Cleared Traditional

K904175 - RAICHEM (TM) SPIA (TM) - ACID GLYCOPROT...

K904175 is the FDA 510(k) clearance for RAICHEM (TM) SPIA (TM) - ACID GLYCOPROT... by Reagents Applications, Inc.. It is a Class 1 Immunology device (product code LKL) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K904175 · Reagents Applications, Inc. · Immunology device
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Nov 1990
Decision
63d
Days
Class 1
Risk

K904175 is an FDA 510(k) clearance for the RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5420 - 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K904175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date November 13, 1990
Days to Decision 63 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
41d faster than avg
Panel avg: 104d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

Devices cleared under the same product code (LKL) and FDA review panel - the closest regulatory comparables to K904175.
K-ASSAY ALPHA-1 AG
K993441 · Kamiya Biomedical Co. · Nov 1999
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
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K922417 · The Binding Site, Ltd. · Aug 1992
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · Technicon Instruments Corp. · Nov 1988
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · Unipath , Ltd. · Oct 1987
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960 · Kent Laboratories, Inc. · Jul 1983