Cleared Traditional

K932084 - AIA-PACK E2 ASSAY

K932084 is the FDA 510(k) clearance for AIA-PACK E2 ASSAY by Tosoh Medics, Inc.. It is a Class 1 Chemistry device (product code CHP) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K932084 · Tosoh Medics, Inc. · Chemistry device
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Nov 1993
Decision
193d
Days
Class 1
Risk

K932084 is an FDA 510(k) clearance for the AIA-PACK E2 ASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on November 9, 1993 after a review of 193 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 K932084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1993
Decision Date November 09, 1993
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 31
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K932084.
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
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IMMULITE ESTRADIOL
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CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
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STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
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OPUS ESTRADIOL
K933066 · Pb Diagnostic Systems, Inc. · Sep 1993
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K931740 · Bio-Rad · Aug 1993