Cleared Traditional

CONTACT-K APTT REAGENT (K834086) - FDA 510(k) Clearance

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

K834086 · Pacific Hemostasis · Microbiology device
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Feb 1984
Decision
67d
Days
Class 2
Risk

K834086 is an FDA 510(k) clearance for the CONTACT-K APTT REAGENT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.5425 - the FDA microbiology 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: 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 Pacific Hemostasis devices

Submission Details

510(k) Number K834086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date February 03, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
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 Microbiology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

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