Cleared Traditional

K862671 - MICROALBUMINURIA ASSAY

K862671 is an FDA 510(k) clearance for MICROALBUMINURIA ASSAY, manufactured by Orion Corp.. The device is a Class 2 Immunology device with product code DCF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K862671 · Orion Corp. · Immunology device
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Sep 1986
Decision
66d
Days
Class 2
Risk

K862671 is an FDA 510(k) clearance for the MICROALBUMINURIA ASSAY. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on September 18, 1986 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5040 - 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 Orion Corp. devices

FDA 510(k) Submission Details - K862671

510(k) Number K862671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date September 18, 1986
Days to Decision 66 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
39d faster than avg
Panel avg: 105d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K862671.
QM300 ALBUMIN ANTIBODY PACK
K881126 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988
ALBUMIN IN SERUM
K873862 · Unipath , Ltd. · Oct 1987
ALBUMIN IN URINE
K873861 · Unipath , Ltd. · Oct 1987
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
K851285 · Cooper Biomedical, Inc. · Jun 1985
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM
K812496 · Dako Corp. · Sep 1981
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
K802404 · Ortho Diagnostics, Inc. · Oct 1980