Cleared Traditional

K993441 - K-ASSAY ALPHA-1 AG

K993441 is the FDA 510(k) clearance for K-ASSAY ALPHA-1 AG by Kamiya Biomedical Co.. It is a Class 1 Immunology device (product code LKL) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K993441 · Kamiya Biomedical Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
43d
Days
Class 1
Risk

K993441 is an FDA 510(k) clearance for the K-ASSAY ALPHA-1 AG. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 43 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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K993441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date November 24, 1999
Days to Decision 43 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
61d faster than avg
Panel avg: 104d · This submission: 43d
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 K993441.
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
K964257 · Beckman Instruments, Inc. · Mar 1997
AL-ACID GLYCOPROTEIN RID KIT
K922417 · The Binding Site, Ltd. · Aug 1992
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · Reagents Applications, Inc. · Nov 1990
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · Technicon Instruments Corp. · Nov 1988
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · Unipath , Ltd. · Oct 1987