Cleared Traditional

AMICON ULTRAFILTRATION MEMBRANES CMII (K810810) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810810 · Amicon, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
24d
Days
Class 2
Risk

K810810 is an FDA 510(k) clearance for the AMICON ULTRAFILTRATION MEMBRANES CMII. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Amicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 24 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amicon, Inc. devices

Submission Details

510(k) Number K810810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date April 17, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHX System, Test, Carcinoembryonic Antigen
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 Chemistry devices follow this clearance model.

Regulatory Peers - DHX System, Test, Carcinoembryonic Antigen

All 27
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K810810.
Access CEA
K223921 · Beckman Coulter, Inc. · Sep 2023
VITROS Immunodiagnostic Products CEA Reagent Pack
K231517 · Ortho-Clinical Diagnostics · Aug 2023
ADVIA Centaur CEA Assay
K200215 · Siemens Healthcare Disgnostics, Inc. · Apr 2020
VIDAS CEA (S) ASSAY
K080194 · bioMerieux, Inc. · Oct 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · Dade Behring, Inc. · Jun 2008
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
K031270 · Beckman Coulter, Inc. · May 2003