Cleared Traditional

K932084 - AIA-PACK E2 ASSAY

K932084 is an FDA 510(k) clearance for AIA-PACK E2 ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K932084

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.

CHP Device Classification - Class 1, General Controls

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 42
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
K933464 · Baxter Diagnostics, Inc. · Oct 1993
OPUS ESTRADIOL
K933066 · Pb Diagnostic Systems, Inc. · Sep 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993