Cleared Traditional

K843395 - ENCORE TSH REAGENT

K843395 is an FDA 510(k) clearance for ENCORE TSH REAGENT, manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K843395 · Hybritech, Inc. · Chemistry device
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Oct 1984
Decision
43d
Days
Class 2
Risk

K843395 is an FDA 510(k) clearance for the ENCORE TSH REAGENT. 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 October 11, 1984 after a review of 43 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

FDA 510(k) Submission Details - K843395

510(k) Number K843395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1984
Decision Date October 11, 1984
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 200
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K843395.
TSH-STAT
K844583 · Nuclear Medical Laboratories, Inc. · Mar 1985
TERUMO SENSIBEAD EIA TSH KIT
K850376 · Terumo Medical Corp. · Mar 1985
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · Abbott Laboratories · Nov 1984
TSH QUIK RIA KIT
K843545 · Pacific Biotech, Inc. · Oct 1984
ACCUSCREEN TSH
K843281 · Neometrics, Inc. · Sep 1984
SUCROSEP THYROID STIMULATING HORMONE
K842593 · Boots-Celltech Diagnostics, Inc. · Sep 1984