Cleared Traditional

K781905 - RIA KIT

K781905 is the FDA 510(k) clearance for RIA KIT by Kallestad Laboratories, Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K781905 · Kallestad Laboratories, Inc. · Chemistry device
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Jan 1979
Decision
51d
Days
Class 2
Risk

K781905 is an FDA 510(k) clearance for the RIA KIT, QUANTITOPE T3 UPTAKE. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 51 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K781905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1978
Decision Date January 03, 1979
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
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 54
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K781905.
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
RIA, T3 UPTAKE SOLID PHASE
K781662 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978
CLINIRIA T-3 UPTAKE TEST
K781180 · Miles Laboratories, Inc. · Aug 1978
T-3 UPTAKE (SORBENT) KIT
K780525 · Amersham Corp. · May 1978