Cleared Traditional

K911899 - RAICHEM SPIA C4 REAGENT

K911899 is the FDA 510(k) clearance for RAICHEM SPIA C4 REAGENT by Reagents Applications, Inc.. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K911899 · Reagents Applications, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
13d
Days
Class 2
Risk

K911899 is an FDA 510(k) clearance for the RAICHEM SPIA C4 REAGENT. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on May 9, 1991 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 K911899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date May 09, 1991
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 104d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K911899.
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · Olympus America, Inc. · Oct 1996
QUANTEX C4
K962198 · Instrumentation Laboratory CO · Sep 1996
IL TEST COMPLEMENT 4
K920010 · Instrumentation Laboratory CO · Mar 1992
EZ COMPLEMENT C4
K892129 · Diamedix Corp. · Apr 1989
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621 · Technicon Instruments Corp. · Jul 1988
QM300 C4 ANTIBODY PACK
K872599 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987