Cleared Traditional

K860813 - MICROMEDIC HTSH MONOCLONAL IRMA KIT

K860813 is an FDA 510(k) clearance for MICROMEDIC HTSH MONOCLONAL IRMA KIT, manufactured by Micromedic Systems. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K860813 · Micromedic Systems · Chemistry device
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Jul 1986
Decision
132d
Days
Class 2
Risk

K860813 is an FDA 510(k) clearance for the MICROMEDIC HTSH MONOCLONAL IRMA KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Micromedic Systems (Horsham, US). The FDA issued a Cleared decision on July 14, 1986 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedic Systems devices

FDA 510(k) Submission Details - K860813

510(k) Number K860813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date July 14, 1986
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

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 203
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K860813.
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
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · American Dade · Aug 1986
V-TREND EIA TSH
K861918 · V-Tech, Inc. · Jul 1986
TSH IRMA KIT
K862249 · Pacific Biotech, Inc. · Jun 1986
TERUMO SENSIBEAD EIA TSH KIT
K861573 · Terumo Medical Corp. · Jun 1986