Cleared Traditional

K944846 - AURAFLEX B2-MICROGLOBULIN

K944846 is an FDA 510(k) clearance for AURAFLEX B2-MICROGLOBULIN, manufactured by Organon Teknika Corp.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K944846 · Organon Teknika Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
263d
Days
Class 2
Risk

K944846 is an FDA 510(k) clearance for the AURAFLEX B2-MICROGLOBULIN. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 263 days - an extended review 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: 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K944846

510(k) Number K944846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1994
Decision Date June 20, 1995
Days to Decision 263 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
159d slower than avg
Panel avg: 104d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZG Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K944846.
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
K946068 · The Binding Site, Ltd. · Jan 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
K946069 · The Binding Site, Ltd. · Jan 1996
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
K946070 · The Binding Site, Ltd. · Jan 1996
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993