Cleared Traditional

K972720 - FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)

K972720 is an FDA 510(k) clearance for FOLLICLE STIMULATING HORMONE (FSH) MICR..., manufactured by Monobind. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K972720 · Monobind · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
43d
Days
Class 1
Risk

K972720 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300). Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on September 2, 1997 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Monobind devices

FDA 510(k) Submission Details - K972720

510(k) Number K972720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1997
Decision Date September 02, 1997
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 69
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K972720.
ONE STEP FSH MENOPAUSAL TEST
K052662 · Ind Diagnostic, Inc. · Nov 2005
MOMENTS MENOPAUSE CHECK, MODEL 9113
K043599 · Phamatech, Inc. · Feb 2005
FSH MENOPAUSE PREDICTOR TEST
K041165 · ACON Laboratories, Inc. · Jun 2004
SEALITE SCIENCES AQUALITE FSH
K970085 · Sealite Sciences, Inc. · Feb 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
K964720 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996