Cleared Traditional

RAPID IMMUNO-ASSAY SYS (K840257) - FDA 510(k) Clearance

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

K840257 · Applied Polytechnology, Inc. · Chemistry device
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Apr 1984
Decision
87d
Days
Class 2
Risk

K840257 is an FDA 510(k) clearance for the RAPID IMMUNO-ASSAY SYS. Classified as Kit, Igg, Platelet Associated (product code LLG), Class II - Special Controls.

Submitted by Applied Polytechnology, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.5425 - 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 Applied Polytechnology, Inc. devices

Submission Details

510(k) Number K840257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date April 19, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 88d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLG Kit, Igg, Platelet Associated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.