Cleared Traditional

K840853 - IMMPULSE TBC ASSAY REAGENTS

K840853 is the FDA 510(k) clearance for IMMPULSE TBC ASSAY REAGENTS by Paragon Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K840853 · Paragon Diagnostics, Inc. · Chemistry device
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Apr 1984
Decision
37d
Days
Class 2
Risk

K840853 is an FDA 510(k) clearance for the IMMPULSE TBC ASSAY REAGENTS. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Paragon Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 Paragon Diagnostics, Inc. devices

Submission Details

510(k) Number K840853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date April 01, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 59
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K840853.
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