Cleared Traditional

K863859 - TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THY...

K863859 is the FDA 510(k) clearance for TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THY... by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K863859 · Hybritech, Inc. · Chemistry device
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Nov 1986
Decision
49d
Days
Class 2
Risk

K863859 is an FDA 510(k) clearance for the TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 1986 after a review of 49 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 Hybritech, Inc. devices

Submission Details

510(k) Number K863859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date November 21, 1986
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 145
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K863859.
TSH MAB IRMA
K864839 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT
K864133 · Diagnostic Systems Laboratories, Inc. · Dec 1986
DSL-4800 ACTIVE TM TSH EIA SYSTEM
K864134 · Diagnostic Systems Laboratories, Inc. · Dec 1986
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
K862407 · Ciba Corning Diagnostics Corp. · Aug 1986
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · American Dade · Aug 1986
MICROMEDIC HTSH MONOCLONAL IRMA KIT
K860813 · Micromedic Systems · Jul 1986