Cleared Traditional

K884597 - BECKMAN LAMBDA LIGHT CHAIN REAGENT

K884597 is an FDA 510(k) clearance for BECKMAN LAMBDA 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 55-day FDA review.

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

FDA 510(k) Submission Details - K884597

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.

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 K884597.
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