Cleared Traditional

K790581 - CHROMATOGRAPHY TUBES

K790581 is the FDA 510(k) clearance for CHROMATOGRAPHY TUBES by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K790581 · Miles Laboratories, Inc. · Chemistry device
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May 1979
Decision
49d
Days
Class 2
Risk

K790581 is an FDA 510(k) clearance for the CHROMATOGRAPHY TUBES. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 K790581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date May 15, 1979
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 91
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K790581.
VENTRE/SEP T3 TEST SET
K791588 · Ventrex Laboratories, Inc. · Sep 1979
QUANTIMUNE T-3 FIA
K790960 · Bio-Rad · Aug 1979
RIA, TEST SET CENTRIA T3
K790908 · Ventrex Laboratories, Inc. · Jun 1979
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978
T3 RIA
K771623 · Hoffmann-La Roche, Inc. · Sep 1977
REAGENT, T-3 UPTAKE
K770738 · G.D. Searle and Co. · Jun 1977