Cleared Traditional

K964791 - B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K964791 is an FDA 510(k) clearance for B2 MICROGLOBULIN ASSAY FOR THE TECHNICO..., manufactured by Bayer Corp.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K964791 · Bayer Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
181d
Days
Class 2
Risk

K964791 is an FDA 510(k) clearance for the B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC.... Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on May 29, 1997 after a review of 181 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 Bayer Corp. devices

FDA 510(k) Submission Details - K964791

510(k) Number K964791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date May 29, 1997
Days to Decision 181 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
76d slower than avg
Panel avg: 105d · This submission: 181d
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 46
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K964791.
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
N LATEX B2-MICROGLOBULIN REAGENT
K955596 · Behring Diagnostics, Inc. · Oct 1996
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