Cleared Traditional

K875081 - IMMPULSE T4 ASSAY REAGENTS

K875081 is the FDA 510(k) clearance for IMMPULSE T4 ASSAY REAGENTS by Sclavo, Inc.. It is a Class 2 Toxicology device (product code CDX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K875081 · Sclavo, Inc. · Toxicology device
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Feb 1988
Decision
64d
Days
Class 2
Risk

K875081 is an FDA 510(k) clearance for the IMMPULSE T4 ASSAY REAGENTS. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1700 - the FDA toxicology 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 Sclavo, Inc. devices

Submission Details

510(k) Number K875081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date February 11, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 Toxicology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K875081.
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475 · Baxter Healthcare Corp · Jun 1990
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K894575 · Technicon Instruments Corp. · Oct 1989
DELFIA THYROXINE (T4) KIT
K883559 · Pharmacia, Inc. · Dec 1988
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · Ciba Corning Diagnostics Corp. · Jul 1987
DELFIA(TM) THYROXINE (T4) KIT
K871303 · Lkb Instruments, Inc. · Jun 1987
MICROMEDIC NEONATAL T4 KIT
K871008 · Micromedic Systems · May 1987