Cleared Traditional

K930454 - BOEHRINGER MANNHEIM COAGUCHEK SYSTEM

K930454 is an FDA 510(k) clearance for BOEHRINGER MANNHEIM COAGUCHEK SYSTEM, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K930454 · Boehringer Mannheim Corp. · Hematology device
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Aug 1993
Decision
190d
Days
Class 2
Risk

K930454 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM COAGUCHEK SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 5, 1993 after a review of 190 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 - K930454

510(k) Number K930454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1993
Decision Date August 05, 1993
Days to Decision 190 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
77d slower than avg
Panel avg: 113d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 119
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K930454.
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · R & D Batteries, Inc. · Dec 1993
CA-1000 AUTOMATED COAGULATION ANALYZER
K931149 · Toa Medical Electronics USA, Inc. · Nov 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · Baxter Diagnostics, Inc. · Sep 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
K930849 · Organon Teknika Corp. · Apr 1993
COAGULATION CONTROL CONTAINING HEMOGLOBIN
K925340 · Analytical Control Systems, Inc. · Mar 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · Helena Laboratories · Feb 1993