Cleared Traditional

K962571 - COAGUCHEK PST SYSTEM

K962571 is an FDA 510(k) clearance for COAGUCHEK PST SYSTEM, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K962571 · Boehringer Mannheim Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
295d
Days
Class 2
Risk

K962571 is an FDA 510(k) clearance for the COAGUCHEK PST SYSTEM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 295 days - an extended review cycle.

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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K962571

510(k) Number K962571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date April 22, 1997
Days to Decision 295 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
182d slower than avg
Panel avg: 113d · This submission: 295d
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 100
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K962571.
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · Instrumentation Laboratory CO · Jul 1998
MDA SIMPLASTIN HTF
K974566 · Organon Teknika Corp. · Feb 1998
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · Sigma Diagnostics, Inc. · Oct 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · International Technidyne Corp. · Mar 1997
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · Nova Biomedical Corp. · Jun 1996
THROMBOPLASTIN-LI REAGENT
K951820 · Helena Laboratories · Oct 1995