Cleared Traditional

K931228 - PROGESTERONE RADIOIMMUNOASSAY KIT

K931228 is an FDA 510(k) clearance for PROGESTERONE RADIOIMMUNOASSAY KIT, manufactured by Immunotech Corp.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K931228 · Immunotech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
226d
Days
Class 1
Risk

K931228 is an FDA 510(k) clearance for the PROGESTERONE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Immunotech Corp. (Cedex 9 (France), FR). The FDA issued a Cleared decision on October 22, 1993 after a review of 226 days - an extended review cycle.

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 Immunotech Corp. devices

FDA 510(k) Submission Details - K931228

510(k) Number K931228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date October 22, 1993
Days to Decision 226 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 88d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

JLS Device Classification - Class 1, General Controls

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 40
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K931228.
IMMULITE PROGESTERONE
K944211 · Diagnostic Products Corp. · Dec 1994
IMMULITE PROGESTERONE
K935138 · Diagnostic Products Corp. · Jan 1994
SYNELISA PROGESTERONE
K933128 · Elias U.S.A., Inc. · Nov 1993
AIA-PACK(R) PROG ASSAY
K933269 · Tosoh Medics, Inc. · Oct 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
K933635 · Baxter Diagnostics, Inc. · Oct 1993
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955 · Ciba Corning Diagnostics Corp. · Aug 1993