Cleared Traditional

K153128 - Kolplast Cervical Sample Collection Kit (FDA 510(k) Clearance)

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

K153128 · Kolplast CI SA · Pathology device
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Jan 2017
Decision
442d
Days
Class 2
Risk

K153128 is an FDA 510(k) clearance for the Kolplast Cervical Sample Collection Kit. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Kolplast CI SA (Itupeva- Sp, BR). The FDA issued a Cleared decision on January 13, 2017 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 884.4530 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Kolplast CI SA devices

Submission Details

510(k) Number K153128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2015
Decision Date January 13, 2017
Days to Decision 442 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 77d · This submission: 442d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Pathology devices follow this clearance model.