Cleared Traditional

K935081 - DIRECTDRAW SUPERSERUM-MINI

K935081 is the FDA 510(k) clearance for DIRECTDRAW SUPERSERUM-MINI by International Technidyne Corp.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K935081 · International Technidyne Corp. · Chemistry device
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Jan 1994
Decision
78d
Days
Class 2
Risk

K935081 is an FDA 510(k) clearance for the DIRECTDRAW SUPERSERUM-MINI. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - 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 International Technidyne Corp. devices

Submission Details

510(k) Number K935081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1993
Decision Date January 11, 1994
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 104
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K935081.
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