Cleared Traditional

K902797 - OPUS TM T-UPTAKE TEST SYSTEM

K902797 is an FDA 510(k) clearance for OPUS TM T-UPTAKE TEST SYSTEM, manufactured by Pb Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K902797 · Pb Diagnostic Systems, Inc. · Chemistry device
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Jul 1990
Decision
34d
Days
Class 2
Risk

K902797 is an FDA 510(k) clearance for the OPUS TM T-UPTAKE TEST SYSTEM. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 34 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 Pb Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K902797

510(k) Number K902797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1990
Decision Date July 30, 1990
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K902797.
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
K911912 · Serono-Baker Diagnostics, Inc. · Sep 1991
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K911093 · Ciba Corning Diagnostics Corp. · Apr 1991
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990
FIAGEN T3 UPTAKE CATALOGUE #101-402
K895186 · Cyberfluor, Inc. · Nov 1989
EMIT T-UPTAKE ASSAY
K894145 · Syva Co. · Sep 1989
VENTREX COATED TUBE T3 UPTAKE
K891068 · Ventrex Laboratories, Inc. · Apr 1989