Cleared Traditional

K960550 - ACTIVE T3 RIA

K960550 is an FDA 510(k) clearance for ACTIVE T3 RIA, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K960550 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
27d
Days
Class 2
Risk

K960550 is an FDA 510(k) clearance for the ACTIVE T3 RIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on March 6, 1996 after a review of 27 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 Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K960550

510(k) Number K960550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1996
Decision Date March 06, 1996
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K960550.
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
K961236 · United Biotech, Inc. · May 1996
ACCESS FREE T3 ASSAY
K960913 · Bio-Rad Laboratories, Inc. · Mar 1996
T-3 MICROWELL EIA MODEL 7013
K960412 · Biomerica, 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
OPUS T3
K953160 · Behring Diagnostics, Inc. · Aug 1995