Cleared Traditional

K870520 - TANDEM-M FSH IMMUNOENZYMETRIC ASSAY

K870520 is the FDA 510(k) clearance for TANDEM-M FSH IMMUNOENZYMETRIC ASSAY by Hybritech, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K870520 · Hybritech, Inc. · Chemistry device
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Mar 1987
Decision
32d
Days
Class 1
Risk

K870520 is an FDA 510(k) clearance for the TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY. 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 March 10, 1987 after a review of 32 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 K870520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1987
Decision Date March 10, 1987
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K870520.
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · Nichols Institute Diagnostics · Apr 1988
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · American Dade · Oct 1987
MICROMEDIC COMBOSTAT LH/FSH KIT
K872309 · Micromedic Systems · Jul 1987
TERUMO SENSIBEAD EIA FSH KIT
K863928 · Terumo Medical Corp. · Dec 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678 · Nichols Institute Diagnostics · Oct 1986
DELFIA (TM) HFSH KIT
K862043 · Lkb Instruments, Inc. · Jun 1986