Cleared Traditional

K141427 - ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (FDA 510(k) Clearance)

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

K141427 · Accumetrics, Inc. · Hematology device
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Jul 2015
Decision
420d
Days
Class 2
Risk

K141427 is an FDA 510(k) clearance for the ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Accumetrics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 24, 2015 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology 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 Hematology submissions.

View all Accumetrics, Inc. devices

Submission Details

510(k) Number K141427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2014
Decision Date July 24, 2015
Days to Decision 420 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
307d slower than avg
Panel avg: 113d · This submission: 420d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 Hematology devices follow this clearance model.