Cleared Traditional

TSHK-NN RIA KIT (K860824) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860824 · Cis-Us, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
55d
Days
Class 2
Risk

K860824 is an FDA 510(k) clearance for the TSHK-NN RIA KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Cis-Us, Inc. (Lake Success, US). The FDA issued a Cleared decision on April 28, 1986 after a review of 55 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 Cis-Us, Inc. devices

Submission Details

510(k) Number K860824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date April 28, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
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 73
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K860824.
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · American Dade · Aug 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
ECHOCLONAL HTSH IRMA
K860288 · Bio-Rad · Apr 1986
TSH-IRMA COAT-A-COUNT KIT
K860054 · Diagnostic Products Corp. · Mar 1986
NML TSH IRMA
K854087 · Organon Teknika Corp. · Oct 1985