Cleared Traditional

K894418 - RAICHEM(TM) SPIA(TM) IGA REAGENTS

K894418 is an FDA 510(k) clearance for RAICHEM(TM) SPIA(TM) IGA REAGENTS, manufactured by Reagents Applications, Inc.. The device is a Class 2 Chemistry device with product code CZP cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K894418 · Reagents Applications, Inc. · Chemistry device
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Aug 1989
Decision
16d
Days
Class 2
Risk

K894418 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) IGA REAGENTS. Classified as Iga, Antigen, Antiserum, Control (product code CZP), 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 866.5510 - 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

FDA 510(k) Submission Details - K894418

510(k) Number K894418 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
Combination Product No
PCCP Authorized No
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.

CZP Device Classification - Class 2, Special Controls

Product Code CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CZP Iga, Antigen, Antiserum, Control

All 48
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K894418.
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