Cleared Special

K212779 - Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (FDA 510(k) Clearance)

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

K212779 · Coagusense, Inc. · Hematology device
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Oct 2022
Decision
399d
Days
Class 2
Risk

K212779 is an FDA 510(k) clearance for the Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Coagusense, Inc. (Fremont, US). The FDA issued a Cleared decision on October 5, 2022 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coagusense, Inc. devices

Submission Details

510(k) Number K212779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2021
Decision Date October 05, 2022
Days to Decision 399 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 113d · This submission: 399d
Pathway characteristics
Modification to existing cleared device.

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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