Cleared Traditional

K860924 - RAMP PROGESTURINE PDG ASSAY--48 TEST KIT

K860924 is an FDA 510(k) clearance for RAMP PROGESTURINE PDG ASSAY--48 TEST KIT, manufactured by Monoclonal Antibodies, Inc.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K860924 · Monoclonal Antibodies, Inc. · Chemistry device
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Jul 1986
Decision
113d
Days
Class 1
Risk

K860924 is an FDA 510(k) clearance for the RAMP PROGESTURINE PDG ASSAY--48 TEST KIT. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Monoclonal Antibodies, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 2, 1986 after a review of 113 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 Monoclonal Antibodies, Inc. devices

FDA 510(k) Submission Details - K860924

510(k) Number K860924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date July 02, 1986
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
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 41
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K860924.
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · Amersham Corp. · Apr 1988
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
K873431 · Serono Diagnostics, Inc. · Oct 1987
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · Amersham Corp. · Feb 1987
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · Immuchem Corp. · Feb 1986
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985