Cleared Traditional

K001603 - REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)

K001603 is an FDA 510(k) clearance for REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT..., manufactured by Repromedix Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K001603 · Repromedix Corp. · Chemistry device
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Oct 2000
Decision
134d
Days
Class 2
Risk

K001603 is an FDA 510(k) clearance for the REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105). Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), 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 862.1700 - 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 - K001603

510(k) Number K001603 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.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 Chemistry devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 71
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