Cleared Traditional

K884147 - IMMUNOCHEMICAL DETERMINATION OF IMMUNOG...

K884147 is the FDA 510(k) clearance for IMMUNOCHEMICAL DETERMINATION OF IMMUNOG... by Orion Diagnostica, Inc.. It is a Class 2 Chemistry device (product code DFT) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K884147 · Orion Diagnostica, Inc. · Chemistry device
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Oct 1988
Decision
24d
Days
Class 2
Risk

K884147 is an FDA 510(k) clearance for the IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 27, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5550 - the FDA in vitro diagnostics and chemistry 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 Diagnostica, Inc. devices

Submission Details

510(k) Number K884147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1988
Decision Date October 27, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Chemistry devices follow this clearance model.

Regulatory Peers - DFT Igm, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K884147.
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · Randox Laboratories, Ltd. · Apr 1996
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K901453 · Isolab, Inc. · Apr 1990
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · Reagents Applications, Inc. · Aug 1989
WAKO(TM) IGM-HA DIRECT
K880828 · Wako Chemicals USA, Inc. · Mar 1988
IMMUNOGLOBULINS M
K873871 · Unipath , Ltd. · Oct 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987