Cleared Traditional

K991065 - CARESIDE PT

K991065 is an FDA 510(k) clearance for CARESIDE PT, manufactured by Careside, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K991065

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
Combination Product No
PCCP Authorized No
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.

GJS Device Classification - Class 2, Special Controls

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 112
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K991065.
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
K994006 · Avocet Medical, Inc. · Feb 2000
AVOCET ACUSURE SYSTEM
K991286 · Avocet Medical, Inc. · Nov 1999
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
DADE INNOVIN
K974343 · Dade Intl., Inc. · Jul 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · Instrumentation Laboratory CO · Jul 1998