Cleared Abbreviated

K111952 - ACCESS FOLATE CALIBRATORS ON THE ACCESS...

K111952 is the FDA 510(k) clearance for ACCESS FOLATE CALIBRATORS ON THE ACCESS... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 39-day FDA review.

K111952 · Beckman Coulter, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
39d
Days
Class 2
Risk

K111952 is an FDA 510(k) clearance for the ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 39 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. 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 K111952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2011
Decision Date August 19, 2011
Days to Decision 39 days
Submission Type Abbreviated
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
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 145
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