Cleared Traditional

K001607 - REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)

K001607 is an FDA 510(k) clearance for REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT..., manufactured by Repromedix Corp.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K001607 · Repromedix Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
134d
Days
Class 2
Risk

K001607 is an FDA 510(k) clearance for the REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104). Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Repromedix Corp. (Woburn, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Repromedix Corp. devices

FDA 510(k) Submission Details - K001607

510(k) Number K001607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2000
Decision Date October 05, 2000
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
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 119
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K001607.
CHIRON DIAGNOSTICS ACS: 180 FT3
K991692 · Chiron Diagnostics Corp. · Jun 1999
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
K991311 · Biocheck, Inc. · Jun 1999
AIA-PACK FT3 ASSAY
K991252 · Tosoh Medics, Inc. · May 1999
OPTICOAT T3 EIA KIT
K981824 · Biotecx Laboratories, Inc. · Dec 1998
ABBOTT ARCHITECT TOTAL T3
K983434 · Abbott Laboratories · Nov 1998
ABBOTT ARCHITECT FREE T3
K983439 · Abbott Laboratories · Nov 1998