Cleared Traditional

K862428 - STRATUS TSH FLUOROMETRIC ENZYME IMMUNOA...

K862428 is the FDA 510(k) clearance for STRATUS TSH FLUOROMETRIC ENZYME IMMUNOA... by American Dade. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K862428 · American Dade · Chemistry device
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Aug 1986
Decision
54d
Days
Class 2
Risk

K862428 is an FDA 510(k) clearance for the STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 American Dade devices

Submission Details

510(k) Number K862428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date August 19, 1986
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 143
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K862428.
DSL-4800 ACTIVE TM TSH EIA SYSTEM
K864134 · Diagnostic Systems Laboratories, Inc. · Dec 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
K863859 · Hybritech, Inc. · Nov 1986
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
K862407 · Ciba Corning Diagnostics Corp. · Aug 1986
MICROMEDIC HTSH MONOCLONAL IRMA KIT
K860813 · Micromedic Systems · Jul 1986
TERUMO SENSIBEAD EIA TSH KIT
K861573 · Terumo Medical Corp. · Jun 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986