Cleared Traditional

K901674 - AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM

K901674 is an FDA 510(k) clearance for AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM, manufactured by Tosoh Corp.. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K901674 · Tosoh Corp. · Chemistry device
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May 1990
Decision
22d
Days
Class 1
Risk

K901674 is an FDA 510(k) clearance for the AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Tosoh Corp. (Washington, D.C., US). The FDA issued a Cleared decision on May 2, 1990 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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 Tosoh Corp. devices

FDA 510(k) Submission Details - K901674

510(k) Number K901674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date May 02, 1990
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 32
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K901674.
OPUS MAGNUM ANALYZER
K926131 · Pb Diagnostic Systems, Inc. · Jun 1993
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888 · Dynatech Laboratories, Inc. · Mar 1992
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991
DELFIA PLATE FLUOROMETER 1232
K895240 · Pharmacia, Inc. · Oct 1989
OPUS IMMUNOASSAY SYSTEM
K894159 · Pb Diagnostic Systems, Inc. · Aug 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · Baxter Healthcare Corp · Mar 1989