Cleared Traditional

K894761 - TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

K894761 is the FDA 510(k) clearance for TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT by Hybritech, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K894761 · Hybritech, Inc. · Chemistry device
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Sep 1989
Decision
48d
Days
Class 1
Risk

K894761 is an FDA 510(k) clearance for the TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 48 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 Hybritech, Inc. devices

Submission Details

510(k) Number K894761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date September 13, 1989
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 46
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K894761.
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640 · Medix Biotech, Inc. · Jan 1990
MILENIA(TM) FSH (MKFS1,5)
K895005 · Diagnostic Products Corp. · Oct 1989
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 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