Cleared Traditional

AIA-PACK(R) PROG ASSAY (K933269) - FDA 510(k) Clearance

Class I Chemistry device.

K933269 · Tosoh Medics, Inc. · Chemistry device
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Oct 1993
Decision
108d
Days
Class 1
Risk

K933269 is an FDA 510(k) clearance for the AIA-PACK(R) PROG ASSAY. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on October 22, 1993 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - 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 K933269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date October 22, 1993
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
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 - JLS Radioimmunoassay, Progesterone

All 56
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K933269.
ELECSYS PROGESTERONE ASSAY
K964841 · Boehringer Mannheim Corp. · Mar 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · bioMerieux, Inc. · Jan 1997
AXSYM PROGESTERONE
K955025 · Abbott Laboratories · Mar 1996
IMMULITE PROGESTERONE
K944211 · Diagnostic Products Corp. · Dec 1994
IMMULITE PROGESTERONE
K935138 · Diagnostic Products Corp. · Jan 1994
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992