Cleared Traditional

AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K923021) - FDA 510(k) Clearance

Class I Hematology device.

K923021 · Tosoh Corp. · Hematology device
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Jul 1992
Decision
28d
Days
Class 1
Risk

K923021 is an FDA 510(k) clearance for the AIA-1200DX - 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 July 21, 1992 after a review of 28 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K923021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date July 21, 1992
Days to Decision 28 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 37
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K923021.
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · Baxter Healthcare Corp · Mar 1989
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
SYVA ADVANCE TM FLUOROMETER
K813146 · Syva Co. · Nov 1981
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579 · Abbott Laboratories · Nov 1980
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · Bio-Rad · Jul 1979