Cleared Traditional

RAICHEM(TM) SPIA(TM) IGM REAGENTS (K894417) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894417 · Reagents Applications, Inc. · Chemistry device
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Aug 1989
Decision
16d
Days
Class 2
Risk

K894417 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) IGM REAGENTS. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on August 2, 1989 after a review of 16 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K894417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date August 02, 1989
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 32
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K894417.
IGM
K983132 · Abbott Laboratories · Nov 1998
QUANTEX IGM
K962201 · Instrumentation Laboratory CO · Sep 1996
TITAN GEL IMMUNOFIX CONTROLS
K871498 · Helena Laboratories · Apr 1987
TINA-QUANT(R) IGM
K862762 · Boehringer Mannheim Corp. · Sep 1986
ACA IMMUNOGLOBIN M TEST PACK
K812632 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981