Cleared Traditional

K852247 - LASER CERULOPLASMIN KIT(CERULOPLASMIN R...

K852247 is the FDA 510(k) clearance for LASER CERULOPLASMIN KIT(CERULOPLASMIN R... by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code DDB) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K852247 · Behring Diagnostics, Inc. · Immunology device
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Jul 1985
Decision
48d
Days
Class 2
Risk

K852247 is an FDA 510(k) clearance for the LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS). Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on July 10, 1985 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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 K852247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1985
Decision Date July 10, 1985
Days to Decision 48 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
56d faster than avg
Panel avg: 104d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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 - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K852247.
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1989
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · Sigma Diagnostics, Inc. · Mar 1986
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · Kent Laboratories, Inc. · Nov 1985
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · Kallestad Laboratories, Inc. · Nov 1982
IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL
K812486 · Dako Corp. · Sep 1981
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
K801661 · J.T. Baker Chemical Co. · Sep 1980