Cleared Traditional

K892706 - SR1 (FSH) IMMUNOENZYMETRIC ASSAY

K892706 is the FDA 510(k) clearance for SR1 (FSH) IMMUNOENZYMETRIC ASSAY by Serono-Baker Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K892706 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Jun 1989
Decision
56d
Days
Class 1
Risk

K892706 is an FDA 510(k) clearance for the SR1 (FSH) IMMUNOENZYMETRIC ASSAY. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 56 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 Serono-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K892706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1989
Decision Date June 09, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 47
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K892706.
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · Hybritech, Inc. · Sep 1989
COAT-A-COUNT (TM) FSH IRMA
K893976 · Diagnostic Products Corp. · Aug 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · Ciba Corning Diagnostics Corp. · Dec 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988