Cleared Traditional

K800170 - AMES RIALYZE - UPTAKE CHROM. TUBES

K800170 is the FDA 510(k) clearance for AMES RIALYZE - UPTAKE CHROM. TUBES by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K800170 · Miles Laboratories, Inc. · Chemistry device
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Feb 1980
Decision
19d
Days
Class 2
Risk

K800170 is an FDA 510(k) clearance for the AMES RIALYZE - UPTAKE CHROM. TUBES. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 19 days - a notably fast clearance cycle.

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: 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K800170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1980
Decision Date February 13, 1980
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K800170.
ANALYTE T3 UPTAKE
K802246 · Technicon Instruments Corp. · Oct 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · Abbott Laboratories · Jun 1980
VENTRE/SEP T3 UPTAKE RADIOASSAY
K800165 · Ventrex Laboratories, Inc. · Feb 1980
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM
K792662 · Micromedic Systems · Jan 1980
T3 UPTAKE (T3U) REAGENTS
K792607 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1980
T-3 UPTAKE (MAA) KIT
K790461 · Amersham Corp. · May 1979