Cleared Traditional

K834209 - STRATUS THYROID UPTAKE FLUOROMETRIC

K834209 is an FDA 510(k) clearance for STRATUS THYROID UPTAKE FLUOROMETRIC, manufactured by American Dade. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K834209 · American Dade · Chemistry device
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Mar 1984
Decision
95d
Days
Class 2
Risk

K834209 is an FDA 510(k) clearance for the STRATUS THYROID UPTAKE FLUOROMETRIC. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 American Dade devices

FDA 510(k) Submission Details - K834209

510(k) Number K834209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date March 09, 1984
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 73
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K834209.
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · American Dade · Apr 1986
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · Terumo Medical Corp. · Sep 1984
T3 UPTAKE
K841927 · Syncor Intl. Corp. · Jun 1984
TRI-TUBE RIA
K840589 · Nuclear Medical Laboratories, Inc. · Mar 1984
ACA THYROXINE UPTAKE ANALYTICAL TEST
K833703 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984
MAGIC TM 125I T3 UPTAKE RADIOASSAY
K831613 · Corning Medical & Scientific · Aug 1983