Cleared Traditional

TIPSEP-TBG ASSAY (K861735) - FDA 510(k) Clearance

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

K861735 · Nuclear Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
38d
Days
Class 2
Risk

K861735 is an FDA 510(k) clearance for the TIPSEP-TBG ASSAY. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Troy, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1685 - 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 Nuclear Diagnostics, Inc. devices

Submission Details

510(k) Number K861735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date June 13, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 - CEE Radioimmunoassay, Thyroxine-binding Globulin

Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K861735.
ENZYMUN TEST(R) TBK
K896991 · Boehringer Mannheim Corp. · Mar 1990
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658 · Technicon Instruments Corp. · Dec 1987
ENZYMUN TEST TBG
K862109 · Boehringer Mannheim Corp. · Jun 1986
RIA PHASE TBG
K800204 · Boehringer Mannheim Corp. · Mar 1980
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134 · Bio-Rad · Jul 1976