Cleared Traditional

BECKMAN LAMBDA LIGHT CHAIN REAGENT (K884597) - FDA 510(k) Clearance

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

K884597 · Beckman Instruments, Inc. · Immunology device
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Dec 1988
Decision
55d
Days
Class 2
Risk

K884597 is an FDA 510(k) clearance for the BECKMAN LAMBDA LIGHT CHAIN REAGENT. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 6, 1988 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 K884597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date December 06, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 104d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 19
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K884597.
Diazyme Human Kappa Free Light Chain Assay
K181438 · Diazyme Laboratories, Inc. · Jun 2018
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
K964260 · Beckman Instruments, Inc. · Feb 1997
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902484 · Beckman Instruments, Inc. · Jun 1990
BECKMAN KAPPA LIGHT CHAIN REAGENT
K884276 · Beckman Instruments, Inc. · Nov 1988
N-IMMUNOGLOBULIN LIGHT CHAIN KIT
K880341 · Behring Diagnostics, Inc. · Feb 1988
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
K842470 · Miles Laboratories, Inc. · Aug 1984