Cleared Traditional

K883745 - IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES

K883745 is an FDA 510(k) clearance for IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883745 · Diagnostic Products Corp. · Chemistry device
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Nov 1988
Decision
90d
Days
Class 1
Risk

K883745 is an FDA 510(k) clearance for the IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K883745

510(k) Number K883745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1988
Decision Date November 30, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 67
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K883745.
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884708 · Cyberfluor, Inc. · Jan 1989
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · Ciba Corning Diagnostics Corp. · Dec 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · Binax, Inc. · Oct 1988
PHASE II FSH KIT
K883279 · Vitek Systems, Inc. · Sep 1988
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
K881142 · Amersham Corp. · Jul 1988