Cleared Traditional

K000777 - SAMPLOK

K000777 is an FDA 510(k) clearance for SAMPLOK, manufactured by Itl Corporation Pty, Ltd.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K000777 · Itl Corporation Pty, Ltd. · Chemistry device
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Apr 2000
Decision
33d
Days
Class 2
Risk

K000777 is an FDA 510(k) clearance for the SAMPLOK. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Itl Corporation Pty, Ltd. (Rockville, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 33 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 Itl Corporation Pty, Ltd. devices

FDA 510(k) Submission Details - K000777

510(k) Number K000777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2000
Decision Date April 11, 2000
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 129
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