Cleared Traditional

K983895 - IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MI...

K983895 is the FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MI... by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K983895 · Beckman Coulter, Inc. · Immunology device
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Nov 1998
Decision
22d
Days
Class 2
Risk

K983895 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - 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: 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K983895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1998
Decision Date November 25, 1998
Days to Decision 22 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
82d faster than avg
Panel avg: 104d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 - JZG System, Test, Beta-2-microglobulin Immunological

All 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K983895.
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
K993711 · Bayer Corp. · Dec 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · Olympus America, Inc. · May 1999
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · Boehringer Mannheim Corp. · Oct 1998
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · Beckman Instruments, Inc. · Nov 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
K964767 · R&D Systems, Inc. · May 1997