Cleared Traditional

K993549 - BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR

K993549 is an FDA 510(k) clearance for BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY ..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code CFN cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K993549 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
105d
Days
Class 2
Risk

K993549 is an FDA 510(k) clearance for the BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULI.... Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K993549

510(k) Number K993549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1999
Decision Date February 01, 2000
Days to Decision 105 days
Submission Type Traditional
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
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFN Device Classification - Class 2, Special Controls

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 56
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K993549.
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
K012295 · The Binding Site, Ltd. · Aug 2001
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
K000701 · The Binding Site, Ltd. · Apr 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
K993547 · Beckman Coulter, Inc. · Feb 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993924 · Wako Chemicals USA, Inc. · Jan 2000
IGM MININEPH ANTISERUM
K981784 · The Binding Site, Ltd. · Dec 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
K982100 · The Binding Site, Ltd. · Dec 1999