Cleared Special

K072612 - ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647

K072612 is an FDA 510(k) clearance for ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code MOI cleared through the Special 510(k) pathway after a 39-day FDA review.

K072612 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
39d
Days
Class 2
Risk

K072612 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 3.... Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 26, 2007 after a review of 39 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 - K072612

510(k) Number K072612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date October 26, 2007
Days to Decision 39 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
66d faster than avg
Panel avg: 105d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

MOI Device Classification - Class 2, Special Controls

Product Code MOI System, Test, Immunological, Antigen, Tumor
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 - MOI System, Test, Immunological, Antigen, Tumor

All 27
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K072612.
Elecsys CA 15-3 II
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Elecsys CA 15-3 II
K171605 · Roche Diagnostics · Feb 2018
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
K100344 · Siemens Healthcare Diagnostics · Apr 2011
ARCHITECT CA 15-3 ASSAY
K042732 · Fujirebio Diagnostics,Inc. · Dec 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
K033036 · Beckman Coulter, Inc. · Feb 2004
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · Bayer Diagnostics Corp. · Nov 2002
K072612 · ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
Download PDF FDA Summary Beckman Coulter, Inc.