Cleared Abbreviated

HANDHELD BASE UNIT (K072920) - FDA 510(k) Clearance

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K072920 · Roche Diagnostics Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
108d
Days
Class 2
Risk

K072920 is an FDA 510(k) clearance for the HANDHELD BASE UNIT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2008 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K072920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2007
Decision Date January 31, 2008
Days to Decision 108 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 113d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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.

Regulatory Peers - GJS Test, Time, Prothrombin

All 126
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