Cleared Traditional

K860894 - BEHRING NEPHELOMETER SYSTEM

K860894 is the FDA 510(k) clearance for BEHRING NEPHELOMETER SYSTEM by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K860894 · Behring Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
36d
Days
Class 2
Risk

K860894 is an FDA 510(k) clearance for the BEHRING NEPHELOMETER SYSTEM. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on April 15, 1986 after a review of 36 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K860894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date April 15, 1986
Days to Decision 36 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
68d faster than avg
Panel avg: 104d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 51
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K860894.
WAKO IGG-HA
K923070 · Wako Chemicals USA, Inc. · Aug 1992
N PROTEIN STANDARD PLASMA (HUMAN)
K880356 · Behring Diagnostics, Inc. · Apr 1988
QM2/QM300 BUFFER AND DILUENT PACK
K871343 · Kallestad Diag, A Div. of Erbamont, Inc. · May 1987
LAS-R TEST PROGRAM
K771226 · Hyland Therapeutic Div., Travenol Laboratories · Jul 1977