Cleared Traditional

K001606 - REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

K001606 is an FDA 510(k) clearance for REPROBEAD TSH ENZYME IMMUNOASSAY REAGEN..., manufactured by Repromedix Corp.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K001606 · Repromedix Corp. · Chemistry device
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Oct 2000
Decision
134d
Days
Class 2
Risk

K001606 is an FDA 510(k) clearance for the REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107). Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), 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 862.1690 - 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 - K001606

510(k) Number K001606 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.

JLW Device Classification - Class 2, Special Controls

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 200
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