Cleared Traditional

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103) - FDA 510(k) Clearance

Class I Chemistry device.

K971103 · Tosoh Medics, Inc. · Chemistry device
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Jun 1997
Decision
93d
Days
Class 1
Risk

K971103 is an FDA 510(k) clearance for the AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Tosoh Medics, Inc. devices

Submission Details

510(k) Number K971103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date June 27, 1997
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
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 K971103.
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
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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