Cleared Traditional

K771078 - PHADEBAS T3 U TEST

K771078 is the FDA 510(k) clearance for PHADEBAS T3 U TEST by Pharmacia, Inc.. It is a Class 2 Immunology device (product code KHQ) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K771078 · Pharmacia, Inc. · Immunology device
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Jun 1977
Decision
12d
Days
Class 2
Risk

K771078 is an FDA 510(k) clearance for the PHADEBAS T3 U TEST. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1977 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1715 - the FDA immunology device 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K771078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1977
Decision Date June 27, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 104d · This submission: 12d
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 Immunology 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 K771078.
T-3 UPTAKE (SORBENT) KIT
K780525 · Amersham Corp. · May 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
AMES T-3 UPTAKE STRIP TEST
K772088 · Miles Laboratories, Inc. · Dec 1977
DATA-TOPE T3 UPTAKE PROCEDURE
K761281 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1977
SPAC TM T3 UPTAKE KIT
K770033 · Mallinckrodt Critical Care · Feb 1977
T-3 UPTAKE KIT
K760802 · Diagnostic Products Corp. · Oct 1976