Cleared Traditional

K884276 - BECKMAN KAPPA LIGHT CHAIN REAGENT

K884276 is an FDA 510(k) clearance for BECKMAN KAPPA LIGHT CHAIN REAGENT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K884276 · Beckman Instruments, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
35d
Days
Class 2
Risk

K884276 is an FDA 510(k) clearance for the BECKMAN KAPPA 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 November 16, 1988 after a review of 35 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

FDA 510(k) Submission Details - K884276

510(k) Number K884276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date November 16, 1988
Days to Decision 35 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
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFH Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K884276.
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 LAMBDA LIGHT CHAIN REAGENT
K884597 · Beckman Instruments, Inc. · Dec 1988
N-IMMUNOGLOBULIN LIGHT CHAIN KIT
K880341 · Behring Diagnostics, Inc. · Feb 1988
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
K875164 · Kallestad Diag, A Div. of Erbamont, Inc. · Jan 1988
QUANTIMETRIC PLUS KAPPA REAGENT KIT
K855008 · Kallestad Laboratories, Inc. · Feb 1986