Cleared Traditional

K953160 - OPUS T3

K953160 is the FDA 510(k) clearance for OPUS T3 by Behring Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K953160 · Behring Diagnostics, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
48d
Days
Class 2
Risk

K953160 is an FDA 510(k) clearance for the OPUS T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K953160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1995
Decision Date August 24, 1995
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 91
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K953160.
ACTIVE T3 RIA
K960550 · Diagnostic Systems Laboratories, Inc. · Mar 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557 · Sigma Diagnostics, Inc. · Jan 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · Bio-Rad Laboratories, Inc. · Jan 1996
IMX T3 ASSAY
K944808 · Organon Teknika Corp. · Dec 1994
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc. · Sep 1994
AIA-PACK TT3 ASSAY
K936229 · Tosoh Medics, Inc. · Jul 1994