Cleared Traditional

K011337 - ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) (FDA 510(k) Clearance)

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

K011337 · Accumetrics, Inc. · Hematology device
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Oct 2001
Decision
167d
Days
Class 2
Risk

K011337 is an FDA 510(k) clearance for the ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA). 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 October 16, 2001 after a review of 167 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Accumetrics, Inc. devices

Submission Details

510(k) Number K011337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date October 16, 2001
Days to Decision 167 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
54d slower than avg
Panel avg: 113d · This submission: 167d
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.