Cleared Traditional

K991065 - CARESIDE PT

K991065 is the FDA 510(k) clearance for CARESIDE PT by Careside, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K991065 · Careside, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 1999
Decision
117d
Days
Class 2
Risk

K991065 is an FDA 510(k) clearance for the CARESIDE PT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on July 26, 1999 after a review of 117 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 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 Careside, Inc. devices

Submission Details

510(k) Number K991065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1999
Decision Date July 26, 1999
Days to Decision 117 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
4d slower than avg
Panel avg: 113d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 95
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K991065.
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · Lifescan, Inc. · May 2001
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 2001
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
K992492 · Roche Diagnostics Corp. · Nov 1999
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
K972866 · International Technidyne Corp. · Sep 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · Instrumentation Laboratory CO · Jul 1998
MDA SIMPLASTIN HTF
K974566 · Organon Teknika Corp. · Feb 1998