Cleared Traditional

ACE T UPTAKE REAGENT TU CALIBRATORS (K981375) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981375 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Jun 1998
Decision
55d
Days
Class 2
Risk

K981375 is an FDA 510(k) clearance for the ACE T UPTAKE REAGENT TU CALIBRATORS. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on June 10, 1998 after a review of 55 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 Schiapparelli Biosystems, Inc. devices

Submission Details

510(k) Number K981375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date June 10, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
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 92
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K981375.
ELECSYS T-UPTAKE ASSAY
K961488 · Boehringer Mannheim Corp. · Jun 1996
CEDIA T UPTAKE ASSAY
K954807 · Boehringer Mannheim Corp. · Dec 1995
AXSYM(TM) T-UPTAKE
K934312 · Abbott Laboratories · Jun 1994
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · Roche Diagnostic Systems, Inc. · May 1993
VISTA THYROXINE UPTAKE ASSAY
K923676 · Syva Co. · Oct 1992
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990