRITECH P2PSA QC ON THE ACCESS... by Beckman Coulter, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K112603 · Beckman Coulter, Inc. · Immunology device
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Nov 2011
Decision
58d
Days
Class 1
Risk

K112603 is an FDA 510(k) clearance for the ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K112603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date November 04, 2011
Days to Decision 58 days
Submission Type Abbreviated
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
46d faster than avg
Panel avg: 104d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

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