Cleared Traditional

K133303 - PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device (FDA 510(k) Clearance)

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

K133303 · Bio-Analysis, Inc. · Chemistry device
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Nov 2014
Decision
390d
Days
Class 2
Risk

K133303 is an FDA 510(k) clearance for the PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Bio-Analysis, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on November 19, 2014 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bio-Analysis, Inc. devices

Submission Details

510(k) Number K133303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date November 19, 2014
Days to Decision 390 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 88d · This submission: 390d
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 235
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