Cleared Traditional

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT (K973813) - FDA 510(k) Clearance

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

K973813 · Beckman Instruments, Inc. · Immunology device
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Nov 1997
Decision
44d
Days
Class 2
Risk

K973813 is an FDA 510(k) clearance for the IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 44 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 Instruments, Inc. devices

Submission Details

510(k) Number K973813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1997
Decision Date November 20, 1997
Days to Decision 44 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
60d faster than avg
Panel avg: 104d · This submission: 44d
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 17
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K973813.
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · Olympus America, Inc. · May 1999
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895 · Beckman Coulter, Inc. · Nov 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · Boehringer Mannheim Corp. · Oct 1998
N LATEX B2-MICROGLOBULIN REAGENT
K955596 · Behring Diagnostics, Inc. · Oct 1996
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994