Cleared Traditional

K860138 - NO. 615 DETERMINATION OF CERULOPLASMIN ...

K860138 is the FDA 510(k) clearance for NO. 615 DETERMINATION OF CERULOPLASMIN ... by Sigma Diagnostics, Inc.. It is a Class 2 Immunology device (product code DDB) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K860138 · Sigma Diagnostics, Inc. · Immunology device
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Mar 1986
Decision
73d
Days
Class 2
Risk

K860138 is an FDA 510(k) clearance for the NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 28, 1986 after a review of 73 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K860138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date March 28, 1986
Days to Decision 73 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
31d faster than avg
Panel avg: 104d · This submission: 73d
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 K860138.
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · Beckman Instruments, Inc. · Apr 1997
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
K913668 · The Binding Site, Ltd. · Dec 1991
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1989
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · Kent Laboratories, Inc. · Nov 1985
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · Behring Diagnostics, Inc. · Jul 1985
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · Kallestad Laboratories, Inc. · Nov 1982