Cleared Traditional

K951635 - BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT

K951635 is an FDA 510(k) clearance for BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K951635 · Beckman Instruments, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
38d
Days
Class 2
Risk

K951635 is an FDA 510(k) clearance for the BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALI.... Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 - K951635

510(k) Number K951635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1995
Decision Date May 15, 1995
Days to Decision 38 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
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DEW Igg, Antigen, Antiserum, Control

All 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K951635.
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
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K955798 · Randox Laboratories, Ltd. · Apr 1996
BEHRING NEPHELOMETER II
K943997 · Behring Diagnostics, Inc. · Oct 1994
OT IGG SORBENT
K934324 · Organon Teknika Corp. · Apr 1994
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · Bio-Rad · Sep 1993